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

Milestones :: Perspectives :: Research

COVAX: Vaccine Supply/Deployment

COVAX updates participants on delivery delays for vaccines from Serum Institute of India (SII) and AstraZeneca
Statement 03/25/2021
[Editor’s text bolding]
:: The COVAX Facility has notified participating economies that deliveries of doses from the Serum Institute of India (SII) will be delayed in March and April
:: Delays in securing supplies of SII-produced COVID-19 vaccine doses are due to the increased demand for COVID-19 vaccines in India
:: Separately, participating economies in the COVAX Facility that have been allocated doses from the AstraZeneca manufacturing network have been notified that some first deliveries anticipated in March will now take place in April

GENEVA/NEW YORK/OSLO, 25 March 2021 – Deliveries of COVID-19 vaccines produced by the Serum Institute of India (SII) to lower-income economies participating in the COVAX Facility will face delays during March and April as the Government of India battles a new wave of COVID-19 infections. COVAX and the Government of India remain in discussions to ensure some supplies are completed during March and April.

According to the agreement between Gavi and the Serum Institute of India (SII), which included funding to support an increase in manufacturing capacity, SII is contracted to provide COVAX with the SII-licensed and manufactured AstraZeneca (AZ)-Oxford vaccine (known as COVISHIELD) to 64 lower-income economies participating in the Gavi COVAX AMC (including India), alongside its commitments to the Government of India.

To date, COVAX has been supplied with 28 million COVISHIELD doses and was expecting an additional 40 million doses to be available in March, and up to 50 million doses in April.

COVAX has notified all affected economies of potential delays. SII has pledged that, alongside supplying India, it will prioritize the COVAX multilateral solution for equitable distribution.

Participating economies have also received WHO guidance on optimizing the national deployment doses of the AstraZeneca-Oxford vaccine in a constrained supply environment.

Separately, the COVAX Facility has informed participants allocated AstraZeneca-manufactured doses of the AstraZeneca-Oxford vaccine that some of the first deliveries due in March are now set to take place in April.

In this early phase of COVID-19 vaccine roll-out, vaccine manufacturers require time to scale and optimize their production processes. AstraZeneca, which uses a novel supply chain network with sites across multiple continents, is working to enable initial supply to 82 countries through COVAX in the coming weeks.

COVAX retains its objective of supplying initial doses of vaccines to all participating economies in the first half of the year before ramping up significantly in the second half of 2021. To date, COVAX has shipped vaccines to over 50 countries and economies.

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Editor’s Note:
No media release or statement on the manufacturing/supply issues above was identified on the Serum Institute website or the AstraZeneca website.

Milestones :: Perspectives :: Research

Gavi Board approves COVAX Buffer for high-risk groups in humanitarian settings
:: 5% of the total number of available doses procured through the COVAX Facility will be allocated to the COVAX Buffer
:: The COVAX Buffer will ensure access to vaccines for populations in humanitarian settings
:: José Manuel Barroso: “While the first resort in covering all high-risk groups, irrespective of their legal status, is including them in national vaccination plans, the COVAX Buffer will serve as a safety net to ensure these populations do not get left behind”

Geneva, 23 March 2021 – The Board of Gavi, the Vaccine Alliance has approved the COVAX Buffer to ensure access to COVID-19 vaccines for high-risk populations in humanitarian settings and enable an emergency release of doses for severe outbreaks. The volume of the COVAX Buffer will be up to 5% of doses procured through the COVAX Facility, thus making up to 100 million vaccine doses available by end of 2021.

While national governments are ultimately responsible for providing access to COVID-19 vaccines for all high-risk groups within their respective territory, the COVAX Buffer will be available for use where there are unavoidable gaps in coverage, for example in instances of state-failure and conflict, and in areas controlled by non-state armed groups inaccessible to governments.

The Inter-Agency Standing Committee (IASC) – a forum of UN and non-UN organisations working to improve the delivery of humanitarian assistance to affected populations – estimates that 167 million people are at risk of exclusion from COVID-19 vaccination. Over two-thirds are in economies eligible for support through the Gavi COVAX Advance Market Commitment (AMC), many in non-government-controlled areas and therefore out of reach of national vaccination campaigns.

“Equitable access is the foundational goal of COVAX, and the available doses should be distributed in accordance with humanitarian principles and upholding governments’ obligations towards populations within their territory,” said José Manuel Barroso, who led his first meeting as a Chair of the Gavi Board. “However, we cannot stop there. While the first resort in covering all high-risk groups, irrespective of their legal status, is including them in national vaccination plans, the COVAX Buffer will serve as a safety net to ensure these populations do not get left behind.”

COVAX Buffer will also provide a contingency for severe outbreaks of COVID-19 by enabling emergency release of doses where regular vaccine allocation timelines may not be sufficient. This surge of doses, aimed at addressing acute outbreaks, is only going to be considered once all COVAX Facility participants have been allocated a base amount of vaccine doses. All COVAX Facility participants, both self-financing and AMC-eligible economies, as well as national and international humanitarian agencies will have access to doses through the COVAX Buffer.

“As we have started the rollout of millions of doses of COVID-19 vaccines to COVAX economies, it is essential to also protect high-risk groups caught in crisis settings,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “This means not forgetting the millions of people in conflict-affected settings or in settings that are not under the control of national governments, for it is in these last mile communities where the need for equity is most pronounced.”…

Milestones :: Perspectives :: Research

World Bank: WBG Vaccine Announcement– Key Facts
Date: March 23, 2021
COVID-19 vaccines, alongside widespread testing, improved treatment and strong health systems are critical to save lives and strengthen the global economic recovery. To provide relief for vulnerable populations, low- and middle-income countries need fair, broad, and fast access to effective and safe vaccines.

That’s why the World Bank (WB) is building on its initial COVID-19 response with $12 billion to help poor countries purchase and distribute vaccines, tests, and treatments. The first WB-financed operation to support vaccine rollout was approved in January 2021.

Financing:
:: The financing scales up our assistance to help low & middle-income countries procure and get ready to deploy vaccines and strengthen national systems for public health preparedness. This financing is part of the Bank’s initial COVID-19 response announced in April 2020 which is currently supporting more than 110 countries.
:: All Eligible low- and middle-income countries (IBRD/IDA) will be able to access the vaccine financing package within their current lending envelopes for IDA countries and exposure limits for IBRD.
:: The financing package, which is underway and will be rolled out over the next 24 months, helps signal to the research and pharmaceutical industry that people in developing countries need equal access to safe and effective COVID-19 vaccines. Only once the pandemic is contained in all countries will each country be safe from a resurgence.

How it works:
:: The approach draws on the WBG’s significant expertise in supporting large scale immunization programs for vaccine preventable diseases, as well as public health programs to tackle infectious diseases such as HIV, tuberculosis, malaria and neglected tropical diseases.
:: The Bank is working with partners to assess the readiness of countries’ health systems for vaccine deployment and identify gaps and areas for possible investment.  This allows Bank financing to support each country’s priority needs. The assessments involve analysis of policy and regulatory capacities, data and tracking systems, health infrastructure including cold chains and training of health workers. Assessments are already underway in more than 140 countries.
:: Developing countries have flexibility to use the financing in ways that best help them, based on their specific context and needs. The financing can be used for the purchasing of vaccines, the distribution of vaccines and strengthening on health systems or a combination of these financing options to meet countries’ vaccine needs.

Vaccine purchase: The WB provides options for vaccine purchase and financing mechanisms including:
–  Direct purchases by countries from vaccine manufacturers, either individually or jointly with other countries;
–  Purchase of excess stocks from other countries that reserve excess doses;
–  Advance purchase mechanisms, such as participating in COVAX.
Vaccine distribution: To help countries get ready to deploy vaccines and strengthen their health systems, which are key for effective vaccine distribution, WB financing will be used to establish policies for safe and effective deployment, expand storage and building cold chains, develop data and tracking systems, train health workers and build trust in immunizations through citizen and community engagement. The financing can also be used to purchase and distribute COVID-19 tests and treatments.

IFC’s support on vaccines
Another important part of the World Bank Group’s response comes from IFC, our private sector development arm. The $4 billion Global Health Platform supports private companies in delivering health products and services – including vaccines – to developing countries. This includes:
:: Investments in vaccine manufacturers to foster expanded production of COVID-19 vaccines in low- and middle-income countries, with production reserved for emerging markets.
:: Ability to invest in production to address other potential bottlenecks, including vials, needles and syringes, and cold storage capacity.
:: Support for mapping COVID-19 vaccine manufacturing capacity, focusing on potential bottlenecks in manufacturing processes…

Milestones :: Perspectives :: Research

COVID Response – Equity

New Red Cross and Red Crescent plan to counter “deep and pervasive” inequities in pandemic response
Geneva, 24 March 2021 (ICRC/IFRC) – The International Red Cross and Red Crescent Movement has today launched a new plan that aims to tackle “deep and pervasive” inequities in the global response to the COVID-19 pandemic.

While no one has been spared from the effects of COVID-19, the consequences of this pandemic have not been equally felt. This crisis has been defined by profound and persistent inequities both in terms of who is most at risk, and how the world has responded.

The new Red Cross and Red Crescent analysis released today shows that, although present in all countries, these inequities have been particularly pronounced and damaging for people living in countries affected by humanitarian crises.

According to this analysis:
:: Countries that are not dealing with humanitarian crises have reported carrying out nearly 48 times more COVID-19 tests per capita than countries facing “severe” or “very severe” humanitarian crises.

:: People living in countries facing either no humanitarian crisis or crises that are considered “low” in severity are more than three times as likely to be supported with contact tracing for COVID-19.

:: Less than 2 per cent of COVID-19 vaccine doses globally have reportedly been administered in the 32 countries currently facing “severe” or “very severe” humanitarian crises.

Jagan Chapagain, Secretary General of the International Federation of Red Cross and Red Crescent Societies (IFRC), said: “Since the start of the outbreak, we have seen the virus discriminate through its impacts on the elderly, on people with pre-existing conditions, and on people who do not have the economic resources to isolate and protect themselves. What our data shows is that the response to COVID-19 also discriminates. These deep and pervasive inequities mean that, no matter where they are, people in vulnerable settings are more likely than the general population to be infected, are more likely to die once infected, and are least likely to be appropriately supported through the response, including through vaccination campaigns. The same is also true for vulnerable groups in non-crisis settings.”

Robert Mardini, Director-General of the International Committee of the Red Cross (ICRC), said:
“Communities affected by armed conflict have been among the hardest hit by COVID-19, including those who have been displaced, people separated from their families, those deprived of their livelihoods and people in detention. That is why the ICRC is supporting National Societies, vital health infrastructure, access to health care, efforts to prevent the spread of disease in places of detention, access to clean water, and the safe and dignified management of human remains in places experiencing conflict and violence.”

