Vaccines and Global Health: The Week in Review :: 09 January 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

Public Health Emergency of International Concern (PHEIC)

Coronavirus [COVID-19]

Public Health Emergency of International Concern (PHEIC)

 

Weekly Epidemiological and Operational updates

Last update: 9 January 2021

Confirmed cases ::    87 589 206    [week ago: 82 356 727]    [two weeks ago: 78 604 532]

Confirmed deaths ::    1 906 606    [week ago:   1 815 433]   [two weeks ago:   1 744 235]

Countries, areas or territories with cases :: 222

WHO Director-General’s opening remarks at the media briefing on COVID-19 – 8 January 2021

Milestones :: Perspectives :: Research

WHO Director-General’s opening remarks at the media briefing on COVID-19 – 8 January 2021
:: COVAX – set up by GAVI, CEPI and WHO in April last year – has now secured contracts of 2 billion doses of safe and effective COVID-19 vaccines, which we are ready to rollout as soon as the vaccines are delivered.  
:: However, this is where the current challenge is. Rich countries have bought up the majority of the supply of multiple vaccines.  Going forward, I want to see manufacturers prioritise supply and rollout through COVAX.  
:: If I said one thing to people in areas where there are high numbers of cases, it would be to do all you can to avoid mixing with people from other households, especially inside.  
:: This year is the year of the health and care worker. Let’s show our respect and appreciation for health workers by protecting each other and vaccinating all health workers everywhere now. 

COVAX – set up by GAVI, CEPI and WHO in April last year – has now secured contracts of 2 billion doses of safe and effective COVID-19 vaccines, which we are ready to rollout as soon as the vaccines are delivered. And we also have the right of first refusal on an additional 1 billion doses.

However, this is where the current challenge is: At present, 42 countries are rolling out safe and effective COVID-19 vaccines. 36 of these are high-income countries and six are middle-income.

So there’s a clear problem that low- and most middle-income countries are not receiving the vaccine yet. This is a problem we can and we must solve together through COVAX and the ACT-Accelerator.

At the outset, rich countries have bought up the majority of the supply of multiple vaccines. Now we’re also seeing both high and middle-income countries, that are part of COVAX, making additional bilateral deals. This potentially bumps up the price for everyone and means high-risk people in the poorest and most marginalized countries don’t get the vaccine.

And some companies and countries have not submitted critical data, which we need to issue Emergency Use Listings, which blocks the whole system of procurement and delivery.   

Vaccine nationalism hurts us all and is self-defeating. But on the flipside, vaccinating equitably saves lives, stablises health systems and would lead to a truly global economic recovery that stimulates job creation…

…Going forward, I want to see manufacturers prioritise supply and rollout through COVAX.

I urge countries that have contracted more vaccines than they will need, and are controlling the global supply, to also donate and release them to COVAX immediately, which is ready TODAY to rollout quickly.

And I urge countries and manufacturers to stop making bilateral deals at the expense of COVAX. No country is exceptional and should cut the queue and vaccinate all their population while some remain with no supply of the vaccine.

Science has delivered, let’s not waste the opportunity to protect lives of those most at risk and ensure all economies have a fair shot at recovery…

Extraordinary meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) – 5 January 2021 [Pfizer-BioNTech COVID-19 vaccine BNT162b2]

Milestones :: Perspectives :: Research

 

Extraordinary meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) – 5 January 2021 [Pfizer-BioNTech COVID-19 vaccine BNT162b2]
This extraordinary virtual meeting for the Strategic Advisory Group of Experts on Immunization (SAGE) was held on Tuesday 05 January 2021 to propose recommendations to WHO on the use of COVID-19 vaccine(s).

Interim recommendations for use of the Pfizer–BioNTech COVID-19 vaccine, BNT162b2, under Emergency Use Listing
WHO Team: WHO Headquarters (HQ)
Reference numbers: WHO Reference Number: WHO/2019-nCoV/vaccines/SAGE_recommendation/BNT162b2/2021.1
Copyright CC BY-NC-SA 3.0 IGO
Full text PDF: https://apps.who.int/iris/rest/bitstreams/1326072/retrieve [7 pages]

[Selected Excerpts; Full text at pdf link above]
General goal and strategy for the use of the mRNA vaccine BNT162b2 against COVID-19 (Pfizer–BioNTech)
The COVID-19 pandemic has caused significant morbidity and mortality throughout the world, as well as major social, educational and economic disruptions. There is an urgent global need for effective and safe vaccines. On 31 December 2020, WHO listed the COVID-19 mRNA vaccine BNT162b2 for emergency use, making the Pfizer–BioNTech vaccine the first to receive emergency validation from WHO since the outbreak began a year earlier. The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.

BNT162b2, an mRNA vaccine against COVID-19 developed by BioNTech and Pfizer, has been shown to have an efficacy of approximately 95%, based on a median follow-up of two months. The data reviewed by WHO at this time support the conclusion that the known and potential benefits of BNT162b2 outweigh the known and potential risks. As sufficient vaccine supply will not be immediately available to immunize all who could benefit from it, countries are recommended to use the WHO Prioritization Roadmap [4] and the WHO Values Framework [5] as guidance for their prioritization of target groups. As long as vaccine supplies are very limited (stage I in the WHO Prioritization Roadmap), in settings with community transmission, the Roadmap recommends that priority be given initially to health workers at high risk and older people with and without comorbidities. Protecting high-risk health workers has a threefold purpose: (i) to protect the individual health workers; (ii) to protect critical essential services during the COVID-19 pandemic, and (iii) to prevent onward transmission to vulnerable people. Protecting older people will have the greatest public health impact in terms of reducing the number of deaths. As more vaccine becomes available, additional priority groups should be vaccinated as outlined in the WHO Prioritization Roadmap [4], taking into account national epidemiological data and other relevant considerations…

 

… Considerations for deferring the second dose
WHO acknowledges that a number of countries face exceptional circumstances of vaccine supply constraints combined with a high disease burden. Some countries have therefore considered delaying the administration of the second dose to allow for a higher initial coverage. This is based on the observation that efficacy has been shown to start from day 12 after the first dose and reached about 89% between days 14 and 21, at the time when the second dose was given. No data on longer term efficacy for a single dose of the mRNA vaccine BNT162b2 currently exist, as the trial participants received 2 doses with an interval between doses in the trial ranging from 19 to 42 days. Of note, neutralizing antibody responses are modest after the first dose and increase substantially after the second dose.

Countries experiencing exceptional epidemiological circumstances may consider delaying for a short period the administration of the second dose as a pragmatic approach to maximizing the number of individuals benefiting from a first dose while vaccine supply continues to increase. WHO’s recommendation at present is that the interval between doses may be extended up to 42 days (6 weeks), on the basis of currently available clinical trial data. Should additional data become available on longer intervals between doses, revision of this recommendation will be considered. Countries should ensure that any such programme adjustments to dose intervals do not affect the likelihood of receiving the second dose…

 

…Special settings
Persons in settings such as refugee and detention camps, prisons, slums, and other settings with high population densities, where physical distancing is not implementable, should be prioritized for vaccination as outlined in the WHO Prioritization Roadmap [4], taking into account national epidemiological data, vaccine supply and other relevant considerations.

As noted in the WHO Prioritization Roadmap, national programmes should give special consideration to groups that are disproportionately affected by COVID-19 or that face health inequities as a result of social or structural inequities. Such groups should be identified, barriers to vaccination should be addressed, and programmes should be developed to enable equitable access to vaccines.

In the current period of very limited vaccine supply, preferential vaccination of international travelers would counter the principle of equity. Because of this and the lack of evidence on whether vaccination reduces the risk of transmission, WHO currently does not recommend COVID-19 vaccination of travelers (unless they are also part of a high-risk group or in epidemiological settings identified in the WHO Prioritization Roadmap [4]). With increasing vaccine supply, these recommendations will be revisited…

 

…Community engagement, effective communication, and legitimacy
Community engagement and effective communication (including risk communication) are essential to the success of COVID-19 vaccination programmes. Prioritization decisions should be made through transparent processes that are based on shared values, the best available scientific evidence, and appropriate representation and input by affected parties. Furthermore, communication about the mechanism of action of mRNA vaccines, and efficacy and safety data derived from clinical trials and post-marketing studies, needs to be strengthened. Strategies should include: (1) culturally acceptable and linguistically accessible communications regarding COVID-19 vaccination made freely available; (2) active community engagement and involvement of community opinion leaders and trusted voices to improve awareness and understanding of such communications, and (3) inclusion of diverse and affected stakeholder opinions in decision-making. Such efforts are especially important in subpopulations who may be unfamiliar with or distrustful of health care systems and immunization…

 

…Recommendations on addressing current knowledge gaps through further research
In order to confirm the safety profile demonstrated in the clinical trials in the short term, active surveillance of large numbers of vaccinated individuals is necessary in the general population studied for a longer duration, as well as of specific at-risk subpopulations. It is essential for Pfizer–BioNTech and vaccination providers to report the following to adverse event reporting systems in countries: all vaccine administration errors, serious adverse events, cases of multisystem inflammatory syndrome (MIS) following vaccination, anaphylaxis and other serious allergic reactions, Bell`s palsy, and cases of COVID-19 following vaccination that result in hospitalization or death.

