Pfizer applies for full FDA approval of COVID-19 vaccine

Pfizer’s application for full FDA approval of its COVID-19 vaccines could impact vaccine hesitancy and businesses that may consider vaccine mandates. 

Pfizer hopes to join the ranks of the flu shot, measles, mumps, rubella shot and other vaccines that are fully FDA approved and licensed. The company submitted paperwork to the Food and Drug Administration this month, wanting to move from an experimental shot approved for emergency use to a fully-fledged vaccine.

"The FDA doesn’t make these decisions lightly, and it’s a sign also of the confidence in this vaccine," said Dr. Nicole Iovine, the chief hospital epidemiologist at UF Health.

Dr. Iovine said full FDA approval may help ease concerns about adverse side effects.

"Its efficacy is well established, and this will provide I hope some more reassurance to people that are still having concerns about the safety of the vaccine," said Iovine.

Along with nudging the hesitant, an official stamp may impact businesses. Public health professor Dr. Jay Wolfson of USF Health said FDA approval opens up vaccine mandates.

"There are a lot of drugs that are listed that are not required, but private organizations depending on the circumstance, may have the prerogative of saying in order to come back to work to protect the health and welfare of the rest of us we want you to take the vaccine," said Dr. Wolfson.

Health care systems, long-term care facilities and schools often require shots, and the FDA’s decision may encourage other employers. 

"Once you’re licensed as an FDA approved drug, that’s a real significant obstacle to overcome and it certainly makes the drug more marketable in a way," said Wolfson.

Pfizer asked for a priority review from the FDA, meaning the FDA would make a decision within six months instead of the usual 10 months.