In a rare weekend press conference, the U.S. Food and Drug Administration (FDA) -- who is responsible for authorizing widespread use of Pfizer’s coronavirus vaccine on Friday -- discussed some of people’s biggest concerns about the vaccine.
On Friday, Dec. 11, the FDA granted emergency use authorization for Pfizer’s COVID-19 vaccine, allowing its widespread use amid a surge in coronavirus spread across the U.S.
Following a rapid development and review process, many people still have questions about who is safe to receive the vaccine.
Amid two recent cases of allergic reactions to Pfizer’s coronavirus vaccine in the U.K., FDA officials addressed concerns about individuals with a history of allergic reactions receiving the vaccine. Officials say that people with allergies can get vaccinated, but are encouraged to check with a doctor first.
“About 1.6 percent of the population has had a severe allergic reaction of some sort or another to a food or some environmental aspect and we really would not like to have that many people not be able to receive the vaccine,” said FDA Biologics Director, Dr. Peter Marks during the press conference Saturday. “So we looked very closely at the databases and we feel comfortable and that we’re telling people unless they’ve had a severe reaction to the vaccine or one its components they can receive it.”
Health officials have determined that only Americans above the age of 16 years are eligible to receive Pfizer’s coronavirus vaccine based on current data. Some people have expressed concern about whether or not it is safe for teenagers to receive the vaccine -- it was the reason that four members of the 21-member board voted not to authorize widespread use of the vaccine earlier this week.
The FDA typically takes adult findings from clinical trials and research and compares those findings to individuals in their late teens. FDA officials said Saturday that they’ve followed that process when reviewing Pfizer’s vaccine, and they feel confident that it is safe for this age group to receive the shots.
“There was enough (data) there to make us comfortable that the known and potential benefits outweigh the known and potential risks, after all,” Marks said of the vaccine Saturday.
Officials also advised women who are pregnant or breastfeeding to consult with their health care providers before receiving the vaccine.
“For pregnant women and the immunocompromised at this point it will be something that providers will need to consider on an individual basis for patients,” Marks said.
During Saturday’s news briefing, officials made it clear that pressure from the White House did not force the FDA to authorize use of the vaccine too early. Officials said that reports published this week were incorrect, and that the organization followed data and expedited processes where possible to
“First of all, the representations in the press that I was threatened to be fired if we didn’t get it done by a certain date is inaccurate. So just want to put that on the record and I’ve been clear with that and in our response to those press reports,” said FDA Commissioner Dr. Stephen M. Hahn.
“We’re going to maintain the integrity of the scientific process,” Hahn added. “We’re going to let our scientists do their job and review, and go through the thoroughness of that review -- the gold standard, if you will.”
The FDA is unique in analyzing drugmakers’ raw data, a process that takes longer than many other countries’ regulatory reviews. In addition, the FDA insisted that large COVID-19 vaccine studies track at least half the participants for two months to look for side effects, a time period when historically any vaccine problems appear.
Officials affirmed Saturday that the FDA will work closely with the U.S. Centers for Disease Control and Prevention (CDC) to monitor vaccine distribution and effects in recipients.