The revised International Red Cross and Red Crescent Movement plan is designed to counter some of the more severe inequities by expanding care, treatment and support for people in all countries, including those affected by humanitarian crises such as conflict and disasters. The plan also includes a range of measures designed to support and extend COVID-19 immunization campaigns so that marginalized and isolated groups — including people living in conflict zones, migrants and displaced people, people living in urban slums, and isolated communities in non-crisis affected countries — can access vaccines.

In all, the revised International Red Cross and Red Crescent Movement appeal seeks 2.729 billion Swiss francs…

To read the revised Movement plan, click here.

Milestones :: Perspectives :: Research

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

Weekly Epidemiological and Operational updates
Last update: 23 January 2021
Confirmed cases :: 125 781 957 [week ago: 121 969 223] [two weeks ago: 118 754 336]
Confirmed deaths :: 2 759 432 [week ago: 2 694 094] [two weeks ago: 2 634 370]
Countries, areas or territories with cases :: 223

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Weekly operational update on COVID-19 – 22 March 2021
Overview
In this edition of the Weekly Operational Update on COVID-19, highlights of country-level actions and WHO support to Member States include:
:: Calls for maintaining essential health services amid disruptions from COVID-19 pandemic
:: The role of traditional leaders for community-based interventions against COVID-19
:: The 1-year anniversary of Partners Platform and the COVID-19 Publication Review Committee
:: Support in minimizing risks from mass gatherings, preparing and supporting a COVID-19 vaccine campaign and support to virology laboratories
:: The Strategic Preparedness and Response Plan (SPRP) 2021 Operational Planning Guidelines, resource requirements and progress made to continue investing in the COVID-19 response and for building the architecture to prepare for, prevent and mitigate future health emergencies is included.
:: Updates on WHO/PAHO procured items, participation in the Unity Studies, and select indicators from the COVID-19 Monitoring and Evaluation Framework

Weekly epidemiological update on COVID-19 – 23 March 2021
Overview
Globally, COVID-19 confirmed cases continued to rise for a fourth consecutive week, with just under 3.3 million new cases reported in the last week . Concurrently, the number of new deaths reported plateaued after a six week decrease, with just over 60 000 new deaths reported. A marked increase in the number of new cases was reported from the South East Asia, Western Pacific, European and Eastern Mediterranean regions, all of which are on an upward trajectory in recent weeks. The European Region and the Region of the Americas continue to account for nearly 80% of all the cases and deaths.

In this edition, special focus updates are provided on:
:: Release of the WHO COVID-19 Detailed Surveillance Dashboard
:: SARS-CoV-2 variants of concern

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WHO – Feature COVID stories from around the globe
25 March 2021
A virus that respects no borders: protecting refugees and migrants during COVID-19

24 March 2021
Sudan’s community dialogues empower disadvantaged populations to decide on their health priorities

23 March 2021
WHO supports COVID-19 vaccine rollout, highlights women in health and boosts telemedicine during the pandemic thanks to donors

22 March 2021
El Salvador’s President takes the lead in promoting a stringent lockdown against COVID-19 with support from all levels, including the PAHO/WHO country office

Milestones :: Perspectives :: Research

WHO – COVID Vaccines EUAL, Prequalification

Draft landscape and tracker of COVID-19 candidate vaccines
12 March 2021  | Publication
The COVID-19 candidate vaccine landscape and tracker database compiles detailed information on COVID-19 vaccine candidates in development.
The landscape is updated regularly – twice a week (Tuesday and Friday, 17:00 CET).
Download: https://cdn.who.int/media/docs/default-source/blue-print/12.03.2021-novel-coronavirus_landscape_covid-19.xlsx.zip?sfvrsn=c2a25511_3&download=true

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Status of COVID-19 Vaccines within WHO EUL/PQ evaluation process 23 Mar 2021
For 16 vaccine candidates, the presents Manufacturer, Name of Vaccine, NRA of Record, Platform, EOI Accepted Status, Pre-submission Meeting Held Status, Dossier Accepted for Review, Status of Assessment; Anticipated/Completed Decision Date
[click on the link above for full scale view]

Milestones :: Perspectives :: Research

UNICEF COVID-19 Vaccine Market Dashboard :: Agreements Table Accessed 27 Mar 2021
An overview of information collected from publicly announced bilateral and multilateral supply agreements [Agreements view from 2021-03-14 to date]

Milestones :: Perspectives :: Research

Our World in Data
Coronavirus (COVID-19) Vaccinations – Fully Vaccinated Population Percentage

Milestones :: Perspectives :: Research

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

White House [U.S.]
Briefing Room
Press Briefing by White House COVID-19 Response Team and Public Health Officials
March 26, 2021 • Press Briefings

FACT SHEET: Biden Administration Announces Historic $10 Billion Investment to Expand Access to COVID-19 Vaccines and Build Vaccine Confidence in Hardest-Hit and Highest-Risk Communities
March 25, 2021 • Statements and Releases

Press Briefing by White House COVID-19 Response Team and Public Health Officials
March 24, 2021 • Press Briefings

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

COVID Data Tracker March 27, 2021

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NIAID Statement on AstraZeneca Vaccine
March 22, 2021 — Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.
Authorization and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees…

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

EMA
EMA: Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna
News  26/03/2021
EMA’s human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU.

New manufacturing site for AstraZeneca’s COVID-19 vaccine
A new manufacturing site has been approved for the production of AstraZeneca’s COVID-19 vaccine active substance. The Halix site is located in Leiden, the Netherlands, and will bring the total number of manufacturing sites licensed for the production of the active substance of the vaccine to four.

New manufacturing site and more flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine
A new site has also been approved for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. The facility, which is in the German city of Marburg, will produce both active substance and the finished product. There are currently three active substance manufacturing sites supplying the EU included in the marketing authorisation.
In addition to the new manufacturing facility for this vaccine, the CHMP has also given a positive opinion to allow transportation and storage of vials of this vaccine at temperatures between -25 to -15˚C (i.e. the temperature of standard pharmaceutical freezers) for a one-off period of two weeks. This is an alternative to the long-term storage of the vials at a temperature between -90 to -60˚C in special freezers. It is expected to facilitate the rapid roll-out and distribution of the vaccine in the EU by reducing the need for ultra-low temperature cold storage conditions throughout the supply chain.

New manufacturing site and scaled-up processes for Moderna’s COVID-19 vaccine
Already last week, the CHMP recommended approving the addition of a new manufacturing site for the production of active substance and finished product intermediates for Moderna’s COVID-19 vaccine. The addition of the new manufacturing lines at the Lonza facility, located in Visp, Switzerland, together with other changes to the manufacturing processes that were greenlighted by the Committee are intended to scale-up production capacity and increase supply of the vaccine for the EU market.

The changes described will be included in the publicly available information on these vaccines on EMA’s website…

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European Commission

Remarks by Executive Vice-President Dombrovskis at the press conference on the export transparency and authorisation mechanism and an accelerated approval of adapted vaccines against COVID-19 variants
Speech 24 March 2021
… Today, the Commission has adopted an implementing regulation to adapt our export authorisation mechanism for vaccines, with the aim of preserving the security of our supply chains.
As you know, the mechanism was introduced on 30 January 2021, and was recently extended until 30 June, with wide support of EU Member States.
The system has introduced much-needed transparency in relation to vaccine deliveries in the EU.
We have used this mechanism in a balanced way.
We have authorised exports on the basis that they did not threaten the commitments undertaken by pharmaceutical companies under their Advance Purchase Agreements. Of 381 requests, 380 have been approved.
Only one request for export authorisation was not granted, since it would have compromised the commitments of AstraZeneca. I remind you that AstraZeneca has only delivered a small portion of its agreed contractual commitments.
Europe has taken every step to act fairly and responsibly, mindful of our global leadership role, since the start of the pandemic. The EU remains the biggest global exporter of vaccines. We are the largest contributor to low and middle income countries in the so-called COVAX facility.
You only have to look at the figures: 43 million vaccines to 33 countries since the end of January.
And that only covers the countries which are subject to export authorisation systems. There are many more vaccines going to other countries. No one else has done as much.
We see, however, that continuing shortfalls in production are not distributed fairly across different contracting countries.
The EU is the only OECD producer that continues to export vaccines to countries that have production capacities of their own. But when these countries do not export to the EU, there is no reciprocity.
The EU still faces a very serious epidemiological situation and continues to export significantly to countries whose epidemiological situation is less serious than ours, or whose vaccination roll-out is more advanced than ours.
To address these imbalances, President von der Leyen last Wednesday called for reciprocity and proportionality to be introduced in our transparency and authorisation regime. Accordingly, we have today adopted two adjustments to the existing mechanism.
These are necessary to achieve our objective of ensuring timely access to COVID-19 vaccines for EU citizens.
Going forward, Member States and the Commission should now consider two additional elements when assessing the impact of planned exports.
First, reciprocity.
If the country of destination, which has a large production capacity, restricts its own exports of vaccines or substances – either by law or other means – it may be appropriate to consider whether exports to this country are justified.
The second element is proportionality – which means finding the right balance:
Member states and the Commission will consider the conditions prevailing in the country of destination, in particular the epidemiological situation, its vaccination rate and the existing availability of COVID-19 vaccines.
Of course, the important consideration to respect Advance Purchasing Agreement remains in place.
It is appropriate that we should distinguish between poorly performing companies and well-performing ones that are on track to meet their contractual obligations.
In addition, the new act includes some countries, previously exempted, in the scope of the regulation. The primary objective of this adjustment is to have more transparency on exports, and to obtain a full picture on what is happening outside the EU, so as to avoid possible circumvention of the rules.
Exports to low- and middle-income countries, supplies through COVAX and exports to EU overseas countries and territories remain unconditionally exempted.
The added value of this proposal is that it should allow us to arrive at a more cooperative approach with our partner countries, especially those in a less dire situation.
This will also help ensure the well-functioning flow of vaccine and ingredients to give predictability to companies to ramp up global production and safeguard a fair distribution of vaccines.
The regulation will help us to meet the expectations of EU citizens, while maintaining our responsibilities to our partners around the world.
The most important thing at this crucial moment is to stabilise and accelerate the delivery of vaccines.
Thank you.

