UK investigates possible allergic reactions to COVID-19 shot

“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,” Powis said in a statement. “Both are recovering well.”

The medical regulatory agency also said vaccinations should not be carried out in facilities that don’t have resuscitation equipment.

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

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 shot during those trials.

“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.

As the UK rolls out its mass Pfizer-BioNTech coronavirus vaccinations, Australia is preparing to do the same early next year. Australia is slated to initially receive 10 million doses, which is enough for 5 million Australians to get a dose and booster shot.

Dr June Raine, head of the MHRA, told a UK Parliamentary committee that regulators had received reports of two allergic reactions from the vaccine.

“We know from the very extensive clinical trials that this wasn’t a feature,” she said. “But if we need to strengthen our advice, now that we have had this experience with the vulnerable populations, the groups who have been selected as a priority, we get that advice to the field immediately.

Raine’s comments came as part of a general discussion of how her agency will continue to monitor people who receive the vaccine authorised for emergency use last week.

The warning on Wednesday came a day after the UK became the first western nation to begin a COVID-19 vaccination program, following approval of the shot last week by the Medicines and Healthcare Products Regulatory Agency.

The UK agency had already warned in its prescribing information that people who are allergic to any ingredients in the vaccine shouldn’t take it. Patients with a history of severe adverse reactions to a vaccine or severe allergic reactions to any component of the treatment were excluded from participating in the large study run by the companies before approval.

Even in non-emergency situations, health authorities must closely monitor new vaccines and medications because studies in tens of thousands of people can’t detect a rare risk that would affect 1 in 1 million.

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

AP, with Bloomberg