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

Just Posted

Oak Bay police issued these surveillance images after a theft from the Cork & Barrel liquor store. The bottle of stolen whisky was valued at $4,636.99. (Courtesy Oak Bay Police Department)
Suspect swipes $5,000 bottle of whisky from Oak Bay liquor shop

Fiat towed after driver fails field sobriety test

(Black Press Media file photo)
University of Victoria clears parking hurdle for new Indigenous laws building

Oak Bay approves parking variance for new National Centre for Indigenous Laws

Victoria police found and returned this tricycle to a local graphics company after it was reported stolen in downtown Victoria last week. (Photo courtesy of VicPD)
UPDATE: Police find stolen tricycle, return it to Victoria company

The three-wheeler was taken from the 2100-block of Store Street on June 17

Mieran Loira, who works at Moxie’s restaurant on Yates Street, was named a winner in the BC Restaurant and Foodservices Association’s #StandUpForService campaign. (Courtesy Town Hall Brands)
Victoria Moxies server can’t hide her smile, earns provincial kudos for pandemic work

Personality, charisma shine despite masks, coronavirus challenges

Swanwick Ranch in Metchosin, featuring an award-winning home on 67 acres of property overlooking the ocean, recently sold for a record-setting, yet undisclosed amount. (Sotheby’s International Realty Canada photo)
Sale of oceanfront property in Metchosin yields new record for Greater Victoria

Listed at $14.1 million, Swanwick Ranch sold to an undisclosed buyer

A person stands in a tower on the perimeter of the Number 3 Detention Center in Dabancheng in western China’s Xinjiang Uyghur Autonomous Region on April 23, 2021. Human rights groups and Western nations led by the United States, Britain and Germany accused China of massive crimes against the Uyghur minority and demanded unimpeded access for U.N. experts at a virtual meeting on Wednesday, May 12, 2021 denounced by China as “politically motivated” and based on “lies.” THE CANADIAN PRESS/AP-Mark Schiefelbein
VIDEO: Trudeau demands truth from China about Uyghurs

PM says Canada has admitted broken Indigenous relationship, unlike China on Uyghurs

CELEBRATING INDIGENOUS PEOPLES DAY
Council members and witnesses from the Hupacasath First Nation, left, and Tseshaht First Nation, right, prepare to raise their respective flags in front of Port Alberni City Hall on Monday, June 21, 2021. The flags will permanently fly as part of the city’s reconciliation work. See more coverage from the flag raising ceremony on page A5. (SUSAN QUINN/ Alberni Valley News)
Vancouver Island First Nations flags to fly permanently at city hall

Addition of flags are one Port Alberni response to reconciliation

Kelowna Mayor Colin Basran, middle right, participates in a ribbon-cutting ceremony in honour of the launch of Kelowna’s plasma donor centre at Orchard Plaza Mall on June 22. From left to right: Canadian Blood Services’ business development manager Janna Pantella, Canadian Blood Services’ operational excellence manager Tyler Burke, Kelowna Mayor Colin Basran and Canadian Blood Services’ centre manager Janine Johns. (Aaron Hemens/Capital News)
B.C.’s first dedicated plasma donor centre opens in Kelowna

The Kelowna location is the third dedicated plasma donor to open in Canada

Children walk with their parents to Sherwood Park Elementary in North Vancouver for the first day back to school on Sept. 10, 2020. THE CANADIAN PRESS/Jonathan Hayward
Study reassures parents, teachers that COVID-19 infrequently shared at school

Federally funded study in Vancouver finds risk in the classroom and in the community identical

Conservative MP Kevin Waugh rises during Question Period in the House of Commons Tuesday April 13, 2021 in Ottawa. THE CANADIAN PRESS/Adrian Wyld
Single-game sports betting about to become legal in Canada

Senate passes bill to take sports gambling away from overseas agencies

Point Roberts is part of the mainland United States but not physically connected to it, to reach the community by land one must pass through Canada. THE CANADIAN PRESS/Darryl Dyck
Closed Canadian border leaves Point Roberts’ only grocery store on verge of closure

‘We’re Americans but we’re not attached to America. It’s easy to forget we’re here,’ says owner Ali Hayton

The Somass Sawmill sits idle in early May 2021. While the kilns have been in use occasionally, and the lot has been used to store woodchips this spring, the mill has been curtailed since July 27, 2017. (SUSAN QUINN/ Alberni Valley News)
Port Alberni to expropriate Somass Sawmill from Western Forest Products

Sawmill has been ‘indefinitely’ curtailed since 2017

Robin Sanford and her fiance Simon Park were married in an impromptu ceremony at Abbotsford Regional Hospital on June 16. (Submitted photo)
Mom dies day after witnessing daughter’s hospital wedding in Abbotsford

Nurses help arrange impromptu ceremony in 3 hours for bride and groom

B.C. Finance Minister Selina Robinson with Premier John Horgan after the budget speech Tuesday, April 20, 2021. THE CANADIAN PRESS/Chad Hipolito
B.C. home owner grant won’t be altered, despite expert advice

Tax break for residences worth up to $1.6 million too popular

Most Read