Pfizer and BioNTech said they were supporting the MHRA investigation.
London:
Britain’s drug regulator said that anyone with a history of anaphylaxis to a drug or food should not receive the Pfizer-BioNTech COVID-19 vaccine, providing more comprehensive guidance on a previous allergy warning about the vaccine.
Starting with the elderly and frontline workers, Britain began mass vaccinating its population on Tuesday, part of a global push that poses one of the greatest logistical challenges in peacetime history.
The Medicines and Healthcare Products Regulatory Agency (MHRA) said there have been two reports of anaphylaxis and one report of a possible allergic reaction since the launch began.
“Anyone with a history of anaphylaxis to a vaccine, drug or food should not receive the Pfizer BioNTech vaccine,” said MHRA Executive Director June Raine in a statement.
“Most people will not experience anaphylaxis, and the benefits of protecting people against COVID-19 outweigh the risks … You can be completely confident that this vaccine has met the robust safety, quality and efficacy standards of the MHRA “.
Anaphylaxis is an overreaction of the body’s immune system, described by the National Health Service as serious and sometimes life-threatening.
The most comprehensive guide, clarifying that the main risk was specifically anaphylaxis, was issued after consulting allergy experts. The MHRA had initially advised anyone with a history of a “significant allergic reaction” not to inject.
Pfizer and BioNTech said they were supporting the MHRA investigation.
Last week, Britain’s MHRA became the first in the world to approve the vaccine, developed by BioNTech and Germany’s Pfizer, while the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continue to evaluate the data.
A senior US official said Wednesday that Americans with known severe allergic reactions may not be candidates for Pfizer’s COVID-19 vaccine until what happened is better understood.
Canada’s Health Ministry said it would look at adverse reactions reported in Britain, but said adverse events were expected and would not necessarily change the risk / benefit of the injection, after the country approved the vaccine.
Allergic reaction
MHRA chief Raine told lawmakers that such allergic reactions had not been a feature of Pfizer’s clinical trials.
Pfizer has said that people with a history of serious adverse allergic reactions to the candidate’s vaccines or ingredients were excluded from its late-stage trials, which is reflected in the MHRA’s emergency approval protocol.
However, the allergic reactions may have been caused by a component of Pfizer’s vaccine called polyethylene glycol or PEG, which helps stabilize the injection and is not found in other types of vaccines.
Paul Turner of Imperial College London, an expert on allergies and immunology, who has been advising the MHRA on its revised guide, told Reuters: “As we have had more information, the initial concern that it may affect all people with allergies is not true.. “
“Ingredients like PEG, which we think might be responsible for reactions, are not related to things that can cause food allergies. Likewise, people with a known allergy to a single drug should not be at risk,” he said Turner to Reuters.
The EMA said in an email that all quality, safety and efficacy data would be taken into account when evaluating the vaccine, including data generated outside the EU.
In the United States, the FDA released documents Tuesday in preparation for an advisory committee meeting Thursday, saying that the efficacy and safety data for the Pfizer vaccine met its expectations for authorization.
The information papers said that 0.63% of people in the vaccine group and 0.51% in the placebo group reported possible allergic reactions in the trials, which Peter Openshaw, professor of experimental medicine at Imperial College from London, he said it was a very small number.
“The fact that we know so early about these two allergic reactions and that the regulator has acted on it to issue precautionary advice shows that this monitoring system is working well,” he said.
However, Gregory Poland, a virologist and vaccine researcher at the Mayo Clinic in Rochester, Minnesota, said the MHRA and the NHS had initially overreacted.
“I wouldn’t have expanded to the extent that they did,” he said.
“It is reasonable to let the world know about this and be aware of it in terms of people who have had reactions like this to vaccines. I think that saying drugs, food or any other allergy is beyond the limits of science.”
(Except for the headline, this story has not been edited by NDTV staff and is posted from a syndicated feed.)
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