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

Bella Coola’s new WildSafeBC co-ordinator, Rae Kokeš, has spent the last 10 years in Africa working in lion, human, conflict, and is a wildlife biologist by trade. (Photo submitted)
From the savannas of Africa to the Bella Coola Valley

New Wildsafe BC coordinator ready to tackle wildlife conflict

Bella Coola Valley Ridge Riders Horse Club board member Annika Granander watches, and participates in the gymkhana Sunday (Photo submitted)
Sunshine and smiles all around Bella Coola Ridge Riders Horse Club gymkhana

The event was the first of the year, with COVID-19 safety precautions in place

A build up of lint in a clothes dryer is believed to have caused a house fire in Alexis Creek Sunday evening, April 4, 2021. (Photo submitted)
Clothing dryer suspected cause of Alexis Creek home fire, owner wants to warn others

Neil Miller is thankful he still has his horses, community support and his life

This will be the second year the Bella Coola Valley Rodeo won’t take place due to the pandemic. (Michael Wigle file photo)
Bella Coola Valley Rodeo cancelled for 2021

Club organizers say next year’s rodeo will be bigger and better than ever

Jose Marchand prepares Pfizer COVID-19 vaccination doses at a mobile clinic for members of First Nations and their partners, in Montreal, Friday, April 30, 2021. The National Advisory Committee on Immunization is coming under fire after contradicting the advice Canadians have been receiving for weeks to take the first vaccine against COVID-19 that they’re offered. THE CANADIAN PRESS/Ryan Remiorz
Trudeau says he is glad he got AstraZeneca, vaccines are only way out of pandemic

‘The most important thing is to get vaccinated with the first vaccine offered to you’

B.C.’s provincial health officer, Dr. Bonnie Henry. THE CANADIAN PRESS/Jonathan Hayward
Dip in COVID-19 cases with 572 newly announced in B.C.

No new deaths have been reported but hospitalized patients are up to 481, with 161 being treated in intensive care

Solar panels on a parking garage at the University of B.C. will be used to separate water into oxygen and hydrogen, the latter captured to supply a vehicle filling station. (UBC video)
UBC parkade project to use solar energy for hydrogen vehicles

Demonstration project gets $5.6M in low-carbon fuel credits

FILE – A student arrives at school as teachers dressed in red participate in a solidarity march to raise awareness about cases of COVID-19 at Ecole Woodward Hill Elementary School, in Surrey, B.C., on Tuesday, February 23, 2021. THE CANADIAN PRESS/Darryl Dyck
B.C. ‘should be able to’ offer 1st dose of COVID vaccine to kids 12+ by end of June: Henry

Health Canada authorized the vaccine for younger teens this morning

Cannabis bought in British Columbia (Ashley Wadhwani/Black Press Media)
Is it time to start thinking about greener ways to package cannabis?

Packaging suppliers are still figuring eco-friendly and affordable packaging options that fit the mandates of Cannabis Regulations

A woman in the Harrison Mills area was attacked by a cougar on Tuesday, May 4. B.C. Conservation Officers killed two male cougars in the area; the attack was determined to be predatory in nature. (File photo)
2 cougars killed following attack on woman in Agassiz area

Attack victim remains in hospital in stable condition

A woman wears a face mask and shield to curb the spread of COVID-19 while walking in North Vancouver, B.C., on Wednesday, January 6, 2021. THE CANADIAN PRESS/Darryl Dyck
B.C. CDC updates info, acknowledging small respiratory droplets can spread COVID-19

Large droplets, not aerosols had been fixture of public health messaging for many months

A picture of Shirley Ann Soosay was rendered from a postmortem photographer and circulated on social media. (DDP graphic)
B.C. genealogist key to naming murder victim in decades-old California cold case

In July 1980, Shirley Ann Soosay was raped and stabbed to death

Most Read