WHO recommends the following research and post-authorization monitoring activities:
vaccine effectiveness over time;
ongoing collection of safety data in vaccine recipients;
surveillance for COVID-19 among vaccinated individuals, looking for vaccine-induced enhanced disease (possibly as vaccine-induced antibody levels decline);
safety data from inadvertently vaccinated pregnant women during trials and post-authorization;
safety data from pregnant women who receive vaccine because they are members of prioritized groups, e.g. health workers;
prospective studies on the safety of BNT162b2 in pregnant women;
impact on infants of vaccination of breastfeeding mothers;
safety data on vaccination in immunocompromised persons, including persons living with HIV and persons with autoimmune disease;
impact of delayed second dose as currently implemented by certain countries;
clinical trials on the efficacy and safety of vaccination of children below the age of 16 years;
immunogenicity and safety studies of co-administration with other vaccines, including influenza and pneumococcal vaccines, to adults and older persons;
studies to determine how protection changes with time since vaccination and whether protection can be prolonged by booster doses;
studies to demonstrate whether this vaccine reduces SARS-CoV-2 transmission and viral shedding;
stability of vaccine under alternative cold-chain distribution and storage conditions;
effectiveness of the proposed strategies for the prevention and management of anaphylactic reactions;
interchangeability and “mix and match” studies within and across COVID-19 vaccine platforms;
global surveillance of virus evolution and the impact of virus mutants on vaccine effectiveness to support possible update of vaccines if needed;
head-to-head studies with other vaccines on extent and duration of immunity using standardized neutralization assays and mucosal immunity assays.

 

::::::

Meeting materials
Please find related materials for the meeting, including a final agenda, list of participants, declaration of interests, background materials and presentations made during the meeting, below.

Background Materials
:: Final Meeting Agenda
:: Background paper on Covid-19 disease and vaccines
:: mRNA vaccines against COVID-19: Pfizer-BioNTech COVID-19 vaccine BNT162b2

Presentations
:: Introduction, session objective setting, update on regulatory decisions and overview of Working Group deliverables H. NOHYNEK. pdf, 4.1Mb
:: Safety monitoring S. Pal. pdf, 1Mb
:: Assessment of Evidence (SAGE working group)

FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines

Milestones :: Perspectives :: Research

 

FDA

FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
January 04, 2021
Commissioner of Food and Drugs – Food and Drug Administration, Stephen M. Hahn M.D.
Director – Center for Biologics Evaluation and Research (CBER), Peter Marks M.D., PhD.

Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 infection in adults. As the first round of vaccine recipients become eligible to receive their second dose, we want to remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness.

We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19. These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.

 

The available data continue to support the use of two specified doses of each authorized vaccine at specified intervals. For the Pfizer-BioNTech COVID-19 vaccine, the interval is 21 days between the first and second dose. And for the Moderna COVID-19 vaccine, the interval is 28 days between the first and second dose. 

What we have seen is that the data in the firms’ submissions regarding the first dose is commonly being misinterpreted. In the phase 3 trials, 98% of participants in the Pfizer-BioNTech trial and 92% of participants in the Moderna trial received two doses of the vaccine at either a three- or four-week interval, respectively. Those participants who did not receive two vaccine doses at either a three-or four-week interval were generally only followed for a short period of time, such that we cannot conclude anything definitive about the depth or duration of protection after a single dose of vaccine from the single dose percentages reported by the companies.

Using a single dose regimen and/or administering less than the dose studied in the clinical trials without understanding the nature of the depth and duration of protection that it provides is concerning, as there is some indication that the depth of the immune response is associated with the duration of protection provided. If people do not truly know how protective a vaccine is, there is the potential for harm because they may assume that they are fully protected when they are not, and accordingly, alter their behavior to take unnecessary risks.

 

We know that some of these discussions about changing the dosing schedule or dose are based on a belief that changing the dose or dosing schedule can help get more vaccine to the public faster. However, making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health.

We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine. 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

EMA

Milestones :: Perspectives :: Research

 

EMA

 

News: Extra dose from vials of Comirnaty COVID-19 vaccine
Last updated: 08/01/2021
EMA’s human medicines committee (CHMP) has recommended updating the product information for Comirnaty to clarify that each vial contains 6 doses of the vaccine.
In order to extract six doses from a single vial, low dead-volume syringes and/or needles should be used. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microliters. If standard syringes and needles are used, there may not be enough of the vaccine to extract a sixth dose from a vial.
If the amount of vaccine remaining in the vial after the fifth dose cannot provide a full dose (0.3 ml), the healthcare professional must discard the vial and its contents. There should be no pooling from multiple vials to make up a full dose, and any unused vaccine should be discarded 6 hours after dilution. Further information on all the steps for using Comirnaty is available in the updated product information

 

News: EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU (updated)
Last updated: 06/01/2021
EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent Coronavirus disease (COVID-19) in people from 18 years of age. This is the second COVID-19 vaccine that EMA has recommended for authorisation.
EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission. This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns.
“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, Executive Director of EMA. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.
“As for all medicines, we will closely monitor data on the safety and effectiveness of the vaccine to ensure ongoing protection of the EU public. Our work will always be guided by the scientific evidence and our commitment to safeguard the health of EU citizens.”…

FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines

Milestones :: Perspectives :: Research

 

FDA

FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
January 04, 2021
Commissioner of Food and Drugs – Food and Drug Administration, Stephen M. Hahn M.D.
Director – Center for Biologics Evaluation and Research (CBER), Peter Marks M.D., PhD.

Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 infection in adults. As the first round of vaccine recipients become eligible to receive their second dose, we want to remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness.

We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19. These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.

 

The available data continue to support the use of two specified doses of each authorized vaccine at specified intervals. For the Pfizer-BioNTech COVID-19 vaccine, the interval is 21 days between the first and second dose. And for the Moderna COVID-19 vaccine, the interval is 28 days between the first and second dose. 

What we have seen is that the data in the firms’ submissions regarding the first dose is commonly being misinterpreted. In the phase 3 trials, 98% of participants in the Pfizer-BioNTech trial and 92% of participants in the Moderna trial received two doses of the vaccine at either a three- or four-week interval, respectively. Those participants who did not receive two vaccine doses at either a three-or four-week interval were generally only followed for a short period of time, such that we cannot conclude anything definitive about the depth or duration of protection after a single dose of vaccine from the single dose percentages reported by the companies.

Using a single dose regimen and/or administering less than the dose studied in the clinical trials without understanding the nature of the depth and duration of protection that it provides is concerning, as there is some indication that the depth of the immune response is associated with the duration of protection provided. If people do not truly know how protective a vaccine is, there is the potential for harm because they may assume that they are fully protected when they are not, and accordingly, alter their behavior to take unnecessary risks.

 

We know that some of these discussions about changing the dosing schedule or dose are based on a belief that changing the dose or dosing schedule can help get more vaccine to the public faster. However, making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health.

We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine. 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

News: Extra dose from vials of Comirnaty COVID-19 vaccine

Milestones :: Perspectives :: Research

 

EMA

 

News: Extra dose from vials of Comirnaty COVID-19 vaccine
Last updated: 08/01/2021
EMA’s human medicines committee (CHMP) has recommended updating the product information for Comirnaty to clarify that each vial contains 6 doses of the vaccine.
In order to extract six doses from a single vial, low dead-volume syringes and/or needles should be used. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microliters. If standard syringes and needles are used, there may not be enough of the vaccine to extract a sixth dose from a vial.
If the amount of vaccine remaining in the vial after the fifth dose cannot provide a full dose (0.3 ml), the healthcare professional must discard the vial and its contents. There should be no pooling from multiple vials to make up a full dose, and any unused vaccine should be discarded 6 hours after dilution. Further information on all the steps for using Comirnaty is available in the updated product information

 

News: EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU (updated)
Last updated: 06/01/2021
EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent Coronavirus disease (COVID-19) in people from 18 years of age. This is the second COVID-19 vaccine that EMA has recommended for authorisation.
EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission. This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns.
“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, Executive Director of EMA. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.
“As for all medicines, we will closely monitor data on the safety and effectiveness of the vaccine to ensure ongoing protection of the EU public. Our work will always be guided by the scientific evidence and our commitment to safeguard the health of EU citizens.”…

U.K.

