Milestones :: Perspectives :: Research

COVAX announces additional deals to access promising COVID-19 vaccine candidates; plans global rollout starting Q1 2021
:: COVAX now has agreements in place to access nearly two billion doses of several promising vaccine candidates, and laid the groundwork for further doses to be secured through contributions from donors
:: These agreements mean that all COVAX’s 190 participating and eligible economies will be able to access doses to protect vulnerable groups in the first half of 2021. At least 1.3 billion donor-funded doses will be made available to 92 economies eligible for the Gavi COVAX AMC, targeting up to 20% population coverage by the end of the year.
:: Funding raised in 2020 and early pledges toward 2021 targets, alongside these agreements, offer clearest pathway yet to ending the acute phase of the pandemic globally by the end of 2021

Geneva/Oslo, 18 December 2020 – COVAX, the global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income level, today announced that it had arrangements in place to access nearly two billion doses of COVID-19 vaccine candidates, on behalf of 190 participating economies. For the vast majority of these deals, COVAX has guaranteed access to a portion of the first wave of production, followed by volume scales as further supply becomes available. The arrangements announced today will enable all participating economies to have access to doses in the first half of 2021, with first deliveries anticipated to begin in the first quarter of 2021 – contingent upon regulatory approvals and countries’ readiness for delivery.

Given these are arrangements for 2 billion doses of vaccine candidates which are still under development, COVAX will continue developing its portfolio: this will be critical to achieve its goal of securing access to 2 billion doses of safe and effective, approved vaccines that are suitable for all participants’ contexts, and available by the end of 2021. However, today’s announcements offer the clearest pathway yet to end the acute phase of the pandemic by protecting the most vulnerable populations around the world. This includes delivering at least 1.3 billion donor-funded doses of approved vaccines in 2021 to the 92 low- and middle-income economies eligible for the COVAX AMC.

The new deals announced today include the signing of an advance purchase agreement with AstraZeneca for 170 million doses of the AstraZeneca/Oxford candidate, and a memorandum of understanding (MoU) with Johnson & Johnson for 500 million doses of the Janssen candidate, which is currently being investigated as a single dose vaccine.. These deals are in addition to existing agreements COVAX has with the Serum Institute of India (SII) for 200 million doses – with options for up to 900 million doses more – of either the AstraZeneca/Oxford or Novavax candidates, as well as a statement of intent for 200 million doses of the Sanofi/GSK vaccine candidate.

In addition to this, COVAX also has – through R&D partnership agreements – first right of refusal in 2021 to access potentially more than one billion doses (based on current estimates from the manufacturing processes under development) that will be produced, subject to technical success and regulatory approval, by candidates in the COVAX R&D Portfolio…

Milestones :: Perspectives :: Research

COVID – UNICEF Updates

Remarks by Henrietta Fore, UNICEF Executive Director, at briefing on COVAX progress to date
Statement – As delivered
New York, 18 December – “As we prepare to turn the calendar on what has been one of the darkest years imaginable, today we pause to recognize there is a light at the end of the tunnel. Today’s announcement is the latest positive momentum in our shared objective to ensure this light shines for everyone.

“At UNICEF we are ready. We are bringing the full weight of our experience — as the world’s largest single procurer of vaccines for children — to help procure and deliver COVID-19 vaccines, and to help countries prepare to receive and administer them.

“Here is how we’re doing this. We are working with PAHO, we have launched a tender to purchase and deliver vaccines to 92 low- and lower middle-income economies who are participating in the COVAX Facility. The first supply agreements are expected to be signed in early January, which will allow UNICEF to procure doses just as soon as they have received approval from WHO.

“In addition to securing the vaccine doses, UNICEF has already pre-positioned more than half a billion syringes and is purchasing 5 million safety boxes so the used syringes and needles can be disposed of in a safe manner by health workers. To be ready and efficient for deployment of vaccines we are bundling ‘the syringes and safety boxes’ and we have expanded our storage capacity in our global logistics hubs in Copenhagen, Dubai and Shanghai to support with delivery of COVID19 vaccines.

“Working with airlines, freight providers and organizations such as IATA, and WEF and once the vaccines are available, we are preparing to transport up to 850 tonnes of COVID-19 vaccines per month next year. This is more than double the average weight of vaccines UNICEF transports each month.

“Working with WHO and Gavi, we are helping countries prepare and develop national deployment and vaccination plans for the large-scale roll out of the vaccines. For example, to fill gaps in cold chain capacity, we are procuring and helping install 70,000 cold-chain fridges in lower-income countries by the end of 2021. This is part of a programme which began in 2017 with support from Gavi.

“So, working with governments on the ground, we are working to strengthen cold and supply chains, train health workers, and build trust in vaccines.

“Working with WHO, GAVI, and NGOs to design and operationalize access of COVID19 vaccines in humanitarian settings.

“So, in conclusion, this is a mammoth challenge. The stakes are incredibly high. But we are ready.”

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UNICEF outlining plans to transport up to 850 tonnes of COVID-19 vaccines per month on behalf of COVAX, in ‘mammoth and historic’ logistics
UNICEF – in partnership with Gavi and WHO – is also helping low- and lower-middle-income countries prepare to receive COVID-19 vaccines in 2021
NEW YORK, 18 December 2020 – UNICEF could potentially transport up to 850 tonnes of COVID-19 vaccines per month in 2021, should such quantities become available, according to a new assessment. This is more than double the average weight of vaccines UNICEF transports every month.

The assessment is part of UNICEF’s work to lead on the procurement and delivery of COVID-19 vaccines for 92 low- and lower middle-income countries on behalf of the COVAX Facility, in collaboration with the Pan American Health Organization (PAHO).

“This is a mammoth and historic undertaking,” said Henrietta Fore, UNICEF Executive Director. “The scale of the task is daunting, and the stakes have never been higher, but we are ready to take this on.”

The UNICEF assessment looked at global airfreight capacity and transport routes to better understand the challenges of delivering COVID-19 vaccines in 2021. It found that commercial airlines will be able to deliver vaccines to almost all 92 low- and lower-middle-income countries, which are among the 190 economies participating in the COVAX Facility, at an estimated cost of up to US$70 million.

Comparing vaccine volume estimates against commercial and cargo routes across the globe, the assessment also found that current air cargo capacity would be sufficient to make deliveries covering 20 per cent of the population for most of the 92 countries. COVID-19 vaccines are expected to be primarily shipped using existing passenger and cargo flight capacity, although charters or alternative transport options may still be needed for some small countries and others with access issues. UNICEF is working with airlines and the wider logistics industry to prioritise the delivery of COVID-19 vaccines around the world.

One major challenge in the COVID-19 vaccine operation is local cold chain capacity for vaccine storage within some low- and lower-middle-income countries. UNICEF, WHO and Gavi, the Vaccine Alliance, developed a guidance note on supply and logistics to help countries develop their supply chain strategies to receive, store, distribute and manage COVID-19 vaccines and related products. Given the range of storage temperatures required for COVID-19 vaccines, countries will continue to train logisticians and health workers on how to keep COVID-19 vaccines at the right temperatures.

As part of a programme that started in 2017, with support from Gavi, UNICEF continues to procure and support the installation of 70,000 cold-chain fridges in lower-income countries by the end of 2021, which will help in the roll-out of COVID-19 vaccines that need to be stored at 2 to 8 degrees Celsius. Almost half of these will be solar powered.

UNICEF, WHO and Gavi are also working to help countries prepare and develop national deployment and vaccination plans for the large-scale roll out of COVID-19 vaccines. Currently, countries are continuing to monitor their readiness against key milestones, which include expediting regulatory approvals and putting in place ways to monitor vaccine safety.

In addition, a UNICEF meeting this week with more than 300 vaccine procurement experts globally, including government officials, looked at ways to procure and roll-out COVID-19 vaccines and strengthen regulatory systems and supply chains.

Funding is critical. UNICEF has called for US$410 million to help countries with the delivery of vaccines, therapeutics and diagnostic tools in 2021. Further, UNICEF estimates a funding gap of US$133 million to cover in-country vaccine logistics and the required cold chain equipment for the poorest 92 countries.

“With the imminent arrival of globally approved COVID-19 vaccines, we can begin to see signs of hope. But hope will not be restored by the vaccine alone,” said Fore. “Countries need urgent technical and financial support to strengthen their capacities for cold and supply chains, to train health workers, and to work with communities in combatting misinformation and building trust in vaccines. Without urgent funding and support, many of the poorest countries still risk being left behind.”

Milestones :: Perspectives :: Research

Statement on COVID-19 Immunization and Equitable Access to Vaccines
WFPHA: World Federation of Public Health Associations
Dec 17, 2020
PDF: https://drive.infomaniak.com/app/share/141741/8c4e56c4-6620-4c77-8095-e967707d8c8a/17300/download
Purpose
The Global Taskforce of the WFPHA understands the importance of equity as a determinant
of health outcomes and is concerned that the distribution of COVID-19 vaccines may not be
done on an equitable basis.

Immunisation
Immunisation is one of the most successful public health measures. According to a World
Health Organization report on the prevention of infectious diseases, it is second only to clean
water as a preventive health measure (WHO 2008). Annually immunisation prevents an
estimated 2.5 million deaths globally and considerably reduces disease-specific treatment
costs (WHO 2018).

Prevention
For all the devastation caused by COVID-19, an important lesson is that the balance needs to
shift from treating disease to preventing it. Immunisation has an important role to play in
prevention not only for infants but throughout life as a key component of healthy ageing. It
saves, prolongs and improves the quality of lives. At the same time, by saving time and other
resources, immunisation leads to sustainable healthcare systems (UK Chief Medical Officers’
Guidelines 2011). Additionally, immunisation has positive long-term impacts, contributing to
make communities healthier and promoting social and economic development.

