A nurse holds a phial of the Pfizer-BioNTech COVID-19 vaccine at Guy’s Hospital in London, Tuesday, Dec. 8, 2020, as the U.K. health authorities rolled out a national mass vaccination program. U.K. regulators said Wednesday Dec. 9, 2020, that people who have a “significant history’’ of allergic reactions shouldn’t receive the new Pfizer/BioNTech vaccine while they investigate two adverse reactions that occurred on the first day of the country’s mass vaccination program. (AP Photo/Frank Augstein, Pool)

A nurse holds a phial of the Pfizer-BioNTech COVID-19 vaccine at Guy’s Hospital in London, Tuesday, Dec. 8, 2020, as the U.K. health authorities rolled out a national mass vaccination program. U.K. regulators said Wednesday Dec. 9, 2020, that people who have a “significant history’’ of allergic reactions shouldn’t receive the new Pfizer/BioNTech vaccine while they investigate two adverse reactions that occurred on the first day of the country’s mass vaccination program. (AP Photo/Frank Augstein, Pool)

UK probing if allergic reactions linked to Pfizer vaccine

Pfizer and BioNTech said they were working with investigators ‘to better understand each case and its causes’

Britain’s medical regulator warned Wednesday that people with a history of serious allergic reactions shouldn’t receive the COVID-19 vaccine from Pfizer and BioNTech as investigators look into whether two reactions on the first day of the country’s vaccination program were linked to the shot.

Professor Stephen Powis, medical director for National Health Service in England, said the advice was issued on a “precautionary basis” and that the people who had reactions had recovered.

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

In the meantime, the Medical and Healthcare Products Regulatory Agency has said people should not received the vaccine if they have had a significant allergic reaction to a vaccine, medicine or food, such as those who have been told to carry an adrenaline shot — such as an EpiPen — or others who have had potentially fatal allergic reactions. The medical regulator also said vaccinations should be carried out only in facilities that have resuscitation equipment.

WATCH: 90-year-old woman receives UK’s 1st COVID-19 vaccine dose

Such advice isn’t uncommon; several vaccines already on the market carry warnings about allergic reactions, and doctors know to watch for them when people who’ve had reactions to drugs or vaccines in the past are given new products.

The two people who reported reactions were NHS staff members who had a history of significant allergies and carried adrenaline shots. Both had serious reactions, but recovered after treatment, the NHS said.

Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said the regulator had done the right thing, but the general public shouldn’t be worried about getting the vaccine.

“For the general population, this does not mean that they would need to be anxious about receiving the vaccination,” he said. “One has to remember that even things like marmite can cause unexpected severe allergic reactions.”

The warning comes just a day after Britain rolled out its mass vaccination program amid efforts to control a pandemic that has killed more than 62,000 people across the country. The MHRA gave an emergency authorization to the Pfizer-BioNtech vaccine last week, making Britain the first country to approve its widespread use. Canada’s regulator authorized the vaccine Wednesday.

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. Authorities have not said how many people have received the shot in Britain so far, but they plan to give 800,000 doses in the first phase, which will target people over 80, nursing home staff and some NHS workers.

Late-stage trials of the vaccine found “no serious safety concerns,” Pfizer and BioNTech said. More than 42,000 people have received two doses of the shot during those trials.

Detailed data from the vaccine’s trials showed potential allergic reactions in 0.63% of those who received the vaccine, compared with 0.51% of those who received the placebo. Reviewers from the U.S. Food and Drug Administration called this a “slight numerical imbalance.”

Documents published by the two companies showed that people with a history of severe allergic reactions were excluded from the trials, and doctors were advised to look out for such reactions in trial participants who weren’t previously known to have severe allergies.

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 about safety and effectiveness.

The agency is monitoring the vaccine rollout closely and “will now investigate these cases in more detail to understand if the allergic reactions were linked to the vaccine or were incidental,” Powis said. “The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well.”

Dr. June Raine, head of the medical regulatory agency, informed a Parliamentary committee about the reactions during previously scheduled testimony on the pandemic.

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

Danica Kirka, The Associated Press

Like us on Facebook and follow us on Twitter.

Want to support local journalism? Make a donation here.

