WASHINGTON – Officials at the Food and Drug Administration, which authorized the Pfizer-BioNTech vaccine for emergency use Friday night, took steps Saturday to try to reassure the public that the vaccine was safe and that its clearance was not driven by politics.
They also said that, as a precaution, health-care sites administering the shots would be equipped with safety equipment to treat potential severe allergic reactions.
At a news conference, FDA Commissioner Stephen Hahn said he would “absolutely” get the vaccine as soon as he is eligible.
Hahn denied, as he did Friday, that the White House had threatened his job if the agency didn’t move quickly on the vaccine. The Washington Post reported Friday that White House Chief of Staff Mark Meadows called Hahn on Friday morning to warn him to be ready to submit his resignation if the agency didn’t clear the shots by the end of the day, according to multiple people knowledgeable about the situation and who spoke on the condition of anonymity because they but did not have permission to speak publicly.
“Science and data guided the FDA’s decision,” Hahn told reporters, adding the agency had maintained “the integrity of the scientific process” while moving as quickly as possible given the urgent situation.
Discussing the possibility of rare severe allergic reactions, Peter Marks, director of the division that regulates vaccines, said officials looked carefully at such side effects and concluded people should receive the vaccine unless they were allergic to one of its components.
Two health-care workers in Britain had severe anaphylactic reactions after getting the vaccine, according to authorities. Both had a history of serious allergic reactions and carry epinephrine auto-injectors, known as EpiPens, for such emergencies. A third person reportedly suffered a rapid heartbeat.
Marks said medical sites giving the shots will be equipped with EpiPens and other supplies, such as Benadryl and steroids, to counter possible severe allergic reactions.
“Hopefully, it will just be there as a safety precaution,” he said.
The FDA, in clearing the vaccine Friday, issued a broad authorization for people 16 and older. Marks said Saturday the agency was “very comfortable that the safety profile” for 16- and 17-year-olds was “acceptable” even though there were fewer clinical trial participants of those ages.
He said the agency didn’t have enough data to recommend the vaccine for younger children or pregnant women. The latter should talk to their doctors about whether to get the shots, he said.