Pfizer has initiated the process of seeking full FDA approval for its Covid-19 vaccine.
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Pfizer and its partner BioNtech initiated the Biologic License Application (BLA) process, which requires six months of safety data, the company said in a statement. The data will include the company’s analysis from its Phase 3 clinical trial, which showed vaccine efficacy and safety up to six months following injection of the second dose, along with manufacturing and facility records.
“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,” said Pfizer’s CEO Albert Bourla.
The company is currently distributing the vaccine under the FDA approval of the Emergency Use Authorization (EUA), a status that is granted in emergencies like the pandemic, according to ABC News. The EUA process requires only two months of safety data.
“The BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” Ugur Sahin, CEO of BioNTech, said in a statement.
The FDA is likely to take several months to review the additional data and grant full approval, according to ABC News. But Pfizer is seeking approval under a rolling submission basis, a faster process that allows the FDA to review data as soon as the company gets it.
Pfizer and BioNtech also submitted an application to expand their EUA to provide the Covid-19 vaccine to 12- to 15-year-olds. The drugmaker said it has so far delivered over 170 million doses of its vaccine in the U.S.
On Thursday, Moderna said that it similarly plans to initiate its rolling submission for the BLA in May.