UK advises people with severe allergies to avoid Pfizer vaccine after 2 adverse reactions

A vial of Pfizer / BioNTech COVID-19 vaccine is seen before it is administered at the Royal Victoria Hospital, on the first day of the largest immunization program in British history, in Belfast, Northern Ireland, on December 8, 2020. Liam McBurney / Pool via REUTERS

LONDON – Britain’s drug regulator has warned that people with a history of major allergic reactions do not receive the COVID-19 vaccine from Pfizer-BioNTech after two people reported adverse effects on the first day of implementation.

Britain began mass vaccinating its population on Tuesday in a global campaign that poses one of the biggest logistical challenges in peacetime history, starting with the elderly and front-line workers.

National Health Service medical director Stephen Powis said the advice had changed after two NHS workers reported anaphylactoid reactions associated with the vaccine.

“As is common with new vaccines, the MHRA (regulator) has cautioned against people with a significant history of allergic reactions not receiving this vaccine after two people with a history of significant allergic reactions responded adversely yesterday.” Powis said.

“They are both recovering well.”

The MHRA said it would seek more information, and Pfizer and BioNTech said they were supporting the MHRA’s investigation.

The Medicines and Health Products Regulatory Agency (MHRA) was the first in the world to approve the vaccine, developed by BioNTech and Germany’s Pfizer, last week, while the United States Food and Drug Administration (FDA) and The European Medicines Agency (EMA) continue to evaluate the data.

“Last night we were looking at two case reports of allergic reactions. We know from very large clinical trials that this was not a feature, ”June Raine, MHRA executive director, told legislators.

Pfizer has said that people with a history of serious adverse allergic reactions were excluded from its late-stage trials.

The FDA released documents Tuesday in preparation for an advisory committee meeting Thursday, saying that the efficacy and safety data of the Pfizer vaccine met its licensing expectations.

That fact sheet 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, 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 them to issue precautionary advice shows that this monitoring system is working well,” he said.

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