CHARLOTTE, N.C. (FOX 46) – A former FDA commissioner says by law, companies could require COVID shots before the vaccine had full FDA approval, but the designation makes them more likely to mandate vaccines now.
“For anybody who does have doubts, this should help overcome it,” said Dr. Mark McClellan, a Duke University professor and former FDA Commissioner.
The FDA has granted full approval of the Pfizer COVID-19 vaccine.
Dr. McClellan says this could mean people might feel more comfortable rolling up their sleeves now and more companies might make them.
“Companies could do it before. I think they’ll be more confident now and think they’ll get more acceptance from their workers.”
The doctor says full FDA approval of Pfizer means after following people who got the shot for more than six months, the FDA found the vaccine to be safe and effective with no evidence of serious, long-term side effects.
There was a very rare occurrence of pericarditis, which is a cardiac muscle inflammation, but the doctor says the benefits of getting the shot outweigh the risks.
“It didn’t really change the picture at all in terms of very high benefits rate very effective vaccine, very rare side effects but it’s more complete now, we’ve got more data on more people, over 100,000 pregnant women, the vaccine is protective, doesn’t cause any adverse effects there,” said Dr. McClellan.
And Dr. McClellan says parents shouldn’t worry that full FDA approval hasn’t yet come for the Pfizer vaccine for 12-15 year olds.
“If there were any concerns about the use of the vaccine emerging in people 12-15, you would be hearing about it, it’s something the FDA’s staying on top of, and just like we saw with other rare side effects that have turned up infrequently with the vaccines, there will be a close review of that not only by FDA but CDC, as all that data comes together,” said Dr. McClellan.
The doctor expects the FDA to give full approval for the Pfizer vaccine for 12-15 years by late fall and emergency approval for ages 5-12 by the end of the year.
