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Pfizer And BioNTech Seek FDA's Full Approval For COVID-19 Vaccine

Pfizer Inc. (NYSE: PFE) and BioNTech SE - ADR (NASDAQ: BNTX) have started the process to seek full approval from the U.S. Food and Drug Administration (FDA) for a COVID-19 vaccine.

05/07/2021 10:19

Pfizer Inc. (NYSE:PFE) and BioNTech SE - ADR (NASDAQ:BNTX) have started the process to seek full approval from the U.S. Food and Drug Administration (FDA) for a COVID-19 vaccine.

What Happened: The companies’ vaccine was made accessible in the U.S. last December when the FDA issued an Emergency Use Authorization (EUA). Since then, more than 170 million doses of the vaccine have been delivered nationwide.

Because the EUA is only a temporary grant, the companies have initiated a Biologics License Application (BLA), which requires the submission of nonclinical and clinical data to support licensure of the vaccine for use in individuals ages 16 and older. The BLA incorporates the most recent analyses from the vaccine’s Phase 3 clinical trial, where its efficacy and safety profile were tracked for up to six months after the second dose.

The companies added they will submit manufacturing and facility data for licensure in the coming weeks to complete the BLA process. They have also submitted a separate application to expand the EUA for the vaccine to encompass dosages for individuals 12 to 15 years of age.

Related Link: Pfizer And BioNTech Donate COVID-19 Vaccine To Tokyo Olympians

What Else Happened: While Pfizer and BioNTech seek FDA approval on their vaccine, an international effort to waive the patents of all COVID-related vaccines hit a major stumbling block when the German government announced its opposition to this action.

According to a BBC News report, Germany’s opposition followed remarks made by European Commission President Ursula von der Leyen that the European Union was "ready to discuss" the proposal on waiving patents, which was initially raised by the Indian and South African governments and later endorsed by the Biden administration.

In a statement, the German government said "the protection of intellectual property is a source of innovation and must remain so," adding that intellectual property was not standing in the way of mitigating the health crisis.

“The limiting factors in the production of vaccines are the production capacities and the high-quality standards and not patents,” said the German government, whose pharmaceutical industry includes BioNTech.

(Photo by Ali Raza / Pixabay.)