Interesting column in the New York Times last week on the decision by British drug regulators to recommend against use of the coronavirus vaccine made by Pfizer and BioNTech in people who have a history of severe allergic reactions.
The regulators issued the warning after two health care workers, both with such a history, had a serious reaction, anaphylaxis, after receiving the vaccine on the first day it became available in Britain. According to the Times, anaphylaxis can be life-threatening, with impaired breathing and drops in blood pressure that usually occur within minutes or even seconds after exposure to a food or medicine, or even a substance like latex to which the person is allergic.
Both workers were treated and have recovered, the regulators said.
British authorities have since clarified their concerns, changing the wording from “severe allergic reactions” to specify that the vaccine should not be given to anyone who has ever had an anaphylactic reaction to a food, medicine or vaccine. That type of reaction to a vaccine is “very rare,” they said.
The Times goes on to say that here officials of the U.S. Food and Drug Administration said last Thursday that because of the British cases they would require Pfizer to increase its monitoring for anaphylaxis and submit data on it once the vaccine comes into use.
The initial report on the British cases touched off alarm and confusion by advising that people who had ever had a “severe allergic reaction” to a food, drug or vaccine should not receive the vaccine. The nature of the reaction was not explained at first, leaving many people with allergies to food or bee stings wondering if the new vaccine would be safe for them.
Here’s the truth - the regulators’ subsequent clarification specified that their advice applied to people who had ever gone into anaphylaxis. It urged people with a “history of serious allergies” to discuss it with their doctors “prior to getting the jab.”
The two health care workers in Britain had experienced anaphylaxis in the past because of food allergies, a Pfizer official said during the F.D.A. meeting on Thursday. Both carried EpiPen-type devices to inject themselves with epinephrine in case of such a reaction.
They needed epinephrine to treat their reactions to the vaccine, and both recovered. Among those who participated in the Pfizer trials, a very small number of people had allergic reactions. A document published by the F.D.A. on Tuesday said that 0.63 percent of participants who received the vaccine reported potential allergic reactions, compared to 0.51 percent of people who received a placebo.
Dr. Anthony Fauci, the nation’s leading expert on infectious diseases, said on Wednesday that the allergic reactions were concerning but most likely rare, the kind of effects that show up when a vaccine moves out of testing and into broader distribution.
Dr. Fauci, the truth teller, to the rescue once again.