GAVI, WHO and UNICEF have warned that 80 million children under the age of one are at
risk of disease due to disruptions to vital immunisation programmes because of COVID-19
(GAVI 2020a). Specific to COVID-19, almost everyone is at risk and may require vaccination
if given the opportunity. Hence, it is likely that demand will surpass supply. The concern of
the WFPHA Immunisation Taskforce is the tendency for the rich to acquire and pay for the
limited supply of available efficacious vaccines to the detriment of the populations genuinely
at-risk, particularly in low-income settings.

COVID-19 Vaccines and Information
Not surprisingly, the race to produce a safe and efficacious vaccine for COVID-19 has been
on-going and early distribution in the United Kingdom and the United States indicates
success may not be too far away. In the course of immunisation programs, member states
need to tirelessly work to ensure that all information with respect to vaccine distribution is
stored in secure, audited and updated immunisation information systems. This promotes
central reporting, transparency, equitable distribution across the population and informed
decisions leaving no one behind.

An important lesson from previous immunisation programs is that, even when effective and
safe vaccines are available, vulnerable persons in low-income settings usually do not have
access to these vaccines for some time, if at all. There is a myriad of reasons for this state of
affairs. These include (among others) high cost of vaccination programmes for countries,
health systems, families and individual, individual’s poor geographical access to vaccination
centres, and inadequate supply of available vaccines due to competition.

The Global Immunisation Taskforce of the WFPHA supports the efforts of COVAX, a global
collaboration of governments, global health organisations, manufacturers, scientists, private
sector, civil society and philanthropy, in its aim for a global solution to this pandemic by
ensuring equitable access to effective and safe COVID-19 vaccines to all countries no matter
their wealth (GAVI 2020b).

Therefore, the WFPHA Global Immunisation Taskforce recommends:
1. The international community should continue the process of collaboration to support research and development of effective COVID-19 vaccines from multiple centres
2. The international community should establish a COVID-19 vaccination fund to support needy but resource-constrained countries
3. Support for the World Health Organization in its efforts to coordinate the response to COVID-19 and in the development of an appropriate vaccine
4. National authorities financially support the WHO and invest in strengthening national health systems with a particular focus on sustainable immunisation programs
5. Support for COVAX in its efforts to ensure equitable access of COVID-19 vaccines around the world with special focus on vulnerable populations, particularly in resource-constrained countries.

Milestones :: Perspectives :: Research

Executive Order on Ensuring Access to United States Government COVID-19 Vaccines
The White House, USA
Issued on: December 8, 2020
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:
Section 1. Purpose. Through unprecedented collaboration across the United States Government, industry, and international partners, the United States expects to soon have safe and effective COVID-19 vaccines available for the American people. To ensure the health and safety of our citizens, to strengthen our economy, and to enhance the security of our Nation, we must ensure that Americans have priority access to COVID-19 vaccines developed in the United States or procured by the United States Government (“United States Government COVID-19 Vaccines”).
Sec. 2. Policy. It is the policy of the United States to ensure Americans have priority access to free, safe, and effective COVID-19 vaccines. After ensuring the ability to meet the vaccination needs of the American people, it is in the interest of the United States to facilitate international access to United States Government COVID-19 Vaccines.

Sec. 3. American Access to COVID-19 Vaccines.
(a) The Secretary of Health and Human Services, through Operation Warp Speed and with the support of the Secretary of Defense, shall ensure safe and effective COVID-19 vaccines are available to the American people, coordinating with public and private entities — including State, territorial, and tribal governments, where appropriate — to enable the timely distribution of such vaccines.
(b) The Secretary of Health and Human Services, in consultation with the Secretary of Defense and the heads of other executive departments and agencies (agencies), as appropriate, shall ensure that Americans have priority access to United States Government COVID-19 Vaccines, and shall ensure that the most vulnerable United States populations have first access to such vaccines.
(c) The Secretary of Health and Human Services shall ensure that a sufficient supply of COVID-19 vaccine doses is available for all Americans who choose to be vaccinated in order to safeguard America from COVID-19.
Sec. 4. International Access to United States Government COVID-19 Vaccines. After determining that there exists a sufficient supply of COVID-19 vaccine doses for all Americans who choose to be vaccinated, as required by section 3(b) of this order, the Secretary of Health and Human Services and the Secretary of State, in coordination with the Administrator of the United States Agency for International Development, the Chief Executive Officer of the United States International Development Finance Corporation, the Chairman and President of the Export-Import Bank of the United States, and the heads of other agencies, shall facilitate international access to United States Government COVID-19 Vaccines for allies, partners, and others, as appropriate and consistent with applicable law.
Sec. 5. Coordination of International Access to United States Government COVID-19 Vaccines. Within 30 days of the date of this order, the Assistant to the President for National Security Affairs shall coordinate development of an interagency strategy for the implementation of section 4 of this order.
Sec. 6. General Provisions.
(a) Nothing in this order shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary,
administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

DONALD J. TRUMP
THE WHITE HOUSE
December 8, 2020

Milestones :: Perspectives :: Research

COVID-19 Vaccines Regulatory Processes :: Announcements/Meeting Dates/Milestones

December 18, 2020
FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.
“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen M. Hahn, M.D….

December 19-20, 2020
Advisory Committee on Immunization Practices (ACIP) – CDC
Emergency Meetings following VRBPAC Meeting on 17 December 2020.
No official statement at time of publication.

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EMA News: Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application
CHMP, Last updated: 15/12/2020
EMA’s human medicines committee (CHMP) and its experts have been working intensively over the past weeks to evaluate data submitted by BioNTech and Pfizer in the context of the conditional marketing authorisation (CMA) application for BNT162b2, a COVID19 mRNA vaccine.
The rate of progress is reliant on a robust and complete assessment of the quality, safety and efficacy and is determined by availability of additional information from the company to respond to questions raised during the evaluation.
Following receipt yesterday evening of additional data requested by the CHMP from the company and pending the outcome of its evaluation, an exceptional meeting of the CHMP has now been scheduled for 21 December to conclude if possible. The meeting planned for 29 December will be maintained if needed.
The CHMP will conclude its assessment at the earliest possible timepoint and only once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks.
Once the CHMP recommends a marketing authorisation, the European Commission will then fast track its decision-making process with a view to granting a marketing authorisation valid in all EU and EEA Member States within days…

EMA News: Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine
CHMP, Last updated: 17/12/2020
Over the last few weeks, EMA has made good progress on the assessment of the marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine. A continuous dialogue with the company has ensured that questions that arose during the evaluation were swiftly followed up and addressed by the company.
The rate of progress of the further evaluation will depend on the robustness of these data as well as availability of additional information from the company to respond to questions raised during the evaluation. The CHMP will conclude its assessment at the earliest possible timepoint, but only if the evidence shows convincingly that the benefits of the vaccine are greater than any potential risks.
Today, ahead of schedule, the company has submitted the last outstanding data package needed for the assessment of the application. This contains information that is specific to the manufacturing of the vaccine for the EU market.
Taking due account of the progress made, the Committee has scheduled an extraordinary meeting on 6 January 2021 to conclude its assessment, if possible. The meeting planned for 12 January 2021 will be maintained if needed. These two meetings will be virtual, as the EMA premises are closed for external visitors and staff are currently working remotely due to the pandemic…

Milestones :: Perspectives :: Research

COVID-19 Vaccines :: Development/Procurement/Distribution/Logistics

Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S.
December 18, 2020

European Commission Exercises Option for Additional 80 Million Doses of Moderna’s COVID-19 Vaccine Candidate
December 14, 2020

U.S. CDC Committee of Independent Health Experts Recommends Vaccination with Pfizer and BioNTech COVID-19 Vaccine for Persons Ages 16 Years and Older
December 14, 2020

Codagenix and Serum Institute of India Announce Commencement of First-in-Human Trial of COVI-VAC, A Single Dose, Intranasal Live Attenuated Vaccine for COVID-19
Dec 14, 2020, 08:00
– Randomized, double-blind, placebo-controlled, dose-escalation trial
– 48 volunteers to be enrolled at three dose levels
– Endpoints include safety, tolerability and immunogenicity

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Reuters
Health News
December 14, 20204:19 AM Updated 5 days ago
Singapore approves Pfizer’s COVID-19 vaccine in Asia first
By John Geddie, Anshuman Daga
SINGAPORE (Reuters) – Singapore became on Monday the first Asian country to approve Pfizer-BioNTech’s coronavirus vaccine and said it expects to start receiving shots by the end of the year.

Reuters
COVID-19 Pandemic
Saudi Arabia Begins Inoculating People With Pfizer COVID-19 Vaccines
December 17, 2020 11:07 AM

Reuters
Middle East & Africa
December 11, 20203:45 PM Updated 8 days ago
WHO expects decisions on Pfizer, Moderna, AstraZeneca vaccines in weeks
GENEVA (Reuters) – The World Health Organization expects to make decisions on whether to give emergency use approval to COVID-19 vaccines from Pfizer, Moderna and AstraZeneca in the coming weeks, its chief scientist said on Friday.

Milestones :: Perspectives :: Research

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

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Sputnik V – “the first registered COVID-19 vaccine” [to 19 Dec 2020]
https://sputnikvaccine.com/newsroom/pressreleases/
Press Releases
The Sputnik V vaccine’s efficacy is confirmed at 91.4% based on data analysis of the final control point of clinical trials
Press release, 14.12.2020
:: The efficacy of the Sputnik V vaccine is 91.4%, based on the final control point analysis of data obtained 21 days after administering the first dose…
:: The research data will be published by the Gamaleya Center team in one of the leading international peer-reviewed medical journals….

