Pfizer and BioNTech seek full FDA approval of coronavirus vaccine in US
The Pfizer/BioNTech pharmaceutical partnership has started an application for full approval of its Covid-19 vaccine with the US Food and Drug Administration (FDA), the companies announced Friday.
More than 170m doses of the vaccine have been delivered across the US since it was approved for emergency use authorization in December, the first Covid-19 vaccine to receive the authorization from the FDA.
The companies said they initiated the application for full approval by submitting a Biologics License Application (BLA), which requires nonclinical and clinical data, including the most recent analyses from the vaccine’s phase 3 clinical trial.
The trial included more than 40,000 people and showed “the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose”, the companies said in a press release. The companies are also submitting manufacturing and facility data the BLA requires.
It's with great pride that @Pfizer and @BioNTech_Group have initiated our Biologics License Application (BLA) with the @US_FDA for approval of our #COVID19 vaccine to prevent disease in individuals 16 years of age and older: https://t.co/Tv1jlePlMU
— AlbertBourla (@AlbertBourla) May 7, 2021
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the US government,” said Albert Bourla, Pfizer chairman and CEO, in a statement. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”
This application for full approval will apply only to those aged 16 and older. The companies said they are also applying to expand their current emergency use authorization to include adolescents aged 12 to 15.
More details soon …
