The advice on the Covid-19 vaccine leaves some people with allergies in limbo

People with severe allergies say they are confused if they should receive the Covid-19 vaccine produced by Pfizer Inc.

and BioNTech SE,

and public health authorities on both sides of the Atlantic offer conflicting advice.

Two medical workers in Alaska also had allergic reactions after receiving the vaccine, one of which required hospitalization. Unlike the UK regulator, the US Food and Drug Administration and Health Canada have only recommended against the administration of shots to people with a known history of severe allergic reactions to any component of the vaccine itself.

Some patients in the US and the UK have said they are puzzled and unsure of what advice to follow.

In a televised event on Friday, Vice President Mike Pence was given the Pfizer-BioNTech Covid-19 vaccine. Second Lady Karen Pence and Surgeon General Jerome Adams also received the vaccine. Photo: Andrew Harnik / Associated Press

“I’m definitely worried about that,” said Abigail Espinoza, a 43-year-old mother and architecture design student in Astoria, Oregon, who said she was concerned about incidents in the UK. He has severe allergies to pistachios and penicillin, which can lead to breathing problems. To treat possible allergic reactions, she wears an epinephrine auto-injector.

Ms Espinoza, who is not among the first to be vaccinated, said she did not intend to receive the Pfizer-BioNTech vaccine until more data and research on the vaccine and people with allergies were available. He also wants to consult an allergist before he gets a chance.

Doctors say they ask a lot of questions from patients with different types of allergies, who say they are not sure what to do once they become eligible.

Doctors fear that severe reactions and conflicting advice on allergies will discourage patients from being vaccinated as the Pfizer-BioNTech vaccine is launched, with Moderna Inc.

The Covid-19 vaccine may be available soon.

Niraj Patel, allergist and president of the American College of Allergy, Asthma and Immunology Covid-19 Task Force, said he has received many questions about whether people with allergies have a higher risk of having a serious reaction to the vaccine. “They want to know if you’re getting safe,” he said.

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Dr. Patel and other US allergy experts have told worried patients that only people with a history of severe allergic reactions to a specific component of the vaccine – especially a compound called polyethylene glycol – should not receive the vaccine. Otherwise, having a severe allergy to food or oral medications does not increase the chance of an allergic reaction to the vaccine, he said.

Allergists find that some people may have allergies that are related to each other. For example, people who are allergic to one type of nut may also be allergic to other types of nuts because they contain similar chemical structures, something known as cross-reactivity, Dr. Patel said.

“There does not appear to be any cross-reactivity between the agents that are in the Covid vaccine and other common proteins that cause anaphylaxis, such as food or medicine,” he said. Anaphylaxis is the most severe form of allergic reaction, which can lead to airway closure and death.

Prior to the UK’s launch of the Pfizer vaccine on December 8, the country’s advice was in line with its guidelines for all vaccines and reflected the recommendations of Pfizer and BioNTech for their vaccine: those with allergies to the vaccine or its components should not takes.

Chris Whitty, medical director for England, said the UK changed its advice based on real-world reactions that had not occurred in clinical trials. This has led to an improvement over time in the number of cases of anaphylaxis after injections, Whitty said on Wednesday.

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Sometimes the ingredient that triggered the reaction – the allergen – is not known, said the British regulatory agency for medicines and medical products. “Therefore, as a precaution, our current advice is that anyone with a history of anaphylaxis with immediate onset of a vaccine, drug, or food should not receive the Pfizer-BioNTech vaccine,” an MHRA spokeswoman said. “Further investigations into these cases are ongoing,” she added.

Professor Saad Shakir, director of the UK’s drug safety research unit, said the decision to extend restrictions on vaccine recipients was “the right action to minimize risks”.

“It is reassuring that the decision was made and communicated so promptly,” he said.

Anaphylaxis after vaccines generally occurs only once per million doses, according to the ACAAI. People who have had severe allergic reactions, such as anaphylaxis, to any component of the Pfizer-BioNTech vaccine should not receive the vaccine, according to the FDA and the US Centers for Disease Control and Prevention. The components of the vaccine can be found on the FDA website.

People with severe allergies to any other vaccine or injection may receive the vaccine, but should talk to their healthcare providers beforehand about weighing the risks of an allergic reaction with the benefits of receiving the vaccine, the agency recommends. And there’s no reason why people with a history of mild or severe allergic reactions to food, pets, oral medications or environmental allergens, such as pollen, shouldn’t get the vaccine, the CDC says.

The CDC also says that all vaccine recipients must be observed for 15 minutes after vaccination to monitor for possible side effects. People with a history of anaphylaxis should be observed for 30 minutes after vaccination, he says.

Pfizer and BioNTech have said that people with severe allergic reactions to the vaccine or its components should not receive the vaccine. Vaccine clinical trials did not include people with that profile, according to the companies.

Anaphylaxis was not observed during clinical trials of the Pfizer-BioNTech vaccine, although 0.63% of a subgroup of vaccinated participants in subsequent studies had so-called hypersensitivity adverse events that could have been allergic reactions. . In the placebo group, 0.51% had these reactions.

Moderna said there was an anaphylactic reaction to a vaccine recipient in her study, but it occurred two months after the second dose in a person with a history of asthma and shellfish allergy. Allergists say that anaphylactic reactions are unlikely to occur so late; most reactions would occur within minutes. The company said it intends to continue monitoring such events.

Some US experts in vaccines and allergies have said they do not agree with the UK’s decision to prevent vaccination of all people with severe allergies to food, medicine or vaccines. They said such a policy was too broad, given that there were only two cases of severe allergic reactions in the UK out of 138,000 doses given in the first week.

“Talk about eliminating tens of millions of people” from the vaccination program if you prevent people with severe food or drug allergies from getting injected, said Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia, who is on the Advisory Committee. of the FDA Covid-19 vaccine. The FDA said it is investigating the two allergic reactions in Alaska.

People with allergies need to understand that they are generally at the same risk of having an allergic reaction to the vaccine as anyone else, he said. “We need to give people some comfort that this will not be a problem for them,” said Dr. Offit.

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Write to Sarah Toy at [email protected] and Joanna Sugden at [email protected]

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