Milestones :: Perspectives :: Research

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

Africa’s Telecom and Technology Industry Leads the Charge against COVID-19 by Backing AU Covid-Tech & Vaccine Passport System
26 March 2021
[See COVID Passports below for detail]

Milestones :: Perspectives :: Research

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

Russia: Sputnik V – “the first registered COVID-19 vaccine”
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
Antigua and Barbuda authorizes Sputnik V
Press release, 26.03.2021

RDIF and “Torlak” Institute agree to produce Sputnik V vaccine in Serbia
Press release, 25.03.2021

Russia is the most trusted vaccine producer alongside the US, with Sputnik V being the most recognizable vaccine, a YouGov poll shows
Press release, 24.03.2021

Sputnik V approved in Vietnam
Press release, 23.03.2021

Mauritius becomes the 55th country to approve Sputnik V
Press release, 22.03.2021

RDIF and Virchow Biotech partner for production of Sputnik V vaccine in India
Press release, 22.03.2021

Milestones :: Perspectives :: Research

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

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

Editor’s Note:
See COVAX announcement above on delays in shipments resulting from India’s curtailment of vaccine exports. Media sources report that the Indian government has not formally commented on these export restrictions.

Milestones :: Perspectives :: Research

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

National Health Commission of the People’s Republic of China [to 27 Mar 2021]
http://en.nhc.gov.cn/
News
March 27: Daily briefing on novel coronavirus cases in China
On March 26, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 12 new cases of confirmed infections.

Chinese drug firm Sinovac: No vaccine-related abnormality monitored in people aged above 60
2021-03-26

Shanghai starts vaccinating expats
2021-03-24

Xi delivers video speech to Colombian people as Chinese vaccines arrive
2021-03-22

Vaccinated from overseas not exempt from COVID-19 control measures
2021-03-22

Chinese expert says COVID-19 origin research excludes lab leak, denies conflicts within WHO-China team
2021-03-22

National Medical Products Administration – PRC [to 27 Mar 2021]
http://english.nmpa.gov.cn/news.html
News
China approves clinical trials for CanSino’s inhaled COVID-19 vaccine
2021-03-26
China’s drug authority has approved clinical tests for an inhaled COVID-19 vaccine co-developed by domestic company CanSino Biologics, the Agence France-Presse (AFP) reported on March 23.

China’s daily output of COVID-19 vaccines reaches 5m doses
2021-03-25
The daily output of Chinese COVID-19 vaccines has reached 5 million doses, a senior official said.

Nation prepares mass domestic COVID inoculations
2021-03-25
China had administered nearly 82.85 million doses of COVID-19 vaccine as of Tuesday as it prepares a campaign to vaccinate its entire population, the State Council’s Joint Prevention and Control Mechanism said on March 24.

Over 100 mln Chinese vaccine doses administered world wide
2021-03-24
Over 100 million doses of COVID-19 vaccines produced by China have been administered at home and abroad, according to the State Council’s COVID-19 response inter-agency task force.

Milestones :: Perspectives :: Research

COVID Vaccine Developer Announcements [selected]

Moderna
Moderna Announces New Supply Agreement with the Philippines for 7 Million Additional Doses of COVID-19 Vaccine Moderna
March 22, 2021

Pfizer
EMA Approves New Storage Option for Pfizer-BioNTech Vaccine, Easing Distribution and Storage of Doses Across European Union
March 26, 2021
:: New stability data show vaccine can be stored at -25°C to -15°C for a total of two weeks and support decentralized distribution plans for vaccination at general practitioners’ offices
:: Label update offers greater flexibility for distributing, storing and administering the vaccine within the European Union

Pfizer Initiates Phase 1 Study of Novel Oral Antiviral Therapeutic Agent Against SARS-CoV-2
March 23, 2021
:: In-vitro studies conducted to date show that the clinical candidate PF-07321332 is a potent protease inhibitor with potent anti-viral activity against SARS-CoV-2
:: This is the first orally administered coronavirus-specific investigational protease inhibitor to be evaluated in clinical studies, and follows Pfizer’s intravenously administered investigational protease inhibitor, which is currently being evaluated in a Phase 1b multi-dose study in hospitalized clinical trial participants with COVID-19

AstraZeneca
Press Releases
AZD1222 US Phase III primary analysis confirms safety and efficacy
25 March 2021

Statement on COVID-19 vaccine supply at Anagni plant in Italy
24 March 2021

Update following statement by NIAID on AZD1222 US Phase III trial data
23 March 2021

AZD1222 US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis
22 March 2021

Milestones :: Perspectives :: Research

COVID Vaccination: Incentives/Mandates/Certificates/Passports

WHO – Call for public comments: Interim guidance for developing a Smart Vaccination Certificate – Release Candidate 1
19 March 2021 Call for consultation
Interim Guidance pdf: https://cdn.who.int/media/docs/default-source/documents/interim-guidance-svc_20210319_final.pdf?sfvrsn=b95db77d_11&download=true

In response to the Statement on the sixth meeting of the International Health Regulations (2005) Emergency Committee regarding the coronavirus disease (COVID-19) pandemic, and the need for WHO to support Member States to deliver COVID-19 vaccines, at scale, with digital tools, WHO has developed this guidance and technical specifications document, in collaboration with a multi-disciplinary group of experts. The Guidance aims to support WHO Member States in adopting interoperability standards for digital documentation of vaccination status (i.e. Smart Vaccination Certificates). 

It is critical to reiterate that the Smart Vaccination Certificate (SVC) is not intended to serve as an “immunity passport”. Furthermore, as per the “Interim position paper: considerations regarding proof of COVID-19 vaccination for international travellers”, currently, proof of COVID-19 vaccination is not recommended as a condition of departure or entry for international travel. Countries are advised to take a risk-based approach to international travel in the context of COVID-19. Additionally, along with the digital implementation of SVCs, it is recommended that the COVID-19 vaccination status should still be recorded through the paper-based International Certificate for Vaccination, and Prophylaxis based on the model presented in Annex 6 of the IHR.

Due to the constantly evolving context of the COVID-19 pandemic, this document is intended to have three releases prior to the release of the final version, with public feedback and input considered for all three releases. This document is the first of three releases. Release candidate 1 (this document) contains the key business requirements for an SVC for national adoption that includes the prioritized scenarios of use, use cases, key workflows, a core data set with preferred terminology code sets, and an initial FHIR Implementation Guide for the content in Release Candidate 1. This document will also begin to outline the international trust framework and a high-level overview of a governance mechanism.

As this is Release Candidate 1, which is an initial release of the technical specification for the Smart Vaccination Certificate, no digital solutions have met this specification yet.

As part of the public consultation, you can provide constructive feedback on this document by 12 April 2021. Please use the link to the feedback form to provide your comments. For any additional inquiries, please contact smartvaccination@who.int.

::::::

Africa’s Telecom and Technology Industry Leads the Charge against COVID-19 by Backing AU Covid-Tech & Vaccine Passport System
26 March 2021
Africa CDC obtains highly positive feedback from a  consultative meeting with mobile and technology players on the Africa CDC Trusted Travel Policy.

ADDIS ABABA, ETHIOPIA, 26 March 2021 – More than a year into the global pandemic, the coronavirus disease 2019 (COVID-19) pandemic has shown that health is central to everything we do on the planet. The profound impact of the virus and of the measures which have been necessary to contain it have worsened economic inequalities and social insecurities, and deepened challenges in our already under-pressure health systems on the continent…

The Africa Against COVID-19: Saving Lives, Economies and Livelihoods campaign is part of the African Union Commission’s answer to the challenge of fighting and containing the disease, while at the same time protecting African economies and livelihoods…

A key element of the campaign is the “Trusted Travel Platform”, which automates cross-border verification of health certificates (whether for testing or vaccines). This platform, which went live on 2 October 2020, is an excellent example of the dual goal of preserving lives and livelihoods: By preventing the use of fake certificates, it helps manage the spread of the disease. By facilitating cross-boarder travel, it helps restore travel, tourism and trade – major pillars of our African economies.

The Trusted Travel Platform is also an excellent example of the potential of strategic collaborations between the Africa CDC and private sector technology partners. It was developed in collaboration with the AfroChampions-convened Panabios Consortium and Econet, while an algorithm co-sponsored by the United Nations development Programme (UNDP) and Koldchain has dramatically boosted the ability to screen and onboard international laboratories and transport operators to the scheme.

Indeed, because of the combined efforts of these pan-African stakeholders, two million Africans have already benefitted from Trusted Travel; lab registries in 35 countries in Africa have been digitised; and 10 airlines are currently integrating. More intriguingly, laboratories and travel operators in 17 countries in Europe and North America have enrolled through the Global Haven window for access to the Trusted Travel network.

On 26 March 2021, the Africa CDC convened key leaders to further explore how technology and innovation can and will shape the post-COVID-19 new public health order in Africa. Sixty of Africa’s leading tech and telecom executives and experts, many allied with key partners in the public and private sector, civil society and academia, explored further partnerships and collaboration across the African technology landscape to scale promising Pan-African innovation platforms like Trusted Travel. They also deliberated on how specific interventions such as the use of digital technology to boost vaccine equity and accountability in Africa and quell hesitancy can provide general blueprints for health sector transformation…

More information on Trusted Travel is available at: www.africacdc.org/trusted-travel

::::::

Joint Statement on prioritization of COVID-19 vaccination for seafarers and aircrew
By International Civil Aviation Organization (ICAO), International Labour Organization (ILO), International Maritime Organization (IMO), International Organization for Migration (IOM) and World Health Organization (WHO)
25 March 2021 Statement
…More than 80% of global trade by volume is moved by maritime transport. The global economy depends on the world’s 2 million seafarers who operate the global fleet of merchant ships. Seafarers have been severely impacted by the travel restrictions imposed during the pandemic. As of January 2021, it is estimated that some 400,000 seafarers are stranded on board commercial vessels, long past the expiry of their contracts and unable to be repatriated. A similar number of seafarers urgently need to join ships to replace them…

With this statement, our organizations also call on governments to prioritize seafarers and aircrew in their national COVID-19 vaccination programmes, together with other essential workers, in accordance with the advice from the WHO SAGE Roadmap for prioritizing the use of COVID-19 vaccines in the context of limited supply published in November 20202. Seafarers and aircrew need to be protected through vaccination as soon as possible, to facilitate their safe movement across borders. We also call on governments to identify and prepare for the challenges of COVID-19 vaccination of seafarers and aircrew, particularly for seafarers spending long periods of time away from their home country.

Our organizations fully support the timely development of an international harmonized framework for vaccination certificates, to facilitate international travel for seafarers and aircrew.

In December 2020, WHO established a Smart Vaccination Certificate working group to ensure that digitalized versions of vaccine certificates are interoperable3, and the UN Crisis Management Team for COVID-19, under the leadership of WHO, recognized that all countries should consider seafarers and aircrew, who are required to travel across borders during the pandemic, for essential allocation of vaccines.

We invite governments and other stakeholders to bring the contents of this joint statement to the attention of the competent authorities and all parties concerned.