Milestones :: Perspectives :: Research

 

U.K.

 

Medicines and Healthcare products Regulatory Agency (MHRA)
https://www.gov.uk/coronavirus
Announcements
Third vaccine (Moderna) approved by UK regulator
Published 8 January 2021
The vaccine has been approved after meeting the required safety, quality and effectiveness standards.

 

U.K. Joint Committee on Vaccination and Immunisation (JCVI)
https://www.gov.uk/search/all?keywords=JCVI
Independent report
Priority groups for coronavirus (COVID-19) vaccination: advice from the JCVI, 30 December 2020
Advice from the Joint Committee on Vaccination and Immunisation (JCVI) on the groups that should be prioritised for vaccination
Updated: 6 January 2021
Update to footnote 2: the Pfizer-BioNTech vaccine is authorised in those aged 16 years and over. The AstraZeneca vaccine is only authorised for use in those aged 18 years and over.

COVID Vaccines: Company Announcements on Development/Regulatory Actions/Procurement/Deployment

Milestones :: Perspectives :: Research

 

COVID Vaccines: Company Announcements on Development/Regulatory Actions/Procurement/Deployment

An In Vitro Study Shows Pfizer-BioNTech COVID-19 Vaccine Elicits Antibodies that Neutralize SARS-CoV-2 with a Mutation Associated with Rapid Transmission
New York, NY and Mainz, Germany, January 8, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE
(Nasdaq: BNTX) today announced results from an in vitro study conducted by Pfizer and the University of Texas Medical Branch (UTMB) that shows the antibodies from people who have received the Pfizer-BioNTech COVID-19 vaccine effectively neutralize SARS-CoV-2 with a key mutation that is also found in two highly transmissible strains. The results were published on the preprint server bioRxiv and are available here.

Rapidly spreading variants of SARS-CoV-2 have been reported, initially in the United Kingdom and South Africa. These variants have multiple mutations in their spike or S glycoproteins, which are key targets of virus neutralizing antibodies. Though these two rapidly spreading viruses are different, they share the N501Y mutation, which is located in the receptor binding site of the spike protein and results in the virus’s spike protein binding more tightly to its receptor. It has been shown to infect mice more efficiently.1

To determine if sera of people who had received the Pfizer-BioNTech COVID-19 vaccine could neutralize SARS-CoV-2 with the N501Y mutation, a virus with this substitution was generated in UTMB’s laboratory. The sera of 20 participants from the previously reported Phase 3 trial neutralized the virus with the mutation as well as they neutralized virus without the mutation.

While the virus tested in this experiment did not include the full set of spike mutations found on the rapidly spreading strains in the U.K. or South Africa, neutralization of virus with the N501Y mutation by the Pfizer- BioNTech vaccine-elicited human sera is consistent with preserved neutralization of a panel of 15 pseudoviruses bearing spikes with other mutations found in circulating SARS-CoV-2 strains. This indicates that the key N501Y mutation, which is found in the emerging U.K and South Africa variants, does not create resistance to the Pfizer-BioNTech vaccine induced immune responses.

Pfizer, BioNTech, and UTMB are encouraged by these early, in vitro study findings. Further data are needed to monitor the Pfizer-BioNTech COVID-19 vaccine’s effectiveness in preventing COVID-19 caused by new virus variants. If the virus mutates such that an update to the vaccine is required to continue to confer protection against COVID-19, we believe that the flexibility of BioNTech’s proprietary mRNA vaccine platform is well suited to enable an adjustment to the vaccine…

United Kingdom Medicines and Healthcare products Regulatory Agency Authorizes Use of COVID-19 Vaccine Moderna
January 08, 2021
:: UK MHRA authorization is based on a rolling review of COVID-19 Vaccine Moderna data, including data from the Phase 3 COVE study
:: UK government secured an additional 10 million doses for a total of 17 million doses of the vaccine with supply beginning in early 2021
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved its mRNA vaccine against COVID-19 (COVID-19 Vaccine Moderna) for use under Regulation 174. The temporary authorization permits the supply of COVID-19 Vaccine Moderna in Great Britain and is based upon the advice of the UK Commission on Human Medicines…

European Commission Authorizes COVID-19 Vaccine Moderna in Europe
January 06, 2021
:: Authorization follows European Medicines Agency recommendation of COVID-19 Vaccine Moderna
:: European Commission has secured 160 million doses; first deliveries to countries will begin next week
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union. The authorization is based upon the recommendation of the European Medicines Agency (EMA) for use of the COVID-19 Vaccine Moderna for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older..

Israeli Ministry of Health Authorizes COVID-19 Vaccine Moderna for Use in Israel
January 04, 2021
Ministry of Health of Israel has secured 6 million doses and first deliveries expected to begin in January
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Israel’s Ministry of Health (MOH) has given authorization to import the COVID-19 Vaccine Moderna in Israel.
“Today’s authorization is a landmark moment in our company’s history and in the global fight against COVID-19,” said Stéphane Bancel, Chief Executive Officer of Moderna. “This is the third regulatory authorization for the COVID-19 Vaccine Moderna, and its first outside of North America…

COVID Vaccines Development/Procurement/Distribution/Policy – Russia, China, India

Milestones :: Perspectives :: Research

 

COVID Vaccines Development/Procurement/Distribution/Policy – Russia, China, India

 

Editor’s Note:
We include the coverage immediately below to help assure a reasonably comprehensive view of COVID vaccines regulatory action and deployment occurring globally – even as we recognize that the evidentiary thresholds employed in the underlying decisions are highly variable, weak or even absent.

 

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Russia: Sputnik V – “the first registered COVID-19 vaccine” [to 9 Jan 2021]
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
Bolivia has registered Sputnik V vaccine based on Russian clinical trial data
Press release, 06.01.2021
… The vaccine was registered under the emergency use authorization procedure and was approved by AGEMED based on the results of Phase III clinical trials in Russia, without additional trials in Bolivia. Sputnik V was registered by Argentina’s regulator ANMAT under the same procedure on December 23, 2020…

RDIF to supply 2 million doses of Sputnik V vaccine to Serbia
Press release, 06.01.2021
The agreement between RDIF and the Government of Serbia will enable the vaccination of 1 million people. The supplies will help Serbia secure a diversified portfolio of vaccines against coronavirus. Deliveries will be facilitated by RDIF’s international partners in India, China, South Korea and other countries…

 

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China: COVID-19 Vaccines – Regulatory Actions/Deployment

National Health Commission of the People’s Republic of China [to 9 Jan 2021]
http://en.nhc.gov.cn/
China pledges safety, effectiveness as vaccination to be carried out nationwide
2021-01-05
BEIJING — China’s State Council joint prevention and control mechanism against COVID-19 has ordered the strict inspection of vaccine quality, safety and smooth cold-chain transportation, as well as timely and accurate delivery of vaccines, as the country’s first self-developed vaccine got market approval with the vaccination campaign to be carried out nationwide gradually.

China has always attached great importance to the safety and effectiveness of COVID-19 vaccines. The mechanism has also emphasized the importance of providing medical support and service. It especially applies to timely treatment and reporting of adverse reactions during the vaccination drive.
The National Medical Products Administration also established a traceability information system for the management of approved vaccines.

China approved the emergency use of COVID-19 vaccines in June, targeting groups with high risks of infection. By the end of November, more than 1.5 million doses of Chinese COVID-19 vaccines had been distributed for emergency use, and 60,000 vaccinated people have traveled abroad to high-risk regions, with no severe adverse reactions reported.

On Dec 15, China officially launched a vaccination program for this winter-spring period targeting a number of key groups, including those engaged in handling imported cold-chain products, customs officers, medical workers and people working in public transport and fresh markets. The COVID-19 vaccines will be provided free of charge to all Chinese people…

… Some countries, including the United Arab Emirates and Bahrain, have approved the Chinese inactivated vaccine registration according to the World Health Organization technical standards. Egypt licensed China’s inactivated COVID-19 vaccine for emergency use on Saturday. Countries, including Brazil, Indonesia, Turkey, Chile and Malaysia, have ordered vaccines developed by Sinovac Biotech.

