The World Health Organization (WHO) said Pfizer and BioNTech’s COVID-19 vaccine BNT162b2 became the first vaccine to receive WHO validation for emergency use since the pandemic began. According to the WHO, BNT162b2 has met the agency’s “must-have” criteria for safety and efficacy, with its benefits offsetting any potential risks, and noted that validation opens the door for countries to speed up their own regulatory processes to import and administer BNT162b2.
“This is a very positive step towards ensuring global access to COVID-19 vaccines,” remarked Mariângela Simão, WHO assistant-director general for access to medicines and health products. However, she emphasised “the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere.”
Talks with COVAX alliance
The WHO, along with the GAVI Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations, is spearheading the global COVAX effort aimed at equitably distributing coronavirus vaccines around the world. The COVAX alliance has agreements for nearly 2 billion COVID-19 vaccine doses, with first deliveries due in early 2021, and has been in discussions with Pfizer and BioNTech to secure BNT162b2.
Pfizer and BioNTech’s mRNA-based vaccine, which was found to be 95% effective after two doses given 21 days apart, is approved in several countries including the UK, US and Europe, where it is branded as Comirnaty.
The WHO noted that it is helping to advise national health authorities about BNT162b2 and its “anticipated benefits.” Meanwhile, Simão said the “WHO and our partners are working night and day to evaluate other vaccines that have reached safety and efficacy standards.” The agency’s Strategic Advisory Group of Experts on Immunization (SAGE) is set to meet on January 5 to “formulate…specific policies and recommendations” for COVID-19 vaccines.