Pfizer Seeks Full FDA Approval For COVID-19 Vaccine
PITTSBURGH (KDKA) - Pfizer is seeking full FDA approval for its COVID-19 vaccine -- the first COVID vaccine in the U.S. to go through the process.
"The FDA is now going to say this is fully approved whether there is a pandemic or not, whether there's an emergency need for the use," says AHN Med-Peds Dr. Jennifer Preiss.
Currently, the vaccine is available for people 16 and older under emergency use authorization.
"It allowed us to have confidence the vaccines that were being released for emergency use were both safe and effective," says Dr. Patrick Moore, a virologist at the UPMC Hillman Cancer Center.
The full approval process involves the drug maker submitting manufacturing and facilities information to show production will be reliable and consistent.
Also, the company must turn in all of its clinical trial data. Pfizer says its two-dose vaccine is 91% effective against symptomatic illness for at least 6 months.
Pfizer is already ahead of the game, according to Dr. Patrick Moore, who serves on the FDA's vaccine advisory panel.
"This vaccine has met all the hurdles that we would normally expect for licensure," he says.
Pfizer has asked the FDA to prioritize its review and make a decision within 6 months instead of 10.
Full approval could help improve immunization rates.
"It says again that FDA has gone through its usual high standards," says Dr. Moore. "They've made a very serious decision, not based on money, not based on any other considerations, not politics, not anything. Purely science."
"This is just going to reassure a lot larger population who's been a bit skeptical," says Dr. Preiss. "I do hear a lot of patients say it has been too short a period of time to be studied. The actual development of this type of vaccine, mRNA vaccine, has been in the works since about 2008."
But also with full approval, some employers could then mandate the vaccine.
"I have quite a few people who are airline attendants, and they are requiring vaccines to come back to work," Dr. Preiss says. "I do hear that healthcare systems are definitely thinking about it."
"I hope it doesn't get to the point where there are very rigid rules for vaccinating people, because that only promotes a level of divisiveness in our society and we have more than enough divisiveness," says Dr. Moore.
"For the greater good, for the public, it makes a difference, but we also live in the United States," says Dr. Preiss. "I don't know politically how this is all going to play out."
Dr. Moore says FDA approval is likely to occur in stages, with people 16 and older first, followed by younger age groups, as the clinical trial data become available.
