The World Health Organization (WHO) today listed the Comirnaty COVID-19 mRNA vaccine as an emergency use, which makes the Pfizer/BioNTech vaccine the first vaccine to be urgently confirmed by the WHO since the outbreak a year ago.
The WHO Emergency Use List (EUL) has opened the door for countries to speed up the regulatory approval process for the import and management of vaccines. It also enables UNICEF and the Pan American Health Organization to purchase vaccines for distribution to countries in need.
“This is a very positive step to ensure global access to the COVID-19 vaccine. But I want to emphasize that greater global efforts are needed to provide sufficient vaccine supplies to meet the needs of priority populations around the world.” “WHO Work with our partners day and night to evaluate other vaccines that meet safety and efficacy standards. We encourage more developers to come forward for review and evaluation. It’s vital that we make sure that The critical supply necessary for all countries to provide services and contain this epidemic.”
Regulatory experts convened by the World Health Organization and World Health Organization’s own teams reviewed data on the safety, efficacy, and quality of Pfizer/BioNTech vaccines as part of the risk and benefit analysis. The review found that the vaccine meets the essential safety and effectiveness standards set by the World Health Organization, and the benefits of using the vaccine to solve COVID-19 offset the potential risks.
The vaccine is also under policy review. The WHO Strategic Advisory Group of Experts on Immunization (SAGE) will hold a meeting on January 5, 2021, and formulate specific vaccine policies for the use of the product in the population based on SAGE population priority recommendations for COVID-19 vaccines in general And suggestions. September 2020.
Comirnaty vaccine requires ultra-cold chain storage; it needs to be stored at a temperature of -60°C to -90°C. This requirement makes it more challenging to deploy vaccines in environments where ultra-cold chain equipment cannot be used or reliably used. Therefore, WHO is working hard to support countries in evaluating their delivery plans and preparing them for use if possible.
How the emergency use list works
The Emergency Use List (EUL) program assesses the suitability of new health products in public health emergencies. The goal is to provide medicines, vaccines and diagnostics as soon as possible in response to emergencies while complying with strict standards for safety, efficacy and quality. This assessment weighs the threats posed by emergencies, the benefits of using the product, and any potential risks.
The EUL approach involves rigorous evaluation of data from phase II and phase III late clinical trials, as well as a large number of other data related to safety, efficacy, quality and risk management plans. These data are reviewed by independent experts and the WHO team, who will consider the latest evidence about the vaccine, plans to monitor its use, and plans for further research.
Invite experts from various national authorities to participate in the EUL review. Once a vaccine is listed as an emergency use by WHO, WHO will work with its regional regulatory network and partners to notify national health authorities of the vaccine and its expected benefits based on clinical research data to date.
In addition to the global, regional, and national regulatory procedures for emergency use, each country is developing policies and procedures to decide whether and where to use vaccines, and assigns the priority of the earliest use. Countries have also conducted vaccine readiness assessments, which provide a basis for implementing vaccine deployment and introduction plans in accordance with EUL.
As part of the EUL process, companies that produce vaccines must commit to continuing to generate data to achieve full vaccine licensing and WHO prequalification. The WHO prequalification process will roll-over evaluation of other clinical data generated during vaccine trials and deployment to ensure that the vaccine meets the necessary quality, safety, and effectiveness standards to provide wider availability.