“China will vaccinate the eligible population as widely as possible, and gradually build an immune barrier in the whole population to control the epidemic,” said Zeng. He added that 60 or even 70 percent of the vaccination rate is needed to establish universal protection.

 

::::::

India: COVID-19 Vaccines – Regulatory Actions/Deployment

Bharat Biotech’s ‘COVAXIN™’ Emergency Use Authorization approval by DCGI-CDSCO, MoH&FW, a significant landmark in India’s Scientific Discovery, and Scientists Capability
Hyderabad, January 03, 2021:
Expressing delight about Ministry of Health & Family Welfare announcement today from the statement from DCGI – Central Standards Control Organization (CDSCO) Grant of permission for emergency use of its Covid-19 Vaccine, the Chairman and Managing Director of Bharat Biotech Dr. Krishna Ella said “The approval of COVAXIN™ for emergency use is a giant leap for Innovation and novel product development in India. It is a proud moment for the nation and a great milestone in India’s scientific capability, a kickstart to the innovation ecosystem in India. While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most. COVAXIN™ has generated excellent safety data with robust immune responses to multiple viral proteins that persist.”…
…The Phase III human clinical trials of COVAXIN™ began mid-November, targeted to be done in “26,000” volunteers across India, this is India’s first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India. COVAXIN™ has been evaluated in approximately 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals…

PRESS INFORMATION BUREAU – GOVERNMENT OF INDIA
Press Statement by the Drugs Controller General of India (DCGI) on Restricted Emergency approval of COVID-19 virus vaccine
New Delhi, 3rd January, 2021
The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on 1st and 2nd January, 2021 and made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of M/s Serum Institute of India and M/s Bharat Biotech as well as Phase III clinical trial of M/s Cadila Healthcare Ltd…
… M/s Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on Vero cell platform, which has well established track record of safety and efficacy in the country & globally.
The firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters. All these data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approx.800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, ~22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date.
The Subject Expert Committee (SEC) has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue….

POLIO Public Health Emergency of International Concern (PHEIC); WHO/OCHA Emergencies

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 30 December 2020
:: The COVID-19 pandemic has triggered a deep global health and economic crisis. The Polio Oversight Board (POB) remains steadfast in its resolve to secure a polio-free world, while reaffirming its commitment that polio-funded assets are at the service of countries to respond to this public health emergency, especially in the critical next phase of COVID-19 vaccine introduction and delivery. Read more on the last POB statement of 2020.

Summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):
:: Pakistan: one WPV1 case, seven WPV1 and 16 cVDPV2 positive environmental samples
:: Benin: one cVDPV2 positive environmental sample
:: Chad: one cVDPV2 case
:: Cote D’Ivoire: three cVDPV2 cases
:: Democratic Republic of the Congo: one cVDPV2 case
:: Mali: one cVDPV2 positive environmental sample

::::::

POLIO OVERSIGHT BOARD :: STATEMENT ON NEXT PHASE OF GPEI SUPPORT FOR COVID-19 RESPONSE
04 January 2021
The COVID-19 pandemic has triggered a deep global health and economic crisis. The Polio Oversight Board (POB) remains steadfast in its resolve to secure a polio-free world, while reaffirming its commitment that polio-funded assets are at the service of countries to respond to this public health emergency, especially in the critical next phase of COVID-19 vaccine introduction and delivery.

When the pandemic was declared, the POB issued a Call to Action for polio-funded assets to support the response, and for a pause in polio immunization campaigns to reduce the risk of COVID-19 transmission. The Call also emphasized the importance of maintaining essential polio eradication functions, including surveillance for poliovirus. Since then, the value of polio-funded staff and assets contributed to the COVID-19 response in more than 50 countries is estimated at USD $104 million. In June 2020, faced with a concerning rise in polio cases and disruption to essential immunization, GPEI issued guidelines for safe implementation of house to house vaccination campaigns, developed with immunization partners. With the support of donors, polio campaigns have restarted in nearly 20 countries since August, while polio staff continue to simultaneously support the COVID-19 response. In November, UNICEF and WHO issued a joint Call to Action to respond to polio and measles outbreaks and prioritize funding immunization in national budgets. Polio vaccination campaigns have served as an opportunity to educate communities about essential public health measures to protect against COVID-19 and to deliver other needed health interventions. The POB would like to express their appreciation to all polio-funded staff who have taken on these dual roles with unwavering commitment.

GPEI’s core competencies for the next phase of COVID-19 response – vaccine introduction and delivery.
The POB emphasizes the importance of maintaining GPEI’s focus on urgently eradicating all forms of poliovirus. In view of the overwhelming public health imperative to end the COVID-19 pandemic, the POB commits to the polio programme’s continued support for the next phase of COVID-19 response, COVID-19 vaccine introduction and delivery, through existing assets, infrastructure and expertise in key geographies.

More than thirty years of eradicating polio has taught us that for vaccines to be effective, their delivery must be rooted in rapid and equitable access for everyone, everywhere, and that no one is safe until we are all safe.

The polio programme has core expertise in important areas of collaboration in vaccine introduction that can help in this phase of the pandemic, including campaign planning and monitoring; data collection; programme advocacy and resource mobilization; community engagement; microplanning; frontline worker training and cold chain management. These are areas in which polio-funded staff at country level can add value, under the leadership of national governments.

In November 2020 the type 2 novel oral polio vaccine (nOPV2) was the first vaccine to receive a WHO Emergency Use Listing (EUL) recommendation, and will be used to respond to circulating vaccine-derived poliovirus type 2 outbreaks. The rollout of nOPV2 under the EUL recommendation can provide lessons and experiences for countries introducing COVID-19 vaccine, if emergency regulatory pathways such as WHO EUL are used, including in the areas of monitoring readiness-verification, safety surveillance, and regulatory considerations. Levels of support will vary by country and will be determined based on discussions with host national governments, ACT-A and COVAX partners, and availability of sufficient financial resources to ensure simultaneous support for COVID-19 vaccine delivery without significant delays to the urgent polio eradication effort.

The POB is conscious that this decision may impact polio eradication, including programmatic and financial risks. However, the overwhelming need to end the COVID-19 pandemic and its ongoing impact on immunization coverage including polio, underlines the urgency of this action. The POB also believes that this will be mutually beneficial, as the polio programme can support COVID-19 response while also learning from the collaboration, including how best to integrate coordination, planning and service delivery.

To best support this decision the POB encourages countries, donors and polio stakeholders to:
:: Maintain certification-level disease surveillance as required for polio eradication.
:: Conduct, as feasible and required, high quality polio immunization campaigns in endemic and outbreak countries.
:: Seek opportunities actively to fund polio programme assets that can contribute to COVID-19 activities and future emergency response and continue to report to GPEI on the work of polio-funded staff in the COVID-19 response to ensure transparency and accountability for GPEI donors.
:: Protect children from polio, measles and other vaccine-preventable diseases by continuing to ensure the recovery of immunization services from the disruption caused by the pandemic, and by including bOPV in preventive, multi-antigen, mass vaccination campaigns.

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

Editor’s Note:
Continuing with this edition, we include information about the last apparent update evident on the WHO emergency country webpages, recognizing almost universal and significant interims between such updates regardless of the level of the emergency listed.

WHO Grade 3 Emergencies [to 9 Jan 2021]

Democratic Republic of the Congo – No new digest announcements identified [Last apparent update: 15 October 2020]
Mozambique floods – No new digest announcements identified [Last apparent update: 3 November 2020]
Nigeria – No new digest announcements identified [Last apparent update: 29 Jun 2020]
Somalia – No new digest announcements identified [Last apparent update: 17 July 2020]
South Sudan – No new digest announcements identified [Last apparent update: 4 February 2020]
Syrian Arab Republic – No new digest announcements identified [Last apparent update: 24 October 2020]
Yemen – No new digest announcements identified [Last apparent update: 30 June 2020]

::::::

WHO Grade 2 Emergencies [to 9 Jan 2021]
Myanmar
:: 3 January 2021 News release Advancing Digital Health strategy in Bangladesh

