Vaccines and Global Health: The Week in Review :: 27 November 2021

Vaccines and Global Health: The Week in Review is a weekly digest  summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated with the current issue date

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy

COVID – Omicron VOC [Variant of Concern]

COVID – Omicron VOC [Variant of Concern]

Coronavirus pandemic
WHO calls for balanced response to new virus variant
Growing evidence that Omicron has spread to Europe
Donato Paolo Mancini in London
Financial Times, 27 Nov 2021
The World Health Organization has called for a balanced global response to the Omicron coronavirus variant, saying countries which report cases of the new strain should not be penalised, as the South African scientists behind its discovery prepare to ship samples to labs worldwide.

The discovery of a new, highly mutated coronavirus variant in Botswana earlier this month has alarmed global health officials, as it appears to be behind a surge in cases in South Africa. The so-called Omicron variant displays preliminary characteristics that suggest it is able to reinfect patients and evade vaccines. It is not yet known whether it worsens symptoms.

A number of countries have imposed severe travel restrictions on the southern African region. Switzerland has also restricted travel from Israel, Hong Kong and Belgium, where two cases of the variant have been confirmed…

“We have countries that are reporting this information and we don’t want them to be further stigmatised,” Maria Van Kerkhove, the Covid-19 technical lead at WHO, told the Financial Times. “There needs to be a balance in the response.”

Asked whether travel bans were justified, Van Kerkhove said countries should increase surveillance for this variant and others, increase testing capacity and do “intelligent sequencing” that was “more geographically representative, covering more countries, and strategically testing, not just more, but strategic locations”. “

“We need people to have a measured approach to risk,” she said. “Delta is [still] circulating around the world and killing people around the world. We can’t forget how many people are infected with Delta.”…

Van Kerkhove stressed the WHO did not want people to panic, and that “there are already sharing agreements in place where the virus can be shared, so scientists can collaborate in real time” on studying the effect of vaccines and immune responses. Results were expected in two to three weeks at earliest, she said.

Van Kerkhove said this “could be” a December 2019/January 2020 moment, when the world first learned of the coronavirus outbreak in Wuhan, China.

“South Africa presented to [the WHO] this week. We acted fast,” she said. “No regrets.”

 

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Classification of Omicron (B.1.1.529): SARS-CoV-2 Variant of Concern – WHO
26 November 2021 Statement
The Technical Advisory Group on SARS-CoV-2 Virus Evolution (TAG-VE) is an independent group of experts that periodically monitors and evaluates the evolution of SARS-CoV-2 and assesses if specific mutations and combinations of mutations alter the behaviour of the virus. The TAG-VE was convened on 26 November 2021 to assess the SARS-CoV-2 variant: B.1.1.529.

The B.1.1.529 variant was first reported to WHO from South Africa on 24 November 2021. The epidemiological situation in South Africa has been characterized by three distinct peaks in reported cases, the latest of which was predominantly the Delta variant. In recent weeks, infections have increased steeply, coinciding with the detection of B.1.1.529 variant. The first known confirmed B.1.1.529 infection was from a specimen collected on 9 November 2021.

This variant has a large number of mutations, some of which are concerning. Preliminary evidence suggests an increased risk of reinfection with this variant, as compared to other VOCs. The number of cases of this variant appears to be increasing in almost all provinces in South Africa. Current SARS-CoV-2 PCR diagnostics continue to detect this variant. Several labs have indicated that for one widely used PCR test, one of the three target genes is not detected (called S gene dropout or S gene target failure) and this test can therefore be used as marker for this variant, pending sequencing confirmation. Using this approach, this variant has been detected at faster rates than previous surges in infection, suggesting that this variant may have a growth advantage.

There are a number of studies underway and the TAG-VE will continue to evaluate this variant. WHO will communicate new findings with Member States and to the public as needed.

Based on the evidence presented indicative of a detrimental change in COVID-19 epidemiology, the TAG-VE has advised WHO that this variant should be designated as a VOC, and the WHO has designated B.1.1.529 as a VOC, named Omicron.

 

As such, countries are asked to do the following:
enhance surveillance and sequencing efforts to better understand circulating SARS-CoV-2 variants.
submit complete genome sequences and associated metadata to a publicly available database, such as GISAID.
report initial cases/clusters associated with VOC infection to WHO through the IHR mechanism.
where capacity exists and in coordination with the international community, perform field investigations and laboratory assessments to improve understanding of the potential impacts of the VOC on COVID-19 epidemiology, severity, effectiveness of public health and social measures, diagnostic methods, immune responses, antibody neutralization, or other relevant characteristics.

Individuals are reminded to take measures to reduce their risk of COVID-19, including proven public health and social measures such as wearing well-fitting masks, hand hygiene, physical distancing, improving ventilation of indoor spaces, avoiding crowded spaces, and getting vaccinated.
For reference, WHO has working definitions for SARS-CoV-2 Variant of Interest (VOI) and Variant of Concern (VOC).

 

A SARS-CoV-2 VOI is a SARS-CoV-2 variant:
with genetic changes that are predicted or known to affect virus characteristics such as transmissibility, disease severity, immune escape, diagnostic or therapeutic escape; AND
that has been identified as causing significant community transmission or multiple COVID-19 clusters, in multiple countries with increasing relative prevalence alongside increasing number of cases over time, or other apparent epidemiological impacts to suggest an emerging risk to global public health.

A SARS-CoV-2 VOC is a SARS-CoV-2 variant that meets the definition of a VOI (see above) and, through a comparative assessment, has been demonstrated to be associated with one or more of the following changes at a degree of global public health significance:
increase in transmissibility or detrimental change in COVID-19 epidemiology; OR
increase in virulence or change in clinical disease presentation; OR
decrease in effectiveness of public health and social measures or available diagnostics, vaccines, therapeutics

 

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Africa Centres for Disease Control and Prevention’s Statement regarding the new SARS-COV-2 virus variant B.1.1.529
26 November 2021

CDC Statement on B.1.1.529 (Omicron variant)
Friday, November 26, 2021

CEPI Statement: Emergence of a new SARS-CoV-2 variant, B.1.1.529
Statement from CEPI CEO, Dr Richard Hatchett.
26 Nov 2021

Premier Alan Winde: Weekly digital press conference 26 Nov
26 Nov 2021
Media release by Premier Winde [Western Cape. South Africa] at his weekly digital press conference
“We urge our excellent scientists to provide clarity, as soon as possible, on the many unknowns regarding the newly identified variant”

We note with concern that a new variant, B.1.1.529, has been identified by scientists in South Africa. What is clear from the announcement made yesterday afternoon by our world-class scientists is that there are a number of unknowns regarding how this new variant will impact the pandemic in our province, our country and indeed, around the world.

This uncertainty is creating panic and unfortunately resulting in many countries taking precautionary, temporary steps by banning travel to South Africa and our region. This is a blow to our economy and will be felt most in our province, as our tourism and hospitality sector is highly reliant on international travellers over this peak season to sustain itself and create jobs.

 

That is why I urge our scientific community to act with urgency to provide this clarity so that this uncertainty can be removed and so that we can, through clear data and evidence, engage with the public and the international community with all factors being known. I know that they are working around the clock on this already and I thank them for this.

For our residents, my main message to you is to not panic but to increase your vigilance during this time. If you have not yet been vaccinated, now is the time to do it, especially if you are 50 years and older or have comorbidities. We know that the virus spreads through the air, and so also be mindful of your airspace, by ensuring good ventilation, being outdoors more, and wearing a mask…

WHO – Interim statement on COVID-19 vaccination for children and adolescents

WHO – Interim statement on COVID-19 vaccination for children and adolescents
24 November 2021
Statement
WHO, with support of the Strategic Advisory Group of Experts (SAGE) on Immunization and its COVID-19 Vaccines Working Group, is reviewing the emerging evidence on the need for and timing of vaccinating children and adolescents with the currently available COVID-19 vaccines which have received Emergency Use Listing (EUL). SAGE is continuously reviewing the literature and has reached out to vaccine manufacturers, the research community and Member States to obtain the most complete and recent data on the issue.  This interim statement was developed with additional support from the Strategic and Technical Advisory Group of Experts (STAGE) on maternal, newborn, child, and adolescent health, and nutrition.

 

Background
Although the majority of COVID-19 vaccines are only approved for use in adults aged 18 years and above, an increasing number of vaccines are now also being authorized for use in children. Some countries have given emergency use authorization for mRNA vaccines for use in the adolescent age group (aged 12-17 years): BNT162b2 developed by Pfizer, and mRNA 1273 developed by Moderna. In November 2021, one stringent regulatory authority approved the mRNA vaccine BNT162b2 for the use in children aged 5-11. Trials in children as young as age 3 years were completed for two inactivated vaccines (Sinovac-CoronaVac and BBIBP-CorV) and these products were approved by Chinese authorities for the age indication of 3-17 years; although these vaccine products have received EUL for adults, they have not yet received WHO EUL for children. Covaxin, an adjuvanted inactivated vaccine developed by Bharat, was approved in India for the age indication of 12-17 years; but not yet received WHO EUL for this age indication. The Indian regulatory authorities have given approval to ZycovD, a novel DNA vaccine, for ages 12-17 years; however, this vaccine has not yet received WHO EUL. Several COVID-19 vaccines are undergoing trials in younger age groups (including as young as 6 months of age), but results have not yet been published.

The greatest burden of disease in terms of severe disease and deaths remains among older persons and those with comorbidities, the evidence of which led to the WHO Prioritization Roadmap which identifies high priority-use groups according to vaccine supplies available to countries(1). WHO recognizes that various countries are in different pandemic phases with different vaccination coverage rates. The WHO global vaccination strategy targets remain: 40% of each country’s population by end of 2021, and 70% by mid-2022(2). These coverage targets were set to ensure an equitable pace of global vaccine rollout & prioritization of those at highest risk. To date, these targets have not yet been achieved.

 

This interim statement examines the role of COVID-19 vaccines in adolescents and children in the global context of inequitable vaccine distribution across countries and globally limited vaccine supply.

Burden of disease in children and adolescents
Overall, there are proportionally fewer symptomatic infections, and cases with severe disease and deaths from COVID-19 in children and adolescents, compared with older age groups.  Age-disaggregated cases reported to WHO from 30 December 2019 to 25 October 2021(3) show that children under five years of age represent 2% (1 890 756) of reported global cases and 0.1% (1 797) of reported global deaths. Older children and younger adolescents (5 to 14 years) account for 7% (7 058 748) of reported global cases and 0.1% (1 328) of reported global deaths while older adolescents and young adults (15 to 24 years) represent 15% (14 819 320) of reported global cases and 0.4% (7 023) of reported global deaths. Deaths for all ages less than 25 years represented less than 0.5% of reported global deaths.

Children and adolescents usually demonstrate fewer and milder symptoms of SARS-CoV-2 infection compared to adults and are less likely than adults to experience severe COVID-19(4). Milder symptoms and asymptomatic presentations may mean less frequent care seeking in these groups, thus children and adolescents tend to be tested less and cases may go unreported. An age-dependent risk of severe disease with those under one year of age experiencing more severe disease has been suggested(5), although several reviews show that neonates (infants in the first 28 days of life) have mild disease when compared with other paediatric patients(6, 7). It is important to note that children under the age of five years have a higher risk of other diseases with clinical presentations that overlap with COVID-19, such as pneumonia and other viral upper respiratory tract infections, which may lead to misclassification. Additionally, age disaggregation has not been systematically provided in the literature, and the results of these studies are context-specific depending on factors such as timing within the pandemic and an emphasis on hospitalized patients(8).

Children and adolescents can experience prolonged clinical symptoms (known as “long COVID-19”, post COVID-19 condition(9), or post-acute sequelae of SARS-CoV-2 infection), however, the frequency and characteristics of these conditions are still under investigation. Additionally, a hyperinflammatory syndrome, referred to as  paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS) in Europe and multisystem inflammatory syndrome in children (MIS-C) in the United States, although rare, has been reported to occur world-wide and complicate recovery from COVID-19(10).

Several risk factors for severe COVID-19 in children have been reported recently, including older age, obesity, and preexisting conditions. The preexisting conditions associated with higher risk of severe COVID-19 include type 2 diabetes, asthma, heart and pulmonary diseases, and neurologic and neuromuscular conditions(11).

The preponderance of evidence on the risk for severe COVID-19 and death in children and adolescents comes from studies in high resource settings, so the applicability of the following observations to lower resource settings remains to be determined. One systematic review suggests that there may be larger impact of paediatric COVID-19 related fatality in low to middle income countries versus high income countries(12).

 

The role of children and adolescents in transmission of SARS-CoV-2
Multiple population-based SARS-CoV-2 seroprevalence and viral shedding studies have investigated whether children and adolescents are infected at the same rate as adults, but the results have been mixed, possibly because of the studies being conducted at different time points in the pandemic when populations were subjected to different public health and social measures (PHSM)(13). A serosurvey done in India during June-July 2021 after the second wave (Delta variant) showed that seropositivity in children 6-18 years was similar to that in older age groups – except in those older than 60 years in whom the immunization rate was high. Overall, it appeared that whether schools were open or closed, infection rates in children and adults were similar.  Thus, it appears that children of all ages can become infected and can spread the virus to others.

Outbreaks of COVID-19 have been identified in secondary schools, summer camps and day care centres, particularly when neither physical distancing nor masks were used to reduce infection transmission risk. There is some preliminary evidence that younger children may be less infectious, as measured by secondary attack rates, than adolescents and adults(14). Data on the global incidence of COVID-19 suggest adolescents test positive for SARS-CoV-2 at a higher proportion than younger children, however seroprevalence surveys are required to provide more conclusive information on infection rates.

Children who become infected with SARS-CoV-2 shed the virus in their respiratory tract and also in their faeces(15). Amongst individuals positive for SARS-CoV-2 who were tested at the same time point after symptom onset, levels of SARS-CoV-2 viral RNA shedding in the respiratory tract appeared similar in children, adolescents, and adults(16).

