NEW YORK CITY (dpa-AFX) - The World Health Organization has granted emergency use validation for Pfizer-BioNTech's COVID-19 vaccine. This makes the vaccine the first to receive emergency validation from WHO since the pandemic began a year ago.
The WHO's Emergency Use Listing allows countries to expedite their own regulatory approval processes to import and use the vaccine. It also allows UNICEF and the Pan-American Health Organization to purchase the vaccine for distribution to countries in need.
'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's 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.
Pfizer-BioNTech's Covid vaccine has received approval in the UK, the US and the European Union. The approval was based on pivotal Phase 3 clinical study data, which demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection.
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