Afghanistan – No new digest announcements identified [Last apparent update: 5 July 2020]
Angola – No new digest announcements identified [Last apparent update: 03 December 2020]
Burkina Faso – No new digest announcements identified [Last apparent update: 17 décembre 2020]
Burundi – No new digest announcements identified [Last apparent update: 04 July 2019]
Cameroon – No new digest announcements identified [Last apparent update: 22 August 2019]
Central African Republic – No new digest announcements identified [Last apparent update: 12 June 2018]
Ethiopia – No new digest announcements identified [Last apparent update: 22 August 2019]
Iran floods 2019 – No new digest announcements identified [Last apparent update: 12 March 2020]
Iraq – No new digest announcements identified [Last apparent update: 16 December 2020]
Libya – No new digest announcements identified [Last apparent update: 7 October 2019]
Malawi Floods – No new digest announcements identified [Last apparent update: 09 October 2019]
Measles in Europe – No new digest announcements identified [Last apparent update: 16-12-2020]
MERS-CoV – No new digest announcements identified [Last apparent update: 8 July 2019]
Mozambique – No new digest announcements identified [Last apparent update: 03 November 2020]
Niger – No new digest announcements identified [Last apparent update: 29 December 2020]
occupied Palestinian territory – No new digest announcements identified [Last apparent update: 4 September 2019]
HIV in Pakistan – No new digest announcements identified [Last apparent update: 27 August 2019]
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements
Sudan – No new digest announcements identified [Last apparent update: 24 June 2020]
Ukraine – No new digest announcements identified [Last apparent update: 1 May 2019]
Zimbabwe – No new digest announcements identified [Last apparent update: 10 May 2019]

::::::

WHO Grade 1 Emergencies [to 9 Jan 2021]

Chad – No new digest announcements identified [Last apparent update: 30 June 2018]
Djibouti – No new digest announcements identified [Last apparent update: 25 novembre 2020]
Kenya – No new digest announcements identified [Last apparent update: 11 December 2020]
Mali – No new digest announcements identified [Last apparent update: 3 May 2017]
Namibia – viral hepatitis – No new digest announcements identified [Last apparent update: 20 July 2018]
Tanzania – No new digest announcements identified [Last apparent update: 21 October 2020]

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

UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic – No new digest announcements identified
Yemen – No new digest announcements identified

::::::

UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
COVID-19
:: Coronavirus Disease (COVID-19): Weekly Epidemiological Update (5 January 2020)

East Africa Locust Infestation
:: Desert Locust situation update – 4 January 2021

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

WHO & Regional Offices [to 9 Jan 2021]

WHO & Regional Offices [to 9 Jan 2021]

 

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
No new digest content identified

WHO Region of the Americas PAHO
No new digest content identified

WHO South-East Asia Region SEARO
No new digest content identified

WHO European Region EURO
:: A challenging start to 2021, new COVID-19 variants and promising vaccine progress 07-01-2021
:: Decade of Healthy Ageing 2021 – 2030 06-01-2021

WHO Eastern Mediterranean Region EMRO::
:: Five million COVID-19 cases reported in WHO’s Eastern Mediterranean Region
Cairo, 7 January 2021 – Countries in the World Health Organization (WHO)’s Eastern Mediterranean Region have reported over 5 million cases of COVID-19 and 123 725 deaths since the first cases was reported in the Region on 29 January 2020. “The past year has been an exceptionally challenging time for us all. The pandemic has taken a dreadful toll on people…
:: Responding to Cyclone Gati in Somalia 7 January 2021
:: Improving water, sanitation and hygiene services in Yemen 5 January 2021
:: WHO and IOM welcome EU contribution to strengthen management of TB in Libya 4 January 2021

WHO Western Pacific Region
No new digest content identified

CDC/ACIP [to 9 Jan 2021]

CDC/ACIP [to 9 Jan 2021]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
HHS Announces $22 Billion in Funding to Support Expanded Testing, Vaccination Distribution
Thursday, January 7, 2021
The Department of Health and Human Services (HHS) today announced two upcoming actions by the Centers for Disease Control and Prevention (CDC) to provide more than $22 billion in funding to states, localities, and territories in support of the nation’s response to the COVID-19 pandemic, as directed by the Coronavirus Response and Relief Supplemental Appropriations Act.
Funding will provide critical support for testing and vaccination-related activities to jurisdictions before January 19, 2021:
:: More than $19 billion will be allocated to jurisdictions through the existing CDC Epidemiology and Laboratory Capacity (ELC) cooperative agreement. These awards will support testing, contract tracing, surveillance, containment, and mitigation to monitor and suppress the spread of COVID-19. Award recipients will include 64 jurisdictions including all 50 states, the District of Columbia, five major cities, and U.S. territories/islands. Consistent with Congressional direction, funds will be allocated by a population-based formula.
:: Over $3 billion will be made available in an initial award to jurisdictions through the existing CDC Immunization and Vaccines for Children cooperative agreement. These awards will support a range of COVID-19 vaccination activities across jurisdictions. Award recipients will include 64 jurisdictions including all 50 states, the District of Columbia, five major cities, and U.S. territories/islands. Consistent with Congressional direction, funds will be allocated by a  population-based formula…

Transcript: CDC Update on COVID-19
Wednesday, January 6, 2021

MMWR News Synopsis
Friday, January 8, 2020
:: Time from Start of Quarantine to SARS-CoV-2 Positive Test Among Quarantined College and University Athletes — 17 States, June–October 2020
:: Assessment of Day-7 Postexposure Testing of Asymptomatic Contacts of COVID-19 Patients to Evaluate Early Release from Quarantine — Vermont, May–November 2020
:: Opening of Large Institutions of Higher Education and County-Level COVID-19 Incidence — United States, July 6–September 17, 2020
:: Participation in Fraternity and Sorority Activities and the Spread of COVID-19 Among Residential University Communities — Arkansas, August 21-September 5, 2020

China CDC

China CDC
http://www.chinacdc.cn/en/
No new digest content identified.

National Health Commission of the People’s Republic of China [to 9 Jan 2021]
http://en.nhc.gov.cn/
News
Jan 9: Daily briefing on novel coronavirus cases in China
On Jan 8, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 33 new cases of confirmed infections.

Hebei strengthens curbs as confirmed cases rise to 127
2021-01-08
Shijiazhuang, capital of Hebei province, has been put under a lockdown after the city reported the highest daily COVID-19 case numbers since the outbreak occurred over the past weekend.

China pledges safety, effectiveness as vaccination to be carried out nationwide
2021-01-05

National Medical Products Administration [to 9 Jan 2021]
http://english.nmpa.gov.cn/news.html
News
Free virus vaccinations for overseas travel
2021-01-07
Shanghai residents who need to travel overseas for personal reasons will be able to make reservations for COVID-19 vaccine inoculation beginning on Thursday, the municipal government announced on Jan 6.

Chinese mainland reports 52 new locally transmitted COVID-19 cases
2021-01-07
China’s National Health Commission said on Jan 7 that it received reports of 63 newly confirmed COVID-19 cases on the Chinese mainland on Jan 6, of which 52 were locally transmitted and 11 were imported.

Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 9 Jan 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 9 Jan 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

 

BMGF – Gates Foundation [to 9 Jan 2021]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 9 Jan 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 9 Jan 2021]
https://carb-x.org/
News
No new digest content identified.

 

Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 9 Jan 2021]
https://centerforvaccineethicsandpolicy.net/
News/Analysis/Statements
An Informed Choice/Consent/Right-to-Refuse Imperative :: Statement on Immunization Involving COVID-19 Vaccines Under Emergency Use Authorization/Listing [EUA/L]
1 January 2021 The GE2P2 Global Foundation’s Center for Vaccine Ethics and Policy has developed a statement that argues that immunization involving COVID-19 vaccines available under emergency use mechanisms or expanded access/compassionate use triggers an imperative to assure that individuals receive the information required to support free exercise of meaningful informed choice/consent, with a right to refuse such vaccination for any reason or no reason. The full statement is available here: http://www.ge2p2.org/the-informed-choice/consent/right-to-refuse-imperative

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 9 Jan 2021]
http://cepi.net/
Latest News
No new digest content identified.

 

EDCTP [to 9 Jan 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
No new digest content identified.

 

Emory Vaccine Center [to 9 Jan 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 9 Jan 2021]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Extra dose from vials of Comirnaty COVID-19 vaccine
Last updated: 08/01/2021
[See COVID above for detail]

 

 

News: EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU (updated)
Last updated: 06/01/2021
[See COVID above for detail]

 

European Vaccine Initiative [to 9 Jan 2021]
http://www.euvaccine.eu/
Latest News
Website not responding at inquiry

 

FDA [to 9 Jan 2021]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
January 8, 2021 – Coronavirus (COVID-19) Update: January 8, 2021
:: The FDA alerted clinical laboratory staff and health care providers that genetic variants of SARS-CoV-2 may lead to false negative results with molecular tests for SARS-CoV-2. The Letter to Clinical Laboratory Staff and Health Care Providers includes important information about potential false negative results with molecular tests, including:
. Details on the effect of genetic variants on test performance.
. Recommendations for clinical laboratory staff and health care providers.
. Actions the FDA has taken.
. Instructions for reporting problems with a test.
:: This week, the FDA posted a new webpage, Moderna COVID-19 Vaccine Frequently Asked Questions. Questions cover specifics, such as what data did the FDA review when deciding whether to authorize the vaccine for emergency use, how well the vaccine prevents COVID-19, and more.