 

The relationship between age, viral load, and transmission across the full symptom spectrum of SARS-CoV-2 infection has not been comprehensively investigated because people with no, or mild symptoms are seldom tested systematically. The relative transmissibility of SARS-CoV-2 at different ages remains uncertain, largely due to the challenges involved in disentangling the influences of biological, host, virus, variants of concern, and environmental factors(17). 

Socio-economic impact of the COVID-19 pandemic and pandemic response on children and adolescents
Despite their lower risk of severe COVID-19 disease, children and adolescents have been disproportionately affected by COVID-19 control measures. The most important indirect effects are related to school closures which have disrupted the provision of educational services and increased emotional distress and mental health problems. When unable to attend school and in social isolation, children are more prone to maltreatment and sexual violence, adolescent pregnancy, and child marriage, all of which increase the probability of missing further education and of poor pregnancy outcomes. A range of follow-on effects of school closures occur. These include disruption in physical activity and routines and loss of access to a wide range of school-provided services such as school meals, health, nutrition, water, sanitation and hygiene (WASH) and services targeted to children with special needs such as learning support, speech therapy and social skills training. Children not attending school face enhanced risks of cyberbullying from other children, and the potential for predatory behavior from adults related to spending more time online. Longer-term, prolonged school closures lead to education loss and exacerbation of pre-existing inequalities and marginalization of learning. It is estimated that 24 million children are at risk of not returning to school owing to the pandemic(18); those affected have been estimated to incur a US$10 trillion loss in lifetime earnings(19). At societal level, economic devastation wrought by COVID-19 may take years to overcome, exacerbating economic inequalities, poverty, unemployment, household financial insecurity, food insecurity, and malnutrition, all of which negatively impact children, often disproportionately. Routine immunization services have also been negatively affected as a result of the pandemic response, thereby exacerbating the potential resurgence of vaccine-preventable diseases such as measles, tetanus, yellow fever, HPV, and others(20).

 

Efficacy and safety of COVID-19 vaccines in adolescents and children:
In Phase 2/3 trials for both mRNA vaccines, efficacy and immunogenicity were similar or higher compared to adults; safety and reactogenicity profiles in adolescents were similar to young adults. A very rare signal of myocarditis/pericarditis has been reported with mRNA COVID-19 vaccines as some countries have started to use these vaccines in their COVID-19 programmes. These cases occurred more often in younger men (16-24 years of age) and after the second dose of the vaccine, typically within a few days after vaccination. As the mRNA vaccines are just being rolled out in adolescents in some countries, the risk of myocarditis in that age group has not yet been fully determined. Available data suggest that the cases of myocarditis and pericarditis following vaccination are generally mild and respond to conservative treatment, and are less severe with better outcomes than classical myocarditis(21) or COVID-19. The risk of myocarditis/pericarditis associated with SARS-CoV-2 infection is higher than the risk after vaccination(21). In October 2021, the Global Advisory Committee on Vaccine Safety (GACVS) concluded that in all age groups the benefits of mRNA COVID-19 vaccines in reducing hospitalizations and deaths due to COVID-19 outweigh the risks. The risk of Thrombosis with Thrombocytopenia Syndrome (TTS) following adenoviral-vector vaccines, although overall low, was higher in younger adults compared to older adults, but no data are available on the risk below the age of 18 years.

 

Global equity and public health goals 
In the context of ongoing global COVID-19 vaccine supply constraints, the focus of immunization programs must remain on protecting sub-populations at highest risk of hospitalizations and deaths, according to the WHO Prioritization Roadmap. There is now overwhelming evidence that immunisation of all adults with COVID-19 vaccines provides important health returns on investment. Adult immunisation is feasible in all countries with the right investments and is being actively pursued in almost all countries. However, the benefits of vaccinating children to reduce the risk of severe disease and death are much less than those associated with vaccinating older adults. Countries with few or no vaccine supply constraints should consider the issues of  global equity  when making policy decisions about vaccinating children and adolescents. Any guidance on vaccine use prioritization, including booster dose policy, cannot ignore the current, on-going profound inequities in global vaccine access. While higher-income countries expand their vaccination programmes to adolescents, children, and, in some countries, booster doses to a large proportion of their populations, many lower-income countries still lack sufficient vaccine supply to offer a primary vaccination series to their highest priority-use groups, including older adults and health care workers who comprise only a small proportion of their populations.

 

Rationale for vaccinating adolescents and children
Vaccines which have received authorization by stringent regulatory authorities for the age indication of children and adolescents are safe and effective in reducing disease burden in these age groups.

Although benefit-risk assessments clearly underpin the benefit of vaccinating all age groups, including children and adolescents, the direct health benefit of vaccinating children and adolescents is lower compared with vaccinating older adults due to the lower incidence of severe COVID-19 and deaths in younger persons. Safety signals identified after widespread roll-out, such as myocarditis, albeit rare, are reported more frequently in young persons aged 16-24 years, particularly males; the risk of myocarditis in adolescents and/or children has not yet been determined.

Reducing intergenerational transmission is an important additional public health objective when vaccinating children and adolescents. Prior to the emergence of the delta variant, it was reported that the risk of symptomatic cases in household contacts of vaccinated cases was about 50% lower than that among household contacts of unvaccinated cases(22). However, the impact of vaccination on reducing transmission in the context of the more transmissible delta variant appears to be lower(23). Teachers, family members, and other adult contacts of children and adolescents should all be vaccinated.

Vaccinating children and adolescents may also help advance other highly valued societal goals. Maintaining education for all school-aged children should be an important priority during this pandemic. School attendance is critical to the well-being and life prospects of children and to parental participation in the economy. Vaccinating school-aged children may help minimize school disruptions by reducing the number of infections at school and the number of children required to miss school because of quarantine requirements.

 

The benefit of vaccinating children and adolescents may be lower in settings with high seropositivity rates in that age group, however, more evidence is needed on seroprevalence of school-aged children.

Conclusions
Countries should consider the individual and population benefits of immunising children and adolescents in their specific epidemiological and social context when developing their COVID-19 immunisation policies and programs.  As children and adolescents tend to have milder disease compared to adults, unless they are in a group at higher risk of severe COVID-19, it is less urgent to vaccinate them than older people, those with chronic health conditions and health workers.

There are benefits of vaccinating children and adolescents that go beyond the direct health benefits. Vaccination that decreases COVID transmission in this age group may reduce transmission from children and adolescents to older adults, and may help reduce the need for mitigation measures in schools. Minimizing disruptions to education for children and maintenance of their overall well-being, health and safety are important considerations.  Countries’ strategies related to COVID-19 control should facilitate children’s participation in education and other aspects of social life, and minimize school closures, even without vaccinating children and adolescents(24). UNICEF and WHO have developed guidance on how to minimize transmission in schools and keep schools open, regardless of vaccination of school-aged children(25).

Aligned and coordinated action is needed to achieve the global COVID-19 vaccination targets. Given current global inequity in vaccine access, the decision to vaccinate adolescents and children must account for prioritization to fully protect the highest risk subgroups through primary vaccination series, and as vaccine effectiveness declines with time since vaccination, through booster doses. As such, before considering implementing primary vaccination series in adolescents and children, attaining high coverage of primary series – and booster doses as needed based on evidence of waning and optimizing vaccination impact – in highest risk subgroups, such as older adults, must be considered(26).

As a matter of global equity, as long as many parts of the world are facing extreme vaccine shortages, countries that have achieved high vaccine coverage in their high-risk populations should prioritize global sharing of COVID-19 vaccines through the COVAX facility before proceeding to vaccination of children and adolescents who are at low risk for severe disease.

It is of utmost importance for children to continue to receive the recommended childhood vaccines for other infectious diseases.

[References available at title link above]

WHASS2: Special session of the World Health Assembly referred to in decision WHA74(16)

WHASS2: Special session of the World Health Assembly referred to in decision WHA74(16)
29 November – 1 December 2021
Geneva, Switzerland | Virtual event
Webcast page: https://www.who.int/news-room/events/detail/2021/11/29/default-calendar/second-special-session-of-the-world-health-assembly

The World Health Assembly (WHA) will gather for a special session 29 November to 1 December to consider developing a WHO convention, agreement, or other international instrument on pandemic preparedness and response.

The WHA normally meets each May. This special session (the second in the history of the WHO) was called for in a decision adopted by the Member States at the Seventy-fourth World Health Assembly: Decision WHA74(16).

During the session, the Member States will consider the following single substantive agenda item:
Consideration of the benefits of developing a WHO convention, agreement or other international instrument on pandemic preparedness and response with a view towards the establishment of an intergovernmental process to draft and negotiate such a convention, agreement or other international instrument on pandemic preparedness and response, taking into account the report of the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies.

The Working Group on Strengthening WHO Preparedness and Response to Health Emergencies, established after the WHA74, has met on four occasions and considered findings from several bodies in preparing its report. The sessions will be public and webcast on this page and other WHO channels.

WHASS2 Documents [at 27 Nov 2021]

Main documents
SSA2/1 – Provisional agenda
SSA2/1 Add.1 – Preliminary daily timetable
SSA2/2 – Special procedures
SSA2/3 – Report of the Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies to the special session of the World Health Assembly ]23 Nov 2021 :: 10 pages]

 

Information documents
SSA2/INF./1
Decision-making and procedural issues at the hybrid Second special session of the World Health Assembly [25 Nov 2021 :: 5 pages]
SSA2/INF./2
Summary of the Secretariat analysis prepared for the consideration of the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies [23Nov 2021 :: 3 pages]

 

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IFPMA Statement – Special Session of World Health Assembly on Pandemic Treaty
Published on: 24 November 2021
IFPMA welcomes the opportunity to contribute to the Special Session of the World Health Assembly in this unique and unprecedented moment to take lessons learned from fighting COVID-19 into tackling future global health crises. The COVID response has revealed to all the value of the rapid development and manufacture of vaccines and treatments, the importance of true multistakeholder collaboration, the power of regulatory cooperation and the importance of vaccine confidence and trust in public health officials. We also acknowledge that much more needs to be done to ensure equitable and fair distribution and access of pandemic products around the world. Vaccine supply continues to expand and we are committed to playing our part in improving equitable access.

However, we are concerned that some of the focus of discussions throughout this pandemic have, whilst being well-intentioned, the potential to detract from the real issues and undermine the successes we have achieved together. Weakened IP in future pandemics will undoubtedly lead to a decline in R&D and impede the ability to collaborate that is essential to the COVID-19 response. Complex negotiations between stakeholders around potential benefits will also hinder immediate and timely pathogen sharing, also undermining R&D efforts.

We view the Special Session as an important opportunity for governments to show leadership and to re-commit to increased global solidarity for the future and urge countries to focus on what matters most, such as building strong health systems, securing sustainable financing, ensuring effective pandemic procurement and continuing to build and foster regulatory agility and harmonization.

The private sector is crucial to developing and scaling-up diagnostics, vaccines and therapies for pandemics. Industry should be an active participant in collaborative efforts to design a fit-for-purpose global health crisis infrastructure informed by our COVID-19 experience. Throughout the WGPR process, we have welcomed the inclusion of the private sector as a valued contributor through the role given to IFPMA to actively attend, and hope that the private sector will continue to be part of any negotiation process launched after the World Health Assembly Special Session to provide constructive and meaningful input towards the creation of any pandemic response.

We are committed to working with governments, international organizations and other stakeholders to make sure that policies and plans are developed in a way that achieves the effective response the world requires to tackle any future pandemic.

TRIPS Waiver

TRIPS Waiver

Statement by President Joe Biden on the Omicron COVID-⁠19 Variant
November 26, 2021 • Statements and Releases
…In addition, I call on the nations gathering next week for the World Trade Organization ministerial meeting to meet the U.S. challenge to waive intellectual property protections for COVID vaccines, so these vaccines can be manufactured globally.  I endorsed this position in April; this news today reiterates the importance of moving on this quickly.

 

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WTO – General Council decides to postpone MC12 indefinitely
26 November 2021
The General Council agreed late Friday (26 November) to postpone the imminent Ministerial Conference after an outbreak of a particularly transmissible strain of the COVID-19 virus led several governments to impose travel restrictions that would have prevented many ministers from reaching Geneva.

The 12th Ministerial Conference (MC12) was due to start on 30 November and run until 3 December, but the announcement of travel restrictions and quarantine requirements in Switzerland and many other European countries led General Council Chair Amb. Dacio Castillo (Honduras) to call an emergency meeting of all WTO members to inform them of the situation.

“Given these unfortunate developments and the uncertainty that they cause, we see no alternative but to propose to postpone the Ministerial Conference and reconvene it as soon as possible when conditions allow,” Amb. Castillo told the General Council. “I trust that you will fully appreciate the seriousness of the situation.”

Director-General Ngozi Okonjo-Iweala said the travel constraints meant that many ministers and senior delegates could not have participated in face-to-face negotiations at the Conference. This would render participation on an equal basis impossible, she said

WTO members were unanimous in their support of the recommendations from the Director-General and the General Council Chair, and they pledged to continue working to narrow their differences on key topics like the WTO’s response to the pandemic and the negotiations to draft rules slashing harmful fisheries subsidies. The Director-General and Amb. Castillo urged delegations to maintain the negotiating momentum that had been established in recent weeks.
“This does not mean that negotiations should stop. On the contrary, delegations in Geneva should be fully empowered to close as many gaps as possible. This new variant reminds us once again of the urgency of the work we are charged with,” the DG said.

Director-General Okonjo-Iweala said she had scheduled a series of discussions over the weekend with ambassadors and visiting negotiators and that she planned to go ahead with these meetings. Negotiating group chairs said the same thing…

No date has been set for the rescheduling of the Ministerial Conference.

 

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WTO | Ministerial conferences – MC12 briefing note
24 Nov 2021
Trade and health: WTO response to the COVID-19 pandemic
The COVID-19 pandemic represents an unprecedented disruption to the global economy and world trade, as production and consumption have been impacted across the globe. Since the pandemic outbreak, WTO members have been working on a holistic approach in formulating a multilateral response to COVID-19 which takes into account the exceptional character of the current crisis – in terms of the loss of human lives and the economic and social challenges.