Coronavirus

Get local stories you won't find anywhere else right to your inbox.
Sign up here

Just Posted

Residents in the past have protested trees being cut in areas in Qualicum Beach. (PQB News file photo)
Concern raised over trees to be cut at Qualicum Beach’s new public works location

Coun. Westbroek wants council to discuss tree-planting initiative

A B.C. Centre for Disease Control map shows new COVID-19 cases by local health area for the week of April 11-17. (BCCDC image)
BCCDC says fresh COVID-19 cases down in most Island Health areas

Nanaimo sees its fewest new COVID-19 cases since mid January

Pharmacist Barbara Violo arranges empty vials of the Oxford-AstraZeneca COVID-19 vaccine that she has provided to customers at the Junction Chemist, an independent pharmacy in Toronto, Monday, April 19, 2021. Younger Canadians in several provinces are now able to get the AstraZeneca vaccine. THE CANADIAN PRESS/Nathan Denette
AstraZeneca vaccine appointments fill up fast on Vancouver Island

More pharmacies expected to be added as supply increases

Canadian Prime Minister Justin Trudeau and United States President Joe Biden smile as they say farewell following a virtual joint statement in Ottawa, Tuesday, February 23, 2021. THE CANADIAN PRESS/Adrian Wyld
Trudeau pledges to cut emissions by 40% to 45% by 2030, short of U.S. goal

Trudeau announced target during a virtual climate summit convened by U.S. President Joe Biden

Minister of Public Safety and Solicitor General Mike Farnworth speaks to media at the Legislature in Victoria, B.C., on Monday February 5, 2018. Farnworth says the government will release details of what is considered essential travel later in the week where the province is considering using roadblocks to limit the spread of COVID-19. THE CANADIAN PRESS/Chad Hipolito
B.C. officials to announce travel restrictions today to limit COVID-19 spread

Mike Farnworth is expected to give details of what the government views as essential travel

Richard Desautel with supporters outside the courthouse in Nelson, B.C., in 2016. Photo: Bill Metcalfe
BREAKING: Sinixt, First Nation bordering Canada-U.S., can claim Indigenous rights, top court rules

The decision essentially reverses a 1956 declaration the Sinixt were extinct

MLA Shirley Bond, right, answers questions during a press conference at Legislature in Victoria, B.C., on February 19, 2019. THE CANADIAN PRESS/Chad Hipolito
Former B.C. gaming minister says she wasn’t told directly about dirty cash flowing to casinos

Shirley Bond said Thursday civil forfeiture, gang violence and gambling addiction were also major concerns in 2011

RCMP Constable Etsell speaks to tourists leaving the area at a police roadblock on Westside Road south of Fintry, B.C., Thursday, July 23, 2009. THE CANADIAN PRESS/ Yvonne Berg
B.C. police say they take ‘exception’ to conducting roadblocks limiting travel

Asking the police to enforce roadblocks exposes officers to further risk and possible COVID-19 infections, says federation president Brian Sauve

As part of the province’s strategy to combat the opioid overdose crisis, take-home naloxone kits have been distributed throughout the province. (Courtesy of Gaëlle Nicolussi)
Vancouver Island could be at its worst point of overdose crises yet: medical health officer

Island Health issued overdose advisories for Victoria, various communities in the last two weeks

The conservation service confirmed they do not relocate cougars from settled areas but that euthanasia is not necessarily the fate for an animal in the Fanny Bay area. The hope is that the animal will move on to wild areas. (File photo)
Woman hopes cat-stalking Fanny Bay cougar can avoid euthanization

Conservation officers do not relocate the animals from Vancouver Island

Tofino residents expressed frustration over a recent post by Long Beach Lodge owner Tim Hackett that falsely claimed all residents have been vaccinated. (Westerly file photo)
Resort owner apologizes for suggesting Tofino is safe to travel to

Long Beach Lodge owner Tim Hackett apologizes to community and visitors

BC Hydro released a survey Thursday, April 22. It found that many British Columbians are unintentionally contributing to climate change with their yard maintenance choices. (Pixabay)
Spend a lot of time doing yard work? It might be contributing to climate change

Recent BC Hydro survey finds 60% of homeowners still use gas-powered lawnmowers and yard equipment

Most Read