The number of Russians ready to be vaccinated against coronavirus has reached 42%, a FOM poll shows
Press release, 14.12.2020
A vaccine produced in Russia is the most trusted with 66% of those surveyed preferring it

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CHINA

National Medical Products Administration [to 19 Dec 2020]
http://english.nmpa.gov.cn/news.html
News
China prepares for mass production of COVID-19 vaccines: official
Xinhua | Updated: 2020-12-17
BEIJING — China’s COVID-19 vaccine development has entered the “final sprint,” with the country preparing for the mass production of COVID-19 vaccines, according to an official from the National Health Commission (NHC).
The evaluation of a vaccine requires a number of comprehensive indicators, of which safety, effectiveness, accessibility and affordability are the most important, said Zheng Zhongwei, an official from the NHC.
China has adopted five technological approaches in developing COVID-19 vaccines, with 15 vaccines entering clinical trials, of which five are undergoing phase-3 clinical trials.
China is scientifically and rigorously promoting phase-3 clinical trials of COVID-19 vaccines and conducting review and approval in strict accordance with laws, regulations and internationally recognized technical standards to ensure the vaccines are safe, effective and can stand the test of time, according to Zheng.
The five vaccines in phase-3 clinical trials include two inactivated vaccines developed by the China National Biotec Group affiliated to Sinopharm, an inactivated vaccine developed by Sinovac Biotech, an adenovirus vector vaccine developed by the Academy of Military Sciences and CanSino Biologics Inc., and a recombinant sub-unit vaccine jointly developed by Anhui Zhifei Longcom Biopharmaceutical Co., Ltd. and the Institute of Microbiology under the Chinese Academy of Sciences.
As the epidemic has been effectively controlled in China, the country no longer has the conditions to carry out phase-3 clinical trials. These are being carried out overseas, which also brings some difficulties and challenges, according to Zheng.
China granted emergency use of COVID-19 vaccines in June.

China honors its commitments on COVID-19 vaccine
2020-12-16
BEIJING — China is fulfilling its commitments with concrete actions to ensure the accessibility and affordability of COVID-19 vaccines in developing countries, a Foreign Ministry spokesperson said on Dec 15.
Chinese vaccine companies are sparing no effort to advance their vaccine research and development, and several vaccines have entered phase-three clinical trials, spokesperson Wang Wenbin said at a daily news briefing in response to a relevant question.
The Chinese government has been actively supporting cooperation between Chinese companies and other countries in vaccine research and development, he said, adding that China is in close communication and cooperation with the World Health Organization and the Global Alliance for Vaccines and Immunization.
The Chinese government will continue to work together with the international community to help ensure all countries will have equal access to safe and effective vaccines. For underdeveloped or some developing countries, China will help with their vaccine accessibility and affordability through such means as aid, Wang said.
When answering a question on the transparency in authorizing emergency use of the COVID-19 vaccine, the spokesperson said China always attaches great importance to vaccine safety and efficacy.
“Chinese vaccine companies advance research and development in strict accordance with science and regulation requirements and engage in international cooperation in strict compliance with international standards and relevant laws and regulations,” said Wang.
He said that some countries had already approved China’s vaccine for use, which had proved the safety and efficacy of China’s vaccine.
“We stand ready to work with other countries to advance vaccine research and development cooperation and contribute to vaccine accessibility and affordability in the world, in particular developing countries so the world can vanquish the pandemic at an early date,” Wang added.

EMERGENCIES

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

Weekly Epidemiological and Operational updates
Last update: 5 December 2020, 9:02 am GMT-5
Confirmed cases :: 74 299 042 [week ago: 69 808 588] [two weeks ago: 65 257 767]
Confirmed deaths :: 1 669 982 [week ago: 1 588 854] [two weeks ago 1 513 179
Countries, areas or territories with cases :: 222

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15 December 2020
Weekly epidemiological update – 15 December 2020

14 December 2020
Weekly operational update – 14 December 2020

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Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 09 December 2020
:: The EB reports on both polio eradication and polio transition planning/post-certification are now available here under “148th Executive Board”. These reports will help inform the discussions on polio eradication by Member States at the upcoming EB to be held on 18 – 26 January 2021.
:: Revision to WHO global poliovirus containment guidance – Following a Containment Advisory Group (CAG) recommendation, revision to WHO’s chief guidance document for poliovirus containment – GAPIII– has been initiated. The aim is to harmonize GAPIII requirements with other relevant biorisk management standards and CAG recommendations, through wide stakeholder engagement. Comments are still being received; contact hsingh@who.int for more information. The revised draft is expected to be ready for publication in Q1 2021, with critical review and endorsement of the document by CAG to follow.
:: New online tool to identify and assess potentially infectious material – A Potentially Infectious Materials (PIM), Poliovirus Identification and Assessment Digital Online Tool has been developed to assist all labs to identify samples or collections as PIM and carry out appropriate measures. The tool, to be available in Q1 2021, is to be used in conjunction with WHO’s PIM guidance. Thanks to facilities which helped pilot the tool.

Summary of new WPV and cVDPV viruses this week (AFP cases and ES postitives):
:: Afghanistan: 54 cVDPV2 cases
:: Pakistan: three WPV1 and two cVDPV2 positive environmental samples
:: Chad: two cVDPV2 cases
:: Democratic Republic of the Congo: two cVDPV2 cases
:: Nigeria: two cVDPV2 cases and one positive environmental sample
:: South

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WHO Grade 3 Emergencies [to 19 Dec 2020]

Democratic Republic of the Congo – No new digest announcements identified
Mozambique floods – No new digest announcements identified
Nigeria – No new digest announcements identified
Somalia – No new digest announcements identified
South Sudan – No new digest announcements identified
Syrian Arab Republic – No new digest announcements identified
Yemen – No new digest announcements identified

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WHO Grade 2 Emergencies [to 19 Dec 2020]
Iraq
:: WHO hands over essential health commodities to the Ministry of Health to contain COVID-19 in Iraq
Baghdad, 16 December 2020 – The World Health Organization (WHO) has today handed over essential medical supplies to the Iraqi Ministry of Health to strengthen its capacity to respond to the COVID-19 pandemic.
The supplies, which included personal protective equipment (58 800 face shields, 9800 protective goggles, 10 600 isolation gowns and 28 000 N95 face masks), were handed over to the Ministry of Health by the WHO Representative in Iraq, Dr Adham Ismail….

Burkina Faso
:: Améliorer la prévention et le contrôle de infections (PCI) dans les structures…17 décembre 2020
:: Réglementation des médicaments et produits de santé : L’OMS appuie à distance l’autoévaluation de l…16 décembre 2020

Measles in Europe
:: Republic of Moldova launches campaign to raise awareness about vaccines and encourage catch up on missed immunizations 16-12-2020

Myanmar
:: 12 December 2020 News release Closer to Measles and Rubella elimination from Bangladesh, 34 million children will be immunized within 6 weeks

Afghanistan – No new digest announcements identified
Angola – No new digest announcements identified
Burundi – No new digest announcements identified
Cameroon – No new digest announcements identified
Central African Republic – No new digest announcements identified
Ethiopia – No new digest announcements identified
Iran floods 2019 – No new digest announcements identified
Libya – No new digest announcements identified
Malawi Floods – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Mozambique – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
HIV in Pakistan – No new digest announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

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WHO Grade 1 Emergencies [to 19 Dec 2020]

Kenya
:: Keeping to the universal health coverage path in Kenya 11 December 2020

Chad – No new digest announcements identified
Djibouti – No new digest announcements identified
Mali – No new digest announcements identified
Namibia – viral hepatitis – No new digest announcements identified
Tanzania – No new digest announcements identified

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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

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UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
COVID-19
:: Coronavirus Disease (COVID-19): Weekly Epidemiological Update (13 December 2020)

East Africa Locust Infestation
:: Desert Locust situation update 19 December 2020

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WHO & Regional Offices [to 19 Dec 2020]
18 December 2020 Departmental news
Meet the 100+ outstanding Nurses and Midwives

18 December 2020 Joint News Release
COVAX Announces additional deals to access promising COVID-19 vaccine candidates; plans global rollout starting Q1 2021

17 December 2020 Joint News Release
New PSA campaign from WHO and YouTube is a playbook for a safe holiday season

17 December 2020 Departmental news
WHO launches Baseline report for Decade of Healthy Ageing

17 December 2020 Departmental news
Launch of the Tripartite Joint Risk Assessment Operational Tool

17 December 2020 Departmental news
Joint Risk Assessment Operational Tool in the time of COVID-19

17 December 2020 Departmental news
A parasitic infection that can turn fatal with administration of corticosteroids

17 December 2020 Departmental news
New study highlights cost-effectiveness of bans on pesticides as a suicide prevention strategy

15 December 2020 Departmental news
Updated WHO Information Note: Ensuring continuity of TB services during the COVID-19 pandemic

15 December 2020 Departmental news
Monitoring childbirth in a new era for maternal health

15 December 2020 Departmental news
Neglected tropical diseases: WHO and Sanofi renew decades-long collaboration to sustain elimination efforts

14 December 2020 Departmental news
Available for review: Chemical background documents for the WHO Guidelines for Drinking-water Quality

14 December 2020 News release
World’s largest youth organizations, representing 250 million members, and WHO launch global mobilization to respond to disruptive impacts of COVID-19 on young people

::::::

Weekly Epidemiological Record, 18 December 2020, vol. 95, 51-52 (pp. 641–652)
Index of countries/areas
Index, Volume 95, 2020, Nos. 1–52
Strategic and Technical Advisory Group for Infectious Hazards: 10th Ebola outbreak in Ituri, North Kivu and South Kivu provinces, Democratic Republic of the Congo – A technical review

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Responding to a yellow fever outbreak in Nigeria amidst a global pandemic
14 December 2020 In early November 2020, positive samples for yellow fever were reported from five Nigerian states. Nigeria is a high-risk country for yellow fever and is a priority country for the global eliminate yellow fever epidemics (EYE) strategy. The re-emergence of the virus there in September 2017 has been marked by outbreaks throughout the country.