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 24 March 2021
:: On Tuesday 16 March, Egypt and United Arab Emirates were elected to co-chair the new ministerial-level subcommittee on polio eradication in the Eastern Mediterranean Region giving a major push to polio eradication efforts in the region. Read more…
:: The Financial Accountability Committee (FAC) meets quarterly to advise the POB on key financial issues, ensure the quality of GPEI’s financial accountability practices, and serve as a forum for donor engagement on financial commitments and accountability requirements. Take a look at the new 2021 FAC terms of reference available here.

Summary of new WPV and cVDPV viruses this week (AFP cases and ES positives):
:: Afghanistan: one WPV1 and four cVDPV2 positive environmental samples
:: Pakistan: three WPV1 and four cVDPV2 positive environmental samples
:: Côte d’Ivoire: two cVDPV2 positive environmental samples
:: Liberia: one cVDPV2 positive environmental sample
:: Niger: one cVDPV2 positive environmental sample
:: South Sudan: three cVDPV2 cases
:: Tajikistan: two cVDPV2 cases and two cVDPV2 positive environmental samples

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

WHO/OCHA Emergencies

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 since last update regardless of the level of the emergency listed.

WHO Grade 3 Emergencies [to 27 Mar 2021]

Democratic Republic of the Congo – No new digest announcements [Last apparent update: 12 Jan 2021]
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 27 Mar 2021]
Afghanistan – No new digest announcements identified [Last apparent update: 5 July 2020]
Angola – No new digest announcements identified [Last apparent update: 16 March 2021]
Burundi – No new digest announcements identified [Last apparent update: 04 July 2019]
Burkina Faso – No new digest announcements identified [Last apparent update: 10 mars 2021]
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: 2 March 2020]
Iraq – No new digest announcements identified [Last apparent update: 21 February 2020]
Libya – No new digest announcements identified [Last apparent update: 7 October 2019]
Malawi Floods – No new digest announcements identified [Last apparent update 05 March 2021]
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]
Myanmar – No new digest announcements identified [Last apparent update: 11 février 2021]
Niger– No new digest announcements identified [Last apparent update:06 mars 2021]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 27 Mar 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: 06 March 2021]
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 – No new digest announcements identified
East Africa Locust Infestation – No new digest announcements identified

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

WHO & Regional Offices [to 27 Mar 2021]
26 March 2021
Medical product alert Medical Product Alert N°2/2021: Falsified COVID-19 Vaccine BNT162b2

25 March 2021 Statement
COVAX updates participants on delivery delays for vaccines from Serum Institute of India (SII) and AstraZeneca
[See COVAX above for detail]

25 March 2021 Statement
Joint Statement on prioritization of COVID-19 vaccination for seafarers and aircrew
[See COVAX above for detail]

25 March 2021 Departmental news
WHO validates Cote d’Ivoire for eliminating sleeping sickness as a public health problem

24 March 2021 Departmental news
Introducing the WHO technical package on quality of care in fragile, conflict-affected and vulnerable settings

24 March 2021 Departmental news
WHO Urban Health Initiative releases report on sustainable transport in Ghana

24 March 2021 Departmental news
The Clock is ticking – it’s time to end TB deaths among people with HIV!

22 March 2021 Statement
Statement on Gender-Based Violence in Tigray region of Ethiopia

22 March 2021 News release
COVID-19 highlights urgent need to reboot global effort to end tuberculosis

22 March 2021 Departmental news
Campaign launched to make 30 km/h streets the norm for cities worldwide

22 March 2021 News release
WHO announces 2nd edition Health for All Film Festival shortlist and jury composition

22 March 2021 Departmental news
WHO announces updated guidance on the systematic screening for tuberculosis

::::::

Weekly Epidemiological Record, Vol. 96, No. 12, pp. 80m- 104, 26 March 2021
:: Antigenic and genetic characteristics of zoonotic influenza A viruses and development of candidate vaccine viruses for pandemic preparedness

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: A Women Leader Received “Her Heart’s Desire”, i.e. COVID-19 Vaccine 22 March 2021

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
:: Youth in Uzbekistan: personal stories of living through the COVID-19 pandemic 26-03-2021
:: Dr Kluge meets Ophelia, a TB patient from Azerbaijan 24-03-2021
:: WHO/Europe and ECDC joint press release: Ending tuberculosis is a race against time and drug resistance 22-03-2021

WHO Eastern Mediterranean Region EMRO
:: Iraq receives first delivery of COVID-19 vaccines through the COVAX Facility 26 March 2021
:: COVID-19 vaccines delivered through COVAX Facility arrive in Lebanon 25 March 2021
:: WHO condemns attacks on residential neighbourhoods in Aleppo 23 March 2021

WHO Western Pacific Region
:: 23 March 2021 | Feature story Hope and vigilance as COVID-19 vaccines reach the Western Pacific
:: 23 March 2021 | Statement Vaccines offer hope but are no silver bullet

CDC/ACIP [U.S.] [to 27 Mar 2021]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
CDC Supports Efforts to End Ebola Outbreaks in the Democratic Republic of the Congo and the Republic of Guinea
Friday, March 26, 2021
The U.S. Centers for Disease Control and Prevention (CDC) is committed to bringing an end to the Ebola outbreaks that were announced in February 2021 in the Democratic Republic of the Congo (DRC) and the Republic of Guinea (Guinea).
CDC is working closely with ministries of health and international and local partners in DRC, Guinea, and bordering countries to respond to these outbreaks.
Earlier this month CDC allocated $20 million from the Infectious Disease Rapid Response Reserve Fund for preparedness and response activities in Ebola-affected and border countries to ensure continuation of these efforts.
“Even one case of Ebola is too many,” said CDC Ebola Response Incident Manager Joel Montgomery, PhD, CAPT USPHS. “These funds allow CDC and its partners to quickly put in place response, preparedness, and post-outbreak programs and activities, learn more about the virus, and protect the health of the American people and people around the world.”
CDC has deployed scientific and technical experts to DRC, Guinea, Sierra Leone, and Liberia to respond alongside CDC country office staff…

Media Statement from CDC Director Rochelle P. Walensky, MD, MPH, On COVID-19 Vaccination at Dialysis Centers
Thursday, March 25, 2021

CDC Plans to Provide $332 Million to Support Community Health Workers for COVID-19 Prevention and Control
Thursday, March 25, 2021

MMWR News Synopsis Friday, March 26, 2021
:: Tuberculosis – United States, 2020
:: Declines in Prevalence of Human Papillomavirus Vaccine-Type Infection Among Females After Introduction of Vaccine — United States, 2003-2018
:: Rapid Scale-Up of an Antiretroviral Therapy Program Before and During the COVID-19 Pandemic — Nine States, Nigeria, March 31, 2019–September 30, 2020
:: Epidemiology of Tuberculosis and Progress Toward Meeting Global Targets — Worldwide, 2019
:: County-Level COVID-19 Vaccination Coverage and Social Vulnerability — United States, December 14, 2020–March 1, 2021 (Early Release March 17, 2021)
:: COVID-19 in Primary and Secondary School Settings During the First Semester of School Reopening — Florida, August–December 2020 (Early Release March 19, 2021)
:: Low SARS-CoV-2 Transmission in Elementary Schools — Salt Lake County, Utah, December 3, 2020–January 31, 2021 (Early Release March 19, 2021)
:: Pilot Investigation of SARS-CoV-2 Secondary Transmission in Kindergarten Through Grade 12 Schools Implementing Mitigation Strategies — St. Louis County and City of Springfield, Missouri, December 2020 (Early Release March 19, 2021)

Coronavirus Disease 2019 (COVID-19)– CDC
Selected Resources
:: Overall US COVID-19 Vaccine Distribution and Administration Update as of Fri, 26 Mar 2021 06:00:00 EST
:: County-Level COVID-19 Vaccination Coverage and Social Vulnerability – United States, December 14, 2020-March 1, 2021

Africa CDC [to 27 Mar 2021]
http://www.africacdc.org/
News
Africa’s Telecom and Technology Industry Leads the Charge against COVID-19 by Backing AU Covid-Tech & Vaccine Passport System
26 March 2021
[See COVID above for detail]

Expert and stakeholder virtual consultation meeting to develop the Africa CDC NCD and Mental health strategy, 27-28 April 2021
24 March 2021

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

National Health Commission of the People’s Republic of China [to 27 Mar 2021]
http://en.nhc.gov.cn/
News
March 27: Daily briefing on novel coronavirus cases in China
On March 26, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 12 new cases of confirmed infections.

Chinese drug firm Sinovac: No vaccine-related abnormality monitored in people aged above 60
2021-03-26

Shanghai starts vaccinating expats
2021-03-24

Xi delivers video speech to Colombian people as Chinese vaccines arrive
2021-03-22

Vaccinated from overseas not exempt from COVID-19 control measures
2021-03-22

Chinese expert says COVID-19 origin research excludes lab leak, denies conflicts within WHO-China team
2021-03-22

National Medical Products Administration – PRC [to 27 Mar 2021]
http://english.nmpa.gov.cn/news.html
News
China approves clinical trials for CanSino’s inhaled COVID-19 vaccine
2021-03-26

China’s daily output of COVID-19 vaccines reaches 5m doses
2021-03-25

Nation prepares mass domestic COVID inoculations
2021-03-25

Over 100 mln Chinese vaccine doses administered world wide
2021-03-24

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

Paul G. Allen Frontiers Group [to 27 Mar 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-pr ess/
News
How old is this bat? A new DNA-based test can tell.
March 23, 2021
Molecular clock links immunity, cancer suppression to bats’ extraordinarily long lives; new method could also help conservation efforts…

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

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

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

CARB-X [to 27 Mar 2021]
https://carb-x.org/
News
03.22.2021
World’s leading funders of antibacterial research provide guidance on Stewardship and Access in the fight against antibiotic-resistant bacteria
Leading funders of research and development of new antibiotics and other products targeting antibiotic-resistant bacteria have just released a document providing comprehensive guidance on strategies and activities to support Stewardship and Access for companies bringing new antibacterial products to market. The Stewardship and Access Plan Development Guide provides companies with a framework to develop plans so that their product will be used responsibly, minimizing the spread of antibiotic-resistant bacteria while helping patients get access to life-saving products.

Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 27 Mar 2021]
https://centerforvaccineethicsandpolicy.net/
News/Analysis/Statements
:: Past weekly editions of Vaccines and Global Health: The Week in Review are available here.

CEPI – Coalition for Epidemic Preparedness Innovations [to 27 Mar 2021]
http://cepi.net/
Latest News
No new digest content identified.

DARPA – Defense Advanced Research Projects Agency [to 27 Mar 2021
https://www.darpa.mil/news
News
No new digest content identified.

