Pfizer/BioNTech’s Comirnaty has become the first COVID-19 vaccine to win full approval from the US Food and Drug Administration (FDA).
In December 2020, the FDA approved an emergency use authorisation (EUA) for the Pfizer/BioNTech COVID-19 vaccine, based on preliminary data from a pivotal Phase III clinical trial.
As part of their Biologics License Application (BLA) for Comirnaty, Pfizer and BioNTech submitted a ‘comprehensive’ data package, including long-term follow-up data from the Phase III trial as well as manufacturing and facilities data.
The companies are also planning to submit an application for approval of a third booster dose of Comirnaty in individuals 16 years of age and older via a supplemental BLA.
On top of that, Pfizer and BioNTech also intend to submit another supplemental BLA to support full FDA approval of the vaccine in children aged 12 to 15-years-old, once the required data is available.
“Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. About 60% of eligible Americans are fully vaccinated, and infection, hospitalisation and death rates continue to rise rapidly among unvaccinated populations across the country,” said Albert Bourla, chairman and chief executive officer, Pfizer.
“I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity. Hundreds of millions of doses of our vaccine already have been administered in the US since December 2020, and we look forward to continuing to work with the US government to reach more Americans now that we have FDA approval,” he added.