Regulatory experts convened by the World Health Organization (WHO) from around the world and UN agency’s own teams reviewed the data on the Pfizer/BioNTech vaccine and found on Thursday that it met WHO’s must-have criteria for safety and efficacy – with its benefits offsetting any potential risks. 

“This is a very positive step towards ensuring global access to COVID-19 vaccines,” said Dr. Mariângela Simão, WHO 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”. 

‘Working night and day’  

The move opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine.  

It also enables UNICEF and the Pan-American Health Organization (PAHO) to procure the vaccine for distribution to countries in need. 

At the same time, WHO is encouraging more developers to come forward for review and assessment to satisfy the critical supply for all countries globally to stem the pandemic. 

“WHO and our partners are working night and day to evaluate other vaccines that have reached safety and efficacy standards”, said Dr. Simão. 

Setting policy 

The vaccine is also under policy review.   

Drawing from WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) population prioritization recommendations for COVID-19 vaccines, which were issued in September, the group will convene on 5 January to formulate vaccine specific policies and recommendations.  

Meanwhile, WHO is working with regional partners to advise national health authorities about the two-dose shot and its anticipated benefits. 

The World Health Organization, with the GAVI Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI), are spearheading a global effort called COVAX to secure the equitable distribution of vaccines to all countries and not just to wealthy nations.