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 the WHO since its outbreak a year ago.
The WTO’s list of emergencies (EUL) opens the door for countries to speed up their own approval processes to import and administer the vaccine. It also enables UNICEF and the Pan-American Health Organization to obtain the vaccine for distribution to countries in need.
‘This is a very positive step in ensuring global access to COVID-19 vaccines. But I want to emphasize the need for an even greater global effort to provide enough vaccine supply to meet the needs of priority populations everywhere, ‘said Dr Mariângela Simão, WHO Assistant Director-General for Access to Medicine and Health Products. ‘WHO and our partners work day and night to evaluate other vaccines that meet safety and efficacy standards. We encourage even more developers to come forward for review and review. It is of the utmost importance that we ensure the essential supply to serve all countries around the world and to stop the pandemic. ”
Regulatory experts convened by the WTO from around the world and the WTO’s own teams, evaluated the safety, efficacy and quality data of the Pfizer / BioNTech vaccine as part of a risk-benefit analysis. The review found that the vaccine meets the essential criteria for safety and efficacy as set out by the WHO, and that the benefits of using the vaccine to address COVID-19 offset potential risks.
The vaccine is also undergoing policy review. The WHO’s Strategic Advisory Group on Immunization Experts (SAGE) will meet on 5 January 2021 to formulate vaccine-specific policies and recommendations for the use of this product in populations, with the SAGE population recommendations for COVID-19 vaccines in general, issued in September 2020.
The Comirnaty vaccine requires ultra-cold chain preservation; it should be stored at -60 ° C to -90 ° C degrees. This requirement makes the vaccine more difficult to use in settings where ultra-cold chain equipment is not available or reliably accessible. Therefore, WHO works to support countries to evaluate their delivery plans and, where possible, prepare them for use.
How the list for emergency use works
The Emergency Listing Procedure (EUL) assesses the suitability of new health products during public health emergencies. The aim is to make medicines, vaccines and diagnostics available as soon as possible to address the emergency, while meeting strict criteria of safety, efficacy and quality. The evaluation weighs the threat of the emergency as well as the benefit that the use of the product will have against any potential risks.
The EUL route involves a careful assessment of late-stage and phase III clinical trial data, as well as significant additional data on safety, efficacy, quality, and a risk management plan. These data are reviewed by independent experts and WHO teams who are considering the current evidence on the vaccine being considered, 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 about the vaccine and its expected benefits, based on data from clinical studies to date.
In addition to the global, regional and country emergency procedures for emergency use, each country undertakes a policy process to decide whether and in whom the vaccine should be used, with priorities specified for the earliest use. Countries also undertake a vaccine evaluation level that informs the deployment and introduction plan for the implementation of the vaccine under the EUL.
As part of the EUL process, the company manufacturing the vaccine must commit to continuing to generate data in order to enable full licensing and the WTO’s pre-qualification of the vaccine. The WTO pre-qualification process will assess complementary clinical data generated from vaccine trials and deployments on an ongoing basis to ensure that the vaccine meets the necessary standards of quality, safety and efficacy for wider availability.
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