Pfizer and BioNTech Request Full Approval of Coronavirus Vaccine by US FDA

Pfizer and BioNTech Request Full Approval of Coronavirus Vaccine by US FDA

Pharmaceutical partnership Pfizer / BioNTech has launched an application for full approval of its Covid-19 vaccine with the United States Food and Drug Administration (FDA), the companies said on Friday.

More than 170 million doses of the vaccine have been delivered across the United States since it was approved for emergency use in December, the first Covid-19 vaccine to receive FDA clearance.

The companies said they initiated the full approval request by submitting a Biologics License Application (BLA), which requires non-clinical and clinical data, including the most recent analyzes from the Phase 3 clinical trial of the vaccine.

The trial included more than 40,000 people and showed that “the vaccine’s efficacy and favorable safety profile were observed for up to six months after the second dose,” the companies said in a press release. Companies also submit manufacturing and facility data required by the BLA.

“We are proud of the significant progress we have made since December in delivering vaccines to millions of Americans, working with the US government,” Albert Bourla, CEO of Pfizer, said in a statement. “We look forward to working with the FDA to complete this ongoing submission and support their review, with the goal of achieving full regulatory approval for the vaccine in the coming months.”

This full approval request will only apply to persons aged 16 and over. The companies said they were also asking to extend their current emergency use authorization to teenagers between the ages of 12 and 15.

More details soon


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