WHO Region of the Americas PAHO
No new digest content identified

WHO South-East Asia Region SEARO
:: 18 December 2020 News release
WHO and EU join together to support COVID-19 response and systems strengthening in Asia

WHO European Region EURO
:: International Migrants Day 2020 – Dr Hans Henri P. Kluge meets a migrant health-care worker, “expert by experience” 18-12-2020
:: The holiday season amid COVID-19 and a growing mental health crisis in Europe 18-12-2020
:: Establishing the Pan-European Transformational Leadership Academy 18-12-2020
:: Turning the tide: Slovenia’s success story of fighting cervical cancer 17-12-2020
:: WHO analytical tool helps Ukraine monitor how regions respond to COVID-19 17-12-2020
:: Minimizing the COVID-19 risk: advice to individuals, communities and governments for the winter holidays 16-12-2020
:: New data reveals significant gaps in influenza immunization of those who need it most in Europe 15-12-2020
:: WHO hubs pool resources in the European Region to boost COVID-19 response 14-12-2020

WHO Eastern Mediterranean Region EMRO::
:: WHO hands over essential health commodities to the Ministry of Health to contain COVID-19 in Iraq
16 December 2020
:: A new WHO-KSRelief partnership to support the delivery of essential health services in Yemen
14 December 2020
:: Somalia, United Nations renew promise to deliver health for all 12 December 2020

WHO Western Pacific Region
:: 18 December 2020 | News release
WHO and EU join together to support COVID-19 response and systems strengthening in Asia
This week, the World Health Organization (WHO) and the European Union (EU) agreed to join forces to support eight South East Asian countries in their response to COVID-19 and to strengthen preparedness for future pandemics.
:: 17 December 2020 | News release
From containment to suppression: WHO and Lancet COVID-19 Commission highlight lessons from the Western Pacific Region
Professor Jeffrey D. Sachs, Dr Takeshi Kasai and expert panellists across Asia and the Pacific explored lessons from coronavirus disease 2019 (COVID-19) suppression at a forum jointly hosted today by the Lancet COVID-19 Commission and the World Health Organization (WHO).
:: 17 December 2020 | Statement
Virtual press conference on COVID-19 in the Western Pacific
As 2020 comes to a close, we’ve been reflecting on the response to COVID-19. In particular, how countries and areas in this Region have managed to keep numbers comparatively low, lessons that can help in the year to come, and what each of us needs to do to minimize the illness, death and disruption that this virus can cause going forward.

CDC/ACIP [to 19 Dec 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
Media Statement from CDC Director Robert R. Redfield on Signing the Advisory Committee on Immunization Practices’ recommendation to use Pfizer’s COVID-19 vaccine in people 16 and older
Sunday, December 13, 2020
Coronavirus Disease 2019 (COVID-19)
Selected Resources
:: The Importance of COVID-19 Vaccination for Healthcare Personnel
Friday, December 18, 2020

:: Frequently Asked Questions about COVID-19 Vaccination
Friday, December 18, 2020

:: The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine – United States, December 2020
Thursday, December 17, 2020

:: Importance of COVID-19 Vaccination for Residents of Long-term Care Facilities
Sunday, December 13, 2020

:: Post Vaccine Considerations for Healthcare Personnel
Sunday, December 13, 2020

:: Post Vaccine Considerations for Residents
Sunday, December 13, 2020

Africa CDC [to 19 Dec 2020]
http://www.africacdc.org/
News
Press Releases
Majority of Africans would take a safe and effective COVID-19 vaccine
ADDIS ABABA, ETHIOPIA, 17 DECEMBER 2020. A survey conducted by the Africa Centres for Disease Control and Prevention (Africa CDC), in partnership with the London School of Hygiene & Tropical Medicine (LSHTM) has shown that a predominant majority (79% average) of respondents in Africa would take a COVID-19 vaccine if it were deemed safe and effective.
Conducted between August and December 2020, the survey interviewed more than 15,000 adults, aged 18 years and above, across 15 African countries: Burkina Faso, Côte d’Ivoire, Democratic Republic of the Congo, Ethiopia, Gabon, Kenya, Malawi, Morocco, Niger, Nigeria, Senegal, South Africa, Sudan, Tunisia, and Uganda…

Press Releases
New guidance to expand rapid antigen testing for COVID-19 response in Africa released
16 December 2020

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

National Health Commission of the People’s Republic of China [to 19 Dec 2020]
http://en.nhc.gov.cn/
News
Dec 19: Daily briefing on novel coronavirus cases in China
On Dec 18, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 17 new cases of confirmed infections.

National Medical Products Administration [to 19 Dec 2020]
http://english.nmpa.gov.cn/news.html
News
China prepares for mass production of COVID-19 vaccines: official
2020-12-17
China’s COVID-19 vaccine development has entered the “final sprint,” with the country preparing for the mass production of COVID-19 vaccines, according to an official from the National Health Commission (NHC).
[See COVID above for detail]

China honors its commitments on COVID-19 vaccine
2020-12-16
China is fulfilling its commitments with concrete actions to ensure the accessibility and affordability of COVID-19 vaccines in developing countries, a Foreign Ministry spokesperson said on Dec 15.
[See COVID above for detail]

Announcements

Paul G. Allen Frontiers Group [to 19 Dec 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

BARDA – U.S. Department of HHS [to 19 Dec 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
December 15, 2020: HHS, DOD engage Quantum Leap Research Collaborative in search for effective treatments for the sickest COVID-19 patients

BMGF – Gates Foundation [to 19 Dec 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

Bill & Melinda Gates Medical Research Institute [to 19 Dec 2020]
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 19 Dec 2020]
https://carb-x.org/
News
12.16.2020  |
2020 a year of remarkable progress in supporting the development of new antibiotics, vaccines, diagnostics and other products targeting antibiotic-resistant bacteria
CARB-X has made solid progress in 2020, providing funding and support for innovative products in the race against antibiotic-resistant bacteria, and significantly building the size and scientific diversity of its global portfolio of antibiotics, vaccines, diagnostics and other life-saving products targeting drug-resistant bacteria.

CEPI – Coalition for Epidemic Preparedness Innovations [to 19 Dec 2020]
http://cepi.net/
Latest News
18 Dec 2020
Largest-ever Lassa fever research programme launches in West Africa
New research programme, ‘Enable’, aims to increase knowledge of the disease and assess true case count of those infected across the region.

17 Dec 2020
Equitable access to vaccines is the best way out of COVID-19
How CEPI is enabling access to COVID-19 vaccines

14 Dec 2020
Canada boosts funding for CEPI’s COVID-19 vaccine research
Funding comes as part of a wider investment in the WHO’s Access to COVID-19 Tools (ACT) Accelerator

EDCTP [to 19 Dec 2020]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
No new digest content identified.

Emory Vaccine Center [to 19 Dec 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

European Medicines Agency [to 19 Dec 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine
CHMP, Last updated: 17/12/2020
[See COVID Regulatory above for detail]

News: Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application
CHMP, Last updated: 15/12/2020
[See COVID Regulatory above for detail]

European Vaccine Initiative [to 19 Dec 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

FDA [to 19 Dec 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
December 18, 2020 – FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.
“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen M. Hahn, M.D….

December 17, 2020 – FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

December 17, 2020 – Coronavirus (COVID-19) Update: December 17, 2020
:: Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts from around the country, met to discuss a request for emergency use authorization (EUA) for a vaccine for COVID-19 prevention, submitted by ModernaTX, Inc. This meeting is an important step in the review process, providing an opportunity for outside experts to provide valuable advice and input for the agency to consider as part of its review. Importantly, the final decision about whether to authorize the vaccine for emergency use will be made by FDA’s career officials.
:: Also today, the agency posted a new webpage: Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions. Questions cover specifics, such as what data did the FDA use to make the decision to authorize the vaccine for emergency use, to more general questions, such as how does a vaccine go from emergency use authorization to licensure.

December 16, 2020 – Coronavirus (COVID-19) Update: December 16, 2020

December 14, 2020 – Coronavirus (COVID-19) Update: December 14, 2020
:: Yesterday, the FDA posted the review memorandum outlining the basis of the agency’s decision to authorize the Pfizer-BioNTech COVID-19 Vaccine. To ensure all Americans can have trust and confidence in the carefulness of FDA’s review, we have made, and will continue to make, the vaccine review process as transparent as possible.

FDA – COVID-19 Vaccines [to 19 Dec 2020]
www.fda.gov/covid19vaccines
Upcoming Events
FDA Media Briefing
FDA Commissioner Stephen Hahn and CBER Director Peter Marks discuss the EUA issued for the Moderna COVID-19 Vaccine, December 18, 2020
12/18/2020

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine
Today, the FDA issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
12/18/2020

FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
Press Release / Public Statement
Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the FDA has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.
12/18/2020

Fondation Merieux [to 19 Dec 2020]
http://www.fondation-merieux.org/
News, Events
Press Releases
No new digest content identified.

Gavi [to 19 Dec 2020]
https://www.gavi.org/
News releases
Gavi Board approves new push to reach unvaccinated children worldwide
17 December 2020
[See Milestones above for detail]

COVAX announces additional deals to access promising COVID-19 vaccine candidates; plans global rollout starting Q1 2021
18 December 2020
[See Milestones above for detail]

GHIT Fund [to 19 Dec 2020]
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 19 Dec 2020]
https://www.theglobalfund.org/en/news/
News
The Global Fund Appoints Hui C. Yang as Head of Supply Operations
16 December 2020
The Global Fund to Fight AIDS, Tuberculosis and Malaria has appointed Hui C. Yang, a highly experienced procurement and supply chain executive, as Head of its Supply Operations Department. Ms. Yang brings over two decades of experience in both the public and private sector and will join the Global Fund on 1 March 2021.

Canada Contributes CAD 65 million to Global Fund’s COVID-19 Response
14 December 2020
The Global Fund applauds the government of Canada for allocating CAD 65 million to the Global Fund’s efforts to support low- and middle-income countries to fight COVID-19, including procuring and deploying millions of COVID-19 rapid diagnostics tests as well as reinforcing health systems.

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 19 Dec 2020]
https://www.glopid-r.org/news/
News
No new digest content identified.

