The Food and Drug Administration (FDA) could advise Americans with severe allergies to take Pfizer’s COVID-19 vaccine until more information is known about two allergic reactions to the shot in the UK, Trump’s vaccine chief said.
Two National Health Service (NHS) staff members in the UK had allergic reactions after being among the first people in the world to get Pfizer’s shot on Tuesday.
Both people, who had a history of significant allergic reactions, are recovering.
The UK drug regulator has warned people with a history of significant allergic reactions to avoid the Pfizer vaccine in its current state – and the FDA could follow suit.
The FDA will likely review the allergic reactions in the UK before making a decision. Americans with severe allergies could be advised to not take the vaccine until further investigations have been made, said Moncef Slaoui during a press briefing Wednesday. Slaoui is chief science advisor for the Operation Warp Speed, the White House partnership facilitating the race for a COVID-19 vaccine.
“The expectation will be that subjects with known severe allergic reactions should not take the vaccine, until we understand exactly what happened here,” he said.
“My expectation is that this is new news, and I would assume – but of course the FDA will make those decisions – that tomorrow this will be part of the consideration,” Slaoui said.
Americans may already have to wait longer than expected for the first shots after the head of vaccine rollout in the US said it may take longer to distribute than anticipated. Gustave Perna, the chief operations officer for Operation Warp Speed, said Americans will be vaccinated four days after the shot’s authorization.
Strong allergic reactions, or anaphylaxis, are “a known, although very rare, side effect with any vaccine,” Dr. June Raine, head of the UK’s drug regulator, said.
“Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks,” she added.
A Pfizer representative told Sky its vaccine was “well tolerated” during trials with more than 44,000 participants, with “no serious safety concerns.”
Pfizer and BioNTech are supporting the UK’s investigation into the reactions, the spokesperson added.
Authorities have not yet confirmed which element of the vaccine the staff members were allergic to, but said vaccination should only be carried out in facilities with resuscitation equipment.