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 on 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 non-clinical 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.
“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.
With three Covid-19 vaccines available to adult Americans, the country has fully vaccinated 41% of Americans while 57% have received at least one dose, according to data from the Centers for Disease Control and Prevention.
While it will probably take a few months for the FDA to shift through Pfizer/BioNTech’s application, full approval would be another large step in the country’s vaccination campaign.
With full approval, the companies would be able to market the vaccine directly to Americans, and there may be less hesitation from employers and schools to mandate vaccination.
For example, administrators of the California State University system, which has 23 campuses, said they intend to require vaccination for students, faculty and staff in the fall, though a formal mandate is contingent on full FDA authorization.
Full approval could also help populations that have been hesitant to get inoculated gain confidence in the vaccine. The pace of administered vaccines has slowed as those most eager to get their shots have already gotten them, complicating Joe Biden’s plan to have 70% of American adults receive at least one dose of the vaccine by the Fourth of July holiday.
Biden announced a series of plans to make the vaccine more accessible and convenient, including setting up smaller vaccine locations closer to unvaccinated people in rural areas and directing pharmacies to offer walk-in appointments.