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 worker is seen throwing a chicken in an undercover video in 2017 filmed by California-based animal rights activists Mercy For Animals.
Fraser Valley chicken abuse trial delayed until February

Originally scheduled for a jury trial, Sofina and Chilliwack company now face judge alone

Sheriff Avory Chapman was last seen Jan. 20 on Wellington Avenue in Chilliwack. (RCMP)
RCMP look for missing man last seen in downtown Chilliwack

21-year-old Sheriff Avory Chapman has been missing since Jan. 20

Chilliwack Law Courts. (Black Press file)
Man sentenced to 20 months for sexual interference in Mission

Will Laws Clark was 22 and victim was 13 at time offences began

Abbotsford youngster Hudson Poittris is hoping to raise money to provide students at his school friendship bracelets. (Submitted)
VIDEO: Abbotsford youth launches GoFundMe for friendship bracelets

Hudson Poittris, nine, hopes bracelets will increase inclusivity and kindness

Menno Place. (Google Street View image.)
COVID-19 outbreak declared over at Menno Home in Abbotsford

Long-term care home had 67 cases and 13 deaths since mid-November

Rose Sawka, 91, waves to her son through the window of a care home in Prince Rupert in October. Residents of the care home received their first vaccine dose Jan. 20. (K-J Millar/The Northern View)
B.C. care home visitor access to expand by March, Dix says

Staff, residents, essential visitors top priorities for vaccine

(AP Photo/Elaine Thompson, File)
16% boom predicted for B.C. real estate sales in 2021: experts

Along with sales, the average price of homes is also predicted to rise, by nearly 8 percent

The trial of Harry Richardson began Monday at the Nelson courthouse. File photo
Trial of man accused of shooting RCMP officer in West Kootenay in 2019 begins

Harry Richardson is facing five charges in a Nelson courtroom

FILE – Canadian Prime Minister Justin Trudeau delivers his opening remarks at a news conference outside Rideau cottage in Ottawa, Tuesday, January 19, 2021. THE CANADIAN PRESS/Adrian Wyld
Vaccine CEO ‘very, very clear’ that Canada’s contracts will be honoured: Trudeau

Trudeau says he spoke to Moderna CEO on the morning of Jan. 26

Brad Windsor has been an advocate for years to get sidewalks installed along Milburn Drive in Colwood, but to no avail. He wants city council to commit to making Milburn a priority lane for sidewalk construction in the future. (Aaron Guillen/News Staff)
VIDEO: Dramatic crash caught on B.C. home security camera

Angry residents say video highlights need for sidewalks in B.C. residential neighbourhood

An independent review is underway at the Royal BC Museum after employees called out systemic, individual racism at the institution. (Twitter/RBCM)
Royal BC Museum faces allegations of systemic racism, toxic work environment

Formal investigation, survey and training launched at museum

In this May 23, 2012, file photo, an approximately 2-year-old female cougar runs away from a Washington Department of Fish and Wildlife trap after being released northeast of Arlington, Wash. A cougar has attacked and severely mauled a man in British Columbia. THE CANADIAN PRESS/AP-Mark Mulligan/The Daily Herald via AP
Cougar euthanized in B.C. after severely mauling a man north of Vancouver

Whistler RCMP officers were first on the scene and shot and killed a cougar prowling nearby

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

The SACH Community Hub team, from left to right: Upkar Singh Tatlay, Gary Thandi, Allysha Ram, Jassy Pandher, Harman Pander. (Submitted photo)
There’s help for South Asian men wrestling with drug addiction in Surrey

South Asian deaths related to toxic drugs increased by 255 per cent between 2015 and 2018

Most Read