Pfizer / Bioentech vaccine: UK examines possible allergic reactions to COVID-19 shot

LONDON – British regulators on Wednesday warned people with severe allergic reactions not to get the new Pfizer-Bioentech vaccine as they are investigating 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 are linked to the vaccine. Two of the victims were employees of the National Health Service with a history of allergies, and both are recovering. Officials did not specify what their reactions were.

Meanwhile, the regulator has warned anyone with a significant allergic reaction to the vaccine, medication or food. This includes anyone who has been told to take a shot of adrenaline or others who have dangerous allergic reactions.

“The MHRA has advised as a precaution that people with a significant history of allergic reactions should not receive this vaccine after two individuals with a history of significant allergic reactions have responded negatively yesterday, as is common in new vaccines,” said Professor Stephen Bowis, director of the NHS in the UK. Are coming. “

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The Medical Regulatory Agency also said that vaccinations should not be given in facilities that do not have resuscitation equipment.

Pfizer and Bioendech said they were working with investigators to “better understand each case and its reasons.”

Tests on late vaccination have been reported by companies as “no serious safety concerns”. More than 42,000 people received two dose shots during those trials.

“In the main phase three clinical trials, the vaccine was generally well tolerated by an independent data monitoring group without any serious safety concerns,” the companies said.

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Documents released by both companies showed that people with a history of severe allergic reactions were excluded from the tests, and physicians were instructed to observe similar reactions in test participants who were previously known to have severe allergic reactions.

Even in emergencies, health officials need to keep a close eye on new vaccines and medications because studies conducted on tens of thousands of people cannot detect a rare risk that affects 1 in 1 million people.

Dr. Peter Openshaw, an experimental medical professor at Imperial College London, said there was a “very small” chance of an allergic reaction to any vaccine.

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The MHRA last week gave emergency recognition to the Pfizer-Bioentech vaccine, making Britain the first country to allow its widespread use.

The UK launched its mass vaccination program on Tuesday, delivering the shot to people over the age of 80, nursing home staff and some NHS workers. It is unknown at this time what he will do after leaving the post.

As part of its urgent recognition of the vaccine, it requires health workers to report any adverse reactions that may help regulators gather additional information about safety and efficacy.

The agency is closely monitoring the vaccine roll, “he said, adding that” these cases will now be examined in detail to understand whether allergic reactions are linked to the vaccine or coincidental. ” “The fact that we’re soon aware of these two allergic reactions and that the regulator has acted on them to provide precautionary advice shows that this monitoring system is working better.”

Dr. Jun Raine, chairman of the Medical Regulatory Commission, told a parliamentary committee about the reactions during a previously scheduled testimony about the epidemic.

“We know from very detailed clinical trials that this is not a feature of the vaccine,” he said. “But if we want to strengthen our advice, we now have this experience in vulnerable people, preferably in selected groups, and we get that advice on the field immediately.”