GENEVA (AN) — The World Health Organization listed Pfizer-BioNTech’s coronavirus vaccine Comirnaty® for emergency use on Thursday, the first such designation since the pandemic began and a step towards global access.
The emergency use listing helps nations expedite their own regulatory approval processes and enables UNICEF and the Pan-American Health Organization to help get a vaccine to places where it is most needed, the U.N. health agency said.
“This is a very positive step," said Dr. Mariângela Simão, a Brazilian pediatrician who serves as WHO's assistant director-general for access to medicines and health products. "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."
WHO officials and outside experts did a cost-benefit analysis of the data on the Pfizer-BioNTech vaccine. They also plan to meet next week for a policy review that will include recommended uses for specific populations. Among the nations where the vaccine has been approved for emergency use are Britain and the United States, and it also has conditional marketing approval in Switzerland and the European Union.
How it works
The idea behind the emergency use listing is to help make medicines, vaccines and diagnostics available as quickly as possible. It is not meant to replace the approval process of national regulators.
Data from late Phase II and Phase III clinical trials is analyzed for safety, efficacy, quality and risks. After a vaccine is listed for WHO emergency use, the U.N. health agency said it then "engages its regional regulatory networks and partners to inform national health authorities on the vaccine and its anticipated benefits based on data from clinical studies to date." Companies also must keep providing clinical data from vaccine trials and broader use.
Along with Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations, WHO co-leads the COVAX Facility’s multilateral efforts to secure billions of doses of COVID-19 vaccine candidates for low-income and developing countries. The aim of COVAX is to accelerate the development and production of COVID-19 vaccines and to guarantee all nations will have fair and equitable access.
The Pfizer-BioNTech two-shot vaccine has been found to afford a level of protection seven days after the second injection of the vaccine that is more than 90% effective against COVID-19. The vaccine, best administered with two shots at least 21 days apart, is suitable for anyone who is 16 or older. It uses the brand-new messenger RNA, or mRNA technology, and a person cannot catch COVID-19 from it, since it was not made from the virus itself.