CEPI welcomes US FDA approval of Pfizer/BioNTech’s COVID-19 vaccine

24 Aug 2021

By CEPI


Statement from the CEO of CEPI, Dr. Richard Hatchett, following the announcement from the U.S. Food and Drugs Administration (FDA):

The landmark decision from the U.S. Food and Drug Administration (FDA), providing full licensure to Pfizer/BioNTech’s COVID-19 vaccine in the US, is an important milestone in our ongoing COVID-19 response. By a long margin (roughly two and a half years faster than the previous record), Pfizer and BioNTech have now completed the most rapid vaccine development effort in FDA history. Their achievement shows how, through innovation, investment, teamwork, and scientific ingenuity, we can reduce the time it takes to get safe and effective vaccines fully authorised for use.

The Pfizer/BioNTech vaccine was the first COVID-19 vaccine to receive emergency use authorisation in the UK in December 2020, just 326 days after the SARS-CoV-2 sequence was published. Since then, the vaccine has received emergency authorization in 98 countries and over a billion doses have been delivered, including through the COVAX scheme, co-led by CEPI, which aims to get vaccine distributed more equitably across the world.

Even as we celebrate this great success, we must remember that despite these scientific and regulatory achievements vast inequity in vaccine distribution remains. A global pandemic cannot be stopped at national borders – we have to ensure that we get COVID-19 under control everywhere for us all to be safe.

The world must, together, make it an immediate priority to optimise the use of existing COVID-19 vaccines and advance our work to develop next-generation vaccines so that we are adequately equipped to continue to fight this deadly threat. And as more vaccines come online, we must not lose sight of our ultimate goal: to enable global equitable access to safe and effective doses everywhere. It is only through working in this way that we can hope to turn the tide on this devastating crisis.


portrait of autor