WHO criteria for safety and efficacy met
(Eagle News) — The World Health Organization (WHO) has given emergency validation to the Pfizer/BioNTech mRNA vaccine, the first vaccine against COVID-19 to receive such a validation from WHO since the pandemic.
This was after WHO listed the Comirnaty COVID-19 mRNA vaccine for emergency use. The Comirnaty vaccine requires storage using an ultra-cold chain and needs to be stored at -60°C to -90°C degrees, makes the deployment and distribution of the Pfizer/BioNTech vaccine “more challenging”
But with the “emergency use listing” by WHO of the Comirnaty COVID-19 mRNA vaccine, it “opens the door for countries to expedite their own regulatory approval processes to import and administer” the Pfizer-BioNTech vaccine.
-Distribution to countries in need ensured-
“It also enables UNICEF and the Pan-American Health Organization to procure the vaccine for distribution to countries in need,” WHO said in a statement.
“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.”
-Benefits of vaccine use outweigh risks-
WHO convened regulatory experts from around the world and together with its own teams, they reviewed “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,” it said.
WHO said that the vaccine is “also under policy review.”
WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) will convene on January 5, 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.”
-Ultra-cold storage of -60°C to -90°C needed-
WHO said that it is also “working to support countries in assessing their delivery plans and preparing for use where possible” given that the the Comirnaty vaccine such as that produced by Pfizer and BioNTech requires storage 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,” WHO said.
WHO also explained that as part of the emergency use listing 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,” its statement said.
(Eagle News Service)