January 8, 2021 – FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff
The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus’s genome assessed by that test…

January 5, 2021 – Coronavirus (COVID-19) Update: January 5, 2021
:: Today, the FDA posted a new webpage on the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) highlighting authorities that are intended to enhance the FDA’s ability to identify, prevent, and mitigate possible drug shortages by, among other things, enhancing the FDA’s visibility into drug supply chains…

 

FDA – COVID-19 Vaccines [to 9 Jan 2021]
www.fda.gov/covid19vaccines
News and Updates; Upcoming Events
FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines
Following the Authorized Dosing Schedules for COVID-19 Vaccines
01/04/2021
[See COVID above for detail]

 

Fondation Merieux [to 9 Jan 2021]
http://www.fondation-merieux.org/
News, Events
Press Releases
No new digest content identified.

 

Gavi [to 9 Jan 2021]
https://www.gavi.org/
News releases
No new digest content identified.

 

GHIT Fund [to 9 Jan 2021]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 212 with the aim of developing new tools to tackle infectious diseases that
Press Releases
No new digest content identified.

 

Global Fund [to 9 Jan 2021]
https://www.theglobalfund.org/en/news/
News
Strategic Review 2020 of the Global Fund now available
07 January 2021
The Strategic Review 2020 (SR2020) of the Global Fund and its related documents are now available. As with the SR2015 and SR2017, it was commissioned by the Technical Evaluation Reference Group (TERG). The three main objectives of SR2020 were:
[1] To assess the outcomes and impact of Global Fund investments against the goals and objectives of the 2017–2022 Strategy at its mid-term.
[2] To assess operationalization and implementation of the current Strategy at its mid-term.
[3] To provide an evidence-informed rationale for integrating lessons learned during the first half of the 2017–2022 Strategy, and how to position the Global Fund within the global field of health development organizations in its post-2022 strategic cycle.
Download the Strategic Review 2020 and all its related materials. Learn more about the TERG and its role at the Global Fund.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 9 Jan 2021]
https://www.glopid-r.org/news/
News
No new digest content identified.

 

Hilleman Laboratories [to 9 Jan 2021]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 9 Jan 2021]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.

 

IAVI [to 9 Jan 2021]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
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.

 

 

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

 

 

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

 

IFRC [to 9 Jan 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
No new digest content identified.

 

Institut Pasteur [to 9 Jan 2021]
https://www.pasteur.fr/en/press-area
Press documents
No new digest content identified.

 

IRC International Rescue Committee [to 9 Jan 2021]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
As thousands more fleeing conflict in Ethiopia arrive in Eastern Sudan, the IRC scales up emergency response to protect women and children
January 6, 2021

 

IVAC [to 9 Jan 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

 

IVI [to 9 Jan 2021]
http://www.ivi.int/
Selected IVI News, Announcements, Events
Cellid, IVI exchange ‘COVID-19 Vaccine Research Service Contract’
IVI to analyze samples from Phase 1/2a trials of Cellid’s COVID-19 vaccine to evaluate immunogenicity
January 5, 2021

2020 Year in Review
2020 was an unprecedented year in global health. A novel virus spread to all corners of the world, devastating people’s lives, economies, and ways of life, and the scientific community responded with agility and partnership that will inspire vaccine research and development for years to come. We’re grateful to our global collaborators, supporters, and friends for working with us to advance IVI’s mission to discover, develop, and deliver safe, effective, and affordable vaccines for global health—a mission that feels more urgent than ever and will continue to drive our work in the new year.

 

JEE Alliance [to 9 Jan 2021]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

Johns Hopkins Center for Health Security [to 9 Jan 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 9 Jan 2021]
http://www.msf.org/
Latest [Selected Announcements]
Yellow fever
Fractioning doses of yellow fever vaccine can help save more lives
Press Release 8 Jan 2021

Lebanon
Overlapping crises in Lebanon increase needs and worsen access to …
Project Update 8 Jan 2021

Mali
Patient dies after an MSF ambulance is violently detained in …
Press Release 7 Jan 2021

Palestine
“For one year no one came here” to provide medical care in the W…
Project Update 5 Jan 2021

Central African Republic
MSF provides care in post-election attacks in Bangassou, CAR
Project Update 4 Jan 2021

 

National Vaccine Program Office – U.S. HHS [to 9 Jan 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

 

NIH [to 9 Jan 2021]
http://www.nih.gov/news-events/news-releases
News Releases
Large clinical trial will test combination monoclonal antibody therapy for mild/moderate COVID-19
January 5, 2021 — The Phase 2/3 clinical trial will evaluate experimental antibodies BRII-196 and BRII-198.

 

PATH [to 9 Jan 2021]
https://www.path.org/media-center/
Press Release
PATH condemns violent insurgency in Washington, DC
January 7, 2021 by PATH

PATH supports partners to use environmental surveillance to monitor the presence of COVID-19
January 5, 2021 by PATH
Complementing national COVID-19 surveillance efforts in countries with limited diagnostic capacity to test and trace with expanded data from the environmental surveillance of sewage

 

Sabin Vaccine Institute [to 9 Jan 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 9 Jan 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
8 January 2021
First-ever Jamaica transgender strategy looks beyond health

6 January 2021
Hope from Tiraspol

5 January 2021
Y+ Global launches COVID-19 fund to support young people living with HIV

 

UNICEF [to 9 Jan 2021]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
No new digest content identified.

 

Unitaid [to 9 Jan 2021]
https://unitaid.org/
Featured News
No new digest content identified.

 

Vaccination Acceptance Research Network (VARN) [to 9 Jan 2021]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 9 Jan 2021]
http://www.vaccineconfidence.org/
News, Research and Reports
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 9 Jan 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

 

Wellcome Trust [to 9 Jan 2021]
https://wellcome.ac.uk/news
News
Wellcome appoints new research programmes director 
Cheryl Moore, who is currently the President and Chief Operating Officer of the New York Genome Center, is to become Wellcome’s new Director, Research Programmes.

 

The Wistar Institute [to 9 Jan 2021]
https://www.wistar.org/news/press-releases
Press Releases
Jan. 7, 2021
Wistar Scientists Target an Alternative Fuel Source of Cancer Cells as a Therapeutic Approach for Breast Cancer
New small molecule inhibitor impairs cancer growth in preclinical models by depriving malignant cells of a critical nutrient source.

 

WFPHA: World Federation of Public Health Associations [to 9 Jan 2021]
https://www.wfpha.org/
Latest News
COVID-19 Immunization and Mitigating Vaccine Hesitancy
Jan 6, 2021
… The WFPHA Immunization Taskforce fears that the lack of a coordinated response to growing vaccine hesitancy will further exacerbate the morbidity and mortality rates of the pandemic. In particular, there is concern that the uncontrolled spread of misinformation will disproportionately harm the most at-risk, vulnerable communities. As global COVID-19 immunization begins, health organizations and governments must be equipped to promote trust in the vaccines being distributed and must work alongside healthcare providers who are responsible for delivery. Therefore, the WFPHA International Immunization Policy Task Force in its Statement on COVID-19 Immunization and Mitigating Vaccine Hesitancy, recommends:
1. National authorities, NGOs and health organizations should publicly express support for subnational
and/or community-led initiatives that address vaccine hesitancy to help sustain local COVID-
19 immunization efforts.
2. The international community should acknowledge that life course immunization is a key
component of universal health coverage and a necessary preventative measure that can save millions
of lives.
3. Public health officials and organizations should express their concerns about the lack of investment
and infrastructure needed to target public health messages to at-risk populations and recommend
investing in public health promotion and literacy as a preventative measure.
4. Knowledge translation research efforts be strengthened to enhance communication between
public health professionals, policymakers, and the general public with the goal of establishing a
common agenda.
5. Governments should maintain transparency about vaccine funding and development to ensure
that the general public understands how this intervention best serves public health interests.

 

World Economic Forum [to 9 Jan 2021]
https://agenda.weforum.org/news/
Media
Cities Are Key to India’s Post-Pandemic Growth, Says Report
News 07 Jan 2021
· The World Economic Forum releases a new report, Indian Cities in the Post-Pandemic World, with recommendations from 14 global urban experts to translate lessons learned from the pandemic into a new urban reforms agenda
· Insights compiled through extensive interviews span seven thematic areas: planning, housing, transport, environment, public health, gender and vulnerable populations
· Read the full report here

 

World Organisation for Animal Health (OIE) [to 9 Jan 2021]
https://www.oie.int/en/for-the-media/press-releases/2020/
No new digest content identified.

