FDA Reviewing Data On Pfizer Coronavirus Vaccine
PITTSBURGH (KDKA) -- The Food and Drug Administration is reviewing the raw data on the Pfizer coronavirus vaccine.
"How often do we have to give the vaccine? How long does it last? They're going to look at all of this to make sure it is something to proceed with," says Allegheny Health Network primary care internist Dr. Brian Lamb.
The vaccine trials are not yet completed. But so far, the figures are encouraging.
"When you look at a vaccine that has an efficacy rate above 90 percent, meaning that over 90 percent of people that get it are going to have protection from COVID-19, that's a really promising number," Dr. Lamb said.
The FDA notes partial protection appears two weeks after the first dose, with the greatest protection after the second dose.
"They're looking at how much antibody do they get from serum samples, meaning blood samples, after the first shot versus after the second shot," Dr. Lamb said.
This protection seems to last at least two months. No serious side effects have come up among 37,000 study volunteers in the two months of tracking. Only muscle pain, headache, fatigue, and fever.
In Britain, however, where immunizations with the Pfizer vaccine have begun, two health care workers with a history of allergies had an unspecified reaction. They're both recovering.
"In Britain, they're recommending that people who have histories of anaphylactic reactions to food or medicine maybe not get it yet, because what they need to do is figure out what caused the reaction in the shot," Dr. Lamb says. "That may change where we give the shots."
An independent advisory panel of two dozen experts in vaccines, infectious diseases and medical statistics will meet Thursday to make recommendations to the FDA.
"They're not going to push out something that's risky. They're not going to push out something that's not safe. It's just a matter of fine-tuning how safe it is and who should get it first," says Dr. Lamb.
Among the issues the panel might be examining: has it been sufficiently studied in minority populations? Will people with asymptomatic infections after the vaccine still be able to spread it? And what to tell pregnant women about getting immunized against COVID-19?
No one knows how quickly the FDA will make a decision. If it grants emergency use authorization, health care workers and nursing home residents will receive the first doses.