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

EDCTP [to 27 Mar 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
24 March 2021
World TB Day: the promise of ending the TB epidemic

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

European Commission [to 27 Mar 2021]
http://europa.eu/rapid/search-result.htm?query=18&locale=en&page=1
Latest
Statement 25 March 2021
Statement by President von der Leyen at the joint press conference with President Michel, following the videoconference of the members of the European Council
[See COVID above for detail]

Statement 24 March 2021
Joint statement by the European Commission and Her Majesty’s Government on cooperation in fighting the COVID-19 pandemic

Speech 24 March 2021
Remarks by Executive Vice-President Dombrovskis at the press conference on the export transparency and authorisation mechanism and an accelerated approval of adapted vaccines against COVID-19 variants
[See COVID above for detail]

Press release 24 March 2021
Coronavirus: new procedure to facilitate and speed up approval of adapted vaccines against COVID-19 variants
Today, as an immediate action under the HERA Incubator, the new European bio-defence preparedness plan against COVID-19 variants, the Commission is introducing a measure to speed up the authorisation of adapted COVID-19 vaccines. It will make provisions in the relevant EU legislation to allow companies to focus on gathering the necessary evidence in time and enable the authorisation of adapted vaccines with a smaller set of additional data submitted to the European Medicines Agency…

European Medicines Agency [to 27 Mar 2021]
http://www.ema.europa.eu/ema/
News & Press Releases 
News: Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna (new)
CHMP, Last updated: 26/03/2021
[See COVID above for detail]

News: EMA issues advice on use of regdanvimab for treating COVID-19 (new)
CHMP, Last updated: 26/03/2021

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021 (new)
CHMP, Last updated: 26/03/2021

News: COVID-19 Vaccine AstraZeneca – Update on ongoing evaluation of blood clot cases (new)
PRAC, Last updated: 25/03/2021

News: EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials (new)
Last updated: 22/03/2021

European Vaccine Initiative [to 27 Mar 2021]
http://www.euvaccine.eu/
Latest News
EVI
March 23, 2021
World Tuberculosis Day 2021 – “The clock is ticking”…

FDA [to 27 Mar 2021]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
March 26, 2021 – Coronavirus (COVID-19) Update: March 26, 2021

March 23, 2021 – Coronavirus (COVID-19) Update: March 23, 2021

FDA – COVID-19 Vaccines [to 27 Mar 2021]
www.fda.gov/covid19vaccines
News and Updates; Upcoming Events
03/26/2021
Coronavirus (COVID-19) Update
The FDA issues an emergency use authorization (EUA) to a company for the SARS-CoV-2 NGS Assay and provides a consumer update on common questions about COVID-19 vaccines.

Fondation Merieux [to 27 Mar 2021]
http://www.fondation-merieux.org/
News, Events
Mérieux Foundation event
Vaccine Acceptance webinars: COVAX introduction & acceptance
March 29, 2021 – Virtual Event
These webinars will bring together international experts to showcase examples of challenges and success stories reported in specific countries during the COVID-19 vaccine introduction, adoption and implementation and the related crisis management aspects.
Session 1: March 29, 2021, 8:00 am – 10:30 am (CEST – Paris time)
Session 2: March 29, 2021, 4:00 pm – 6:30 pm (CEST – Paris time)
(Two separate sessions have been set up to facilitate worldwide connection).
To register for the virtual event please contact Marianne Gojon-Gerbelot.

Gavi [to 27 Mar 2021]
https://www.gavi.org/
News Releases
25 March 2021
COVAX updates participants on delivery delays for vaccines from Serum Institute of India (SII) and AstraZeneca
[See COVID above for detail]

24 March 2021
Gavi Board approves COVAX Buffer for high-risk groups in humanitarian settings
[See COVID above for detail]

GHIT Fund [to 27 Mar 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 27 Mar 2021]
https://www.theglobalfund.org/en/news/
News & Stories
News
TB testing in 2020 dropped drastically due to COVID-19
24 March 2021
On World Tuberculosis Day, new data shows the COVID-19 pandemic has had a devastating impact on the fight against another deadly airborne disease: tuberculosis. Global Fund surveys in 13 countries with the highest TB burden in the world reveal that 29% fewer people were tested for TB compared to 2019

Uganda’s Remarkable Response to COVID-19
23 March 2021

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 27 Mar 2021]
https://www.glopid-r.org/news/
News
Publication in The Lancet: A call to action for global R&D funders during epidemics
23/03/2021
Funding organizations must address important gaps to establish a truly efficient and effective end-to-end R&D preparedness and response ecosystem.

COVID-19 research in low and middle income countries
22/03/2021
March 29 & 30, 2021 – 12 pm – 4 pm (BST) – Online event The outline agenda for this…

Hilleman Laboratories [to 27 Mar 2021]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 27 Mar 2021]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.

IAVI [to 27 Mar 2021]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
FEATURES
March 24, 2021
Uhambo: Twists and turns on the journey to an efficacious HIV-1 vaccine
In a new commentary the New England Journal of Medicine (NEJM), Mark Feinberg, M.D., Ph.D., IAVI President and CEO underscores the importance of innovation in HIV vaccine development following the disappointing outcome of the HIV Vaccine Trials Network (HVTN) 702 study (termed Uhambo, Zulu for “journey”). Feinberg’s commentary follows the recent publication of findings from Uhambo today in NEJM.
Says Feinberg: “Even though the HVTN 702 results were disappointing, important recent data have indicated that a sufficient level of a broadly neutralizing antibody against HIV-1 (HIV bnAb) can protect at-risk persons from infection with bnAb-susceptible HIV-1 variants. These findings have established the breadth, potency, and concentration of HIV bnAb as a mechanistic correlate of protection. Although inducing protective bnAb responses by vaccination will be challenging, studies that combine high-resolution structural methods (including crystallography and cryogenic electron microscopy) to reveal important details regarding HIV-1 Env antigenic determinants and insights into how bnAb-producing B cells develop in a subgroup of patients with HIV infection have provided a promising direction for vaccine development. The ability of a defined vaccine immunogen to initiate the process of bnAb evolution in persons without HIV infection was recently shown.”…

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
Press Releases/Announcements
No new digest content identified.

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

IFRC [to 27 Mar 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
New Red Cross and Red Crescent plan to counter “deep and pervasive” inequities in pandemic response
Geneva, 24 March 2021 (ICRC/IFRC) – The International Red Cross and Red Crescent Movement has today launched a new plan that aims to tackle “deep and pervasive” inequities in the global response to the COVID-19 pandemic. While no one has been spared fr …
24 March 2021
[See COVID above for detail]

Europe, Kyrgyzstan, Russia, Tajikistan, Ukraine
World Tuberculosis Day: IFRC calls for increased TB detection and treatment amid pandemic
IFRC is urging decision-makers to ensure tuberculosis patients receive life-saving treatment during the COVID-19 pandemic, after new research showing the pandemic has set back TB detection by 12 years.
23 March 2021

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

IRC International Rescue Committee [to 27 Mar 2021]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
Over 100% price increase in staple food contributes to dire humanitarian need as Yemen enters 7th year of war, says IRC
March 25, 2021

Press Release
The IRC condemns the multiple attacks against civilians in Niger that have killed over 200 people in just ten days
March 25, 2021

Press Release
IRC assessment finds women and children at risk of violence, sleeping on the street in Cox’s Bazar as major fire leaves over 45,000 people without shelter
March 23, 2021

Press Release
Syria: IRC statement on hospital attack in western Aleppo
March 21, 2021

IVAC [to 27 Mar 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
Webinar Recording: SARS-CoV-2 Variants and the Safety of COVID-19 Vaccines in the U.S.
March 2021
The International Vaccine Access Center (IVAC) hosted a webinar on March 23, 2021, “SARS-CoV-2 Variants and the Safety of COVID-19 Vaccines in the U.S.” Description: This webinar presented about COVID-19 vaccine safety in the U.S. and the potential impact new variants will have on vaccine effectiveness. The speed and coordination of the response against COVID-19 […]

IVI [to 27 Mar 2021]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.

JEE Alliance [to 27 Mar 2021]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

Johns Hopkins Center for Health Security [to 27 Mar 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
New Report: National Priorities to Combat Misinformation and Disinformation for COVID-19 and Future Public Health Threats: A Call for a National Strategy
March 23, 2021

MSF/Médecins Sans Frontières [to 27 Mar 2021]
http://www.msf.org/
Latest [Selected Announcements
Coronavirus COVID-19 pandemic
COVID-19 support desperately needed as second wave overwhelms Yemen
Press Release 25 Mar 2021

Coronavirus COVID-19 pandemic
Three questions on worrying COVID-19 surge in Papua New Guinea
Interview 25 Mar 2021

Coronavirus COVID-19 pandemic
Vaccines urgently needed as Palestine struggles under surge of COVID-19
Press Release 24 Mar 2021

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

NIH [to 27 Mar 2021]
http://www.nih.gov/news-events/news-releases
News Releases
Scientists find evidence that novel coronavirus infects the mouth’s cells
March 25, 2021 — NIH-funded findings point to a role for saliva in SARS-CoV-2 transmission.

NIAID Statement on AstraZeneca Vaccine
March 23, 2021 — Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data
[See COVID above for detail]

Investigational AstraZeneca vaccine prevents COVID-19
March 22, 2021 — Results are from a large clinical trial in the United States and South America.

UN OCHA Office for the Coordination of Humanitarian Affairs [to 27 Mar 2021]
https://www.unocha.org/
Press Releases
No new digest content identified.

PATH [to 27 Mar 2021]
https://www.path.org/media-center/
Press Releases
PATH welcomes Dr. Fredrick Were to the board of directors
March 23, 2021 by PATH
PATH’s board of directors has voted to appoint Dr. Fredrick Namenya Were as its new member. Dr. Were brings extensive experience in maternal and newborn health, child nutrition, health services and immunization.