Hilleman Laboratories [to 19 Dec 2020]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 19 Dec 2020]
http://www.humanvaccinesproject.org/media/press-releases/
HPV COVID Report
COVID-19 Vaccines are Here; Will People Take Them?
Interview with Julia Wu, S.D., M.S.
Principal Investigator, Research Scientist
Human Immunomics Initiative
Harvard T.H. Chan School of Public Health

IAVI [to 19 Dec 2020]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
No new digest content identified.

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

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

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

IFRC [to 19 Dec 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Global
IFRC President: Migrants must not be left stranded at back of COVID-19 vaccine queue
Geneva, 17 December 2020 – The President of the world’s largest humanitarian organisation warns that inclusive action is urgently needed to safeguard the health and dignity of migrants worldwide, and to ensure they are not left behind as the first COVID-19 vaccines start being distributed.
Speaking ahead of International Migrants Day tomorrow, the President of the International Federation of Red Cross and Red Crescent Societies (IFRC), Francesco Rocca, said: “As the first COVID-19 vaccines begin to roll out, migrants – irrespective of their status – must not be left at the back of the queue. The pandemic is having a catastrophic impact on people on the move, who are too often left to fall through the cracks when it comes to accessing essential health services. It is imperative that we address the many barriers to universal health coverage and that migrants are fully included in national vaccination campaigns.”
A recent IFRC report “Least Protected, Most Affected: Migrants and refugees facing extraordinary risks during the COVID-19 pandemic” revealed that migrants have been disproportionately exposed to, and affected by, the virus this year due to often limited access to essential health, water, sanitation and hygiene services, as well as poor and unsafe living and working conditions that make it harder to comply with basic preventative measures. It also showed that migrants are being hit hardest by the economic fallout of COVID-19, are widely neglected from formal protection and safeguarding measures, and regularly face stigma and discrimination – sometimes in the form of violence…

Institut Pasteur [to 19 Dec 2020]
https://www.pasteur.fr/en/press-area
Press documents
No new digest content identified.

IRC International Rescue Committee [to 19 Dec 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
IRC’s 2021 Emergency Watchlist: triple threat of COVID, climate change and conflict threatens 200 million people without urgent action
December 16, 2020

IVAC [to 19 Dec 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

IVI [to 19 Dec 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
IVI-SK’s new typhoid conjugate vaccine meets primary endpoints in phase III study in Nepal
Primary analysis also confirms safety of Vi-DT
December 17, 2020 – SEOUL, South Korea – Vi-DT typhoid conjugate vaccine, developed jointly by the International Vaccine Institute (IVI) and SK bioscience, has met the primary endpoints in a phase III study in Nepal. The primary endpoints were based on immune non-inferiority with the WHO-prequalified typhoid conjugate vaccine, Typbar-TCV®, in terms of serconversion rate, which confirms the new candidate TCV induces an immune response that is not inferior to Typbar-TCV®…

JEE Alliance [to 19 Dec 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

Johns Hopkins Center for Health Security [to 19 Dec 2020]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
New Rapid Research Coalition Announced to Increase Local Community Involvement in an Equitable COVID-19 Vaccination Campaign  
launches CommuniVax, a research coalition funded by the Chan Zuckerberg Initiative
On December 15, the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health announced the launch of CommuniVax, a coalition to strengthen the community’s role and involvement in an equitable vaccination campaign. The coalition will conduct rapid ethnographic research related to COVID-19 vaccination among historically underserved communities of color in the United States. Local research teams will listen to community members and work with them to develop suggestions on how to strengthen COVID-19 vaccine delivery and communication strategies. The coalition will synthesize and disseminate community viewpoints to national stakeholders to develop a more equitable and effective vaccination effort, with an enduring impact on public trust. Read more: https://www.centerforhealthsecurity.org/news/center-news/2020-12-15-CommuniVax.html.

MSF/Médecins Sans Frontières [to 19 Dec 2020]
http://www.msf.org/
Latest [Selected Announcements]
Access to medicines
Governments must act fast on consensus supporting historic move to suspend monopoiesduring pandemic
Press Release 15 Dec 2020

Nigeria
Extra-long malaria season in Borno claims lives
Project Update 14 Dec 2020

National Vaccine Program Office – U.S. HHS [to 19 Dec 2020]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

NIH [to 19 Dec 2020]
http://www.nih.gov/news-events/news-releases
News Releases
Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine
December 18, 2020 — The mRNA-1273 vaccine is the second COVID-19 vaccine in the United States to be granted an EUA.

Investigational COVID-19 therapeutics to be evaluated in large clinical trials
December 17, 2020 — NIH trial enrolling people hospitalized with COVID-19.
Two randomized, controlled Phase 3 clinical trials have begun evaluating investigational monoclonal antibodies for their safety and efficacy in treating people hospitalized with moderate COVID-19. The trials are part of the ACTIV-3 master protocol, which has an adaptive design allowing investigators to add new sub-studies of additional investigational agents. ACTIV-3 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
One sub-study is evaluating VIR-7831, a monoclonal antibody developed through a partnership between GlaxoSmithKline plc (Brentford, United Kingdom) and Vir Biotechnology, Inc. (San Francisco). The other sub-study is evaluating the combination of BRII-196 and BRII-198, two neutralizing monoclonal antibodies manufactured by Brii Biosciences (Durham, North Carolina and Beijing). Antibodies are infection-fighting proteins naturally made by the immune system. Antibodies can prevent viruses from infecting cells, sometimes by binding to the surface of the viruses. Synthetic versions of these antibodies, prepared in a laboratory, are known as monoclonal antibodies…

NIH observational study of coronavirus infection and multisystem inflammatory syndrome in children begins
December 16, 2020 — Researchers will enroll at least 250 children and young adults ages 20 years or younger from diverse racial and ethnic backgrounds.

NIH-funded COVID-19 home test is first to receive over-the-counter authorization from FDA
December 15, 2020 — Ellume USA’s rapid at-home test was developed through the NIH RADx Initiative.

PATH [to 19 Dec 2020]
https://www.path.org/media-center/
Press Release
No new digest content identified.

Sabin Vaccine Institute [to 19 Dec 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
Dr. Regina Rabinovich Succeeds Dr. Axel Hoos as Sabin Vaccine Institute Board Chair, Drs. Norman Baylor and JoAnn Suzich Join the Board
Wednesday, December 16, 2020
Washington, D.C. – The Sabin Vaccine Institute (Sabin) is pleased to announce the Board of Trustees has unanimously elected Regina Rabinovich, MD, MPH, as board chair and elected two new trustees, Dr. Norman Baylor and Dr. JoAnn Suzich, to strengthen the organization’s leadership in global immunization and vaccine research and development.
Dr. Rabinovich has served on the board since November 2015, and as chair of the Governance Committee since 2016.
Dr. Rabinovich brings deep global health expertise to the role, with more than three decades of experience in the health and philanthropic sectors. She is currently the ExxonMobil Malaria Scholar in Residence at the Harvard T.H. Chan School of Public Health. In addition, Dr. Rabinovich is chair of the Malaria Eradication Scientific Alliance at ISGlobal, University of Barcelona, where she also serves as director of the Malaria Elimination Initiative…

UNAIDS [to 19 Dec 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
18 December 2020
Lima joins the Fast-Track cities initiative

15 December 2020
Coming together to address the cost of inequality

14 December 2020
New modelling shows COVID-19 should not be a reason for delaying the 2030 deadline for ending AIDS as a public health threat

UNICEF [to 19 Dec 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Statement
12/18/2020
Remarks by Henrietta Fore, UNICEF Executive Director, at briefing on COVAX progress to date
As delivered
[See Milestones above for detail]

Press release
12/18/2020
UNICEF outlining plans to transport up to 850 tonnes of COVID-19 vaccines per month on behalf of COVAX, in ‘mammoth and historic’ logistics
UNICEF – in partnership with Gavi and WHO – is also helping low- and lower-middle-income countries prepare to receive COVID-19 vaccines in 2021
[See Milestones above for detail]

Press release
12/18/2020
COVID-19 has led to dramatic reduction in essential services and protection for migrant and displaced children in countries around the world
New survey data show children on the move largely excluded from pandemic response and recovery

Statement
12/14/2020
Teachers should be prioritized for vaccination against COVID-19
Statement by UNICEF Executive Director Henrietta Fore
NEW YORK, 15 December 2020 – “The COVID-19 pandemic has wreaked havoc on children’s education around the globe. Vaccinating teachers is a critical step towards putting it back on track.
“At their peak in late April 2020, nationwide school closures disrupted the learning of almost 90 per cent of students worldwide. While that number has dropped since, there continues to be an unsupported assumption that closing schools may slow the spread of the disease, despite increasing evidence that schools are not a main driver of community transmission. As a result, as cases are skyrocketing in many countries around the world, communities are again closing schools. As of 1 December, classrooms are closed for nearly 1 in 5 schoolchildren globally – or 320 million children.
“UNICEF is calling for teachers to be prioritized to receive the COVID-19 vaccine, once frontline health personnel and high-risk populations are vaccinated. This will help protect teachers from the virus, allow them to teach in person, and ultimately keep schools open.
“While decisions about vaccine allocation ultimately rest with governments, the consequences of extended missed or impaired education are steep, especially for the most marginalized. The longer children remain out of school, the less likely they are to return, and the more difficult it is for their parents to resume work.
“These are difficult decisions that force difficult tradeoffs. But what should not be difficult is the decision to do everything in our power to safeguard the future of the next generation. This begins by safeguarding those responsible for opening that future up for them.”

