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The U.K. regulator has warned people with a history of “significant allergic reactions” not to have the Pfizer–BioNTech COVID-19 vaccine, after two health-care workers had adverse reactions on the first day of the rollout.
The Medicines and Healthcare products Regulatory Agency (MHRA) said the advice related to “any person with a history of a significant allergic reaction to a vaccine, medicines or food.”
The two National Health Service workers were both recovering well, NHS medical director Stephen Powis said on Wednesday.
The U.K. became the first country to embark on a mass immunization program on Tuesday, as over-80s and health-care staff up and down the country received the jab. The medicines regulator granted emergency authorization for the vaccine developed by U.S. drugmaker Pfizer PFE, +3.18% and its German partner BioNTech BNTX, +1.92% on Dec. 2.
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Powis said: “As is common with new vaccines, the MHRA have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination, after two people with a history of significant allergic reactions responded adversely yesterday. Both are recovering well.”
Dr. June Raine, chief executive of the MHRA, told a parliamentary select committee on Wednesday of the two cases of allergic reactions. “We know from the extensive clinical trials that this was not a feature, but if we need to strengthen our advice now that we have had this experience in vulnerable populations, the groups selected as a priority, we get that advice out immediately.”
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The U.K. has secured 800,000 doses of the Pfizer–BioNTech vaccine, which will be administered in the coming weeks. It has placed orders for 40 million in total — enough for 20 million people, as two shots are required at least 21 days apart.