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

UNAIDS [to 27 Mar 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
26 March 2021
UNAIDS works with partners to support the COVID-19 recovery for vulnerable people in Indonesia

26 March 2021
UNAIDS shows that with the right investment we can end AIDS by 2030
A new report published by UNAIDS today shows the value of investing fully in the HIV response.
UNAIDS modelling shows that investing US$ 29 billion a year in the HIV response in low- and middle-income countries by 2025 will put the world back on track to end AIDS by 2030. The investment, paid for by both donors and the wealthier countries most impacted by the HIV pandemic, would result in annual new HIV infections falling dramatically, from 1.7 million in 2019 to 370 000 in 2025, and annual AIDS-related deaths falling from 690 000 in 2019 to 250 000 in 2025. The number of new HIV infections among children will drop from 150 000 in 2019 to less than 22 000 in 2025…

24 March 2021
Tuberculosis deaths among people living with HIV are declining globally, but worrying gaps in TB care persist

24 March 2021
Huge gaps in TB care for people living with HIV in some countries

24 March 2021
Drop-in centre provides a lifeline for sex workers in Ethiopia

24 March 2021
Drop-in centre for sex workers opened in Togo

22 March 2021
Digital HIV education for Jamaican young people during COVID-19 and beyond

UNDP United Nations Development Programme [to 27 Mar 2021]
http://www.undp.org/content/undp/en/home/presscenter.html
Latest from News Centre
Women’s absence from COVID-19 task forces will perpetuate gender divide, says UNDP, UN Women
Women, on average, still make up only 24 percent of members among 225 COVID-19 task forces examined across 137 countries, as shown by the COVID-19 Global Gender Response Tracker tool that analyzes…
Posted on March 22, 2021

UNESCO [to 27 Mar 2021]
http://en.unesco.org/news
Selected Latest News
Ethical framework for COVID-19 response in the Arab region: views and recommendations from the experts
25/03/2021
03/22/202

UNHCR Office of the United Nations High Commissioner for Refugees [to 27 Mar 2021]
http://www.unhcr.org/en-us/media-centre.htmlS
Selected Announcements
Bangladeshi authorities, aid agencies and refugee volunteers rush to respond as massive fire leaves some 45,000 Rohingya refugees without shelter
23 Mar 2021

UNICEF [to 27 Mar 2021]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Statement
03/25/2021
COVAX updates participants on delivery delays for vaccines from Serum Institute of India (SII) and AstraZeneca
[See COVID above for detail]

Press release
03/25/2021
South Sudan receives first batch of COVID-19 vaccines through the COVAX Facility
JUBA, 25 March 2021 – Today 132,000 doses of the Astra Zeneca COVID-19 vaccine arrived at the Juba International Airport. This is the first of several vaccine shipments scheduled to arrive over the coming months to South Sudan through the support of the COVAX Facility…

Press release
03/21/2021
Arrival of first wave consignment of COVAX COVID-19 vaccine doses to the State of Palestine
RAMALLAH and GAZA CITY, 21 March 2021 – On 17 March, the State of Palestine received the first shipment of 37,440 doses of the Pfizer COVID-19 vaccine and 24,000 doses of the Astra Zeneca COVID-19 vaccine from COVAX facility as part of the first wave allocation. These vaccine doses were transferred to the Ministry of Health’s ultra-cold chain and vaccine storage facilities in the West Bank and the Gaza Strip.
Further consignments of COVAX vaccine doses are planned for the State of Palestine to cover 20 per cent of the population – approximately 1 million people. As with the current consignments, these doses are for both the West Bank and the Gaza Strip, according to the prioritization criteria of the National Deployment and Vaccination Plan…

Unitaid [to 27 Mar 2021]
https://unitaid.org/
Featured News
24 March 2021
Unitaid reaffirms its commitment to combat tuberculosis in times of COVID-19
Geneva – On World Tuberculosis Day 2021, Unitaid renews its strong commitment to fight one the world’s deadliest infectious killers.
Ensuring wider access to better, simpler and more affordable solutions to stop the spread of tuberculosis (TB) has always been at the core of Unitaid’s mission. While the world has come together to combat the COVID-19 pandemic, it is now more important than ever to redouble our efforts when it comes to TB.
Every year, about 1.4 million die from TB and 10 million people fall ill with the disease. The COVID-19 pandemic has intensified existing access challenges to efficient prevention, diagnosis and care, threatening to reverse the gains made over recent years.
Disruptions in TB services, diversion of resources and substantial reductions in TB detection have been observed. Between 2020 and 2025, an additional 1.4 million TB deaths could be registered as direct consequence of the pandemic.
Urgent action must be taken to provide wider access to life-saving preventive tools, tests and treatments if we want to reach our objective of ending TB by 2030.
“In these exceptional times, innovation has proven to be even more critical than ever to tackle tuberculosis. We need to redouble our efforts across prevention, diagnosis and treatment to ensure that affordable, simpler and adapted solutions are made available in low- and middle-income countries, particularly for the people who need them the most” said Dr Philippe Duneton, Unitaid Executive Director.

24 March 2021
Unitaid looks to invest in better tools to improve tuberculosis detection

Vaccination Acceptance Research Network (VARN) [to 27 Mar 2021]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

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

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

Wellcome Trust [to 27 Mar 2021]
https://wellcome.ac.uk/news
Explainer
Why we need to share vaccine doses now and why COVAX is the right way to do it
26 March 2021

Blog
Has Covid-19 changed researcher behaviour?
Georgina Humphreys
25 March 2021

The Wistar Institute [to 27 Mar 2021]
https://www.wistar.org/news/press-releases
Press Releases
Mar. 23, 2021
Richard M. Horowitz Appointed Chair of The Wistar Institute’s Board of Trustees
Richard M. Horowitz is the new Chair of Wistar’s Board of Trustees. Looking forward to future growth under his guidance, the Institute is grateful to former Chair Helen P. Pudlin for her inspiring leadership… Sue Dillon, Ph.D., who is co-founder and CEO of Aro Biotherapeutics, has been elected to serve as the new vice-chair. Dillon was previously global therapeutic area head, Immunology, at Janssen Research & Development, a pharmaceutical company of Johnson & Johnson.

WFPHA: World Federation of Public Health Associations [to 27 Mar 2021]
https://www.wfpha.org/
Latest News
No new digest content identified.

World Bank [to 27 Mar 2021]
http://www.worldbank.org/en/news/all
Selected News, Announcements
New Global Tracker to Measure Pandemic’s Impact on Education Worldwide
Tracker a collaborative effort of Johns Hopkins University, the World Bank, and UNICEF March 26, 2021—The COVID-19 pandemic has disrupted education for 1.6 billion children worldwide over the past…
Date: March 26, 2021 Type: Press Release

WBG Vaccine Announcement– Key Facts
COVID-19 vaccines, alongside widespread testing, improved treatment and strong health systems are critical to save lives and strengthen the global economic recovery. To provide relief for vulnerable populations…
Date: March 23, 2021 Type: Factsheet
[See COVID above for detail]

COVID-19 in Eastern and Southern Africa: Four Hurdles to Recovery in the Race to Protect the Region’s Poorest
One year into the COVID-19 crisis, African countries in Eastern and Southern Africa have been spared the brunt of the pandemic, having recorded 2.1 million cases compared to, for example, close to 20 million…
Date: March 23, 2021 Type: Opinion

World Customs Organization – WCO [to 27 Mar 2021]
http://www.wcoomd.org/
Latest News – Selected Items
No new digest content identified.

World Organisation for Animal Health (OIE) [to 27 Mar 2021]
https://www.oie.int/en/for-the-media/press-releases/2021/
Press Releases
No new digest content identified.

WTO – World Trade Organisation [to 27 Mar 2021]
http://www.wto.org/english/news_e/news_e.htm
WTO News and Events
Post-COVID-19 recovery must not leave anyone behind — DG Okonjo-Iweala at Aid for Trade event
23 March 2021
WTO Director-General Ngozi Okonjo-Iweala, joined by five heads of international organizations, stressed the need to keep global trade flows open to ensure that developing and least-developed countries have access to essential medical goods to control the spread of COVID-19 and are able to use trade to drive sustainable economic recovery. The speakers were taking part in a high-level plenary session held on Day 1 of the online Aid for Trade Stocktaking Event on 23 March.

::::::

ARM [Alliance for Regenerative Medicine] [to 27 Mar 2021]
Press Releases – Alliance for Regenerative Medicine (alliancerm.org)
Press Releases
Alliance for Regenerative Medicine Supports the Council Position on EU Joint Clinical Assessments
BRUSSELS, BELGIUM – March 24, 2021
European Patients Stand To Benefit From Early Focus On Life-Changing ATMPs
The Alliance for Regenerative Medicine (ARM) – the global voice of the regenerative medicine and advanced therapies sector – welcomes the Council of the European Union’s support for EU-level joint clinical assessments. If adopted, joint clinical assessments can eliminate duplicative reviews of transformative Advanced Therapy Medicinal Products (ATMPs) across member states, reducing the time and cost required to bring durable, and potentially curative, cell, gene, and tissue-based therapies to patients anywhere in the EU…

BIO [to 27 Mar 2021]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

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

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

IFPMA [to 27 Mar 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
R&D-based pharmaceutical industry’s innovative partnerships to meet urgent global supply needs
23 March 2021

PhRMA [to 27 Mar 2021]
http://www.phrma.org/
Selected Press Releases, Statements
New report demonstrates the growing importance of partnerships in advancing biomedical innovation
March 24, 2021
…The report Power and Promise of a Collaborative Biopharmaceutical Ecosystem provides a look at the various collaborative partnerships currently taking place across the research ecosystem and healthcare system, playing a crucial role in:
:: Catalyzing research and development (R&D) and innovation,
:: Supporting public health and improving patient outcomes,
:: Enabling manufacturing scalability and supporting distribution and
:: Improving access to cutting edge innovation and cures.

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

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

Measles and rubella serosusceptibity among population vaccinated with different schedules: the potential impact on measles-rubella elimination in Iran
Iranian children were vaccinated with the scheduled two doses of monovalent measles vaccine (mMV) from 1984. In December 2003, a nationwide campaign of measles-rubella (MR) immunization was established to vacc…
Authors: Hana Saffar, Maryam Khalifeloo, Mohammad-Jafar Saffar, Alireza Abdollahi, Mohammad-Reza Parsaei, Gholam-Reza Ghorbani, Samaneh Salarvand and Mohsen Aarabi
Citation: BMC Infectious Diseases 2021 21:305
Content type: Research article
Published on: 25 March 2021

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 27 Mar 2021)

Considerations for applying bioethics norms to a biopharmaceutical industry setting
Authors: Luann E. Van Campen, Tatjana Poplazarova, Donald G. Therasse and Michael Turik
Citation: BMC Medical Ethics 2021 22:31
Content type: Debate
Published on: 25 March 2021
Abstract
Background: The biopharmaceutical industry operates at the intersection of life sciences, clinical research, clinical care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics efforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little examination of its proper scope.
Main text: Any institution with a scientific or healthcare mission should engage bioethics norms to navigate ethical issues that arise from the conduct of biomedical research, delivery of clinical care, or implementation of public health programs. It is reasonable to assume that while bioethics norms must remain constant, their application will vary depending on the characteristics of a given setting. Context “specification” substantively refines ethics norms for a particular discipline or setting and is an expected, needed and progressive ethical activity. In order for this activity to be meaningful, the scope for bioethics application and the relevant contextual factors of the setting need to be delineated and appreciated. This paper defines biopharmaceutical bioethics as: the application of bioethics norms (concepts, principles, and rules) to the research, development, supply, commercialization, and clinical use of biopharmaceutical healthcare products. It provides commentary on this definition, and presents five contextual factors that need to be considered when applying bioethics norms to a biopharmaceutical industry setting: (1) dual missions; (2) timely and pragmatic guidance; (3) resource stewardship; (4) multiple stakeholders; and (5) operational complexity.
Conclusion: Understanding the scope of the biopharmaceutical enterprise and contextual factors of a biopharmaceutical industry setting is foundational for the application of bioethics norms. Establishing a common language and approach for biopharmaceutical bioethics will facilitate breadth and depth of discussion and subsequent implementation to benefit patients, the healthcare system and society.