[Excerpts; Editor’s text bolding]
MC12 outcome
Many delegations have taken the view that any MC12 outcome would be a political declaration and not a new legal instrument seeking to alter existing rights and obligations under the WTO agreements.

A large number of delegations have attached high priority to a meaningful outcome on the use of export restrictions and prohibitions, which have had a severe impact on the availability of essential products needed to combat the pandemic. These restrictions and prohibitions have also disrupted global supply chains and hampered the collective ability to increase global production of essential products, such as vaccines. Discussions have underscored the importance of clearly affirming members’ political resolve to keep markets open and commit to the use of export restrictions only as a last resort.

In the areas of trade facilitation, regulatory coherence and cooperation, and tariffs, members have stressed the importance of experience sharing as it can help identify best practices and prepare recommendations or guidelines. This work could be continued in regular WTO bodies, such as the Trade Facilitation Committee, the Technical Barriers to Trade (TBT) Committee and the Market Access Committee.

 

Further work in the WTO
Many members have called for further work in the WTO to address regulatory bottlenecks affecting production and supply of essential medical goods, i.e. by simplifying regulatory procedures and promoting the sharing of regulatory dossiers and data.

Delegations have acknowledged that tariff reduction or elimination can help facilitate access to essential products during a pandemic, whether on a temporary or permanent basis. In order to do so, the papers on vaccine inputs tariffs and bottlenecks on critical COVID-19 products prepared by the WTO Secretariat can be possible useful reference tools…

 

TRIPS Council
In parallel to the process facilitated by Ambassador Walker, members have been seeking convergence on how best to use the global intellectual property (IP) system to tackle COVID-19 in the context of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS).

 

Waiver request
Over the past year, members have engaged in discussions based on various texts. On 15-16 October 2020, India and South Africa introduced at the TRIPS Council document IP/C/W/669 requesting a waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19. The proposal has since been co-sponsored by the delegations of Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt, the African Group, the LDC Group, the Maldives, Fiji, Namibia, Vanuatu, Indonesia and Jordan.

Since the introduction of the document, discussions have taken place in various formal and informal TRIPS Council meetings. Delegations have exchanged views, asked questions, sought clarifications and provided replies, clarifications and information on the waiver request. On 21 May 2021, the co-sponsors issued a revised proposal, which was circulated in document IP/C/W/669/Rev.1. On 29 September 2021, they circulated a summary of their interventions in document IP/C/W/684.

In the course of discussions on the revised waiver proposal, delegations have held focused discussions on the topics of scope, both from the perspective of products and of IP rights, on duration, implementation and the protection of undisclosed information.

All delegations remain committed to the common goal of providing timely and secure access to high-quality, safe, efficacious and affordable vaccines and medicines for all but discussions have shown that disagreement persists on the fundamental question of whether a waiver is the appropriate and most effective way to address the shortage and inequitable distribution of, and access to, vaccines and other
COVID-19-related products.

 

Proposal for a declaration on TRIPS Agreement and Public Health
In addition, a proposal (IP/C/W/681) for a draft General Council declaration on the TRIPS Agreement and Public Health in the circumstances of a pandemic, issued by the European Union, has also been discussed in meetings since its circulation on 21 June 2021.

The European Union proposal, which is backed by other developed country members, calls for limiting export restrictions, supporting the expansion of production, and facilitating the use of current compulsory licensing provisions in the TRIPS Agreement, particularly by clarifying that the requirement to negotiate with the right holder of the vaccine patent does not apply in urgent situations such as a pandemic, among other issues.

 

Discussions among members
While recognizing that intellectual property rights (IPRs) should not stand in the way of deploying and creating capacity or of ensuring equitable access to vaccines and therapeutics, several developed and developing members have cautioned that this can be attained while maintaining IP as the basis for incentivizing investment in innovation and licensing technology transfer so that members can effectively fight new strains of COVID-19 and any future diseases and pandemics. Some are particularly concerned that waiving IP rights might undermine the existing efforts and arrangements for large-scale production of vaccines that rely, in part, on the IP system.

Since the General Council held on 7 October 2021 and given the sense of urgency ahead of MC12, members have held intense discussions in various configurations. Some members have noted encouraging exchanges in small group discussions and bilateral meetings, which have helped to identify points of convergence on how to provide a common IP response to COVID-19. Others have said that further conversations that move the TRIPS Council towards evidence-based and pragmatic solutions should guide their discussions at this critical juncture.

At a formal meeting of the Council on 18 November, members formally adopted an oral status report to the General Council on 22-23 November indicating that the TRIPS Council has not yet completed its consideration of the revised waiver request. The TRIPS Council will therefore continue its consideration, including through small-group consultations and informal open-ended meetings, and report back to MC12 as stipulated in Article IX:3 of the Marrakesh Agreement. In addition, the TRIPS Council will also continue in the same manner its consideration of the other related proposals by members.

This means the TRIPS Council remains in session, potentially all the way to the Ministerial Conference. In this way, the Council can continue to provide a forum for delegations to provide transparency on their ongoing talks and to adopt any elements or solutions they may have found so that they can be recommended to ministers before MC12 starts….

WTO | intellectual property (TRIPS) – Documentation used in technical cooperation
Nov 26, 2021
Technical Cooperation – Key documents
I. TRIPS Legal texts and the relevant Conventions
II. The Doha Development Agenda
III. TRIPS and Public Health
IV. Review of TRIPS Article 27.3(b); Relationship Between the TRIPS Agreement and the Convention on Biological Diversity; Protection of Traditional Knowledge and Folklore
V. Geographical Indications
VI. Dispute Settlement
VII. Least Developed Country Members
VIII. TRIPS and Trade Policy Reviews, Accessions and Regional Trade Agreements
IX. Other Issues: TRIPS and e-Commerce, and TRIPS and Climate
X. TRIPS Implementation: notifications and reviews
Guide to the TRIPS Agreement

WHO: First meeting of Scientific Advisory Group for the Origins of Novel Pathogens (SAGO)

WHO: First meeting of Scientific Advisory Group for the Origins of Novel Pathogens (SAGO)
24 November 2021 News release
WHO´s Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) held its first meeting yesterday (SAGO) held its first meeting yesterday. The meeting was largely procedural, and included the appointment of the Chair (Dr. Marietjie Venter from South Africa) and Vice-Chair (Dr Jean-Claude Manuguerra from France). As per established WHO procedures for advisory expert groups, SAGO meetings will not be public. WHO will provide updates on their work as appropriate.

The group agreed to meet frequently and focus urgently on advising on the overarching framework to study the emergence of novel pathogens, as well as to rapidly undertake an assessment of the current understanding of the origins of SARS-CoV-2 , the virus that causes COVID-19. SAGO is composed of experts acting in a personal capacity and will work with additional experts from various technical areas as needed.

In its capacity as an advisory body to WHO, the SAGO will have the following functions, as per its terms of reference:
To advise WHO on the development of a WHO global framework to define and guide studies into the origins of emerging and re-emerging pathogens of epidemic and pandemic potential;
To advise WHO on prioritizing studies and field investigations into the origins of emerging and re-emerging pathogens of epidemic and pandemic potential, in accordance with the WHO global framework described in point (1) above;
To provide information and views to assist the WHO Secretariat in the development of a detailed work plan of the SAGO;

In the context of SARS-CoV-2 origins:
To provide the WHO Secretariat with an independent evaluation of all available scientific and technical findings from global studies on the origins of SARS-CoV-2;
To advise the WHO Secretariat regarding developing, monitoring and supporting the next series of studies into the origins of SARS-CoV-2, including rapid advice on WHO’s operational plans to implement the next series of global studies into the origins of SARS-CoV-2, as outlined in the Joint WHO-China Global Study of Origins of SARS-CoV-2: China Part report published on 30 March 2021 and advise on additional studies as needed; and
To provide additional advice and support to WHO, as requested by the WHO SAGO Secretariat, which may include participation in future WHO-international missions to study the origins of SARS-CoV-2 or other emerging pathogens.

Serum Institute of India (SII) re-starts COVAX exports; passes 1billion COVISHIELD dose

Serum Institute of India (SII) re-starts COVAX exports; passes 1billion COVISHIELD dose
:: Total number of COVISHIELD doses produced now surpasses 1.25bn mark.
:: Resumption of global distribution of COVISHIELD via the COVAX mechanism and to low- and middle-income countries.

Pune, 26th November, 2021: Serum Institute of India (SII) today announces it has resumed exports to the international vaccine sharing programme COVAX. The first batches of its COVISHIELD COVID-19 vaccine left the SII manufacturing facility in Pune earlier today, for distribution to low- and middle-income countries via the COVAX mechanism. SII’s supply of doses via COVAX is expected to increase substantially into Quarter 1 2022.

The resumption of exports is linked to SII surpassing its original target to produce 1bn doses of COVISHIELD by the end of this year. SII has reached this milestone ahead of time via rapid expansion of production capacity at its site in Pune.

To bolster its COVID-19 vaccine output even further, SII will bring into production other vaccines under licence. These include COVOVAX, from US-based company Novavax, which received its first Emergency Use Authorisations (EUAs) from regulators in Indonesia and the Philippines this month. Further regulatory reviews are pending for COVOVAX in India and with the World Health Organization, and Novavax has also submitted several additional regulatory filings for its vaccine around the world…

…Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance which leads the COVAX Facility said: “The resumption of supplies from Serum Institute of India is an important development for COVAX as it enters its busiest period yet for shipping vaccines to participating economies. While COVAX’s portfolio is now much more diversified than it was earlier this year when we received our first SII deliveries, COVISHIELD remains an important product which has the potential to help us protect hundreds of millions of people in the months ahead.”…

…Throughout the pandemic, SII has also been able to maintain its supply of non-COVID-19 vaccines to low- and middle-income countries, including vaccines for polio, measles and pneumococcal disease.

Coronavirus [COVID-19] – WHOPublic Health Emergency of International Concern (PHEIC)

Coronavirus [COVID-19] – WHO
Public Health Emergency of International Concern (PHEIC)
https://www.who.int/emergencies/diseases/novel-coronavirus-2019

 

Weekly Epidemiological and Operational updates
Last update: 19 Nov 2021
Confirmed cases :: 259 502 031 [255 324 963 week ago]
Confirmed deaths :: 5 183 003 [5 127 696 week ago]
Vaccine doses administered: 7 702 859 718 [7 370 902 499 week ago]

 

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Weekly epidemiological update on COVID-19 – 23 November 2021
WHO
Overview
Globally, the numbers of weekly COVID-19 cases and deaths have increased for more than a month. During the week of 15-21 November 2021, nearly 3.6 million confirmed new cases and over 51 000 deaths were reported, reflecting a 6% increase for cases and deaths as compared to the previous week. The European Region reported an 11% increase in new weekly cases, while the other regions reported a decrease or incidence similar to the previous week. The largest proportionate decrease was reported from the South-East Asia Region (11%), followed by the Eastern Mediterranean Region (9%). While the Western Pacific Region and the Region of the Americas reported relatively stable case incidence, they both reported large increases in new weekly deaths, 29% and 19% respectively. In contrast, the African and the South-East Asia regions reported a 30% and 19% decrease in new weekly deaths. The cumulative number of confirmed cases reported globally is now over 256 million and the cumulative number of deaths is more than 5.1 million.

In this edition, two special focus updates are provided on:
:: Points of entry, international travel and transport in the context of the COVID-19 pandemic
:: SARS-CoV-2 Variants of Concern (VOCs) and Variants of Interest (VOIs)

WHO Director General Speeches [selected]

WHO Director General Speeches [selected]
https://www.who.int/director-general/speeches
Selected
25 November 2021
Speech
Director-General’s opening remarks at Member States Information Session on COVID-19 – 25 November 2021

24 November 2021
Speech
WHO Director-General’s opening remarks at the media briefing on COVID-19 – 24 November 2021
Data suggest that before the arrival of the Delta variant, vaccines reduced transmission by about 60%. With Delta, that has dropped to about 40%. We cannot say this clearly enough: even if you are vaccinated, continue to take precautions to prevent becoming infected yourself, and to infecting someone else who could die.  And we continue to call on all governments to implement a comprehensive and tailored approach of public health and social measures to prevent transmission, take the pressure off health systems and save lives.
Yesterday, C-TAP and the Medicines Patent Pool finalized a licensing agreement with the Spanish National Research Council for a serological antibody test. This is the first transparent, global and non-exclusive license for a COVID-19 health tool. I would like to thank the government of Spain for its support for C-TAP, and I also thank His Excellency President Carlos Alvarado Quesada of Costa Rica for his leadership in initiating C-TAP last year.  We hope this will be the first of many licenses to be shared through C-TAP.
With the WTO Ministerial Conference next week and with the vast majority of countries now firmly supporting a waiver on intellectual property rights under the TRIPS agreement, I hope that consensus can be found and that we move forward.  
Today marks the end of Antimicrobial Awareness Week. Antimicrobials, including antibiotics, antivirals, antifungals and antiparasitics, are the backbone of modern medicine. But the overuse and misuse of antimicrobials are undermining the effectiveness of these essential medicines.  By using antimicrobials responsibly, and by following the advice of your health care provider, we can all play a part in preserving antimicrobials and preventing drug resistance. 

