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

A pinniped was attacked by an unseen predator off the shores of Dallas Road Monday night. (Courtesy of Steffani Cameron)
VIDEO: Seal attacked by unseen predator in waters off Dallas Road

Victoria woman captures harrowing footage of what appears to be a seal’s final moments

Firefighters respond to a fire on Heatherly Road in Colwood Jan. 19. (Photo courtesy of View Royal Fire Rescue)
Two people escape injury in Colwood house fire

Heatherly Road fire started on a covered porch

West Shore RCMP are looking for a suspect and their mini van, which crashed into a parked vehicle and home along the 200-block of Island Highway in View Royal on Jan. 18. (Black Press Media file photo)
Driver crashes into parked car and home in View Royal, speeds away: RCMP

Incident took place near 200-block of Island Highway Monday night

In January, six flights with cases of COVID-19 onboard have landed at the Victoria International Airport so far. (Black Press Media file photo)
Two new COVID-19 exposures reported on flights to Victoria

A Jan. 10 flight from Toronto and Jan. 11 flight from Calgary were affected

The Starbucks in Langford’s Westshore Town Centre is one of almost 300 storefronts that the U.S. coffee giant will be shutting across Canada by the end of March. (Google Maps)
Langford’s Westshore Town Centre Starbucks to close permanently

Popular coffee chain to close 300 storefronts across Canada by end of March

Provincial health officer Dr. Bonnie Henry prepares a daily update on the coronavirus pandemic, April 21, 2020. (B.C. Government)
B.C. adjusts COVID-19 vaccine rollout for delivery slowdown

Daily cases decline over weekend, 31 more deaths

The British Columbia Hotel Association (BCHA) sent out a sharply worded release late last week, in which it noted that the Tourism Industry Association of BC recently obtained a ‘legal opinion’ on the matter (Alex Passini photo)
Hotel associations push back against any potential ban on inter-provincial, non-essential travel restrictions

B.C. Premier John Horgan is seeking legal advice on banning non-essential travel

JaHyung Lee, “Canada’s oldest senior” at 110 years old, received his first dose of the COVID-19 vaccine on Thursday, Jan. 14, 2021. He lives at Amenida Seniors Community in Newton. (Submitted photo: Amenida Seniors Community)
COVID rapid tests in long-term care key during vaccine rollout: B.C. care providers

‘Getting kits into the hands of care providers should be a top priority,’ says former Health Minister

Island Health chief medical officer Dr. Richard Stanwick receives a first dose of Pfizer vaccine, Dec. 22, 2020. (B.C. government)
B.C. turns to second doses of COVID-19 vaccine as supplies slow

Pfizer shipments down until February, to be made up in March

B.C.’s Ministry of Advanced Education and Skills Training announced funding to train community mental health workers at four B.C. post-secondary institutions. (Stock photo)
B.C. funding training of mental health workers at four post-secondary institutions

Provincial government says pandemic has intensified need for mental health supports

A health-care worker prepares a dose of the Pfizer-BioNTech COVID-19 vaccine at a UHN COVID-19 vaccine clinic in Toronto on Thursday, January 7, 2021. THE CANADIAN PRESS/Nathan Denette
No Pfizer vaccines arriving in Canada next week; feds still expect 4M doses by end of March

More cases of U.K. variant, South African variant found in Canada

Health-care workers wait in line at a UHN COVID-19 vaccine clinic in Toronto on Thursday, January 7, 2021. THE CANADIAN PRESS/Nathan Denette
Canadians who have had COVID-19 should still get the vaccine, experts say

Pfizer-BioNTech and Moderna vaccines were found to have a 95 per cent efficacy

An empty Peel and Sainte-Catherine street is shown in Montreal, Saturday, Jan. 9, 2021, as the COVID-19 pandemic continues in Canada and around the world. THE CANADIAN PRESS/Graham Hughes
Poll finds strong support for COVID-19 curfews despite doubts about effectiveness

The poll suggests 59 per cent remain somewhat or very afraid of contracting COVID-19

Most Read