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 27 Mar 2021)

Pharmacy stakeholder reports on ethical and logistical considerations in anti-opioid vaccine development
As opioid use disorder (OUD) incidence and its associated deaths continue to persist at elevated rates, the development of novel treatment modalities is warranted. Recent strides in this therapeutic area inclu…
Authors: Vincent Wartenweiler, Grace Chung, Amy Stewart and Cody Wenthur
Citation: BMC Medical Ethics 2021 22:30
Content type: Research article
Published on: 25 March 2021

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 27 Mar 2021)

The use of personal health information outside the circle of care: consent preferences of patients from an academic health care institution
Immense volumes of personal health information (PHI) are required to realize the anticipated benefits of artificial intelligence in clinical medicine. To maintain public trust in medical research, consent poli…
Authors: Sarah Tosoni, Indu Voruganti, Katherine Lajkosz, Flavio Habal, Patricia Murphy, Rebecca K. S. Wong, Donald Willison, Carl Virtanen, Ann Heesters and Fei-Fei Liu
Citation: BMC Medical Ethics 2021 22:29
Content type: Research article
Published on: 24 March 2021

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

Determinants of physician attitudes towards the new selective measles vaccine mandate in Germany
In Germany, a mandatory policy on measles vaccination came into effect in March 2020. Physicians, as the main vaccine providers, have a crucial role in implementing it. Mandatory vaccination changes the precon…
Authors: Julia Neufeind, Cornelia Betsch, Vera Zylka-Menhorn and Ole Wichmann
Citation: BMC Public Health 2021 21:566
Content type: Research article
Published on: 22 March 2021

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

Factors associated with measles vaccination status in children under the age of three years in a post-soviet context: a cross-sectional study using the DHS VII in Armenia
The resurgence of measles globally and the increasing number of unvaccinated clusters call for studies exploring factors that influence measles vaccination uptake. Armenia is a middle-income post-Soviet countr…
Authors: Annabell C. Kantner, Sibylle Herzig van Wees, Erik M. G. Olsson and Shirin Ziaei
Citation: BMC Public Health 2021 21:552
Content type: Research article
Published on: 20 March 2021

BMJ Evidence-Based Medicine
February 2021 – Volume 26 – 1
https://ebm.bmj.com/content/26/1?current-issue=y

Evidence synthesis
An evidence map of randomised controlled trials evaluating genetic therapies
http://orcid.org/0000-0002-3044-9090
Eric A. Apaydin^1,2, Andrea S. Richardson³, Sangita Baxi¹, Jerry Vockley⁴, Olamigoke Akinniranye¹, Rachel Ross⁵, Jody Larkin¹, Aneesa Motala¹, Gulrez Azhar¹, Susanne Hempel^1,6
Correspondence to Dr. Eric A. Apaydin, Southern California Evidence-based Practice Center, Health Care, RAND Corporation, Santa Monica, CA 90401-3208, USA; eapaydin@rand.org
First published November 10, 2020.
Abstract
Objectives – Genetic therapies replace or inactivate disease-causing genes or introduce new or modified genes. These therapies have the potential to cure in a single application rather than treating symptoms through repeated administrations. This evidence map provides a broad overview of the genetic therapies that have been evaluated in randomised controlled trials (RCTs) for efficacy and safety.
Eligibility criteria – Two independent reviewers screened publications using predetermined eligibility criteria. Study details and data on safety and efficacy were abstracted from included trials. Results were visualised in an evidence map.
Information sources – We searched PubMed, EMBASE, Web of Science, ClinicalTrials.gov and grey literature to November 2018.
Risk of bias – Only RCTs were included in this review to reduce the risk of selection bias in the evaluation of genetic therapy safety and efficacy.
Included studies – We identified 119 RCTs evaluating genetic therapies for a variety of clinical conditions.
Synthesis of results – On average, samples included 107 participants (range: 1–1022), and were followed for 15 months (range: 0–124). Interventions using adenoviruses (40%) to treat cardiovascular diseases (29%) were the most common.
Description of the effect – In RCTs reporting safety and efficacy outcomes, in the majority (60%) genetic therapies were associated with improved symptoms but in nearly half (45%) serious adverse event (SAEs) were also reported. Improvement was reported in trials treating cancer, cardiovascular, ocular and muscular diseases. However, only 19 trials reported symptom improvement for at least 1 year.
Strengths and limitations of evidence -This is the first comprehensive evidence map of RCTs evaluating the safety and efficacy of genetic therapies. Evidence for long-term effectiveness and safety is still sparse. This lack of evidence has implications for the use, ethics, pricing and logistics of genetic therapies.
Interpretation – This evidence map provides a broad overview of research studies that allow strong evidence statements regarding the safety and efficacy of genetic therapies. Most interventions improve symptoms, but SAE are also common. More research is needed to evaluate genetic therapies with regard to the potential to cure diseases.
http://dx.doi.org/10.1136/bmjebm-2020-111448

Expert Review of Vaccines
Vol 20 (2) 2021
https://www.tandfonline.com/toc/ierv20/current

Article
Biological strategies and political hurdles in developing malaria vaccines
Michael F. Good & Danielle I. Stanisic
Pages: 93-95
Published online: 17 Feb 2021

Expert Review of Vaccines
Vol 20 (2) 2021
https://www.tandfonline.com/toc/ierv20/current

Transmission-Blocking Vaccines: Harnessing Herd Immunity for Malaria Elimination
Patrick E. Duffy
Pages: 185-198
Published online: 31 Jan 2021

Health Economics, Policy and Law 
Volume 16 – Issue 2 – April 2021
https://www.cambridge.org/core/journals/health-economics-policy-and-law/latest-issue

Article
Physicians’ attitudes towards accelerated access to medicines
Jessica Pace, Ian Kerridge, Sallie Pearson, Wendy Lipworth
Published online by Cambridge University Press: 31 October 2019, pp. 154-169
Abstract
In recent years, a variety of ‘accelerated access’ schemes have been introduced by pharmaceutical regulators and funders globally. These schemes aim to overcome perceived regulatory and reimbursement barriers to accessing medicines – particularly for patients with limited time or therapeutic options. However, patient access to approved medicines is mediated by a number of third parties including regulators and payers, and physicians who act both as gatekeepers and guides to prescribed medications. It is therefore essential to know how physicians think about accelerated access as they are responsible for advising patients on and prescribing medicines made available via these pathways. We conducted semi-structured interviews with 18 Australian physicians focusing on their attitudes towards accelerated access. We identified three ‘archetypes’ of physicians: ‘confident accelerators’, ‘cautious accelerators’, and ‘decelerators’. Although all acknowledged the potential risks and benefits of accelerated access, they disagreed on their magnitude and extent and how they should be balanced in both policy formation and clinical practice. Overall, our results illustrate the diversity of clinical opinions in this area and the importance of monitoring both the prescribing and clinical outcomes that result from accelerated access programmes to ensure that these are both clinically and morally acceptable.

Humanitarian Exchange Magazine
Number 78, October 2020
https://odihpn.org/magazine/inclusion-of-persons-with-disabilities-in-humanitarian-action-what-now/

Disability inclusion in humanitarian action
by HPN October 2020
The theme of this edition of Humanitarian Exchange, co-edited with Sherin Alsheikh Ahmed from Islamic Relief Worldwide, is disability inclusion in humanitarian action. Persons with disabilities are not only disproportionately impacted by conflicts, disasters and other emergencies, but also face barriers to accessing humanitarian assistance. At the same time, global commitments and standards and the IASC Guidelines on the inclusion of persons with disabilities in humanitarian action all emphasise how persons with disabilities are also active agents of change. Disability and age-focused organisations have led on testing and demonstrating how inclusion can be done better. Yet despite this progress, challenges to effective inclusion remain.

As Kirstin Lange notes in the lead article, chief among these challenges is humanitarian agencies’ lack of engagement with organisations of persons with disabilities. Simione Bula, Elizabeth Morgan and Teresa Thomson look at disability inclusion in humanitarian response in the Pacific, and Kathy Al Jubeh and Alradi Abdalla argue for a ‘participation revolution’, building on learning from the gender movement. Tchaurea Fleury and Sulayman AbdulMumuni Ujah outline how the Bridge Article 11 training initiative is encouraging constructive exchange between humanitarian and disability actors. The lack of good, disaggregated data is highlighted by Sarah Collinson; Frances Hill, Jim Cranshaw and Carys Hughes emphasise the need for training resources in local languages and accessible formats; and Sophie Van Eetvelt and colleagues report on a review of the evidence on inclusion of people with disabilities and older people.

Rebecca Molyneux and co-authors analyse the findings of a review of a DFID programme in north-east Nigeria, while Carolin Funke highlights the importance of strategic partnerships between disability-focused organisations, drawing on her research in Cox’s Bazar. Sherin Alsheikh Ahmed describes Islamic Relief Worldwide’s approach to mainstreaming protection and inclusion, while Pauline Thivillier and Valentina Shafina outline IRC’s Client Responsive Programming. The edition ends with reflections by Mirela Turcanu and Yves Ngunzi Kahashi on CAFOD’s SADI approach.

International Journal of Infectious Diseases
March 2021 Volume 104 p1-754
https://www.ijidonline.com/current

Editorial
COVID-19 vaccines under the International Health Regulations – We must use the WHO International Certificate of Vaccination or Prophylaxis
Eskild Petersen, et al
Published online: January 19, 2021
p175-177
… We propose that persons who have completed a full course of immunisation with an approved SARS-CoV-2 vaccine by an authorised provider should be allowed to travel freely for a specified period of time after completion of the last dose of immunisation…. In conclusion, standardized documentation of vaccination of travellers against SARS-COV -2 should be considered under the IHR. A number of questions will need to be answered in order to enable adoption by IHR. It is recommended when people are immunized against SARS-COV-2, they bring their WHO Yellow Card with them and ask the provider to enter the vaccine name and batch, date, sign and stamp. If a person does not have a WHO Yellow Card, she/he should obtain a proof of vaccination card with this important information. Immunisation certificates issued by national authorities using approved vaccines should be accepted as proof of immunity by airlines and national authorities.

JAMA
March 23/30, 2021, Vol 325, No. 12, Pages 1125-1234
https://jamanetwork.com/journals/jama/currentissue

Viewpoint
The US Regulatory System and COVID-19 Vaccines – The Importance of a Strong and Capable FDA
Joshua M. Sharfstein, MD; Jesse L. Goodman, MD, MPH; Luciana Borio, MD
free access has active quiz
JAMA. 2021;325(12):1153-1154. doi:10.1001/jama.2021.1961
This Viewpoint examines the important role of the Food and Druf Administration (FDA) in facilitating the rapid development of coronavirus disease 2019 (COVID-19) vaccines.