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 9 Jan 2021]
https://alliancerm.org/
Press Releases
No new digest content identified.

 

BIO [to 9 Jan 2021]
https://www.bio.org/press-releases
Press Releases
BIO’s Dr. Michelle McMurry-Heath Responds to “Unconscionable” Attacks on U.S. Capitol
January 7, 2021
Dr. Michelle McMurry-Heath, President and CEO of the Biotechnology Innovation Organization, made the following comments in response to today’s violence at the United States Capitol: “Today we watched in horror as angry and unruly mobs attacked…

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 9 Jan 2021]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 9 Jan 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.

 

IFPMA [to 9 Jan 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
No new digest content identified.

 

PhRMA [to 9 Jan 2021]
http://www.phrma.org/
Selected Press Releases, Statements
New research shows hotspots of inequity relate to increased COVID-19 hospitalizations
January 8, 2021
As part of PhRMA’s continuing work to address health inequities, we are partnering with researchers to study hotspots of COVID-19 and chronic disease inequities in New York state. Reports this summer show that boroughs in New York City with the lowest per-person income and lowest number of employer establishments had the highest COVID-19 mortality rates.

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

Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure

AJOB Empirical Bioethics
Volume 12, 2020 Issue 1
https://www.tandfonline.com/toc/uabr21/current

 

Article
Exception From Informed Consent: How IRB Reviewers Assess Community Consultation and Public Disclosure
Makini Chisolm-Straker, Denise Nassisi, Mohamud R. Daya, Jennifer N.B. Cook, Ilene F. Wilets, Cindy Clesca & Lynne D. Richardson
Pages: 24-32
Published online: 29 Sep 2020

Legacies of the Holocaust in Health Care

AMA Journal of Ethics
Volume 23, Number 1: E1-81 Jan 2021
https://journalofethics.ama-assn.org/issue/legacies-holocaust-health-care

 

Legacies of the Holocaust in Health Care
Health professionals’ involvement in atrocities of the Holocaust has influenced bioethics in critical ways. From abortion to xeno-transplantation, deliberation on almost every ethics topic in health care today—genetics, informed consent, public health, military and civilian health policy and practice, death and dying, human subjects research, and refugee care—is influenced by Nazi medical crimes. This theme issue is devoted to orienting and reorienting contemporary bioethics to legacies of this tragic history.

“Prevention” and Human Gene Editing Governance

AMA Journal of Ethics
Volume 23, Number 1: E1-81 Jan 2021
https://journalofethics.ama-assn.org/issue/legacies-holocaust-health-care

 

State of the Art and Science
“Prevention” and Human Gene Editing Governance
Eric T. Juengst, PhD
AMA J Ethics. 2021;23(1):E49-54. doi: 10.1001/amajethics.2021.49.
Abstract
The Holocaust and the racial hygiene doctrine that helped rationalize it still overshadow contemporary debates about using gene editing for disease prevention. In part, this is because prevention can mean 3 different things, which are often conflated. Phenotypic prevention involves modifying the expression of pathogenic DNA variants to forestall their clinical effects in at-risk patients. Genotypic prevention involves controlling transmission of pathogenic variants between generations to avoid the birth of affected offspring. Preventive strengthening seeks to improve normal human traits to resist disease. These distinctions have been neglected in human gene editing governance discussions and are clarified in this article.

Attaining 95-95-95 through Implementation Science: 15 Years of Insights and Best Practices from the Walter Reed Army Institute of Research’s Implementation of the U.S. President’s Emergency Plan for AIDS Relief

American Journal of Tropical Medicine and Hygiene
Volume 104, Issue 1, January 2021
http://www.ajtmh.org/content/journals/14761645/104/1

 

Perspective Piece
Attaining 95-95-95 through Implementation Science: 15 Years of Insights and Best Practices from the Walter Reed Army Institute of Research’s Implementation of the U.S. President’s Emergency Plan for AIDS Relief
Elizabeth H. Lee, Kavitha Ganesan, Samoel A. Khamadi, Stanley C. Meribe, Dorothy Njeru, Yakubu Adamu, Fred Magala, Trevor A. Crowell, Eniko Akom, Patricia Agaba, Priyanka Desai, Tiffany Hamm, Deydre Teyhen, Julie A. Ake, Christina S. Polyak, Douglas Shaffer, Fredrick Sawe and Patrick W. Hickey
Pages: 12–25
https://doi.org/10.4269/ajtmh.20-0541

Fighting COVID-19 at the Expense of Malaria in Africa: The Consequences and Policy Options

American Journal of Tropical Medicine and Hygiene
Volume 104, Issue 1, January 2021
http://www.ajtmh.org/content/journals/14761645/104/1

Fighting COVID-19 at the Expense of Malaria in Africa: The Consequences and Policy Options
Abdullahi Tunde Aborode, Kenneth Bitrus David, Olivier Uwishema, Agbendeh Lubem Nathaniel, Jegede Oluwatoyin Imisioluwa, Sherifdeen Bamidele Onigbinde and Fozia Farooq

 

Pages: 26–29
https://doi.org/10.4269/ajtmh.20-1181

The global impact of the COVID-19 pandemic on the prevention, diagnosis and treatment of hepatitis B virus (HBV) infection (5 January, 2021)

BMJ Global Health
January 2021 – Volume 6 – 1
https://gh.bmj.com/content/6/1

 

Analysis
The global impact of the COVID-19 pandemic on the prevention, diagnosis and treatment of hepatitis B virus (HBV) infection (5 January, 2021)
Caitlin M Pley, Anna L McNaughton, Philippa C Matthews, José Lourenço

Selfie consents, remote rapport, and Zoom debriefings: collecting qualitative data amid a pandemic in four resource-constrained settings (8 January, 2021)

BMJ Global Health
January 2021 – Volume 6 – 1
https://gh.bmj.com/content/6/1

 

Practice
Selfie consents, remote rapport, and Zoom debriefings: collecting qualitative data amid a pandemic in four resource-constrained settings (8 January, 2021)
In-person interactions have traditionally been the gold standard for qualitative data collection. The COVID-19 pandemic required researchers to consider if remote data collection can meet research objectives, while retaining the same level of data quality and participant protections. We use four case studies from the Philippines, Zambia, India and Uganda to assess the challenges and opportunities of remote data collection during COVID-19. We present lessons learned that may inform practice in similar settings, as well as reflections for the field of qualitative inquiry in the post-COVID-19 era.
Mark Donald C Reñosa, Chanda Mwamba, Ankita Meghani, Nora S West, Shreya Hariyani, William Ddaaki, Anjali Sharma, Laura K Beres, Shannon McMahon

Vaccination strategies for measles control and elimination: time to strengthen local initiatives

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 9 Jan 2021)

 

Vaccination strategies for measles control and elimination: time to strengthen local initiatives
Through a combination of strong routine immunization (RI), strategic supplemental immunization activities (SIA) and robust surveillance, numerous countries have been able to approach or achieve measles elimina…
Authors: F. T. Cutts, M. J. Ferrari, L. K. Krause, A. J. Tatem and J. F. Mosser
Content type: Opinion
5 January 2021

A feasibility trial of parent HPV vaccine reminders and phone-based motivational interviewing

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles

 

Research
A feasibility trial of parent HPV vaccine reminders and phone-based motivational interviewing
We assessed the feasibility and acceptability of a sequential approach of parent-targeted HPV vaccine reminders and phone-based Motivation Interviewing (MI).
Authors: Stephanie A. S. Staras, Eric Richardson, Lisa J. Merlo, Jiang Bian, Lindsay A. Thompson, Janice L. Krieger, Matthew J. Gurka, Ashley H. Sanders and Elizabeth A. Shenkman
Citation: BMC Public Health 2021 21:109
Content type: Research article
Published on: 9 January 2021

Vaccination concerns, beliefs and practices among Ukrainian migrants in Poland: a qualitative study

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles

 

Vaccination concerns, beliefs and practices among Ukrainian migrants in Poland: a qualitative study
Ukrainians numbering approximately 1.2 million are the largest migrant group in Poland. Data on vaccination coverage among migrants are not collected in EU, including Poland. Therefore, this qualitative study …
Authors: Maria Ganczak, Klaudia Bielecki, Marzena Drozd-Dąbrowska, Katarzyna Topczewska, Daniel Biesiada, Agnieszka Molas-Biesiada, Paulina Dubiel and Dermot Gorman
Citation: BMC Public Health 2021 21:93
Content type: Research article
Published on: 7 January 2021

