What you need to know:
- It enables Unicef and the Pan-American Health Organization to procure the vaccine for distribution to countries in need.
- Regulatory experts reviewed the data on the vaccine’s safety, efficacy and quality.
The World Health Organization (WHO) has listed the Pfizer/BioNTech Covid-19 vaccine for emergency use.
This makes the Comirnaty Covid-19 mRNA vaccine the first to receive emergency validation from WHO since the outbreak began a year ago.
The WHO’s Emergency Use Listing 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 to procure the vaccine for distribution to countries in need. “This is a very positive step. 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,” 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 is important that we secure the critical supply needed to serve all countries around the world and stem the pandemic.”
Regulatory experts reviewed the data on the vaccine’s safety, efficacy and quality as part of a risk-versus-benefit analysis. They found the vaccine met the must-have criteria for safety and efficacy set out by WHO, and the benefits of using the vaccine to address Covid-19 offset potential risks.
The vaccine is also under policy review. WHO’s Strategic Advisory Group of Experts on Immunization will this week formulate vaccine-specific policies and recommendations for this product’s use in populations.