23 November 2021
Speech
WHO Director-General’s opening remarks at the First meeting of the WHO Scientific Advisory Group for the Origins of Novel Pathogens (SAGO)

23 November 2021
Speech
WHO Director-General’s opening remarks at the 2021 SADC seminar on TRIPS waiver – 23 November 2021
…Let me leave you with three requests:
First, we seek the support of the Canadian government for the TRIPS waiver for COVID-19 products at the WTO Ministerial Conference that begins this week.
Second, we seek the support of all countries in speeding up negotiations that result in a text that countries can implement easily in their national legislation.
WHO strongly recommends that the waiver apply not only to vaccines, but also to diagnostics, therapeutics and other tools to prevent, diagnose and treat COVID-19.
Third, we urge all SADC members to explore all avenues to rapidly scale-up production, including through the use of TRIPS flexibilities, technology pools, voluntary licenses, and by investing in local production…

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Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 11 November 2021
For 24 vaccine candidates, presents Manufacturer, Name of Vaccine, NRA of Record, Platform, EOI Accepted Status, Pre-submission Meeting Held Status, Dossier Accepted for Review, Status of Assessment; Anticipated/Completed Decision Date
[Full scale view available at title link above]

 

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COVID Vaccine Developer/Manufacturer Announcements
[relevant press releases/announcement from organizations from WHO EUL/PQ listing above]

 

AstraZeneca
Press Releases
AstraZeneca unveils The Discovery Centre (DISC) in Cambridge
23 November 2021
:: State-of-the-art R&D facility designed to foster collaboration across world-class science ecosystem
:: Sustainable environmental engineering aligned to Company’s zero carbon future
  AstraZeneca will today, in the presence of His Royal Highness The Prince of Wales, formally unveil The Discovery Centre (DISC) in Cambridge, UK – a state-of-the-art research and development (R&D) facility designed to the world’s highest environmental standards and accommodating over 2,200 research scientists.
The new £1bn facility will include the most advanced robotics, high-throughput screening and AI-driven technology. It will support AstraZeneca’s focus on specialised and precision medicines and foster the discovery and development of next generation therapeutics, including nucleotide-based, gene-editing and cell therapies…

 

Bharat Biotech
Press Releases – No new digest announcements identified

BioCubaFarma – Cuba
Últimas Noticias – [Website not responding at inquiry; receiving 403-Forbidden]

 

CanSinoBIO
News – [Website not responding at inquiry]

Clover Biopharmaceuticals – China
News
Nov 26,2021
Clover’s COVID-19 Vaccine Candidate Administered as Heterologous Booster in Investigator-Led Phase 2 Clinical Trial
The Phase 2 trial will evaluate SCB-2019 (CpG 1018/Alum) as a booster dose in individuals previously vaccinated with CoronaVac or recombinant Covid-19 vaccine (AstraZeneca/Fiocruz)
The Phase 2 trial is an investigator initiated study, sponsored by the Instituto D’Or de Pesquisa e Ensino (IDOR) and funded by the Bill & Melinda Gates Foundation
The study will evaluate the immunogenicity and safety of SCB-2019 in approximately 520 healthy adult participants at multiple sites in Brazil
Initial safety and immunogenicity data are anticipated in the first half of 2022

 

Curevac [Bayer Ag – Germany]
News – No new digest announcements identified

 

Gamaleya National Center
Latest News and Events – No new digest announcements identified [See Russia/RFID below]

IMBCAMS, China
Home – No new digest announcements identified

 

Janssen/JNJ
Press Releases
Nov 24, 2021 Canada
Johnson & Johnson COVID-19 Vaccine Fully Approved by Health Canada to Prevent COVID-19 in Individuals 18 years and Older
Vaccine demonstrates protection against COVID-19 related hospitalization and death, and across different variants

 

Moderna
Press Releases
November 26, 2021
Moderna Announces Strategy to Address Omicron (B.1.1.529) SARS-CoV-2 Variant
:: Company testing three existing COVID-19 vaccine booster candidates against the Omicron variant
:: Company announcing a new variant-specific vaccine candidate against Omicron (mRNA-1273.529)
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 26, 2021– Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced updates to its strategy to address SARS-CoV-2 variants of concern, given the emergence of the B.1.1.529 (Omicron) variant.
The recently described Omicron variant includes mutations seen in the Delta variant that are believed to increase transmissibility and mutations seen in the Beta and Delta variants that are believed to promote immune escape. The combination of mutations represents a significant potential risk to accelerate the waning of natural and vaccine-induced immunity. A booster dose of an authorized vaccine represents the only currently available strategy for boosting waning immunity. The Moderna COVID-19 vaccine (mRNA-1273) is authorized as a booster for many populations at the 50 µg dose level. The Company is working rapidly to test the ability of the current vaccine dose to neutralize the Omicron variant and data is expected in the coming weeks.
Since early 2021, Moderna has advanced a comprehensive strategy to anticipate new variants of concern. This strategy includes three levels of response should the currently authorized 50 µg booster dose of mRNA-1273 prove insufficient to boost waning immunity against the Omicron variant…

 

Novavax
Press Releases
Novavax Files for Interim Authorization of COVID-19 Vaccine in Singapore Nov 24, 2021

 

Pfizer
Recent Press Releases
11.25.2021
Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 5 to <12 Years of Age in the European Union
NEW YORK and MAINZ, Germany, November 25, 2021—Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine COMIRNATY® in children 5 to under 12 years of age. The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future…

11.22.2021
Follow-Up Data From Phase 3 Trial of Pfizer-BioNTech COVID-19 Vaccine Support Safety and High Efficacy in Adolescents 12 Through 15 Years of Age
:: Pfizer-BioNTech vaccine demonstrated 100% efficacy against COVID-19 in longer-term analysis, with no serious safety concerns identified
:: Data will support planned submissions for full regulatory approval of the vaccine in this age group in the U.S. and worldwide

 

Sanofi Pasteur
Press Releases – No new digest announcements identified

 

Serum Institute of India
NEWS & ANNOUNCEMENTS
Serum Institute of India (SII) re-starts COVAX exports; passes 1billion COVISHIELD dose
:: Total number of COVISHIELD doses produced now surpasses 1.25bn mark.
:: Resumption of global distribution of COVISHIELD via the COVAX mechanism and to low- and middle-income countries.
[See Milestones above for detail]

 

Sinopharm/WIBPBIBP
News – No new digest announcements identified

 

Sinovac
Press Releases
The 2nd International Conference on the Latest Researches, Experience Sharing on SINOVAC’s COVID-19 Vaccine Was Held 2021/11/26

 

Vector State Research Centre of Viralogy and Biotechnology
Home – No new digest announcements identified

Zhifei Longcom, China
[Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.]
[No website identified]

 

::::::

GSK
Press releases for media – No new digest announcements identified

 

Merck
News releases
Merck and Ridgeback Biotherapeutics Provide Update on Results from MOVe-OUT Study of Molnupiravir, an Investigational Oral Antiviral Medicine, in At Risk Adults With Mild-to-Moderate COVID-19 Nov 26, 2021

 

Novartis
News – No new digest announcements identified

 

SK Biosciences
Press releases – No new digest announcements identified

 

Valneva
Press Releases
Valneva Signs Purchase Agreement with European Commission for its Inactivated COVID-19 Vaccine VLA2001
Saint-Herblain (France), November 23, 2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has signed an Advance Purchase Agreement (APA) with the European Commission (EC) to supply up to 60 million doses of its inactivated COVID-19 vaccine candidate, VLA2001, over two years. The agreement follows the announcement made earlier this month that the EC had approved the APA[1].

IMF-WHO Vaccine Supply Forecast Dashboard

IMF-WHO Vaccine Supply Forecast Dashboard
Updated on 19 November 2021
Many countries are not on track to meet the 40% vaccine coverage target. To make progress towards this target, we must identify: (1) Where and in which countries are the gaps?, and (2) How can gaps the be addressed?
The IMF-WHO COVID-19 Vaccine Supply Forecast Dashboard estimates expected month vaccine supply until the end of 2021 by country, product and channel. The tracker builds on the work of the IMF Staff Discussion Note – A Proposal to End the COVID-19 Pandemic (Agarwal and Gopinath, 2021).

The Race for Global COVID-19 Vaccine Equity

Duke – Launch and Scale Speedometer
The Race for Global COVID-19 Vaccine Equity
A flurry of nearly 200 COVID-19 vaccine candidates are moving forward through the development and clinical trials processes at unprecedented speed; more than ten candidates are already in Phase 3 large-scale trials and several have received emergency or limited authorization. Our team has aggregated and analyzed publicly available data to track the flow of procurement and manufacturing and better understand global equity challenges. We developed a data framework of relevant variables and conducted desk research of publicly available information to identify COVID vaccine candidates and status, deals and ongoing negotiations for procurement and manufacturing, COVID burden by country, and allocation and distribution plans. We have also conducted interviews with public officials in key countries to better understand the context and challenges facing vaccine allocation and distribution
[accessed 24 July 2021]
See our COVID Vaccine Purchases research
See our COVID Vaccine Manufacturing research
See our COVID Vaccine Donations & Exports research

Global Dashboard on COVID-19 Vaccine Equity

Global Dashboard on COVID-19 Vaccine Equity
The Dashboard is a joint initiative of UNDP, WHO and the University of Oxford with cooperation across the UN system, anchored in the SDG 3 Global Action Plan for Healthy Lives and Well-being for All.

Dashboard on Vaccine Equity [accessed 27 Nov 2021]: https://data.undp.org/vaccine-equity/
See also visualization on Vaccine Access and Vaccine Affordability

COVID-19 Data Explorer: Global Humanitarian Operations

COVID Vaccines – OCHA:: HDX

COVID-19 Data Explorer: Global Humanitarian Operations
COVID-19 Vaccine Roll-out
27 Nov 2021 | COVAX (WHO,GAVI,CEPI), UNDESA, Press Reports | DATA
Global COVID-19 Figures: 259M total confirmed cases; 5.2M total confirmed deaths
Global vaccines administered: 7.88B
Number of Countries: 30 [30 week ago]
COVAX Allocations Round 4-9 (Number of Doses): 220M [220M week ago]
COVAX Delivered (Number of Doses): 170M [160M week ago]
Other Delivered (Number of Doses): 280M [260M week ago]
Total Delivered (Number of Doses): 450M [450M week ago]
Total Administered (Number of Doses): 7.9G

Multilateral Leaders Task Force on COVID-19 [IMF, World Bank Group, WHO, WTO]

Multilateral Leaders Task Force on COVID-19 [IMF, World Bank Group, WHO, WTO]
https://data.covid19taskforce.com/data
A global effort to help developing countries access and deliver COVID-19 vaccines, testing, and therapeutics, as they work to end the pandemic and boost economic recovery.
The International Monetary Fund, World Bank Group, World Health Organization and World Trade Organization have joined forces to accelerate access to COVID-19 vaccines, therapeutics and diagnostics by leveraging multilateral finance and trade solutions, particularly in low- and middle-income countries.
Website accessed 27 Nov 2021: https://data.covid19taskforce.com/data The global view below is complemented by country-specific dashboards here.

U.S.: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

U.S.: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

 

 

FDA
Press Announcements
November 23, 2021 – Coronavirus (COVID-19) Update: November 23, 2021

 

 

Vaccines and Related Biological Products Advisory Committee– FDA
https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/vaccines-and-related-biological-products-advisory-committee
No meetings on calendar

 

 

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White House [U.S.]
Briefing Room – Selected Major COVID Announcements
A Proclamation on Suspension of Entry as Immigrants and Nonimmigrants of Certain Additional Persons Who Pose a Risk of Transmitting Coronavirus Disease 2019
November 26, 2021 • Presidential Actions

Statement by President Joe Biden on the Omicron COVID-⁠19 Variant
November 26, 2021 • Statements and Releases

Press Briefing by White House COVID-⁠19 Response Team and Public Health Officials
November 22, 2021 • Press Briefings

 

 

U.S. Department of State
https://www.state.gov/coronavirus/releases/
Media Notes
Remarks
Secretary Antony J. Blinken at the Institute Pasteur of Dakar
Antony J. Blinken November 20, 2021
“…Our ambition is really to impact COVID-19 pandemic by delivering COVID vaccine in Africa for Africa before this pandemic ends.  We also want to establish large capacity for future pandemics, epidemic, and also for routine immunization.  We really looking for partnering with company in pandemic preparedness space in the U.S. and elsewhere, and we are really looking forward to establishing cell culture and RNA messenger capacity for many vaccine important for us, the end goal being to support Africa vaccine autonomy in collaboration with as a regional – that African Union is working on….”

Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

 

 

European Medicines Agency
News & Press Releases 
News: Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11 (new)
CHMP, Last updated: 25/11/2021

 

 

News: A vision for use of real-world evidence in EU medicines regulation (new)
Last updated: 24/11/2021

 

 

News: EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID 19 (new)
CHMP, Last updated: 23/11/2021

 

 

News: EMA evaluating data on booster dose of COVID-19 Vaccine Janssen (new)
CHMP, Last updated: 22/11/2021

 

 

::::::

 

European Centre for Disease Prevention and Control
https://www.ecdc.europa.eu/en
Latest Updates
News
ECDC publishes Threat assessment brief – Emergence of SARS-CoV-2 variant B.1.1.529
News – 26 Nov 2021
The B.1.1.529 variant, first detected in southern Africa, is the most divergent variant that has been detected in significant numbers during the pandemic to date, raising serious concerns that it may significantly reduce the effectiveness of vaccines and increase the risk of reinfections.
ECDC Director Dr Andrea Ammon said: “Today we are releasing a threat assessment on the emergence of a new Sars-COV-2 variant of concern. There is still considerable uncertainty related to the transmissibility, vaccine effectiveness, risk for reinfections and other properties of this variant. At this stage, based on our experience with previous variants we must be proactive and implement measures as a precaution to buy time until we gain more knowledge. Therefore, I would like to reiterate the three key recommendations from our rapid risk assessment from the 24th of November. Firstly, it is imperative we close the immunisation gap. Secondly, booster doses should be considered for all adult individuals, prioritising persons above 40 years of age. Finally, due to the uncertainties involved with this situation, the timely reinforced implementation of non-pharmaceutical interventions is now more important than ever”…

Publication
Threat Assessment Brief: Implications of the emergence and spread of the SARS-CoV-2 B.1.1. 529 variant of concern (Omicron) for the EU/EEA
Risk assessment – 26 Nov 2021

News
WHO/ECDC: Nearly half a million lives saved by COVID-19 vaccination in less than a year
Press release – 25 Nov 2021

 

 

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Accessed 27 Nov 2021
https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#uptake-tab

 

 

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European Commission
https://ec.europa.eu/commission/presscorner/home/en
Statement 26 November 2021
Press statement by President von der Leyen on the new COVID variant

Press release 26 November 2021
EU replaces COVID-19 vaccines export authorisation mechanism with new monitoring tool
The EU will not extend the COVID-19 vaccines export transparency and authorisation mechanism, which expires on 31 December 2021.

