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 the outbreak began a year ago.
The WHO Emergency Use List (EUL) opens the door to countries to speed up their own regulatory approval processes to import and administer the vaccine. It also allows 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 obtain a sufficient amount of vaccine 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 day and night to evaluate other vaccines that have met safety and efficacy standards. We encourage even more developers to come forward for review and evaluation. It is vital to ensure the critical supply needed to serve all countries around the world and stop the pandemic. ”
Regulatory experts convened by WHO around the world and WHO’s own teams analyzed data on the safety, efficacy and quality of the Pfizer / BioNTech vaccine as part of a risk-benefit analysis. The analysis found that the vaccine meets the mandatory safety and efficacy criteria set by the WHO and that the benefits of using the vaccine to address COVID-19 outweigh the potential risks.
The vaccine is also under review. The WHO 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, based on the recommendations for prioritizing the SAGE population for COVID-19 vaccines in issued in September 2020.
Comirnaty vaccine requires storage using an ultra-cold chain; 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 may not be available or reliably accessible. For this reason, WHO is working to support countries in evaluating their delivery plans and preparing them for use where possible.
How the emergency use list works
The Emergency Use Listing Procedure (EUL) assesses the adequacy of new medical products in the event of a public health emergency. The aim is to make medicines, vaccines and diagnoses available as soon as possible in order to address the emergency situation, while respecting strict criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency and the benefits that would result from using the product against any potential risks.
The EUL pathway involves a rigorous assessment of data from phases II and III of late clinical trials, 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 that take into account the current body of evidence on the vaccine in question, its use monitoring plans and further study plans.
Experts from individual national authorities are invited to participate in the EUL review. Once a vaccine has been listed for emergency use by WHO, WHO commits its regional regulatory networks and partners to inform national health authorities about the vaccine and its anticipated benefits based on data from clinical trials to date.
In addition to global, regional and national regulatory procedures for emergency use, each country undertakes a policy process to decide whether and in whom to use the vaccine, with a specified priority for the earliest use. Countries also conduct a vaccine availability assessment that informs vaccine implementation and the introduction plan for vaccine implementation in the EUL.
As part of the EUL process, the vaccine company must commit to continuing to generate data to enable full licensing and WHO prequalification of the vaccine. The WHO pre-qualification process will evaluate the additional clinical data generated from the vaccine studies and implementation on an ongoing basis to ensure that the vaccine meets the required quality, safety and efficacy standards for wider availability.