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British regulators warned on Wednesday (local time) that people who have a history of severe allergic reactions should not receive the new Pfizer-BioNTech vaccine as they investigate two adverse reactions that occurred on the first day of the country’s mass vaccination program.
The UK Medical and Health Products Regulatory Agency is investigating whether the reactions were related to the vaccine. The two affected people were National Health Service staff members who had a history of allergies and both are recovering. Authorities have not specified what their reactions were.
Meanwhile, the regulator has issued a warning for anyone who has had a significant allergic reaction to a vaccine, drug, or food. That includes anyone who has been told to take an adrenaline shot or others who have had life-threatening allergic reactions.
“As is common with new vaccines, the MHRA has advised as a precaution that people with a significant history of allergic reactions not receive this vaccine after two people with a history of significant allergic reactions responded adversely yesterday,” said the Professor Stephen Powis, director of the NHS in England, said in a statement.
“They are both recovering well.”
The medical regulatory agency also said that vaccines should not be performed in facilities that do not have resuscitation equipment.
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Pfizer and BioNTech said they were working with investigators “to better understand each case and its causes.”
The late-stage trials of the vaccine found no “serious safety concerns,” the companies said. More than 42,000 people have received two doses of the injection during those trials.
Frank Augstein / AP
A nurse prepares an injection of the Pfizer-BioNTech Covid-19 vaccine at Guy’s Hospital in London, England.
“In the pivotal phase three clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee,” the companies said.
Documents published by the two companies showed that people with a history of severe allergic reactions were excluded from the trials, and physicians were advised to watch out for such reactions in trial participants previously not known to have severe allergies.
Even in non-emergency situations, health authorities must closely monitor new vaccines and drugs because studies in tens of thousands of people cannot detect a rare risk that would affect 1 in 1 million.
Dr Peter Openshaw, professor of experimental medicine at Imperial College London, said there is a “very small” chance of an allergic reaction to any vaccine.
Stew Milne / AP
UK regulators say that people who have a “significant history” of allergic reactions should not receive the new coronavirus vaccine from Pfizer / BioNTech.
Last week, the MHRA granted emergency authorization to the Pfizer-BioNTech vaccine, making Britain the first country to allow its widespread use.
The UK started its mass vaccination program on Tuesday (local time), offering the vaccine to people over 80, nursing home staff and some NHS workers. It’s unclear how many people have received the jab so far.
As part of its emergency authorization for the vaccine, the MHRA required healthcare workers to report any adverse reactions to help regulators gather more information on safety and effectiveness.
Frank Augstein / AP
One expert said there was a “very small” chance of an allergic reaction to any vaccine.
The agency is closely monitoring the launch of the vaccine and “will now investigate these cases in more detail to understand whether the allergic reactions were related to the vaccine or were incidental,” he said. “The fact that we know about these two allergic reactions so soon and that the regulator has acted on them to issue precautionary advice shows that this monitoring system is working well.”
Dr. June Raine, director of the medical regulatory agency, briefed a parliamentary committee on the reactions during previously scheduled testimony about the pandemic.
“We know from very large clinical trials that this was not a feature” of the vaccine, he said. “But if we need to strengthen our advice, now that we’ve had this experience with vulnerable populations, the groups that have been selected as a priority, we get that advice out into the field immediately.”