Statement 25 November 2021
Statement by President von der Leyen on stepping up vaccination
Vaccination against COVID-19 saves thousands of lives in the European Union. But a new wave is hitting us and we need to step up vaccination further.
The good news is that we have enough vaccine doses. By the end of this week, Europe will have delivered 1 billion doses to our Member States.
And another important news is that you should take your booster shot six months after the original vaccination. We must keep up the immunity of people who are vaccinated. The EU agencies recommend now booster doses for all adults. Boosters give us an even higher level of protection than the original vaccination. They will prevent many hospitalisations and deaths.
Finally, we need to convince more people to get vaccinated. A quarter of EU adults are still not fully vaccinated. If you are unvaccinated, you are more at risk of having severe COVID-19 symptoms.
Vaccination protects you, and the others.

Press release 25 November 2021
Coronavirus: Commission proposes to strengthen coordination of safe travel in the EU
Today, the European Commission has proposed to update the rules on coordination of safe and free movement in the EU, which were put in place in response to the COVID-19 pandemic.

Press release 25 November 2021
Coronavirus: Commission proposes an updated framework for travel from outside the EU, prioritising vaccinated travellers, with strong safeguards
The Commission is proposing today to update the Council recommendation on non-essential travel from outside the EU to simplify the framework and reflect recent developments. Priority will be given to vaccinated travellers.

Russia: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

Russia: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

 

Russia: Sputnik V – “the first registered COVID-19 vaccine”
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
A unique comparative study of five vaccines in EU member Hungary on 3.7 million people shows Sputnik V is the best vaccine to protect against mortality from COVID with 98% efficacy and 85.7% efficacy against infection
Press release, 25.11.2021

RDIF announces major Sputnik V efficacy data from San Marino, an upcoming registration of the Sputnik M vaccine and reiterates vaccine combos are the key to fight the pandemic
Press release, 24.11.2021

Sputnik V shows 80% long-term efficacy against COVID in San Marino from 6th through 8th month after administering the second dose
Press release, 24.11.2021

The single-component Sputnik Light vaccine authorized in Laos
Press release, 23.11.2021

The one-shot Sputnik Light vaccine authorized in San Marino
Press release, 23.11.2021

India: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

India: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

 

 

Ministry of Health and Family Welfare
https://www.mohfw.gov.in/

 

 

Government of India – Press Information Bureau
Latest Press Releases
COVID-19 Vaccination Update – Day 316
:: India’s cumulative vaccination coverage crosses 121.84 crore
:: More than 73 lakh Vaccine doses administered today till 7 pm
Posted On: 27 NOV 2021 8:36PM by PIB Delhi

 

 

Indian Council for Medical Research (ICMR)
https://www.icmr.gov.in/media.html
Press Releases
No new digest content identified.

China: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

China: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

China to donate another 1m Sinovac vaccines to Malaysia
2021-11-24

Over 2.449 bln COVID-19 vaccine doses administered on Chinese mainland
2021-11-24
More than 2.449 billion doses of COVID-19 vaccine had been administered on the Chinese mainland as of Tuesday, data from the National Health Commission showed on Nov 24.

POLIOPublic Health Emergency of International Concern (PHEIC)

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)
https://polioeradication.org/polio-today/polio-now/this-week/

Polio this week as of 24 November 2021
:: The thirtieth meeting of the Emergency Committee under the International Health Regulations (2005) (IHR) on the international spread of poliovirus was convened by the WHO Director-General on 3 November 2021. The meeting statement is now available here [and excerpted below]

 

Summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):
– Afghanistan: two WPV1 cases
– Nigeria: nine cVDPV2 cases and 25 cVDPV2 positive environmental samples
– Yemen: two cVDPV2 cases

 

::::::

Statement of the Thirtieth Polio IHR Emergency Committee
23 November 2021
The thirtieth meeting of the Emergency Committee under the International Health Regulations (2005) (IHR) on the international spread of poliovirus was convened by the WHO Director-General on 3 November 2021 with committee members and advisers attending via video conference, supported by the WHO Secretariat. The Emergency Committee reviewed the data on wild poliovirus (WPV1) and circulating vaccine derived polioviruses (cVDPV). Technical updates were received about the situation in the following State Parties: Afghanistan, China, Guinea Bissau, Mauritania, Nigeria, Pakistan, Senegal and Ukraine.

[Excerpts]
…Conclusion
Although heartened by the apparent progress, the Committee unanimously agreed that the risk of international spread of poliovirus remains a Public Health Emergency of International Concern (PHEIC) and recommended the extension of Temporary Recommendations for a further three months. The Committee recognizes the concerns regarding the lengthy duration of the polio PHEIC but concluded that there are still significant risks despite apparent progress made in the two endemic countries, and that the coming three months would be a critical period to monitor the situation there closely.

 

…States infected with cVDPV2, with or without evidence of local transmission:
Afghanistan              (most recent detection 9 July 2021)
Benin                        (most recent detection 14 May 2021)
Burkina Faso            (most recent detection 9 June 2021)
Cameroon                 (most recent detection 8 September 2021)
CAR                          (most recent detection 29 October 2020)
Chad                         (most recent detection 28 November 2020)
Rep Congo                (most recent detection 14 April 2021)
DR Congo                 (most recent detection 30 April 2021)
Côte d’Ivoire              (most recent detection 23 December 2020)
Egypt                         (most recent detection 8 June 2021)
Ethiopia                     (most recent detection 16 July 2021)
Gambia                     (most recent detection 1 July 2021)
Guinea                      (most recent detection 10 July 2021)
Guinea Bissau          (most recent detection 26 July 2021)
Iran (Islamic Republic of)      (most recent detection 20 February 2021)
Kenya                      (most recent detection 25 January 2021)
Liberia                     (most recent detection 28 May 2021)
Mali                         (most recent detection 23 December 2020)
Mauritania               (most recent detection 1 September 2021)
Niger                       (most recent detection 20 July 2021)
Nigeria                    (most recent detection 12 September 2021)
Pakistan                 (most recent detection 11 August 2021)
Senegal                 (most recent detection 14 September 2021)
Sierra Leone          (most recent detection 1 June 2021
Somalia                 (most recent detection 23 May 2021)
South Sudan         (most recent detection 10 Apr 2021)
Sudan                   (most recent detection 18 December 2020)
Tajikistan               (most recent detection 13 August 2021)
Uganda                 (most recent detection 1 June 2021)
Ukraine                 (most recent detection 7 September 20…

 

…Additional Considerations
The committee noted the convincing efforts by China to rule out further transmission and accepted that nine months after the last detection of cVDPV3, China was no longer infected.
The Committee welcomed the further progress achieved with the introduction and delivery of nOPV2 but was concerned to hear of significant delays in outbreak response timelines as countries opted to delay response in order to use nOPV2. Polio outbreaks should continue to be met with an aggressive and timely response with the immediately available type-2 vaccine.
The Committee warned of the ongoing effects of COVID-19 particularly on essential immunization and possible future disruptions of supply and delivery of vaccines. Zero-dose children and communities were missed before the advent of the pandemic and it is critical that these children and communities are prioritized as essential immunization services are restored. COVID-19 is likely to continue to have adverse effects on all health programs and systems for some time to come so the polio programme must continue to manage its response to overcome the remaining hurdles.
Based on the current situation regarding WPV1 and cVDPV, and the reports provided by affected countries, the Director-General accepted the Committee’s assessment and on 5 November 2021 determined that the situation relating to poliovirus continues to constitute a PHEIC, with respect to WPV1 and cVDPV. The Director-General endorsed the Committee’s recommendations for countries meeting the definition for ‘States infected with WPV1, cVDPV1 or cVDPV3 with potential risk for international spread’, ‘States infected with cVDPV2 with potential risk for international spread’ and for ‘States no longer infected by WPV1 or cVDPV, but which remain vulnerable to re-infection by WPV or cVDPV’ and extended the Temporary Recommendations under the IHR to reduce the risk of the international spread of poliovirus, effective 5 November 2021.

 

::::::
::::::

WHO/OCHA Emergencies

Health emergencies list – WHO
“The health emergencies list details the disease outbreaks, disasters and humanitarian crises where WHO plays an essential role in supporting countries to respond to and recover from emergencies with public health consequences.”
Afghanistan crisis [Last apparent update: 18 Oct 2021]

Crisis in Northern Ethiopia [Last apparent update: 1 June 2021]

Ebola outbreak, Democratic Republic of the Congo, 2021 [Last apparent update: 17 Aug 2021]

Ebola outbreak outbreak, N’Zerekore, Guinea, 2021 [Last apparent update: 17 Aug 2021]

Coronavirus disease (COVID-19) pandemic [See COVID above]

 

Ebola outbreak, Equateur Province, Democratic Republic of the Congo, 2020
[Last apparent update: 17 Aug 2021]

Ebola outbreak, North Kivu, Ituri, Democratic Republic of the Congo, 2018 – 2020
[Last apparent update: 17 Aug 2021]

Ebola outbreak, Democratic Republic of the Congo, 2018 [Last apparent update: 24 July 2018]

Yemen crisis [Last apparent update: 12 February 2021]

Syria crisis [Last apparent update: 18 June 2021]

Somalia crisis [Last apparent update: 24 March 2018]

Nigeria crisis [Last apparent update: 1 Oct 2021]

Ebola outbreak, Democratic Republic of the Congo, 2017 [Last apparent update: 17 Aug 2021]

Zika virus disease outbreak, 2015-2016 [Last apparent update: 24 Jan 2020]

Ebola outbreak: West Africa, 2014-2016 [Last apparent update: 17 Aug 2021]

Iraq crisis [Last apparent update: 9 Jan 2008]

South Sudan crisis [Last apparent update: 23 Sep 2020]

Avian influenza A (H7N9) virus outbreak [Last apparent update: 13 September 2021]

Middle East respiratory syndrome (MERS-CoV) outbreak [Last apparent update: 8 July 2019]

Influenza A (H1N1) virus, 2009-2010 pandemic [Last apparent update: 10 Aug 2010]

 

::::::

UN OCHA – Current Emergencies
Current Corporate Emergencies
Afghanistan
:: Afghanistan: Weekly Humanitarian Update (15 – 21 November 2021)
:: Afghanistan: ICCT Real-Time Response Overview Situation Report (22 November 2021)

 

Northern Ethiopia
Ethiopia – Northern Ethiopia Humanitarian Update Situation Report, 25 Nov 2021
HIGHLIGHTS
NHAS resumed flights to and from Mekelle on 24 November.
An assessment conducted in Debre Berhan, Amhara, to gauge the humanitarian and access situation, and inform on the humanitarian response, following large-scale displacement.
More than 500 health facilities across Amhara Region were damaged due to the conflict, preventing a large number of people from accessing healthcare services.
Nutrition and feeding commodities sufficient to treat severely malnourished children in Afar and Amhara regions for the next two months were dispatched to both regions.
Food partners started a food assistance operation to reach more than 450,000 people in Dessie and Kombolcha over the next two weeks.

 

::::::
::::::

WHO & Regional Offices [to 27 Nov 2021]

WHO & Regional Offices [to 27 Nov 2021]
https://www.who.int/
Selected News, Statements
26 November 2021
Statement
Classification of Omicron (B.1.1.529): SARS-CoV-2 Variant of Concern
[See COVID above for detail]

26 November 2021
Departmental news
WHO publishes updated guidance on validation of elimination of mother-to-child transmission of HIV, syphilis and hepatitis B virus

26 November 2021
Departmental news
Onchocerciasis elimination: achieving NTD road map targets, despite current pandemic challenges

24 November 2021
Statement
Interim statement on COVID-19 vaccination for children and adolescents
[See COVID above for detail]

24 November 2021
News release
First meeting of Scientific Advisory Group for the Origins of Novel Pathogens (SAGO)
[See COVID above for detail]

24 November 2021
Departmental news
What’s new in the TB section of the 2021 WHO Model Lists of Essential Medicines

24 November 2021
Departmental news
WHO releases HIV drug resistance report 2021

23 November 2021
Statement
Statement of the Thirtieth Polio IHR Emergency Committee
[See Polio above for detail]

23 November 2021
News release
WHO issues guidelines on the treatment of children with multisystem inflammatory syndrome associated with COVID-19
WHO today issued updated guidelines on the management of multisystem inflammatory syndrome in children associated with COVID-19 (MIS-C).
MIS-C is a rare but serious condition where children with COVID-19 develop inflammation affecting different organs of the body. Children with this condition need specialized care, and may need to be admitted to intensive care. Although MIS-C is a serious condition, with the right medical care, children with this condition recover.
WHO’s updated guidelines recommend the use of corticosteroids in hospitalized children (aged 0-18 years) with this condition, in addition to supportive treatment and care. This recommendation comes following the availability of three observational studies, pooling data from 885 patients in total.
WHO first described this condition in May 2020, and provided a preliminary clinical definition…

23 November 2021
Joint News Release
WHO and MPP announce the first transparent, global, non-exclusive licence for a COVID-19 technology
WHO’s COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP) today finalized a licensing agreement with the Spanish National Research Council (CSIC) for a COVID-19 serological antibody technology. The test effectively checks for the presence of anti-SARS-CoV-2 antibodies developed either in response to a COVID-19 infection or to a vaccine.  This represents the first transparent, global, non-exclusive licence for a COVID-19 health tool, and the first test licence signed by MPP and included in the WHO Pool…

22 November 2021
Departmental news
Gonorrhoea: latest antimicrobial global surveillance results and guidance for vaccine development published

::::::