Misinformation about COVID-19: evidence for differential latent profiles and a strong association with trust in science

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles

 

Misinformation about COVID-19: evidence for differential latent profiles and a strong association with trust in science
The global spread of coronavirus disease 2019 (COVID-19) has been mirrored by diffusion of misinformation and conspiracy theories about its origins (such as 5G cellular networks) and the motivations of prevent…
Authors: Jon Agley and Yunyu Xiao
Citation: BMC Public Health 2021 21:89
Content type: Research article
Published on: 7 January 2021

Knowledge, attitudes and practices on influenza vaccination during pregnancy in Quito, Ecuador

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles

 

Knowledge, attitudes and practices on influenza vaccination during pregnancy in Quito, Ecuador
Vaccination is the most effective way to prevent infection and severe outcomes caused by influenza viruses in pregnant women and their children. In Ecuador, the coverage of seasonal influenza vaccination in pr…
Authors: Carlos E. Erazo, Carlos V. Erazo, Mario J. Grijalva and Ana L. Moncayo
Citation: BMC Public Health 2021 21:72
Content type: Research article
Published on: 7 January 2021

An experience of mass administration of fractional dose inactivated polio vaccine through intradermal needle-free injectors in Karachi, Sindh, Pakistan

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles

 

An experience of mass administration of fractional dose inactivated polio vaccine through intradermal needle-free injectors in Karachi, Sindh, Pakistan
Inactivated Polio Vaccine (IPV) campaign was conducted in February 2019 in Karachi where needle-free injectors were introduced for the administration of the fractional dose of IPV (fIPV) on a large scale. This…
Authors: Umar Farooq Bullo, Jaishri Mehraj, Syed Musa Raza, Shumaila Rasool, Noreen Naz Ansari, Ahmed Ali Shaikh, Zamir Ali Phul, Sohail Ahmed Memon, Rehan Iqbal Baloch, Zahoor Ahmed Baloch and Shoukat Ali Chandio
Citation: BMC Public Health 2021 21:44
Content type: Research article
Published on: 6 January 2021

Ensuring equitable access to vaccines for refugees and migrants during the COVID-19 pandemic

Bulletin of the World Health Organization
Volume 99, Number 1, January 2021, 1-76
https://www.who.int/bulletin/volumes/99/1/en/

 

Ensuring equitable access to vaccines for refugees and migrants during the COVID-19 pandemic
— Jozef Bartovic, Siddharta Sankar Datta, Santino Severoni & Veronika D’Anna
http://dx.doi.org/10.2471/BLT.20.267690
…To address these issues, national vaccination policies need to adopt innovative measures. Immunization doses missed as a result of COVID-19 pandemic containment measures should be offered as quickly as possible to refugees and migrants. Mobile vaccination clinics, combined health-care services (such as antenatal care and vaccination programmes) and mass vaccination campaigns should be considered to address existing immunity gaps. All efforts must consider delivery of immunization services in hard-to-reach settings and to hard-to-reach population groups…
…Effective measures to address barriers to immunization for refugees and migrants must include strengthening the capacity of health systems and primary health-care providers; setting up or expanding immunization information systems to monitor vaccination coverage; developing training and awareness of health-care providers; establishing health literacy education programmes; and ensuring national immunization programmes are resilient to humanitarian or health crises.3

Informed Consent for Genetic and Genomic Research

Current Protocols in Human Genetics
Volume 108, Issue 1 December 2020
https://currentprotocols.onlinelibrary.wiley.com/toc/19348258/current

 

OVERVIEW
Informed Consent for Genetic and Genomic Research
Jeffrey R. Botkin jeffrey.botkin@hsc.utah.edu
First Published:17 November 2020
Abstract
Genetic research often utilizes or generates information that is potentially sensitive to individuals, families, or communities. For these reasons, genetic research may warrant additional scrutiny from investigators and governmental regulators, compared to other types of biomedical research. The informed consent process should address the range of social and psychological issues that may arise in genetic research. This article addresses a number of these issues, including recruitment of participants, disclosure of results, psychological impact of results, insurance and employment discrimination, community engagement, consent for tissue banking, and intellectual property issues. Points of consideration are offered to assist in the development of protocols and consent processes in light of contemporary debates on a number of these issues.

Nature and history of the CIOMS International Ethical Guidelines and implications for local implementation: A perspective from East Africa

Developing World Bioethics
Volume 20, Issue 4 Pages: 173-230 December 2020
https://onlinelibrary.wiley.com/toc/14718847/current

 

ORIGINAL ARTICLES
Nature and history of the CIOMS International Ethical Guidelines and implications for local implementation: A perspective from East Africa
John Barugahare, Paul Kutyabami
Pages: 175-183
First Published: 23 October 2019

Context matters: On the road to responsible biosafety technologies in synthetic biology

EMBO Reports
Volume 22 Issue 1 7 January 2021
https://www.embopress.org/toc/14693178/current

 

Science & Society 28 December 2020 Open Access
Context matters: On the road to responsible biosafety technologies in synthetic biology
Amalia Kallergi, Enrique Asin‐Garcia, Vitor AP Martins dos Santos, Laurens Landeweerd
Biosafety is a major challenge for developing for synthetic organisms. An early focus on application and their context could assist with the design of appropriate genetic safeguards.

Correlation of population mortality of COVID-19 and testing coverage: a comparison among 36 OECD countries

Epidemiology and Infection
Volume 149 – 2021
https://www.cambridge.org/core/journals/epidemiology-and-infection/latest-issue

 

Short Paper
Correlation of population mortality of COVID-19 and testing coverage: a comparison among 36 OECD countries
C. Wei, C. C. Lee, T. C. Hsu, W. T. Hsu, C. C. Chan, S. C. Chen, C. J. Chen
Published online by Cambridge University Press: 28 December 2020, e1

From impact evaluation to decision-analysis: assessing the extent and quality of evidence on ‘value for money’ in health impact evaluations in low- and middle-income countries [version 1; peer review: awaiting peer review]

Gates Open Research
https://gatesopenresearch.org/browse/articles
[Accessed 9 Jan 2021]

 

Research Article metrics AWAITING PEER REVIEW
From impact evaluation to decision-analysis: assessing the extent and quality of evidence on ‘value for money’ in health impact evaluations in low- and middle-income countries [version 1; peer review: awaiting peer review]
Noemi Kreif, Andrew J. Mirelman, James Love-Koh, Sangjun Kim, Rodrigo Moreno-Serra, Paul Revill, Mark Sculpher, Marc Suhrcke
Peer Reviewers: Invited
Funders: National Institute for Health Research, Gates Foundation
PUBLISHED 07 Jan 2021

An integrated in silico immuno-genetic analytical platform provides insights into COVID-19 serological and vaccine targets

Genome Medicine
https://genomemedicine.biomedcentral.com/articles
[Accessed 9 Jan 2021]

 

An integrated in silico immuno-genetic analytical platform provides insights into COVID-19 serological and vaccine targets
During COVID-19, diagnostic serological tools and vaccines have been developed. To inform control activities in a post-vaccine surveillance setting, we have developed an online “immuno-analytics” resource that…
Authors: Daniel Ward, Matthew Higgins, Jody E. Phelan, Martin L. Hibberd, Susana Campino and Taane G. Clark
Citation: Genome Medicine 2021 13:4
Content type: Database
Published on: 7 January 2021

Sociocultural, behavioural and political factors shaping the COVID-19 pandemic: the need for a biocultural approach to understanding pandemics and (re)emerging pathogens

Global Public Health
Volume 16, 2021 Issue 1
http://www.tandfonline.com/toc/rgph20/current

 

Article
Sociocultural, behavioural and political factors shaping the COVID-19 pandemic: the need for a biocultural approach to understanding pandemics and (re)emerging pathogens
Anna Friedler
Pages: 17-35
Published online: 06 Oct 2020

Regional cooperation is essential to combatting health emergencies in the Global South

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 9 Jan 2021]

 

Regional cooperation is essential to combatting health emergencies in the Global South
Since COVID-19 was first discovered, it exploded into a pandemic resulting in devastating effects on human lives and a global recession. While there have been discussions that COVID-19 will accelerate the ‘end…
Authors: Ana B. Amaya and Philippe De Lombaerde
Citation: Globalization and Health 2021 17:9
Content type: Commentary
Published on: 9 January 2021