LONDON: Britain's medicine regulator has advised that people with a history of significant allergic reactions do not get Pfizer-BioNTech's Covid-19 vaccine after two people reported adverse effects on the first day of roll-out.
Britain began mass-vaccinating its population on Tuesday in a global drive that poses one of the biggest logistical challenges in peacetime history, starting with the elderly and front-line workers.
National Health Service (NHS) medical director Stephen Powis said the advice had been changed after two NHS workers reported anaphylactoid reactions associated with receiving the vaccine.
"As is common with new vaccines, the MHRA (the regulator) has 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," he said.
"Both are recovering well."
The Medicines and Healthcare products Regulatory Agency (MHRA) said it would seek further information, and Pfizer and BioNTech said they were supporting the MHRA's investigation.
MHRA was the first in the world to approve the vaccine last week, while the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) continue to assess the data.
"Last evening, we were looking at two case reports of allergic reactions. We know from the very extensive clinical trials that this wasn't a feature," MHRA chief executive June Raine told lawmakers.
Pfizer has said people with a history of severe adverse allergic reactions were excluded from their late-stage trials.
The new MHRA guidance, sent out to health professionals, said a much broader segment should not take the vaccine.
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"Any person with a history of a significant allergic reaction to a vaccine, medicine or food (such as previous history of anaphylactoid reaction or those who have been advised to carry an adrenaline autoinjector) should not receive the Pfizer BioNtech vaccine," it said.
In the US, the FDA released documents on Tuesday in preparation for an advisory committee meeting today, saying the Pfizer vaccine's efficacy and safety data met its expectations for authorisation.
Part of US President-elect Joe Biden's plan to fight the coronavirus is to vaccinate 100 million Americans in his first 100 days in office.
"In 100 days, we can change the course of the disease and change life in America for the better," said Mr Biden, who takes office on Jan 20.
Meanwhile, an experimental coronavirus vaccine developed by China National Pharmaceutical Group (Sinopharm) has 86 per cent efficacy, the Health Ministry of the United Arab Emirates (UAE) said yesterday, citing an interim analysis of late-stage clinical trials.
While the positive data comes soon after last month's upbeat results from Western rivals, such as Pfizer, Moderna, AstraZeneca and from Russia, neither the UAE nor Sinopharm have released detailed data from the pivotal study.
"The analysis shows no serious safety concerns," the UAE Health Ministry said in a statement carried by the state news agency.
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