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- Pfizer’s recently licensed coronavirus vaccine appears to be safe for people with food or environmental allergies, the FDA said Saturday.
- Two people in the UK reported serious allergic reactions after receiving the injection.
- After careful consideration, the FDA decided not to include warnings against the vaccine for people with a history of severe allergies, as that is a large segment of the population and such complications did not occur in clinical trials.
- Still, there is more to learn, and all vaccine distribution sites will be equipped to treat any allergic reactions that may occur, which the FDA will continue to monitor closely.
People with common allergies to food or things in the environment like pollen or dust probably don’t have to worry about having a serious reaction to the newly licensed Pfizer coronavirus vaccine, the US Food and Drug Administration said. During a press conference on Saturday. .
Even people who have had a severe allergic reaction to food or something in the environment in the past should be fine to receive the vaccine, said Dr. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, during the briefing. The FDA said that people allergic to the vaccine itself or one of its ingredients should not receive it.
“We are telling people that unless they have had a severe allergic reaction to the vaccine or one of its components, they can get it,” Marks said.
The FDA held the briefing to provide more information on Pfizer’s coronavirus vaccine, after authorizing the vaccine on Friday night for emergency use in people 16 and older. In authorizing the vaccine, the FDA said it is generally safe and highly effective in preventing symptomatic cases of COVID-19, the disease caused by the new coronavirus.
The clarification for people with allergies came after two people in the UK with known severe allergies developed non-life threatening anaphylactic reactions shortly after being injected with the vaccine. UK health officials said people with a history of severe or anaphylactic reactions to vaccines, drugs or food should not get the injection.
“I just want to assure the public that although there were few reactions in Britain, we are not seeing them in the larger clinical trial data sets,” Marks said.
The trial included people with common problems like asthma and food allergies, but excluded people with severe allergies to vaccines.
Allergies are common, but serious reactions to this vaccine are not.
About 30% of the world’s population have seasonal allergies, 10% have drug allergies, and 8% of children worldwide have food allergies, according to the American Academy of Allergy, Asthma, and Immunology. In the US, 1 in 10 adults has food allergies, according to reports from Food Allergy Research and Education.
Marks said that 1.6% of the population has had a severe allergic reaction to a food or something in the environment.
“We really don’t want so many people not being able to get the vaccine,” he said.
That is why, after careful consideration, the agency decided not to include a warning about allergic reactions, other than those to the vaccine itself and its components, in its fact sheets.
Still, all vaccination sites will have EpiPens, Benadryl, and hydrocortisone on hand to treat any potential reactions that arise, which the agency will track.
“We have very good security surveillance systems in conjunction with the Centers for Disease Control and Prevention, and we may have to tweak things as we go along,” Marks said. “But for now, we feel comfortable with this [advice]And the extra part of this is that the centers will have the ability to treat allergic reactions. “
Most of the ingredients in Pfizer injections are benign
Marks said people with a history of allergic reactions should speak with their doctor, who can help them determine if they may be allergic to one of the components in the new vaccine, including lipids, potassium, chlorine, salt and sugar. . A complete list of components is available here.
“None of those ingredients appear to be highly allergenic,” Dr. Sanjeev Jain, a board certified allergist, immunologist and CEO of Columbia Allergy, told Business Insider’s Hilary Brueck, emphasizing that most of the chemicals in the new injection are quite benign.
He said there could be some explanations, then, why the two people in Britain experienced severe reactions. In rare cases, people can react to polyethylene glycol, a component of one of the ingredients.
It is also possible that people had “nonspecific” mast cell reactions or that something in the vaccine particles triggered the body’s response to allergens.
Finally, the two people with reactions could have recently had allergy treatment or been in contact with another allergen, which, in combination with the effect of a vaccine on the immune system, “sped it up,” Brueck reported.
“The fact that her immune system was boosted by the vaccine could have triggered a reaction,” Jain said.
