Pfizer is seeking full FDA approval for its COVID-19 vaccine -- the first COVID vaccine in the U.S. to go through the process; KDKA's Dr. Maria Simbra reports.
- Pfizer is seeking full approval from the FDA for its COVID vaccine. Right now, it's received only emergency use authorization. Let's get back to Dr. Maria Simbra.
MARIA SIMBRA: Pfizer is seeking full FDA approval for its COVID-19 vaccine, the first COVID vaccine in the US to go through the process.
JENNIFER PREISS: FDA is now going to say that this is fully approved, whether there is a pandemic or not, whether there's an emergency need for the use.
MARIA SIMBRA: Currently, the vaccine is available to people 16 and older under emergency use authorization.
PATRICK MOORE: It allowed us to have confidence that the vaccines that were being released for emergency use were both safe and effective.
MARIA SIMBRA: The full approval process involves the drug maker submitting manufacturing and facilities information to show production will be consistent and reliable. Also, the company must turn in all of its clinical trials data. Pfizer says its two dose vaccine is 91% effective against symptomatic illness for at least six months. Pfizer is already ahead of the game, according to Dr. Patrick Moore, who serves on the FDA's Vaccine Advisory Panel.
PATRICK MOORE: This vaccine has met all of the hurdles that we normally would expect for licensure.
MARIA SIMBRA: Pfizer has asked the FDA to prioritize its review and make a decision within six months instead of 10. Full approval could help improve immunization rates.
PATRICK MOORE: It says, again, that FDA has gone through its usual high standards.
JENNIFER PREISS: This is just going to reassure a lot larger population who has been a bit skeptical.
MARIA SIMBRA: But also with full approval, some employers could then mandate the vaccine.
JENNIFER PREISS: I have quite a few people who are airline attendants, and they are requiring vaccines to come back to work. I do hear that healthcare systems are definitely thinking about this.
PATRICK MOORE: 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.
MARIA SIMBRA: Dr. Moore says FDA approval is likely to happen in stages with people 16 and older first, followed by younger age groups as clinical trial data becomes available. I'm Dr. Maria Simbra, KDKA News.