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

The concept design for the spray park and playground in Pogadl Park. (Photo Courtesy of Canadian Recreation Solutions)
Sylvan Lake spray park tentatively scheduled to open next year

Sylvan Lake Town Council approved the tender of the spray park and playground in Pogadl Park

Alberta's chief medical officer of health Dr. Deena Hinshaw says Albertans need to keep making safe choices to start bending the curve back down. (Photo by Chris Schwarz/Government of Alberta)
One new COVID-19 death in Red Deer, 257 additional cases province-wide

Red Deer sits at 459 active cases of the virus

One of the oil paintings stolen from a season home near the boat launch on Kuusamo Krest. (Photo Submitted)
Sylvan Lake RCMP search for paintings stolen from vacation home

Three original paintings were reportedly stolen from a seasonal home

A lone skater practises his shot on a melting outdoor rink recently. As of March 2, all outdoor skating rinks, including the ones on the lake, are closed for the season. (Photo Submitted by Town of Sylvan Lake)
All outdoor skating rinks in Sylvan Lake closed for the season

The Town announced Tuesday morning the rinks on the lake were also closed due to the warm weather

A health-care worker looks at a dose of the COVID-19 vaccine at the Palais de Congress site as Quebec begins mass vaccinations based on age across the province, Monday, March 1, 2021 in Montreal.THE CANADIAN PRESS/Ryan Remiorz
Nearly 1 million COVID-19 vaccine doses arriving in Canada this week: Anand

Anita Anand says she’s received assurances from the vaccine manufacturer

A vial of some of the first 500,000 of the two million AstraZeneca COVID-19 vaccine doses that Canada has secured through a deal with the Serum Institute of India in partnership with Verity Pharma at a facility in Milton, Ont., on Wednesday, March 3, 2021. THE CANADIAN PRESS/Carlos Osorio - POOL
Federal panel recommends 4-month gap between COVID vaccine doses due to limited supply

The recommendation applies to all COVID-19 vaccines currently approved in Canada

hands
The call is out in Rimbey to sign on with a group that is all about building connections

‘Already, we are building a network where we can rely on each other and help each other out’

FILE - Dolly Parton arrives at the 61st annual Grammy Awards on Feb. 10, 2019, in Los Angeles. The Grammy-winning singer, actor and humanitarian posted a video on Tuesday, March 2, 2021, of her singing just before getting her COVID-19 vaccine shot. Parton donated $1 million to Vanderbilt University Medical Center in Nashville, Tennessee for coronavirus research. (Photo by Jordan Strauss/Invision/AP, File)
‘Vaccine, vaccine’: Dolly sings ‘Jolene’ rewrite before shot

The Grammy-winning legend turned 75 this year

Deputy Prime Minister and Minister of Finance Chrystia Freeland speaks about the Fiscal update during a news conference in Ottawa, Monday November 30, 2020. THE CANADIAN PRESS/Adrian Wyld
COVID-19: Wage and rent subsidies, lockdown support to be extended until June

Chrystia Freeland says now is not time to lower levels of support

Many rural seniors are having to travel a long way to get vaccinated against COVID-19. Stettler residents are being told to go to Red Deer, Drumheller or Camrose. (Black Press file photo).
Rural central Alberta seniors have to travel far to get vaccines

Stettler residents are being directed to Red Deer, Drumheller or Camrose clinics

Samantha Sharpe, 25, was stabbed to death at Sunchild First Nation on Dec. 12, 2018. Chelsey Lagrelle was sentenced to 4.5 years in prison for manslaughter in a Red Deer courtroom on Tuesday. Photo contributed
Central Alberta woman sentenced to 4 1/2 years for stabbing friend to death in 2018

Chelsey Lagrelle earlier pleaded guilty to stabbing Samantha Sharpe during argument

Calgary police say they received 80 hate crime complaints between January and November 2020. (Pixabay)
‘Racism is a real problem:’ Muslim women fearful following attacks in Edmonton

So far in 2021, three of seven hate-crime-related investigations have involved Somali-Muslim women

Alberta Minister of Health Tyler Shandro speaks during a news conference in Calgary on May 29, 2020. Shandro says Alberta is considering whether to extend the time between COVID-19 vaccine shots to four months. THE CANADIAN PRESS/Jeff McIntosh
Alberta may follow B.C.’s lead on faster rollout of first COVID-19 dose

Tyler Shandro says a committee of COVID-19 experts is analyzing emerging data and a decision is coming

Most Read