Weekly Epidemiological Record, Vol. 96, No. 47, pp. 569–584 26 November 2021
:: Meeting of the Immunization and Vaccine-related Implementation Research Advisory Committee
(IVIR-AC), September 2021
:: Performance of acute flaccid paralysis (AFP) surveillance and incidence of poliomyelitis, 2021
:: Corrigendum to No. 37, 2021

::::::

 

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: WHO Press Briefing on health care workers vaccination 25.11.2021
:: Only 1 in 4 African health workers fully vaccinated against COVID-19 25 November 2021

WHO Region of the Americas PAHO
No new digest content identified

WHO South-East Asia Region SEARO
:: WHO asks countries in South-East Asia Region to be vigilant as cases surge globally and new Variant of Concern is detected 27 November 2021 News release

WHO European Region EURO
:: Women and children experienced higher rates of violence in pandemic’s first months 26-11-2021
:: What are public health and social health measures and why are they still needed at this stage in the COVID-19 pandemic? 25-11-2021
:: WHO Regional Office for Europe: Nearly half a million lives saved by COVID-19 vaccination in less than a year 25-11-2021
:: The WHO European Region could hit over 2 million COVID-19 deaths by March 2022. We can avoid reaching this grim milestone by taking action now 23-11-2021
:: COP26 highlights links between COVID-19 and the SDGs, reinforcing need for bold action in the recovery process 23-11-2021

WHO Eastern Mediterranean Region EMRO
No new digest content identified

WHO Western Pacific Region
No new digest content identified

 

::::::

WHO Events
https://www.who.int/news-room/events/2
[Selected]
Extraordinary meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) – 7 December 2021
7 December 2021
This extraordinary virtual meeting for the Strategic Advisory Group of Experts on Immunization (SAGE) will take place on Tuesday 7 December 2021 to propose recommendations to WHO on the use of COVID-19 vaccine(s).
Agenda: https://cdn.who.int/media/docs/default-source/immunization/sage/2021/december/sage-agenda-7dect2021-virtual-draft-rev26nov.pdf?sfvrsn=f2b71e9f_10

Building stronger, sustainable, equitable societies for pandemic prevention and for navigating the response to the COVID-19 crisis
7 December 2021 12:00 – 13:00 CET
Join us to launch the new WHO evidence brief, “COVID-19 and the social determinants of health and health equity”, and to discuss the implications of the impacts of the social determinants of health equity for pandemic prevention, preparedness, response, and recovery.
* Tuesday 7 December 2021 * 12:00-13:00 Central European Time *
* Join via Zoom * https://who.zoom.us/j/96260096854
Password: Yt@W21bZ

 

::::::

New WHO Publications
https://www.who.int/publications/i
Selected Titles
26 November 2021
Global guidance on criteria and processes for validation: elimination of mother-to-child transmission…

25 November 2021
Caring for women subjected to violence: a WHO curriculum for training health-care providers, revised…

24 November 2021
WHO malaria terminology, 2021 update

24 November 2021
HIV drug resistance report 2021

23 November 2021
WHO third global infodemic management conference: whole-of-society challenges and approaches to responding to infodemics

23 November 2021
Living guidance for clinical management of COVID-19

23 November 2021
WHO preferred product characteristics for gonococcal vaccines

22 November 2021
Paediatric drug optimization standard procedure

22 November 2021
WHO HIV drug resistance network steering group meeting report, June 2021

22 November 2021
Assessment of HIV testing services and antiretroviral therapy service disruptions in the context of COVID-19:…

CDC/ACIP [U.S.] [to 27 Nov 2021]

CDC/ACIP [U.S.] [to 27 Nov 2021]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements [Selected]
CDC Statement on B.1.1.529 (Omicron variant)
Friday, November 26, 2021

ACIP Meetings
No new meeting listed.

MMWR News Synopsis Friday, November 26, 2021
Selected Content
:: Enterovirus D68-Associated Acute Respiratory Illness ─ New Vaccine Surveillance Network, United States, July–November 2018–2020
:: Racial, Ethnic, and Gender Disparities in Awareness of Preexposure Prophylaxis Among HIV-Negative Heterosexually Active Adults at Increased Risk for HIV Infection — 23 Urban Areas, United States, 2019
:: Risk for Stillbirth Among Women With and Without COVID-19 at Delivery Hospitalization — United States, March 2020–September 2021
:: Previously Released: COVID-19–Associated Deaths After SARS-CoV-2 Infection During Pregnancy — Mississippi, March 1, 2020–October 6, 2021

Coronavirus Disease 2019 (COVID-19)– CDC
Approximately 25 announcements/reports/data summaries.
11/26/21
COVID-19 Travel Recommendations by Country

11/24/21
Overall US COVID-19 Vaccine Distribution and Administration Update as of Wed, 24 Nov 2021 06:00:00 EST

11/24/21
Requirement for Proof of COVID-19 Vaccination for Air Passengers

Africa Centres for Disease Control and Prevention’s Statement regarding the new SARS-COV-2 virus variant B.1.1.529

Africa CDC [to 27 Nov 2021]
http://www.africacdc.org/
News
Press Releases
Africa Centres for Disease Control and Prevention’s Statement regarding the new SARS-COV-2 virus variant B.1.1.529
26 November 2021

Press Releases
Mastercard Foundation and Africa CDC’s Saving Lives and Livelihoods initiative delivers first tranche of over 15 million vaccines
ADDIS ABABA, ETHIOPIA, 25 November 2021 — The Mastercard Foundation and Africa CDC jointly announced that 15.2 million vaccines purchased under the Saving Lives and Livelihoods initiative are currently being distributed across Africa. Through Saving Lives and Livelihoods, the Mastercard Foundation is purchasing vaccines for more than 65 million people. This is the first tranche of vaccines to be delivered under the initiative. The vaccines will be distributed within countries by UNICEF.
Launched in June 2021, Saving Lives and Livelihoods is now a $1.5 billion partnership that aims to enable vaccination for millions of people, develop a workforce for vaccine manufacturing, and strengthen the Africa CDC’s capacity to oversee a historic vaccination campaign and effectively respond to future outbreaks.
“Timely delivery of these vaccines underscores the effectiveness of the African Vaccine Acquisition Trust. Working with the Africa CDC and multiple organizations, the Mastercard Foundation will support the roll out of vaccinations to millions across the continent. More remains to be done to urgently increase vaccination rates. We call on governments, funders, civil society and others to step forward to save lives and livelihoods in Africa,” said Reeta Roy, President and CEO of the Mastercard Foundation…

China CDC http://www.chinacdc.cn/en/

China CDC http://www.chinacdc.cn/en/

National Health Commission of the People’s Republic of China [to 27 Nov 2021]
http://en.nhc.gov.cn/
News
Nov 27: Daily briefing on novel coronavirus cases in China
On Nov 26, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 25 new cases of confirmed infections.

China to donate another 1m Sinovac vaccines to Malaysia
2021-11-24

National Medical Products Administration – PRC [to 27 Nov 2021]
http://english.nmpa.gov.cn/
News
Over 2.449 bln COVID-19 vaccine doses administered on Chinese mainland
2021-11-24
More than 2.449 billion doses of COVID-19 vaccine had been administered on the Chinese mainland as of Tuesday, data from the National Health Commission showed on Nov 24.

CCDC Weekly – Weekly Reports: Current Volume (3)
2021-11-26 / No. 48WORLD AIDS DAY ISSUE
PDF of this issue
:: Preplanned Studies: Spatial Analysis of HIV/AIDS Cases Among Out-of-School Youth Aged 15–24 Years — China, 2010–2020
:: Vital Surveillances: Prevention of Mother-To-Child Transmission of HIV — China, 2011–2020
:: Review: Research Progress in the Epidemiology of HIV/AIDS in China
:: Recollections: HIV Prevention and Health Poverty Alleviation — Liangshan Prefecture, Sichuan Province, China, 2017–2020

Organization Announcements

::::::

 

Organization Announcements
Editor’s Note:
Careful readers will note that the number and range of organizations now monitored in our Announcements section below has grown as the impacts of the pandemic have spread across global economies, supply chains and programmatic activity of multilateral agencies and INGOs.

Paul G. Allen Frontiers Group [to 27 Nov 2021]
https://alleninstitute.org/news-press/
News
No new digest content identified.

BARDA – U.S. Department of HHS [to 27 Nov 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
News
No new digest content identified.

BMGF – Gates Foundation [to 27 Nov 2021]
https://www.gatesfoundation.org/ideas/media-center
Press Releases and Statements
No new digest content identified.

Bill & Melinda Gates Medical Research Institute [to 27 Nov 2021]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

CARB-X [to 27 Nov 2021]
https://carb-x.org/
News
No new digest content identified.

Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 27 Nov 2021]
https://centerforvaccineethicsandpolicy.net/
News/Analysis/Statements
:: Past weekly editions and posting of all segments of Vaccines and Global Health: The Week in Review are available here.
:: Informed Consent: A Monthly Review – November 2021 is now posted here

CEPI – Coalition for Epidemic Preparedness Innovations [to 27 Nov 2021]
http://cepi.net/
Latest News
CEPI Statement: Emergence of a new SARS-CoV-2 variant, B.1.1.529
Statement from CEPI CEO, Dr Richard Hatchett.
26 Nov 2021
“The emergence of a SARS-CoV-2 variant B.1.1.529 underscores the critical need for continued COVID-19 vaccine research and development.
“It’s of course critical that we continue to get people vaccinated globally to reduce the amount of virus in circulation but we must also focus effort and resources on improving the current COVID-19 vaccines to make them more effective against multiple variants of SARS-CoV-2.
“Our strategy must seek to optimize the way we deploy our current vaccines so every dose delivers the maximum benefit; improve upon our existing arsenal of vaccines; and prepare now for the possibility of variants that can evade our vaccines.
“CEPI’s world-leading COVID-19 vaccine programme is seeking to do all three…

CEPI funds Aga Khan University-led consortium to conduct mix-and-match trial of COVID-19 vaccines in Pakistan
New collaboration will assess the safety and immunogenicity of heterologous – or ‘mix-and-match’ – combinations of three COVID-19 vaccines currently being deployed in Pakistan.
COVID-19
23 Nov 2021

World’s largest COVID-19 vaccine testing network to assess vaccines against other epidemic and pandemic threats
Set up and funded by CEPI, the network aims to more rapidly, efficiently, and accurately identify the most promising vaccine candidates with the greatest potential to advance to late-stage clinical trials and regulatory review.
22 Nov 2021

DARPA – Defense Advanced Research Projects Agency [to 27 Nov 2021
https://www.darpa.mil/news
News
11/22/2021
Biomanufacturing: Coming Soon to a Galaxy Near You?
The DoD has a role in orbital and lunar missions as defined by the US Space Force (USSF) Space Capstone Publication . In this document, USSF notes the “inherent value of the space domain and the tremendous influence space has on U.S. prosperity and security.” There is a critical DoD need for the continued development and future expansion of orbital manufacturing to enable and ensure supply chain resiliency, sustained technological superiority, and asset security and repair for current and future operations. To meet this unique challenge, DARPA announced today that it was taking an initial step to explore and de-risk manufacturing capabilities that leverage biological processes in resource limited environments with its Biomanufacturing: Survival, Utility, and Reliability beyond Earth (B-SURE) program.

Duke Global Health Innovation Center [to 27 Nov 2021]
https://dukeghic.org/
Our Blog
No new digest content identified.

EDCTP [to 27 Nov 2021]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
News
No new digest content identified.

Emory Vaccine Center [to 27 Nov 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

European Vaccine Initiative [to 27 Nov 2021]
http://www.euvaccine.eu/
Latest News News, Events
EVI
Open call for expert services and trainings by TRANSVAC2

Fondation Merieux [to 27 Nov 2021]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

Gavi [to 27 Nov 2021]
https://www.gavi.org/
News Releases
24 November 2021
Gavi and Switzerland collaborate to prioritise supply to COVAX
Switzerland becomes first country to respond to call to trade places with COVAX in manufacturers’ supply queues
Collaboration will enable COVAX participants to access 1 million doses of the Moderna vaccine earlier, in Q4 2021
Dr Seth Berkley, CEO of Gavi: “This collaboration shows that there is a quick and pragmatic way governments can ensure COVAX participants in lower-income countries have access to COVID-19 vaccines now. I encourage other governments to follow this example and work with COVAX and manufacturers to amend delivery schedules, ensuring commitments under COVAX’s purchase agreements can be fulfilled as a priority.”

22 November 2021
Team Europe vaccine sharing: almost 100 million J & J doses to be donated by the end of 2021 – first doses arriving in African countries this week
The first shipments of almost 100 million doses of the Johnson & Johnson vaccine from Team Europe are arriving in a number of African countries. This donation is facilitated by a tripartite agreement between Belgium (acting on behalf of Team Europe and supported by the European Commission), Johnson & Johnson and Gavi.

GHIT Fund [to 27 Nov 2021]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that
No new digest content identified.

Global Fund [to 27 Nov 2021]
https://www.theglobalfund.org/en/news/
News & Stories
News
Nienke Mulder Joins the Global Fund as Head of Human Resources
22 November 2021
GENEVA – The Global Fund is pleased to announce that Nienke Mulder will join the Global Fund in the role of Chief Human Resources Officer. Nienke has extensive experience and brings more than two decades of leadership and expertise in human resources, change management and diversity and inclusion.
Nienke has been based at GlaxoSmithKline (GSK) in Switzerland for the past five years, where she was a Global Change Director, Global Inclusion & Diversity Strategy Lead and the HR Director for Switzerland.
Prior to GSK, she worked as an independent Strategic Transformation Lead and executive coach for several profit and not-for-profit organizations and leaders…

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 27 Nov 2021]
https://www.glopid-r.org/news/
News
No new digest content identified.

Hilleman Laboratories [to 27 Nov 2021]
http://www.hillemanlabs.org/
No new digest content identified….No “news” page or tab identified.

HHMI – Howard Hughes Medical Institute [to 27 Nov 2021]
https://www.hhmi.org/news
Press Room
Research Nov 22 2021
The Surprising SAGA of a 20-Part Molecular Machine
Scientists solved the structure of a large human protein complex and uncovered some unexpected differences between people and yeast. The structure could guide the development of drugs to treat diseases that arise when this complex malfunctions.

