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

A worker at Wee Geordies Liquor Store held at knifepoint on Wednesday at 3:30 p.m. A female entered the store and grabbed a bottle of liquor and produced a knife and demanded money. She was not located. (Wee Geordies video surveillance screenshot)
VIDEO: Two stores robbed on the same day in Kitimat

The first incident was at 5:45 a.m. and the second incident occurred 3:30 p.m.

Do Your Part Recycling Co is celebrating 15 years of its operation in Terrace this May. (Binny Paul/Terrace Standard)
How a homegrown Terrace business became a vital cog in the regional recycling initiative

Do Your Part Recycling owner Kasey Lewis on how they started 15 years ago

Construction continues on Coast Mountain College’s student residence on May 12, 2021. (Ben Bogstie/Terrace Standard)
VIDEO: Work continues on major projects at Coast Mountain College

Price tag of $35 million set for housing, substantial renovations

Terrace city council gave first and second reading to zoning amendment bylaws for the proposed transload facility located next to Keith Ave. (Image courtesy Hatha Callis, Progressive Ventures Group)
Next inland port public hearings set for June

Terrace council gave first and second reading to establish new zone, rezoning application

Skeena Valley Farmers Market will host Northern Health’s COVID-19 vaccination booth on May 15. ( Skeena Valley Farmers Market/Facebook)
Northern Health to set up COVID-19 vaccine booth at Skeena Valley Farmers Market

The booth will be set up on the south side of the market towards Park Ave. on May 15

Conservation Service Officer Kyle Bueckert holds a gold eagle that was revived from acute rodent poisoning Monday, May 12. Photo: Submitted
‘Obviously, he’s a fighter’: Golden eagle, recovered from poisoning, back in Kootenay wild

CSO Kyle Bueckert released the eagle into the wild Thursday, May 13

Capt. Jenn Casey died in a crash just outside of Kamloops, B.C., on May 17, 2020. (CF Snowbirds)
Snowbirds to honour Capt. Casey, who died in B.C. crash, in 2021 tour

Tour will kick off in Ontario in June before heading west

A pedestrian wearing a mask to curb the spread of COVID-19 is bundled up for the cold weather as snow falls in downtown Vancouver on Saturday, February 13, 2021.THE CANADIAN PRESS/Darryl Dyck
Snow possible in mountain passes as cold front hits southern B.C.

Much of B.C.’s southern interior will see temperatures plunge from highs of 30 C reached over the weekend

A vial of AstraZeneca vaccine is seen at a mass COVID-19 vaccination clinic in Calgary, Alta., Thursday, April 22, 2021. Dr. Ben Chan remembers hearing the preliminary reports back in March of blood clots appearing in a handful of European recipients of the Oxford-AstraZeneca COVID-19 vaccine. THE CANADIAN PRESS/Jeff McIntosh
Science on COVID, VITT constantly changing: A look at how doctors keep up

While VITT can represent challenges as a novel disorder, blood clots themselves are not new

Poached trees that were taken recently on Vancouver Island in the Mount Prevost area near Cowichan, B.C. are shown on Sunday, May 10, 2021. Big trees, small trees, dead trees, softwoods and hardwoods have all become valuable targets of tree poachers in British Columbia as timber prices hit record levels. THE CANADIAN PRESS/Jen Osborne.
Tree poaching from public forests increasing in B.C. as lumber hits record prices

Prices for B.C. softwood lumber reached $1,600 for 1,000 board feet compared with about $300 a year ago

The warm weather means time for a camping trip, or at least an excursion into nature. How much do you know about camps and camping-related facts? (John Arendt - Summerland Review)
QUIZ: Are you ready to go camping?

How many camp and camping-related questions can you answer?

On Friday, May 14 at Meadow Gardens Golf Club in Pitt Meadows, Michael Caan joined a very elite club of golfers who have shot under 60 (Instagram)
Crowds at English Bay were blasted with a large beam of light from an RCMP Air-1 helicopter on Friday, May 14. THE CANADIAN PRESS/Marc Grandmaison
Police enlist RCMP helicopter to disperse thousands crowded on Vancouver beach

On Friday night, police were witness to ‘several thousand people staying well into the evening’

People shop in Chinatown in Vancouver on Friday, February 5, 2021. THE CANADIAN PRESS/Jonathan Hayward
Vancouver community leaders call for action following 717% rise in anti-Asian hate crimes

‘The alarming rise of anti-Asian hate in Canada and south of the border shows Asians have not been fully accepted in North America,’ says Carol Lee

Most Read