JAMA
March 23/30, 2021, Vol 325, No. 12, Pages 1125-1234
https://jamanetwork.com/journals/jama/currentissue

Editorial
Reassuring the Public and Clinical Community About the Scientific Review and Approval of a COVID-19 Vaccine
Howard Bauchner, MD; Preeti N. Malani, MD, MSJ; Joshua Sharfstein, MD

JAMA Network
COVID-19 Update March 27, 2021

These articles on COVID-19 were published across the JAMA Network in the last week.

Journal of Virology
April 2021; Volume 95, Issue 8
http://jvi.asm.org/content/current

Commentary
The Time for COVID-19 Vaccination
The composition and dynamics of viral mutant spectra in infected individuals advise that to avoid selection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) escape mutants, vaccination campaigns for coronavirus disease 2019 (COVID-19) should be launched when disease incidence is low.
Esteban Domingo, Celia Perales

Comment

Announcing the Lancet Commission on Vaccine Refusal, Acceptance, and Demand in the USA

Commissioners of the Lancet Commission on Vaccine Refusal, Acceptance, and Demand in the USA

Vaccines are one of the most effective tools for the prevention of infectious diseases.1 However, the success of immunisation programmes depends on widespread acceptance and high coverage of vaccination.2 Over the past decade, vaccine refusal has accelerated in the USA, with increased non-medical exemptions to school immunisation requirements that have been linked to outbreaks of vaccine-preventable diseases.3 Although vaccine refusal is not uniformly spread across the USA and national childhood vaccination rates remain high, vaccination has declined in many communities and school districts that are consequently at increased risk of outbreaks of vaccine-preventable diseases.4

Achieving optimal and uniform vaccine acceptance is a complex challenge, especially because early evidence suggests that key factors affecting vaccine acceptance may have shifted over the past few years. Anti-vaccine activities are prominent,5 but are only a part of why vaccine refusal has increased. Other factors include ongoing distrust of the medical community, particularly among socially vulnerable communities, and poor or inconsistent public communications on the safety of vaccines to prevent emerging pandemic threats.

Organised anti-vaccine activities are a concern. In the past, the US anti-vaccine movement generally operated at the fringes of society, but it has now expanded its reach through increased political activities and amplification on the internet, social media, and e-commerce platforms.5 Homegrown anti-vaccine organisations at the state and national levels, combined with weaponised health attacks from some foreign nations, now dominate the internet through coordinated disinformation.5,  6,  7,  8

One recent study found that just two homegrown anti-vaccine organisations were responsible for more than half of all anti-vaccine advertisements on Facebook.9 National and international organisations now host regular anti-vaccine conferences and stage rallies.7 Additionally, in many states, such as California, Oklahoma, and Texas, political action committees influence or lobby state legislatures, often through libertarian or far-right legislators touting so-called health freedom.7 This movement has built on a growing interest in non-pharmaceutical interventions and alternative medicine, and heightened scepticism of the drug industry.10

The repercussions of these efforts cost lives. The number of measles cases in the USA increased in the past few years;11 in 2019, there were more than 1200 cases of measles and multiple hospitalisations and intensive care unit admissions. 12 Adolescents are also unnecessarily placed at risk for human papillomavirus cancers as are adults,13 and many Americans die every year from influenza.14

The USA is potentially facing frequent and costly public health crises due to outbreaks of infectious diseases arising from low vaccine acceptance…

Racial, ethnic, and economic disparities are issues that need to be addressed in efforts to build vaccine acceptance. COVID-19 transmission, morbidity, and mortality have disproportionately affected essential workers, Americans living in low-income neighbourhoods, and communities of colour, which reflects the effects of systemic racism.15..

The Lancet has established the Commission for Vaccine Refusal, Acceptance, and Demand in the USA to design a multisectoral plan for public policy to support high acceptance of safe and effective vaccines in the USA. Our goal is to understand and report on the state of vaccine acceptance and its potential link to vaccine hesitancy. Additionally, we will work to identify and predict future trends in vaccine acceptance and impacts on the public health community. We will also identify and assess demand-side vaccine uptake interventions and solutions to counter anti-vaccine information.

Similar disparate health outcomes have occurred in other pandemics, such as the H1N1 influenza pandemic in 2009, and they are likely to arise in future disease outbreaks…

The Commission had its first meeting in 2020, and we aim for a first interim report on COVID-19 vaccines in the coming months. We expect to present a comprehensive report on broader vaccine acceptance and hesitancy in the USA by 2022. We will post updates about the Commission’s ongoing work on the Commission website. We are hopeful that confidence in and acceptance of vaccines in the USA can be improved through a cooperative strategy…

The Lancet
Mar 27, 2021 Volume 397 Number 10280 p1157-1236
https://www.thelancet.com/journals/lancet/issue/current

Editorial
COVID-19: building a stronger Europe
The Lancet
Europe is facing serious third waves of COVID-19 and vaccine roll-out has been fraught. But while much of the focus has been on western Europe, little attention has been paid to central and eastern Europe. This region is large, politically diverse, and historically complex, spanning EU member countries like the Czech Republic, Bulgaria, and the Baltic states, the non-EU western Balkans, and Ukraine further east. It is unclear how some of these countries managed to keep cases low during the first part of 2020. By mid-March 2021, six of the top ten countries globally with the highest death rates per 100 000 people were in central and eastern Europe (up to 230·34 in Czech Republic). This fact raises questions about the general state of health across the region. It also gives urgency to the issue of how Europe as a whole can best ensure its collective health security and prosperity. As COVID-19 brings immediate crises to Europe, health could be a unifying force to strengthen the ties between countries both within and outside the EU….

The Lancet
Mar 27, 2021 Volume 397 Number 10280 p1157-1236
https://www.thelancet.com/journals/lancet/issue/current

Articles
Assessment of protection against reinfection with SARS-CoV-2 among 4 million PCR-tested individuals in Denmark in 2020: a population-level observational study
Christian Holm Hansen, Daniela Michlmayr, Sophie Madeleine Gubbels, Kåre Mølbak, Steen Ethelberg
Our findings could inform decisions on which groups should be vaccinated and advocate for vaccination of previously infected individuals because natural protection, especially among older people, cannot be relied on.

The Lancet
Mar 27, 2021 Volume 397 Number 10280 p1157-1236
https://www.thelancet.com/journals/lancet/issue/current

Health Policy
Urgent lessons from COVID 19: why the world needs a standing, coordinated system and sustainable financing for global research and development
Nicole Lurie, Gerald T Keusch, Victor J Dzau
Summary
The research and development (R&D) ecosystem has evolved over the past decade to include pandemic infectious diseases, building on experience from multiple recent outbreaks. Outcomes of this evolution have been particularly evident during the COVID-19 pandemic with accelerated development of vaccines and monoclonal antibodies, as well as novel clinical trial designs. These products were developed, trialled, manufactured, and authorised for use in several countries within a year of the pandemic’s onset. Many gaps remain, however, that must be bridged to establish a truly efficient and effective end-to-end R&D preparedness and response ecosystem. Foremost among them is a global financing system. In addition, important changes are required for multiple aspects of enabling sciences and product development. For each of these elements we identify priorities for improved and faster functionality. There will be no better time than now to seriously address these needs, however difficult, as the ravages of COVID-19 continue to accelerate with devastating health, social, and economic consequences for the entire community of nations.

Nature
Volume 591 Issue 7851, 25 March 2021
https://www.nature.com/nature/volumes/591/issues/7850

Editorial | 23 March 2021
Politicians must dial down the rhetoric over COVID vaccines
Vaccine confidence will be the casualty of Europe’s war of words over the AstraZeneca–Oxford vaccine.

New England Journal of Medicine
March 25, 2021 Vol. 384 No. 12
http://www.nejm.org/toc/nejm/medical-journal

 Audio Interview
Interview with Dr. Paul Offit on how more than two centuries of vaccine advances have paved the way for Covid-19 vaccines. (07:02)Download

New England Journal of Medicine
March 25, 2021 Vol. 384 No. 12
http://www.nejm.org/toc/nejm/medical-journal

Perspective History of Medicine
On the Shoulders of Giants — From Jenner’s Cowpox to mRNA Covid Vaccines
Angela Desmond, M.D., Ph.D., and Paul A. Offit, M.D.

New England Journal of Medicine
March 25, 2021 Vol. 384 No. 12
http://www.nejm.org/toc/nejm/medical-journal

Original Articles
Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120–MF59 in Adults G.E. Gray and Others
A safe, effective vaccine is essential to eradicating human immunodeficiency virus (HIV) infection. A canarypox–protein HIV vaccine regimen (ALVAC-HIV plus AIDSVAX B/E) showed modest efficacy in reducing infection in Thailand. An analogous regimen using HIV-1 subtype C virus showed potent humoral and cellular responses in a phase 1–2a trial in South Africa. Efficacy data and additional safety data were needed for this regimen in a larger population in South Africa….The ALVAC–gp120 regimen did not prevent HIV-1 infection among participants in South Africa despite previous evidence of immunogenicity.

New England Journal of Medicine
March 25, 2021 Vol. 384 No. 12
http://www.nejm.org/toc/nejm/medical-journal

Editorials
Uhambo — Twists and Turns on the Journey to an Efficacious HIV-1 Vaccine M.B. Feinberg

PLoS Genetics
https://journals.plos.org/plosgenetics/
(Accessed 27 Mar 2021)

Double drives and private alleles for localised population genetic control
Katie Willis, Austin Burt
Research Article | published 23 Mar 2021 PLOS Genetics
https://doi.org/10.1371/journal.pgen.1009333
Author summary
Some disease vectors, invasive species, and other pests cannot be satisfactorily controlled with existing interventions, and new methods are required. Synthetic gene drive systems that are able to spread though populations because they are inherited at a greater-than-Mendelian rate have the potential to form the basis for new, highly efficient pest control measures. The most efficient such strategies use natural gene flow to spread a construct throughout a species’ range, but if control is only desired in a particular location then these approaches may not be appropriate. As some of the most promising gene drive designs use nucleases to target specific DNA sequences, it ought to be possible to exploit sequence differences between target and non-target populations to restrict the spread and impact of a gene drive. In this paper we propose using two-construct “double drive” designs that exploit pre-existing sequence differences between target and non-target populations. Our approaches maintain the efficiencies associated with only small release rates being needed and can work if the differentiated locus is selectively neutral and if the differentiation is far from complete, and therefore expand the range of options to be considered in developing genetic approaches to control pest species.