Statement
12/14/2020
Remarks by UNICEF Executive Director Henrietta Fore at the Nutrition for Growth (N4G) Kick-Off Event
As prepared for delivery

Press release
12/14/2020
Almost 2 billion people depend on health care facilities without basic water services – WHO, UNICEF
Lack of water puts health care workers and patients at higher risk of COVID-19 infection

Unitaid [to 19 Dec 2020]
https://unitaid.org/
Featured News
16 December 2020
Unitaid welcomes contribution from Canada
Geneva – Unitaid welcomes contribution of C$15 million (US$11.7 million) from Canada to its ongoing work on COVID-19 therapeutics and diagnostics under the global Access to Covid-19 Tools (ACT) Accelerator.
The funding, which forms part of a C$255 million overall package of support to the ACT-Accelerator, has been allocated to Unitaid to support equitable access to promising COVID-19 treatments and tests…

14 December 2020
Japan joins Unitaid’s Executive Board
Geneva – On the occasion of the 37th meeting of the Unitaid Executive Board on December 9th-10th 2020, members voted unanimously to welcome Japan to join them.
As a key country of innovation, promoter of universal access to quality health coverage and a major player in the fight against infectious diseases, Japan becomes a member of the Executive Board, alongside delegations from African Countries, Brazil, Chile, Communities Living with the Diseases, Foundations, France, NGOs, Norway, Republic of Korea, Spain, the United Kingdom and WHO…

Vaccination Acceptance Research Network (VARN) [to 19 Dec 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

Vaccine Confidence Project [to 19 Dec 2020]
http://www.vaccineconfidence.org/
News, Research and Reports
Five ways to build confidence in vaccines
11 December 2020
Heidi Larson
Director, Vaccine Confidence Project

Vaccine Education Center – Children’s Hospital of Philadelphia [to 19 Dec 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

Wellcome Trust [to 19 Dec 2020]
https://wellcome.ac.uk/news
News
2020 – a year of science, solutions and solidarity
15 December 2020
In a tumultuous year, Wellcome has been at the heart of the global scientific response to the Covid-19 pandemic, while maintaining support for our broad portfolio of research. Our 2019/20 annual report, published today, reveals Wellcome spent £1.1 billion on research, innovation and advocacy.

A year of Covid-19 – and a year of extraordinary science
15 December 2020
The best of humanity has shone through the gloom of 2020. The dedication of scientists across the globe has been remarkable, not just for producing a string of lifesaving breakthroughs but for doing so at an unprecedented pace. Everyone who has supported the research response to Covid-19 can be proud. But the job isn’t finished yet, so we must redouble our commitments to put an end to the pandemic. Here is a selection of key moments in this great scientific success story.

The Wistar Institute [to 19 Dec 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

WFPHA: World Federation of Public Health Associations [to 19 Dec 2020]
https://www.wfpha.org/
Latest News
Statement on COVID-19 Immunization and Equitable Access to Vaccines
Dec 17, 2020
Statement on COVID-19 Immunization and Equitable Access to Vaccines
[See Milestones above for detail]

Equitable Access to COVID-19 Vaccination: A Distant Dream?
Dec 14, 2020
Equitable Access to COVID-19 Vaccination: A Distant Dream?T he race to produce a safe and efficacious vaccine for COVID-19 has been on-going and there are indications that success may not be too far away. Wealthy nations are trying to secure early…

World Organisation for Animal Health (OIE) [to 19 Dec 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
No new digest content identified.

::::::

ARM [Alliance for Regenerative Medicine] [to 19 Dec 2020]
https://alliancerm.org/
Press Releases
No new digest content identified.

BIO [to 19 Dec 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

DCVMN – Developing Country Vaccine Manufacturers Network [to 19 Dec 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

ICBA – International Council of Biotechnology Associations [to 19 Dec 2020]
https://internationalbiotech.org/news/
News
No new digest content identified.

IFPMA [to 19 Dec 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Call to Action On Routine and Life-Course Immunization in the Context of the COVID-19 Pandemic
09 December 2020
[See Milestones above for detail]

PhRMA [to 19 Dec 2020]
http://www.phrma.org/
Selected Press Releases, Statements
Report: More than 1,300 medicines and vaccines in development to help fight cancer
December 15, 2020
Over the last 30 years, significant progress has been made in the fight against cancer. Researchers have expanded their understanding of how cancer develops and how to target medicines for specific cancer types. Since peaking in 1991, cancer death rates have declined by 29%, leading to more than 2.9 million cancer deaths prolonged. The most recent data shows that between 2016 and 2017 alone, cancer death rates declined by 2.2%, the largest single-year drop ever recorded. Despite the challenges imposed by the COVID-19 pandemic, this momentum continues with biopharmaceutical companies focusing on research and development of innovative cancer therapies.

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

AMA Journal of Ethics
Volume 22, Number 12: E981-1070
https://journalofethics.ama-assn.org/issue/socially-situated-brain-death

Socially Situated Brain Death
In 1980, the Uniform Determination of Death Act (UDDA) defined death as “(1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem … in accordance with accepted medical standards.” Interpreting the UDDA definition and applying neurological criteria for diagnosing brain death sound straightforward. Brain death is, however, socially situated, not observer independent, and fraught with uncertainty and ambiguity. This issue investigates some of the ethical, cultural, and legal complexities of one of medicine’s most critical tasks: being sharp and sure about who is alive and who is dead.
Full Issue PDF

BMC Medicine
http://www.biomedcentral.com/bmcmed/content
(Accessed 19 Dec 2020)

Early detection of cholera epidemics to support control in fragile states: estimation of delays and potential epidemic sizes
Cholera epidemics continue to challenge disease control, particularly in fragile and conflict-affected states. Rapid detection and response to small cholera clusters is key for efficient control before an epidemic propagates. To understand the capacity for early response in fragile states, we investigated delays in outbreak detection, investigation, response, and laboratory confirmation, and we estimated epidemic sizes. We assessed predictors of delays, and annual changes in response time.
Authors: Ruwan Ratnayake, Flavio Finger, W. John Edmunds and Francesco Checchi
Citation: BMC Medicine 2020 18:397
Content type: Research article
Published on: 15 December 2020

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

Research
Lessons learned from the polio eradication initiative in the Democratic Republic of Congo and Ethiopia: analysis of implementation barriers and strategies
Since its inception in 1988, the Global Polio Eradication Initiative (GPEI) has partnered with 200 countries to vaccinate over 2.5 billion children against poliomyelitis. The polio eradication approach has ada…
Authors: Wakgari Deressa, Patrick Kayembe, Abigail H. Neel, Eric Mafuta, Assefa Seme and Olakunle Alonge
Citation: BMC Public Health 2020 20(Suppl 4):1807
Content type: Research
Published on: 18 December 2020

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

A multi-pronged scoping review approach to understanding the evolving implementation of the Smallpox and Polio eradication programs: what can other Global Health initiatives learn?
Previous initiatives have aimed to document the history and legacy of the Smallpox Eradication Program (SEP) and the Global Polio Eradication Initiative (GPEI). In this multi-pronged scoping review, we explore…
Authors: Meike Schleiff, Adetoun Olateju, Ellie Decker, Abigail H. Neel, Rasheedat Oke, Michael A. Peters, Aditi Rao and Olakunle Alonge
Citation: BMC Public Health 2020 20(Suppl 4):1698
Content type: Research
Published on: 18 December 2020

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

Conflict, community, and collaboration: shared implementation barriers and strategies in two polio endemic countries
Afghanistan and Nigeria are two of the three remaining polio endemic countries. While these two countries have unique sociocultural characteristics, they share major polio risk factors. This paper describes th…
Authors: Eme Owoaje, Ahmad Omid Rahimi, Anna Kalbarczyk, Oluwaseun Akinyemi, Michael A. Peters and Olakunle O. Alonge
Citation: BMC Public Health 2020 20(Suppl 4):1178
Content type: Research
Published on: 18 December 2020

Clinical Therapeutics
December 2020 Volume 42Issue 12 p2239-2340, e259-e274
http://www.clinicaltherapeutics.com/current

Editorial
Conversations With the Editors: Promoting Science and Combating Antiscience: A Focus on Communication Strategies
Laura Lindenfeld, Ravi Jhaveri
Published online: November 21, 2020
p2242-2247

Clinical Therapeutics
December 2020 Volume 42Issue 12 p2239-2340, e259-e274
http://www.clinicaltherapeutics.com/current

Conversations With the Editors: Promoting Science and Combating Anti-science: The Past and Present of the Antivaccine Movement
Jeffrey Baker, Ravi Jhaveri
Published online: November 30, 2020
p2248-2252

Globalization and Health
http://www.globalizationandhealth.com/
[Accessed 19 Dec 2020]

Cross-border COVID-19 spread amidst malaria re-emergence in Venezuela: a human rights analysis
Authors: Catalina Correa-Salazar and Joseph J. Amon
Content type: Review
17 December 2020

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 19 Dec 2020]

Health research system resilience: lesson learned from the COVID-19 crisis
Authors: Bahareh Yazdizadeh, Reza Majdzadeh, Ayat Ahmadi and Bita Mesgarpour
Content type: Commentary
18 December 2020

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 Epidemiology
Volume 49, Issue 5, October 2020
https://academic.oup.com/ije/issue

Effect of childhood rotavirus vaccination on community rotavirus prevalence in rural Ecuador, 2008-13
Alicia N M Kraay, Edward L Ionides, Gwenyth O Lee, William F Cevallos Trujillo, Joseph N S Eisenberg
International Journal of Epidemiology, Volume 49, Issue 5, October 2020, Pages 1691–1701, https://doi.org/10.1093/ije/dyaa124

International Journal of Infectious Diseases
December 2020 Volume 101p1-412
https://www.ijidonline.com/current

Original Reports
Integrated control of COVID-19 in resource-poor countries
Asma B. Aziz, et al
Published online: September 08, 2020 p98-101
Abstract
Low- and middle-income countries (LMICs) face many challenges in controlling COVID-19. Healthcare resources are limited and so are ICU beds. RT-PCR testing is conducted on a limited scale and treatment options are few. There is no vaccine. Therefore, what low-cost solutions remain for the prevention, diagnosis, and treatment of SARS-CoV-2? How should these essential health services be delivered in order to reach the most vulnerable in our societies? In this editorial we discuss several important strategies for controlling COVID-19 including: vaccination, molecular and serological diagnostics, hygiene and WaSH interventions, and low-cost therapeutics. We also discuss the delivery of such services in order to reach the most in need. The proposed integrated control strategy requires immediate action and political will in order to reduce the widening health inequalities caused by the pandemic.