Human Vaccines Project [to 27 Nov 2021]
http://www.humanvaccinesproject.org/
News
Press Release Nov 23, 2021
HVP’s 5th Anniversary: Campaign Launched to Catalyze the First AI Model of the Immune System
In recognition of its five-year anniversary, the Human Vaccines Project is seeking to raise $2 million to fund the next steps towards harnessing the power of the human immune system

IAVI [to 27 Nov 2021]
https://www.iavi.org/newsroom
Latest News
No new digest content identified.

 

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
No new digest content identified.

ICRC [to 27 Nov 2021]
https://www.icrc.org/en/whats-new
Selected News Releases, Statements, Reports
ICRC elects new president
The Assembly, the governing body of the International Committee of the Red Cross, announced today that it has elected Mirjana Spoljaric Egger as the ICRC’s next president. She will succeed President Peter Maurer who has decided to step down in September 2022 after he reaches 10 years of service.
Ms Spoljaric Egger is currently the Assistant Secretary-General, Assistant Administrator and Director of the Regional Bureau for Europe and the Commonwealth of Independent States at the United Nations Development Programme (UNDP). She will begin her renewable four-year term as ICRC president on 1 October 2022…

ICRC alarmed at lack of humanitarian access for 26 million people in Africa
Some 26 million people live in areas in Africa where humanitarian groups have difficulty reaching people most in need, where access to basic services like medical care is extremely limited due to violence and armed conflict, according to a new estimate…
23-11-2021 | News release

 

IFFIm
http://www.iffim.org/
Press Releases/Announcements
No new digest content identified.

IFRC [to 27 Nov 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
22/11/2021
Drowning just below the surface: New IFRC research reveals magnitude of socioeconomic impacts of COVID-19 pandemic
Geneva, 22 November 2021 – Women, people in urban areas and those on the move have been disproportionately and uniquely affected by the devastating socioeconomic impacts of the COVID-19 pandemic. These are some of the findings of new research published today by the International Federation of Red Cross and Red Crescent Societies (IFRC).
The COVID-19 pandemic has had major economic impacts on every nation in the world. The IFRC’s new research also shows the extent of the pandemic’s secondary consequences on communities and individuals. This crisis has caused: increased unemployment and poverty; increased food insecurity; a higher vulnerability to violence; and a loss of education and reduced opportunities for children. It has also exacerbated mental health issues.
Francesco Rocca, President of the IFRC, said: “Our research shows what we have long suspected and feared, namely that the destructive secondary impacts of this pandemic have damaged the fabric of our society and will be felt for years, if not decades, to come. People who were already vulnerable, due to conflict, climate-change, and poverty, have been pushed further towards the edge. And many people who were previously able to cope have become vulnerable, needing humanitarian support for the first time in their lives.”
The new research provides a global overview, with a special focus on ten countries: Afghanistan, Colombia, El Salvador, Iraq, Kenya, Lebanon, Philippines, Spain, South Africa and Turkey…

Institut Pasteur [to 27 Nov 2021]
https://www.pasteur.fr/en/press-area
Press Documents
No new digest content identified.

IOM / International Organization for Migration [to 27 Nov 2021]
http://www.iom.int/press-room/press-releases
News – Selected
News 26 Nov 2021
COVID-19 Forces Sharp Rise in Vulnerable Migrants Transiting Americas: IOM Report

ISC / International Science Council [to 27 Nov 2021]
https://council.science/current/
ISC is a non-governmental organization with a unique global membership that brings together 40 international scientific Unions and Associations and over 140 national and regional scientific organizations including Academies and Research Councils.
News
No new digest content identified.

IVAC [to 27 Nov 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

IVI [to 27 Nov 2021]
http://www.ivi.int/
IVI News & Announcements
No new digest content identified.

Johns Hopkins Center for Health Security [to 27 Nov 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
New Report:  Waypoint on the Path to Health Equity: COVID-19 Vaccination at Month 11
November 23, 2021
Tuesday, November 23, 2021 – The CommuniVax Coalition, led by the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health and the Department of Anthropology at Texas State University, released a new report that recounts progress made toward greater equity in the COVID-19 vaccination campaign and proposes steps to advance gains further.
“As the U.S. response to the COVID-19 pandemic progresses through its second year, the ongoing need to identify and implement strategies for improving vaccine equity among BIPOC communities – especially amid historic disparities in healthcare access and utilization – remains,” write the authors of the report, Waypoint on the Path to Health Equity: COVID-19 Vaccination at Month 11. “This collective assessment could help to identify successes, failures, and lessons learned for future efforts around vaccine promotion and building health equity in BIPOC communities.”
The report identifies several key “wins” that have helped propel COVID-19 vaccination uptake amongst BIPOC communities, including:
With substantial federal emergency funding available, public health departments have been able to hire community health workers and other high-impact assets to advance equity in vaccination.
When decision makers have used grassroots input and hard data, service delivery has better matched BIPOC community needs in the pandemic.
Delivering accurate, culturally competent, and language-appropriate information—in a nonjudgmental, ongoing conversation— has contributed to a more equitable COVID-9 vaccination campaign.
Making COVID-19 vaccinations available alongside services for other needs such as food insecurity, unemployment, and immigration concerns has advanced equity in the pandemic response.

MSF/Médecins Sans Frontières [to 27 Nov 2021]
http://www.msf.org/
Latest [Selected Announcements]
No new digest content identified.

National Academy of Medicine – USA [to 27 Nov 2021]
https://nam.edu/programs/
Selected News/Programs/Events
No new digest content identified.

National Academy of Sciences – USA [to 27 Nov 2021]
http://www.nasonline.org/news-and-multimedia/
News
No new digest content identified.

National Vaccine Program Office – U.S. HHS [to 27 Nov 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

NIH [to 27 Nov 2021]
http://www.nih.gov/news-events/news-releases
News Releases
No new digest content identified.

OECD [to 27 Nov 2021]
http://www.oecd.org/newsroom/publicationsdocuments/bydate/
Newsroom
Data show how the COVID-19 pandemic has hit all aspects of people’s well-being
25/11/2021 – The COVID-19 pandemic has not only had devastating effects on physical health and mortality but has touched every aspect of people’s well-being, with far-reaching consequences for how we live and work, according to a new study by the OECD.

COVID-19 and well-being: life in the pandemic says the virus caused a 16% increase in the average number of deaths across 33 OECD countries between March 2020 and early May 2021, compared with same period over the previous four years. Over the same time frame, survey data in the report reveal rising levels of depression or anxiety and a growing sense among many people of loneliness and of feeling disconnected from society.

Government support helped to sustain average household income levels in 2020 and stemmed the tide of job losses, even as average hours worked fell sharply. Although job retention schemes offered workers some protection, 14% of workers in 19 European OECD countries felt it was “likely they would lose their job” within three months, and nearly 1 in 3 people in 25 OECD countries reported financial difficulties.

The report says experiences of the pandemic have varied widely depending on age, gender and ethnicity, as well as on the type of job people do and on their level of pay and skills. The crisis also aggravated existing social, economic and environmental challenges.

In those countries with available data, workers from ethnic minorities have been more likely to lose their jobs during the pandemic. Mental health deteriorated for almost all population groups on average in 2020 but gaps in mental health by race and ethnicity are also visible. COVID-19 mortality rates for some ethnic minority communities have been more than twice those of other groups.

Younger adults experienced some of the largest declines in mental health, social connectedness and life satisfaction in 2020 and 2021, as well as facing job disruption and insecurity…

PATH [to 27 Nov 2021]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

Sabin Vaccine Institute [to 27 Nov 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

UNAIDS [to 27 Nov 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
26 November 2021
Learning lessons from current and future pandemics

26 November 2021
Ready to be the change

25 November 2021
Jamaican parliamentarians committed to ending discrimination

25 November 2021
Community outreach fills the gap in Mauritania

22 November 2021
Condoms are a critical part of combination prevention

UNHCR Office of the United Nations High Commissioner for Refugees [to 27 Nov 2021]
http://www.unhcr.org/en-us/media-centre.htmlS
Selected News Releases, Announcements
No new digest content identified.

UNICEF [to 27 Nov 2021]
https://www.unicef.org/media/press-releases
Press Releases, News Notes, Statements [Selected]
Press release
11/25/2021
Mastercard Foundation and Africa CDC’s Saving Lives and Livelihoods initiative delivers first tranche of over 15 million vaccines
ADDIS ABABA, ETHIOPIA, 25 November 2021 — The Mastercard Foundation and Africa CDC jointly announced that 15.2 million vaccines purchased under the Saving Lives and Livelihoods initiative are currently being distributed across Africa. Through Saving Lives and Livelihoods, the Mastercard Foundation is purchasing vaccines for more than 65 million people. This is the first tranche of vaccines to be delivered under the initiative. The vaccines will be distributed within countries by UNICEF.
Launched in June 2021, Saving Lives and Livelihoods is now a $1.5 billion partnership that aims to enable vaccination for millions of people, develop a workforce for vaccine manufacturing, and strengthen the Africa CDC’s capacity to oversee a historic vaccination campaign and effectively respond to future outbreaks.
“Timely delivery of these vaccines underscores the effectiveness of the African Vaccine Acquisition Trust. Working with the Africa CDC and multiple organizations, the Mastercard Foundation will support the roll out of vaccinations to millions across the continent. More remains to be done to urgently increase vaccination rates. We call on governments, funders, civil society and others to step forward to save lives and livelihoods in Africa,” said Reeta Roy, President and CEO of the Mastercard Foundation…

Unitaid [to 27 Nov 2021]
https://unitaid.org/
Featured News
No new digest content identified.

Vaccine Equity Cooperative [nee Initiative] [to 27 Nov 2021]
https://vaccineequitycooperative.org/news/
News
No new digest content identified.

Vaccination Acceptance & Demand Initiative [Sabin) [to 27 Nov 2021]
https://www.vaccineacceptance.org/
Announcements
No new digest content identified.

Vaccine Confidence Project [to 27 Nov 2021]
http://www.vaccineconfidence.org/
News, Research and Reports
Coronavirus global impact
Launched April 2, 2020 and recurring every 3 days, Premise Data is utilizing its global network of Contributors to assess economic, social, and health sentiment surrounding the coronavirus (COVID-19).

Vaccine Education Center – Children’s Hospital of Philadelphia [to 27 Nov 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

Wellcome Trust [to 27 Nov 2021]
https://wellcome.ac.uk/news
News and reports
News
Fiona Powrie appointed new Deputy Chair of Governors
23 November 2021
Fiona Powrie is Director of the Kennedy Institute of Rheumatology at the University of Oxford. With a background in immunology and translational research, she has been a member of Wellcome’s Board of Governors since January 2018.

The Wistar Institute [to 27 Nov 2021]
https://www.wistar.org/news/press-releases
Press Releases
Nov. 23, 2021
The Wistar Institute Receives $4 Million in Funding From the Commonwealth of Pennsylvania to Advance COVID-19 Research, Address COVID-19 Risk on Vulnerable Populations, and Assess Pandemic Preparedness
PHILADELPHIA — (Nov. 23, 2021) — The Commonwealth of Pennsylvania has granted The Wistar Institute $4 million to fund COVID-19 research focused on understanding the impact of COVID-19 on certain at-risk populations and supporting the commonwealth’s preparation and emergency response planning for future pandemics.

WFPHA: World Federation of Public Health Associations [to 27 Nov 2021]
https://www.wfpha.org/
Latest News – Blog
Waive Vaccine Intellectual Property Rights Now!
Nov 25, 2021
In the current global pandemic, vaccine equity means a fair distribution of vaccine, so that all countries can immunise their populations regardless of their income, pre-existing infrastructure, political context or economic development. People who live in low-and-middle-income countries are significantly less likely to have access to vaccination than those in high income countries, even if they are in the highest clinical risk groups or are health or care workers. COVID-19 vaccines significantly reduce the burden of serious illness, death, duration of symptoms and risk of transmission. Vaccination is our most important means to control the pandemic. Failure to control the level of virus circulating in communities increases the risk that new vaccine-resistant variants will emerge. This will prolong the pandemic for all countries, leaving us all at risk of new, high consequence variants. It remains the case that we will not be free of this virus, until we are all free of it.
The Global Network for Academic Public Health and WFPHA has released a statement in support of waiving intellectual property rights related to COVID-19 vaccines to increase global vaccine equity.

World Bank [to 27 Nov 2021]
http://www.worldbank.org/en/news/all
Selected News, Announcements
Policies Targeting Integration into Global Value Chains Key to Harnessing the Potential of Industrialization in Africa
WASHINGTON, November 23, 2021 — As the world continues to be reshaped by emerging trends in technology, international trade and investment, and the COVID-19 pandemic, Sub-Saharan African countries must…
Date: November 23, 2021 Type: Press Release

World Organisation for Animal Health (OIE) [to 27 Nov 2021]
https://www.oie.int/en/media/news/
Press Releases, Statements
No new digest content identified.

WTO – World Trade Organisation [to 27 Nov 2021]
http://www.wto.org/english/news_e/news_e.htm
WTO News and Events
General Council decides to postpone MC12 indefinitely
26 November 2021
The General Council agreed late Friday (26 November) to postpone the imminent Ministerial Conference after an outbreak of a particularly transmissible strain of the COVID-19 virus led several governments to impose travel restrictions that would have prevented many ministers from reaching Geneva.

DG Okonjo-Iweala briefs members on work to support equitable access to COVID-19 vaccines
25 November 2021
Director-General Ngozi Okonjo-Iweala hosted on 25 November an information session on the work done by the WTO Secretariat to support equitable access to COVID-19 vaccines. A total of 146 representatives from 62 members and observers participated in the briefing session.
[See Milestones above for detail]

 

::::::

ARM [Alliance for Regenerative Medicine] [to 27 Nov 2021]
https://alliancerm.org/press-releases/
Selected Press Releases
No new digest content identified.

