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Britain’s medication regulator said anyone with a history of anaphylaxis to a medicine or food should not get the Pfizer-BioNTech COVID-19 vaccine, giving more advice on an earlier allergy warning about the shot. Starting with the elderly and frontline workers, Britain began mass vaccinating its population on Tuesday, part of a worldwide drive that poses one of the largest logistical challenges in peacetime history.
The Medicines and Healthcare Products Regulatory Agency (MHRA) said there had been two reports of anaphylaxis and one report of a possible allergic reaction because rollout began.
“Any person with a history of anaphylaxis to a vaccine, medication or food should not get the Pfizer BioNTech vaccine,” MHRA Chief Executive June Raine said in a statement.
“Most people won’t get anaphylaxis and the advantages in protecting people against COVID-19 outweigh the risks… You can be completely confident that this vaccine has met the MHRA’s robust standards of safety, quality and effectiveness.”
The fuller guidance, clarifying that the main risk was from anaphylaxis especially, was issued after consulting specialists on allergies. The MHRA had originally advised anyone with a history of a”significant allergic reaction” not to take the shot.
Pfizer and BioNTech said that they were encouraging the MHRA’s investigation.
Last week, Britain’s MHRA became the first in the world to approve the vaccine, developed by Germany’s BioNTech and Pfizer, while the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) continue to assess the data.
A leading U.S. official said on Wednesday that Americans with known severe allergic reactions may not be candidates for Pfizer’s COVID-19 vaccine until more was known about what had happened.
Canada’s health ministry said it would examine the reported adverse reactions in Britain, but said adverse events were to be anticipated and would not necessarily change the risk/benefit of the shooter, following the nation approved the vaccine.
Allergic Reaction
MHRA chief Raine told lawmakers such allergic reactions had not been a characteristic of the Pfizer’s clinical trials.
Pfizer has said people with a history of acute adverse allergic reactions to vaccines or the candidate’s ingredients were excluded from their late phase trials, that can be reflected in the MHRA’s emergency approval protocol.
However, the allergic reactions may have been brought on by a part of Pfizer’s vaccine called polyethylene glycol, or PEG, which will help stabilise the shot and isn’t in other types of vaccines.
Imperial College London’s Paul Turner, an expert in allergy and immunology, that has been advising the MHRA in their revised guidance, told Reuters:”As we have had more info through, the first concern that maybe it impacts everyone with allergies isn’t true.”
“The ingredients such as PEG which we think might cause the reactions aren’t related to things which can cause food allergy. Likewise, people with a known allergy to only 1 medicine should not be at risk,” Turner told Reuters.
The EMA stated in an email that all quality, safety and efficacy data could be taken into account in assessing the vaccine, such as information generated outside the EU.
In the United States, the FDA published documents on Tuesday in preparation for an advisory committee meeting on Thursday, saying the Pfizer vaccine’s effectiveness and safety data met its expectations for authorization.
The briefing documents said 0.63% of people in the vaccine group and 0.51% in the placebo group reported potential allergic reactions in trials, which Peter Openshaw, professor of experimental medicine at Imperial College London, said was a very small number.
“The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system works well,” he said.
“I would not have broadened to the degree they did,” he said.
“It’s reasonable to allow the world know about this, and to be aware of it in relation to men and women who have had reactions such as this to vaccines. I think to say medications, foods or any other allergies is past the boundary of science.”
