WHO issues its first emergency use validation for a COVID-19 vaccine and emphasizes need for equitable global access

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WHO issues its first emergency use validation for a COVID-19 vaccine and emphasizes need for equitable global access
31 December 2020 News release Geneva
The World Health Organization (WHO) today listed the Comirnaty COVID-19 mRNA vaccine for emergency use, making the Pfizer/BioNTech vaccine the first to receive emergency validation from WHO since the outbreak began a year ago.

The WHO’s Emergency Use Listing (EUL) opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine. It also enables UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.

“This is a very positive step towards ensuring global access to COVID-19 vaccines. But I want to emphasize the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. “WHO and our partners are working night and day to evaluate other vaccines that have reached safety and efficacy standards. We encourage even more developers to come forward for review and assessment. It’s vitally important that we secure the critical supply needed to serve all countries around the world and stem the pandemic.”

Regulatory experts convened by WHO from around the world and WHO’s own teams reviewed the data on the Pfizer/BioNTech vaccine’s safety, efficacy and quality as part of a risk-versus-benefit analysis. The review found that the vaccine met the must-have criteria for safety and efficacy set out by WHO, and that the benefits of using the vaccine to address COVID-19 offset potential risks.

The vaccine is also under policy review.  WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) will convene on 5 January, 2021, to formulate vaccine specific policies and recommendations for this product’s use in populations, drawing from the SAGE population prioritization recommendations for COVID-19 vaccines in general, issued in September 2020.

The Comirnaty vaccine requires storage using an ultra-cold chain; it needs to be stored at -60°C to -90°C degrees. This requirement makes the vaccine more challenging to deploy in settings where ultra-cold chain equipment may not be available or reliably accessible. For that reason, WHO is working to support countries in assessing their delivery plans and preparing for use where possible.

How the emergency use listing works
The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.

The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.

Experts from individual national authorities are invited to participate in the EUL review. Once a vaccine has been listed for WHO emergency use, WHO engages its regional regulatory networks and partners to inform national health authorities on the vaccine and its anticipated benefits based on data from clinical studies to date.

In addition to the global, regional, and country regulatory procedures for emergency use, each country undertakes a policy process to decide whether and in whom to use the vaccine, with prioritization specified for the earliest use.  Countries also undertake a vaccine readiness assessment which informs the vaccine deployment and introduction plan for the implementation of the vaccine under the EUL.

As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.

WHO recommendation COVID-19 mRNA vaccine (nucleoside modified) – COMIRNATY®
WHO assessed the Comirnaty, COVID-19 mRNA vaccine (nucleoside modified) submitted by Pfizer under the Emergency Use Listing (EUL). The vaccine is expected to be an important tool in response to the COVID-19 pandemic. Based on the available evidence assessed, WHO find that sufficient data is available on the Comirnaty, COVID-19 mRNA vaccine (nucleoside modified) for an EUL recommendation.

Comirnaty, COVID-19 mRNA vaccine (nucleoside modified) is a vaccine for preventing coronavirus disease 2019 (COVID-19) in individuals aged 16 years and older. The vaccine contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. Novel Covid-19 mRNA vaccine does not contain the virus itself and cannot cause COVID-19.

The use of Comirnaty, COVID-19 mRNA vaccine (nucleoside modified) under an emergency situation has been also endorsed by the European Medicines Agency (EMA), the Food and Drug Administration of the United States of America and Health Canada and other regulatory authorities (including Bahrain, Israel, Kuwait, Mexico, Oman, Qatar, Saudi Arabia, Singapore and the United Kingdom).
PDF: WHO Recommendation COVID-19 mRNA Vaccine (nucleoside modified)COMIRNATY®



Extraordinary meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) – 5 January 2021
5 January 2021 10:00 – 17:00 CET
This extraordinary virtual meeting for the Strategic Advisory Group of Experts on Immunization (SAGE) will be held on Tuesday 05 January 2021 to propose recommendations to WHO on the use of COVID-19 vaccine(s).


Meeting materials
Materials for this meeting such as a provisional list of participants and background documents will be made available nearer the time.
Draft Meeting Agenda [see image below]
Draft Summary of Declaration of Interests


Background documents for the Extraordinary meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) – 5 January 2021
:: mRNA vaccines against COVID-19: Pfizer-BioNTech COVID-19 vaccineBNT162b2
Draft document – Prepared by the Strategic Advisory Group of Experts (SAGE) on Immunization Working Group on COVID-19 vaccines
22 December 2020  | Technical document
WHO Reference Number: WHO/2019-nCoV/vaccines/SAGE_evaluation/BNT162b2/2020.1

:: Background paper on Covid-19 disease and vaccines
Draft document – Prepared by the Strategic Advisory Group of Experts (SAGE) on Immunization Working Group on COVID-19 vaccines
22 December 2020  | Technical document
WHO Reference Number: WHO/2019-nCoV/vaccines/SAGE_background/2020.1



WHO – Planned COVID-19 Vaccine Effectiveness and Impact Studies: Request for Information
22 December 2020
Call for submissions
After COVID-19 vaccines are introduced into countries, it will be vital to generate real-world data on vaccine effectiveness and vaccine impact, as many questions will remain unanswered by the clinical trials.   Studies will likely be done in a variety of countries, in a variety of populations, and using a variety of study designs.
As part of our scoping of the landscape to understand the future availability of data to inform global policy and the gaps that need to be filled, we invite researchers to provide information about their planned work on COVID-19 vaccination effectiveness and/or impact studies.  This can be done by filling out this electronic form with relevant details. This form will take less than 5 minutes  of your time.
Data provided will be used by the Strategic Advisory Group of Experts on Immunization to understand what data will be available and when it will be available  to update their global policy recommendations.
Initial responses are requested as soon as possible. This will be an ongoing process, where updates can be provided in the future as plans change or studies are implemented.
Basic information such as country of study or study design will be made available through the WHO website to highlight the landscape of studies being undertaken.
Please provide preliminary responses by January 15, 2021. Future requests for information will be posted as we know plans are fluid.
Questions can be addressed to covidve@who.int