BIO [to 27 Nov 2021]
https://www.bio.org/press-releases
Press Releases, Letters, Testimony, Comments [Selected]
No new digest content identified.

DCVMN – Developing Country Vaccine Manufacturers Network [to 27 Nov 2021]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

ICBA – International Council of Biotechnology Associations [to 27 Nov 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.

IFPMA [to 27 Nov 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
The European Commission and Innovative Biopharmaceutical Industries to Explore Potential Initiatives to Enhance Local Production
26 November 2021
[See Milestones above for detail]

IFPMA Statement – Special Session of World Health Assembly on Pandemic Treaty
24 November 2021
[See Milestones above for detail]

Joint Statement on World Antimicrobial Awareness Week
24 November 2021

 

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
No new digest content identified.

International Alliance of Patients’ Organizations – IAPO [to 27 Nov 2021]
https://www.iapo.org.uk/news/topic/6
Press and media [Selected]
IAPO’s Joint Statement on World Antimicrobial Awareness Week 2021
Wednesday, 24 November 2021
On World Antimicrobial Awareness Week (WAAW) the International Alliance of Patients’ Organizations (IAPO), the IAPO Patients for Patient Safety Observatory and its AMR Patient Alliance, International Council of Nurses (ICN), International Pharmaceutical Federation (FIP), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the Union for International Cancer Control (UICC), responding to the call to One Health stakeholders to be Antimicrobial Resistance (AMR) Awareness champions, support the 2021 theme “Spread Awareness. Stop Resistance” and call on all stakeholders to encourage best practices amongst all actors of the health system to preserve existing antimicrobials and call for policy reforms to encourage sustainable investment in new antibiotics.

PhRMA [to 27 Nov 2021]
http://www.phrma.org/
Latest News [Selected]
No new digest content identified.

Journal Watch

Journal Watch
Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focu-s on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.
If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

Vaccination distribution by community pharmacists under the COVID-19 vaccine appointment system in Taiwan

Artificial Intelligence – An International Journal
Volume 300 November 2021
https://www.sciencedirect.com/journal/artificial-intelligence/vol/300/suppl/C

 


BMC Cost Effectiveness and Resource Allocation
http://resource-allocation.biomedcentral.com/
(Accessed 27 Nov 2021)
Vaccination distribution by community pharmacists under the COVID-19 vaccine appointment system in Taiwan
Authors: Ya Wen Lin, Che Huei Lin and Ming Hung Lin
Content type: Commentary
22 November 2021

The impact and cost-effectiveness of 9-valent human papillomavirus vaccine in adolescent females in Hong Kong

Artificial Intelligence – An International Journal
Volume 300 November 2021
https://www.sciencedirect.com/journal/artificial-intelligence/vol/300/suppl/C

 

The impact and cost-effectiveness of 9-valent human papillomavirus vaccine in adolescent females in Hong Kong
Authors: Tak Hong Cheung, Sally Shuk Yee Cheng, Danny C. Hsu, Queenie Wing-Lei Wong, Andrew Pavelyev, Anuj Walia, Kunal Saxena and Vimalanand S. Prabhu
Content type: Research
20 November 2021

Acceptability of mobile-phone reminders for routine childhood vaccination appointments in Nigeria – a systematic review and meta-analysis

BMC Health Services Research
http://www.biomedcentral.com/bmchealthservres/content
(Accessed 27 Nov 2021)

 

Acceptability of mobile-phone reminders for routine childhood vaccination appointments in Nigeria – a systematic review and meta-analysis
Mobile-phone reminders have gained traction among policymakers as a way to improve childhood vaccination coverage and timeliness. However, there is limited evidence on the acceptability of mobile-phone reminde…
Authors: Paul Eze, Sergius Alex Agu, Ujunwa Justina Agu and Yubraj Acharya
Citation: BMC Health Services Research 2021 21:1276
Content type: Research
Published on: 26 November 2021

The vaccination threshold for SARS-CoV-2 depends on the indoor setting and room ventilation

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 27 Nov 2021)

 

The vaccination threshold for SARS-CoV-2 depends on the indoor setting and room ventilation
Effective vaccines are now available for SARS-CoV-2 in the 2nd year of the COVID-19 pandemic, but there remains significant uncertainty surrounding the necessary vaccination rate to safely lift occupancy contr…
Authors: A. Mikszewski, L. Stabile, G. Buonanno and L. Morawska
Citation: BMC Infectious Diseases 2021 21:1193
Content type: Research
Published on: 26 November 2021

COVID-19 vaccine acceptance, hesitancy, and determinants among physicians in a university-based teaching hospital in Thailand

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 27 Nov 2021)

 

COVID-19 vaccine acceptance, hesitancy, and determinants among physicians in a university-based teaching hospital in Thailand
The COVID-19 vaccines provide renewed hope in the fight against the recent pandemic. To ensure widespread vaccination, it is crucial to analyze vaccine willingness and its determinants among physicians, key he…
Authors: May Sirikalyanpaiboon, Krittin Ousirimaneechai, Jeerath Phannajit, Panyavee Pitisuttithum, Watsamon Jantarabenjakul, Roongruedee Chaiteerakij and Leilani Paitoonpong
Citation: BMC Infectious Diseases 2021 21:1174
Content type: Research
Published on: 22 November 2021

Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

BMC Infectious Diseases
http://www.biomedcentral.com/bmcinfectdis/content
(Accessed 27 Nov 2021)

 

Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials
Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective…
Authors: Cathrine Axfors, Perrine Janiaud, Andreas M. Schmitt, Janneke van’t Hooft, Emily R. Smith, Noah A. Haber, Akin Abayomi, Manal Abduljalil, Abdulkarim Abdulrahman, Yeny Acosta-Ampudia, Manuela Aguilar-Guisado, Farah Al-Beidh, Marissa M. Alejandria, Rachelle N. Alfonso, Mohammad Ali, Manaf AlQahtani…
Citation: BMC Infectious Diseases 2021 21:1170
Content type: Research article
Published on: 20 November 2021

Safety, infectivity and immunogenicity of a genetically attenuated blood-stage malaria vaccine

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 27 Nov 2021)

 

Safety, infectivity and immunogenicity of a genetically attenuated blood-stage malaria vaccine
There is a clear need for novel approaches to malaria vaccine development. We aimed to develop a genetically attenuated blood-stage vaccine and test its safety, infectivity, and immunogenicity in healthy volun…
Authors: Rebecca Webster, Silvana Sekuloski, Anand Odedra, Stephen Woolley, Helen Jennings, Fiona Amante, Katharine R. Trenholme, Julie Healer, Alan F. Cowman, Emily M. Eriksson, Priyanka Sathe, Jocelyn Penington, Adam J. Blanch, Matthew W. A. Dixon, Leann Tilley, Michael F. Duffy…
Citation: BMC Medicine 2021 19:293
Content type: Research article
Published on: 22 November 2021

Safety, infectivity and immunogenicity of a genetically attenuated blood-stage malaria vaccine

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 27 Nov 2021)

 

Safety, infectivity and immunogenicity of a genetically attenuated blood-stage malaria vaccine
There is a clear need for novel approaches to malaria vaccine development. We aimed to develop a genetically attenuated blood-stage vaccine and test its safety, infectivity, and immunogenicity in healthy volun…
Authors: Rebecca Webster, Silvana Sekuloski, Anand Odedra, Stephen Woolley, Helen Jennings, Fiona Amante, Katharine R. Trenholme, Julie Healer, Alan F. Cowman, Emily M. Eriksson, Priyanka Sathe, Jocelyn Penington, Adam J. Blanch, Matthew W. A. Dixon, Leann Tilley, Michael F. Duffy…
Citation: BMC Medicine 2021 19:293
Content type: Research article
Published on: 22 November 2021

COVID-19 vaccine preferences among university students in Hong Kong: a discrete choice experiment

BMC Research Notes
http://www.biomedcentral.com/bmcresnotes/content
(Accessed 27 Nov 2021)

 

COVID-19 vaccine preferences among university students in Hong Kong: a discrete choice experiment
To promote public health and resume university activities, COVID-19 vaccination has been mandated from an increasing number of universities worldwide. The objective of the study is to understand the factors th…
Authors: Xue Li, Man Yui Chong, Ching Yui Chan, Vindy Wing Sun Chan and Xinning Tong
Citation: BMC Research Notes 2021 14:421
Content type: Research note
Published on: 22 November 2021

Genomic medicine in the Middle East

Genome Medicine
https://genomemedicine.biomedcentral.com/articles
[Accessed 27 Nov 2021]

 

Genomic medicine in the Middle East
We discuss the current state of genomic medicine in Arab countries of the Middle East, a region with outsized contribution to Mendelian genetics due to inbreeding yet has poor representation in global variome …
Authors: Ahmad N. Abou Tayoun, Khalid A. Fakhro, Alawi Alsheikh-Ali and Fowzan S. Alkuraya
Citation: Genome Medicine 2021 13:184
Content type: Comment
Published on: 23 November 2021

Austria: Government Adopts Immediate Nationwide Lockdown; General COVID-19 Vaccine Mandate to Start February 1, 2022

Global Legal Monitor – Library of Congress/USA
https://www.loc.gov/collections/global-legal-monitor/
[Accessed 27 Nov 2021]

 

Article
Austria: Government Adopts Immediate Nationwide Lockdown; General COVID-19 Vaccine Mandate to Start February 1, 2022
On November 21, 2021, the Austrian government adopted the 5th COVID-19 Emergency Measures Regulation (5. COVID-19-Notmaßnahmenverordnung, 5. COVID-19-NotMV) to prevent the collapse of the health care system in Austria due to the unprecedented rapid increase in COVID-19 cases and the worsening availability of beds in hospital and intensive care units. (5. COVID-19-NotMV § 1; Legal … Continue reading “Austria: Government Adopts Immediate Nationwide Lockdown;…
Contributor: Gesley, Jenny
Date: 2021-11-23

Localisation and local humanitarian action

Humanitarian Exchange Magazine
Number 79, May 2021
https://odihpn.org/magazine/localisation-and-local-humanitarian-action/

 

Localisation and local humanitarian action
by HPN October 2020
The theme of this edition of Humanitarian Exchange is localisation+ and local humanitarian action. Five years ago this week, donors, United Nations (UN) agencies,  non-governmental organisations (NGOs), the International Committee of the Red Cross (ICRC) and International Federation of Red Cross and Red Crescent Societies (IFRC) committed within the Grand Bargain to increase multi-year investments in the institutional capacities of local and national responders, and to provide at least 25% of humanitarian funding to them as directly as possible. Since then, there is increasing consensus at policy and normative level, underscored by the Covid-19 pandemic, that local leadership should be supported.  Localisation has gone from a fringe conversation among policy-makers and aid agencies in 2016 to a formal priority under the Grand Bargain. Wider global movements on anti-racism and decolonisation have also brought new momentum to critical reflections on where power, knowledge and capacity reside in the humanitarian system. Yet progress has been slow and major gaps remain between the rhetoric around humanitarian partnerships, funding and coordination and practices on the ground.

Association Between mRNA Vaccination and COVID-19 Hospitalization and Disease Severity

JAMA
November 23/30, 2021, Vol 326, No. 20, Pages 1995-2087
https://jamanetwork.com/journals/jama/currentissue

 

Original Investigation
Association Between mRNA Vaccination and COVID-19 Hospitalization and Disease Severity
Mark W. Tenforde, MD, PhD; Wesley H. Self, MD, MPH; Katherine Adams, MPH; et al.
free access has active quiz
JAMA. 2021;326(20):2043-2054. doi:10.1001/jama.2021.19499
This case-control study explores the association between vaccination with mRNA COVID-19 vaccines and hospitalization for COVID-19, and, among patients hospitalized with COVID-19, the association with progression to critical disease in adults from 18 US states.

The Lancet Commission on diagnostics: transforming access to diagnostics

The Lancet
Nov 27, 2021 Volume 398 Number 10315 p1939-2050, e17
https://www.thelancet.com/journals/lancet/issue/current

 

The Lancet Commissions
The Lancet Commission on diagnostics: transforming access to diagnostics
Kenneth A Fleming, et al
Key messages
47% of the global population has little to no access to diagnostics.
Diagnostics are central and fundamental to quality health care. This notion is under-recognised, leading to underfunding and inadequate resources at all levels.
The level of primary health care is the diagnostic so-called last mile and particularly affects poor, rural, and marginalised communities globally; appropriate access is essential for equity and social justice.
The COVID-19 pandemic has emphasised the crucial role of diagnostics in health care and that without access to diagnostics, delivery of universal health coverage, antimicrobial resistance mitigation, and pandemic preparedness cannot be achieved.
Innovations within the past 15 years in many areas (eg, in financing, technology, and workforce) can reduce the diagnostic gap, improve access, and democratise diagnostics to empower patients.
As an example of the potential impact, 1·1 million premature deaths in low-income and middle-income countries could be avoided annually by reducing the diagnostic gap for six priority conditions: diabetes, hypertension, HIV, and tuberculosis in the overall population, and hepatitis B virus infection and syphilis for pregnant women.
The economic case for such investment is strong. The median benefit–cost exceeds one for five of the six priority conditions in middle-income countries, and exceeds one for four of the six priority conditions in low-income countries, with a range of 1·4:1 to 24:1.
Given the depth and breadth of the problems, sustained access to quality, affordable diagnostics will require multi-decade prioritisation, commitment, and investment. Incorporating diagnostics into universal health coverage packages will begin this process.

Exome sequencing and analysis of 454,787 UK Biobank participants

Nature
Volume 599 Issue 7886, 25 November 2021
https://www.nature.com/nature/volumes/599/issues/7886

 

Article | 18 October 2021 | Open Access
Exome sequencing and analysis of 454,787 UK Biobank participants
Whole-exome sequencing analysis of 454,787 individuals in the UK Biobank is used to examine the association of protein-coding variants with nearly 4,000 health-related traits, identifying 564 distinct genes with significant trait associations.
Joshua D. Backman, Alexander H. Li, Manuel A. R. Ferreira