JAMA Network
COVID-19 Update December 19, 2020

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

JAMA Network

Opinion
Behaviorally Informed Strategies for a National COVID-19 Vaccine Promotion Program
Kevin G. Volpp, MD, PhD; George Loewenstein, PhD; Alison M. Buttenheim, PhD, MBA

JAMA Network

Opinion
The Ethics of Continuing Placebo in SARS-CoV-2 Vaccine Trials
Annette Rid, MD; Marc Lipsitch, DPhil; Franklin G. Miller, PhD

JAMA Network

News & Insight
Experts Discuss COVID-19: Vaccine Allocation, Placebo Groups, and More

JAMA Network

JAMA Network Open
Research
US Public Attitudes Toward COVID-19 Vaccine Mandates
Emily A. Largent, JD, PhD, RN; Govind Persad, JD, PhD; Samantha Sangenito, MPA; et al

The Lancet
Dec 19, 2020 Volume 396 Number 10267 p1941-2084
https://www.thelancet.com/journals/lancet/issue/current

Editorial
Science during COVID-19: where do we go from here?
The Lancet
The emergence of COVID-19 has indelibly marked science and medicine this year. Advances in epidemiology, clinical care, prevention, treatment, and the speed of vaccine development have been unprecedented, driven by global collaboration and data sharing. None of that would have been possible without the tireless work, sacrifice, dedication, and insight of scientists and researchers worldwide, from those working in laboratories to the principal investigators of clinical trials and everyone in between. But those scientific advances have also amplified deficiencies in the scientific research environment and provide important lessons for the future.

Research into topics unrelated to COVID-19 has suffered: Michael Lauer of the US National Institutes of Health has estimated that 80% of clinical trials were stopped or interrupted. Resources have been shifted to the pandemic, and many researchers were forced to suspend their own research to focus on patient care in overwhelmed hospital systems. Long-planned trials on HIV/AIDS and other infectious diseases, for example, were halted as researchers switched to studying COVID-19. It will be years before we know the true cost of these rapid changes in research priorities. There is a need to ensure that research systems have the capacity, and resilience, to adjust to new priorities while limiting the disturbance to ongoing research.

COVID-19 did not create the conditions that make life difficult for researchers early in their careers or for researchers who are women, people with families, or Black, Indigenous, and People of Colour (BIPOC). But it has exacerbated and highlighted those conditions. Health research systems have a history of undervaluing the contributions of these groups and a resistance to confronting issues of lower pay, systemic racism, and inequitable working conditions. Lockdown restrictions worldwide fell heavily on women (including researchers) who were forced to juggle working from home and child care, and BIPOC researchers face institutional racism and come from communities disproportionately affected by COVID-19. The pandemic has already led to a fall in the number of women authors on research papers and could have a long-term effect on careers in science.

The decades-old system that measures success in terms of publications and author order also needs revision. The pandemic has proven that institutions are willing and able to change incentive structures, whether by delaying or extending tenure clocks or extending or modifying research grants. Changes in incentive structures and forms of recognition are necessary, from taking preprint and other forms of research into account, to crediting data analysts, post-doctoral researchers, and other under-recognised contributors whose work is essential to the research enterprise. Scientific progress is made by the combined work of many groups, but too often it is only those at the end of the process who get the credit for the work of many. Science must develop a more thoughtful way of considering how we assess scientific activity that encompasses the whole spectrum of contributors beyond a bare handful of measures.

Open data sharing and collaborations between groups show a potential way to help eliminate the waste, burdensome bureaucracy, and duplicated effort that have been seen in COVID-19 research. It is understandable that clinician–researchers rush to gather what data they can during a pandemic. But a search of ClinicalTrials.gov shows hundreds of small underpowered trials of COVID-19 treatments, and huge numbers of retrospective studies that have attempted to answer similar questions. In the USA, fractured research and health-care systems encourage smaller trials, whereas the RECOVERY treatment trial in the UK leveraged the central administration of the National Health Service. The pandemic has demonstrated the use of data sharing and telemedicine systems to allow research to continue, and those lessons should guide researchers towards a more collaborative and digital future.

The pandemic has stimulated strong public interest in and enthusiasm for science. The advances seen this year could inspire the next generation of scientists, who have seen the potential and promise of research. Fundamentally, science is a collaborative, iterative, and incremental endeavour. It is the responsibility of all of us to ensure that we build on the lessons of 2020 so that the next generation of scientists work in an environment that is fair, conducive to success, and properly incentivised and rewarded.

The Lancet
Dec 19, 2020 Volume 396 Number 10267 p1941-2084
https://www.thelancet.com/journals/lancet/issue/current

Comment
Age and frailty in COVID-19 vaccine development
Melissa K Andrew,Janet E McElhaney

The Lancet
Dec 19, 2020 Volume 396 Number 10267 p1941-2084
https://www.thelancet.com/journals/lancet/issue/current

Offline: The lessons of smallpox eradication for COVID-19
Richard Horton

The Lancet
Dec 19, 2020 Volume 396 Number 10267 p1941-2084
https://www.thelancet.com/journals/lancet/issue/current

Articles
Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial
Maheshi N Ramasamy, et al, and the Oxford COVID Vaccine Trial Group
Open Access
Older adults (aged ≥70 years) are at increased risk of severe disease and death if they develop COVID-19 and are therefore a priority for immunisation should an efficacious vaccine be developed. Immunogenicity of vaccines is often worse in older adults as a result of immunosenescence. We have reported the immunogenicity of a novel chimpanzee adenovirus-vectored vaccine, ChAdOx1 nCoV-19 (AZD1222), in young adults, and now describe the safety and immunogenicity of this vaccine in a wider range of participants, including adults aged 70 years and older.

Nature Medicine
Volume 26 Issue 12, December 2020
https://www.nature.com/nm/volumes/26/issues/12

News Feature | 07 December 2020
2021: research and medical trends in a post-pandemic world
Goodbye 2020, a year of arguably too many challenges for the world. As tempting as it is to leave this year behind, the biomedical community is forever changed by the pandemic, while business as usual needs to carry on. Looking forward to a new year, experts share six trends for the biomedical community in 2021.
Mike May

New England Journal of Medicine
December 17, 2020 Vol. 383 No. 25
http://www.nejm.org/toc/nejm/medical-journal

Original Article
Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults E.J. Anderson and Others
Conclusions
In this small study involving older adults, adverse events associated with the mRNA-1273 vaccine were mainly mild or moderate. The 100-μg dose induced higher binding- and neutralizing-antibody titers than the 25-μg dose, which supports the use of the 100-μg dose in a phase 3 vaccine trial. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 Study ClinicalTrials.gov number, NCT04283461. opens in new tab.)

New England Journal of Medicine
December 17, 2020 Vol. 383 No. 25
http://www.nejm.org/toc/nejm/medical-journal

Original Article
Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults E.J. Anderson and Others
Conclusions
In this small study involving older adults, adverse events associated with the mRNA-1273 vaccine were mainly mild or moderate. The 100-μg dose induced higher binding- and neutralizing-antibody titers than the 25-μg dose, which supports the use of the 100-μg dose in a phase 3 vaccine trial. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 Study ClinicalTrials.gov number, NCT04283461. opens in new tab.)

New England Journal of Medicine
December 17, 2020 Vol. 383 No. 25
http://www.nejm.org/toc/nejm/medical-journal

Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates E.E. Walsh and Others
Conclusions
The safety and immunogenicity data from this U.S. phase 1 trial of two vaccine candidates in younger and older adults, added to earlier interim safety and immunogenicity data regarding BNT162b1 in younger adults from trials in Germany and the United States, support the selection of BNT162b2 for advancement to a pivotal phase 2–3 safety and efficacy evaluation. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728. opens in new tab.

PLoS Neglected Tropical Diseases
http://www.plosntds.org/
(Accessed 19 Dec 2020)

Research Article
Understanding COVID-19 vaccine demand and hesitancy: A nationwide online survey in China
Yulan Lin, Zhijian Hu, Qinjian Zhao, Haridah Alias, Mahmoud Danaee, Li Ping Wong
| published 17 Dec 2020 PLOS Neglected Tropical Diseases
https://doi.org/10.1371/journal.pntd.0008961

Science
18 December 2020 Vol 370, Issue 6523
http://www.sciencemag.org/current.dtl
Special Issue: 2020 Breakthrough of the Year

Shots of hope
By Jon Cohen
Science18 Dec 2020 : 1392-1394 Full Access
Desperately needed vaccines against COVID-19, developed and tested at record speed, are 2020’s breakthrough.

Science
18 December 2020 Vol 370, Issue 6523
http://www.sciencemag.org/current.dtl
Special Issue: 2020 Breakthrough of the Year

Runners-up
By Robert F. Service, Jocelyn Kaiser, Paul Voosen, Daniel Clery, Michael Price, Katie Langin, Jon Cohen, Robert F. Service, Elizabeth Pennisi

Science18 Dec 2020 : 1402-1407 Full Access
Science has named nine scientific advances as runners-up for the 2020 Breakthrough of the Year.
Summary
The runners-up for Science’s 2020 Breakthrough of the Year include the world’s first potential CRISPR-based cures for beta-thalassemia and sickle cell anemia, a tighter range for global warming forecasts, the discovery of the elusive source of fast radio bursts, avian intelligence, and an artificial intelligence program that has solved one of biology’s biggest challenges: predicting the precise 3D shape a string of amino acids will fold into as it becomes a working protein. Other advances include understanding how “elite controllers” keep HIV at bay; achieving, for the first time, room temperature superconductivity; standing up to support Black scientists; and finding the world’s oldest figurative art—a hunting scene deep inside an Indonesian cave.

