WHO publishes first emergency use verification of COVID-19 vaccine • Today News Africa

The World Health Organization (WHO) listed the Comirnaty COVID-19 mRNA vaccine for emergency use on Thursday, and the Pfizer / BioNTech vaccine was the first to receive urgent validation from WHO since its outbreak began a year ago. It became a vaccine.

The WHO Emergency Use List (EUL) opens the door for countries to facilitate their own regulatory approval process for importing and administering vaccines. UNICEF and the Pan American Health Organization can also procure vaccines for distribution to countries in need.

“This is a very positive step towards ensuring global access to the COVID-19 vaccine, but even greater to achieve sufficient vaccine supply to meet the needs of the priority population everywhere. I would like to emphasize the need for global effort, “said Dr. Mariângela Simão, Deputy Director of Access to Pharmaceuticals and Health Products at WHO. “WHO and its partners are working day and night to evaluate other vaccines that meet safety and efficacy criteria. More developers are coming forward for review and evaluation. It is very important to serve all countries around the world and secure the critical supply needed to stop the pandemic. “

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WHO-convened regulatory experts from around the world and WHO’s own team reviewed data on the safety, efficacy and quality of Pfizer / BioNTech vaccines as part of a risk-benefit analysis. The review found that the vaccine meets the essential safety and efficacy criteria set by WHO and that the benefits of using the vaccine to combat COVID-19 offset potential risks.

Vaccines are also under policy review. The WHO Strategic Advisory Group on Immunization (SAGE) will be convened on 5 January 2021 to develop vaccine-specific policies and recommendations for the use of this product in groups. September 2020.

Comirnaty vaccines need to be stored using a super cold chain. Must be stored at -60 ° C to -90 ° C. This requirement makes it more difficult to deploy vaccines in situations where ultra-cold chain devices are unavailable or reliably inaccessible. Therefore, WHO is committed to evaluating each country’s delivery plans and helping them prepare for use when possible.

How the emergency list works

The Emergency Use List (EUL) procedure assesses the suitability of new health products in the event of a public health emergency. The goal is to ensure that medicines, vaccines, and diagnostics are available as quickly as possible to respond to emergencies, while adhering to strict standards of safety, efficacy, and quality. This assessment weighs the threat posed by an emergency against the benefits of using the product for potential risks.

The EUL pathway contains a rigorous assessment of late Phase II and Phase III clinical trial data, as well as substantial additional data on safety, efficacy, quality, and risk management planning. These data will be reviewed by an independent expert and WHO team reviewing the current set of evidence for the vaccine under consideration, plans for monitoring its use, and plans for further research.

Experts from individual national authorities are invited to participate in the EUL review. When vaccines are listed for emergency use by WHO, WHO will work with local regulatory networks and partners to determine the vaccine and its expected benefits based on data from previous clinical studies by national health authorities. Notify to.

In addition to global, regional, and national regulatory procedures for emergency use, countries implement policy processes to determine whether and to whom vaccines should be used and for the earliest use. Specify the priority for. Countries will also conduct a vaccine readiness assessment to inform them of vaccine deployment and introduction plans for the implementation of EUL-based vaccines.

As part of the EUL process, vaccine manufacturers must be committed to continuing to generate data to enable full vaccine approval and WHO pre-certification. The WHO pre-certification process evaluates additional clinical data generated from vaccine testing and deployment on a rolling basis to meet the quality, safety, and efficacy criteria that vaccines require for greater availability. Make sure you are.

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