Science
18 December 2020 Vol 370, Issue 6523
http://www.sciencemag.org/current.dtl
Special Issue: 2020 Breakthrough of the Year

Letters
Transparency is key to ethical vaccine research
By Preston W. Estep, George M. Church
Science18 Dec 2020 : 1422-1423 Full Access

Science
18 December 2020 Vol 370, Issue 6523
http://www.sciencemag.org/current.dtl
Special Issue: 2020 Breakthrough of the Year

Transparency is key to ethical vaccine research—Response
By Christi J. Guerrini, Jacob S. Sherkow, Michelle N. Meyer, Patricia J. Zettler

Science18 Dec 2020 : 1423 Full Access

Science
18 December 2020 Vol 370, Issue 6523
http://www.sciencemag.org/current.dtl
Special Issue: 2020 Breakthrough of the Year

Transparency is key to ethical vaccine research—Response
By Arthur Caplan, Alison Bateman-House

Science
18 December 2020 Vol 370, Issue 6523
http://www.sciencemag.org/current.dtl
Special Issue: 2020 Breakthrough of the Year

Policy Forum
Core commitments for field trials of gene drive organisms
By Kanya C. Long, Luke Alphey, George J. Annas, Cinnamon S. Bloss, Karl J. Campbell, Jackson Champer, Chun-Hong Chen, Amit Choudhary, George M. Church, James P. Collins, Kimberly L. Cooper, Jason A. Delborne, Owain R. Edwards, Claudia I. Emerson, Kevin Esvelt, Sam Weiss Evans, Robert M. Friedman, Valentino M. Gantz, Fred Gould, Sarah Hartley, Elizabeth Heitman, Janet Hemingway, Hirotaka Kanuka, Jennifer Kuzma, James V. Lavery, Yoosook Lee, Marce Lorenzen, Jeantine E. Lunshof, John M. Marshall, Philipp W. Messer, Craig Montell, Kenneth A. Oye, Megan J. Palmer, Philippos Aris Papathanos, Prasad N. Paradkar, Antoinette J. Piaggio, Jason L. Rasgon, Gordana Rašić, Larisa Rudenko, J. Royden Saah, Maxwell J. Scott, Jolene T. Sutton, Adam E. Vorsino, Omar S. Akbari
Science18 Dec 2020 : 1417-1419 Full Access
We must ensure that trials are scientifically, politically, and socially robust, publicly accountable, and widely transparent
Summary
Gene drive organisms (GDOs), whose genomes have been genetically engineered to spread a desired allele through a population, have the potential to transform the way societies address a wide range of daunting public health and environmental challenges. The development, testing, and release of GDOs, however, are complex and often controversial. A key challenge is to clarify the appropriate roles of developers and others actively engaged in work with GDOs in decision-making processes, and, in particular, how to establish partnerships with relevant authorities and other stakeholders. Several members of the gene drive community previously proposed safeguards for laboratory experiments with GDOs (1) that, in the absence of national or international guidelines, were considered essential for responsible laboratory work to proceed. Now, with GDO development advancing in laboratories (2–5), we envision similar safeguards for the potential next step: ecologically and/or genetically confined field trials to further assess the performance of GDOs. A GDO’s propensity to spread necessitates well-developed criteria for field trials to assess its potential impacts (6). We, as a multidisciplinary group of GDO developers, ecologists, conservation biologists, and experts in social science, ethics, and policy, outline commitments below that we deem critical for responsible conduct of a field trial and to ensure that these technologies, if they are introduced, serve the public interest.

Travel Medicine and Infectious Diseases
Volume 38 November–December 2020
https://www.sciencedirect.com/journal/travel-medicine-and-infectious-disease/vol/38/suppl/C

Review article Open access
Reprint of: Air travel and COVID-19 prevention in the pandemic and peri-pandemic period: A narrative review
Michel Bielecki, Dipti Patel, Jochen Hinkelbein, Matthieu Komorowski, … Patricia Schlagenhauf
Article 101939

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 19 Dec 2020)

Open Access Article
Knowledge and Attitudes on Vaccination in Southern Romanians: A Cross-Sectional Questionnaire
by Gabriela Loredana Popa, Andrei-Alexandru Muntean, Mădălina-Maria Muntean and Mircea Ioan Popa
Vaccines 2020, 8(4), 774; https://doi.org/10.3390/vaccines8040774 (registering DOI) – 18 Dec 2020
Viewed by 190
Abstract
Vaccines are fundamental instruments upon which all modern medicine is hinged. This has recently come into the light because of the COVID-19 pandemic caused by SARS-CoV-2. We aimed to assess the knowledge and attitudes of the public regarding vaccination. To this end, a […] Read more.

Vaccines — Open Access Journal
http://www.mdpi.com/journal/vaccines
(Accessed 19 Dec 2020)

Open Access Article
A Review of Adherence and Predictors of Adherence to the CONSORT Statement in the Reporting of Tuberculosis Vaccine Trials
by Veranyuy D. Ngah, Akhona V. Mazingisa, Moleen Zunza and Charles S. Wiysonge
Vaccines 2020, 8(4), 770; https://doi.org/10.3390/vaccines8040770 – 16 Dec 2020
Viewed by 172
Abstract
The statement on Consolidated Standards of Reporting Trials (CONSORT) ensures transparency in the reporting of randomized trials. However, it is unclear if the statement has led to improvement in the quality of reporting of tuberculosis (TB) vaccine trials. We explored the quality of […]

Media/Policy Watch
This watch section is intended to alert readers to substantive news, analysis and opinion from the general media and selected think tanks and similar organizations on vaccines, immunization, global public health and related themes. Media Watch is not intended to be exhaustive, but indicative of themes and issues CVEP is actively tracking. This section will grow from an initial base of newspapers, magazines and blog sources, and is segregated from Journal Watch above which scans the peer-reviewed journal ecology.
We acknowledge the Western/Northern bias in this initial selection of titles and invite suggestions for expanded coverage. We are conservative in our outlook in adding news sources which largely report on primary content we are already covering above. Many electronic media sources have tiered, fee-based subscription models for access. We will provide full-text where content is published without restriction, but most publications require registration and some subscription level.

The Atlantic
http://www.theatlantic.com/magazine/
Accessed 19 Dec 2020
Science
How Science Beat the Virus
And what it lost in the process
Story by Ed Yong
January/February 2021 Issue
As of this writing, the biomedical library PubMed lists more than 74,000 COVID-related scientific papers—more than twice as many as there are about polio, measles, cholera, dengue, or other diseases that have plagued humanity for centuries. Only 9,700 Ebola-related papers have been published since its discovery in 1976; last year, at least one journal received more COVID19 papers than that for consideration. By September, the prestigious New England Journal of Medicine had received 30,000 submissions—16,000 more than in all of 2019. “All that difference is COVID19,” Eric Rubin, NEJM’s editor in chief, says. Francis Collins, the director of the National Institutes of Health, told me, “The way this has resulted in a shift in scientific priorities has been unprecedented.”…

BBC
http://www.bbc.co.uk/
Accessed 19 Dec 2020
Covid vaccine: Woman, 108, gets jab for her second pandemic
A 108-year-old woman from Pembrokeshire has received the Covid-19 vaccine for what is the second pandemic of her lifetime.
Mary Keir was one of 37 people at the Llandeilo site to receive their first dose of the Pfizer-Biontech jab.
She was four years old at the onset of the 1916 Spanish Flu outbreak.
Ms Keir said she felt “very lucky” and “much safer and happier” for having received the vaccine.

The Economist
http://www.economist.com/
Accessed 19 Dec 2020
[No new, unique, relevant content]

Financial Times
https://www.ft.com/
Accessed 19 Dec 2020
Coronavirus pandemic
Scientists alarmed at infectiousness of viral variant
Mutations make new strain 70 per cent more transmissible but are not expected to reduce effectiveness of vaccines
December 19, 2020

Forbes
http://www.forbes.com/
Accessed 19 Dec 2020
Dec 18, 2020
Poll: 57% Of Americans Say Co-Workers Should Have To Take Coronavirus Vaccine
It is legal for employers in the U.S. to require employees to get vaccinated, with some exceptions.
By Elana Lyn Gross Forbes Staff

Foreign Affairs
http://www.foreignaffairs.com/
Accessed 19 Dec 2020
[No new, unique, relevant content]

Foreign Policy
http://foreignpolicy.com/
Accessed 19 Dec 2020
[No new, unique, relevant content]

The Guardian
http://www.guardiannews.com/
Accessed 19 Dec 2020
[No new, unique, relevant content]

New Yorker
http://www.newyorker.com/
Accessed 19 Dec 2020
Q. & A.
The Influence of the Anti-Vaccine Movement
The virologist Peter Hotez discusses the spread of misinformation about the COVID-19 vaccine.
By Isaac Chotiner
December 18, 2020

New York Times
http://www.nytimes.com/
Accessed 19 Dec 2020
Health
C.D.C. Panel Endorses Moderna Vaccine for Americans
The approval sets the stage for widespread inoculations in the United States with a second coronavirus vaccine.
By Katherine J. Wu
PRINT EDITION December 20, 2020

Politics
U.S. General Apologizes for Smaller Vaccine Deliveries in Some States
Gen. Gustave F. Perna, chief operating officer for Operation Warp Speed, apologized after a number of states last week received fewer initial doses of the coronavirus vaccine than planned.
By Reuters December 19, 2020

U.S.
Employers Can Require Workers to Get Covid-19 Vaccine, U.S. Says
The federal Equal Employment Opportunity Commission said employees could be barred from the workplace if they refused the vaccine.
By Vimal Patel Dec. 18

Business
The plan to vaccinate nursing home residents faces a key obstacle: consent.
Dec. 18

Washington Post
https://www.washingtonpost.com/
Europe
Israel is starting to vaccinate, but Palestinians may have to wait months
Steve Hendrix and Shira Rubin · Dec 19, 2020

Chinese and Russian vaccines remain unproven — but desperate countries plan to use them anyway
Emily Rauhala, Eva Dou and Robyn Dixon · Dec 19, 2020