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

Skeena MLA Ellis Ross. (Photo by Peter Versteege)
BC Liberal leadership candidate condemns ‘senseless violence’ of Okanagan church fires

Skeena MLA Ellis Ross says reconciliation isn’t about revenge for past tragedies

(Black Press file photo)
EDITORIAL: Curtailing attempts at scams

The true total of losses from all scams and frauds could be much higher than the figures on file

Penticton Indian Band Chief Greg Gabriel speaks to the Sacred Hearts Catholic Church burning down early Monday morning, June 21, 2021. (Monique Tamminga Western News)
Penticton band chief condemns suspicious burning of 2 Catholic churches

Both Catholic church fires are deemed suspicious, says RCMP

(Drive BC photo)
Vehicle incident closes Highway 3 east of Osoyoos

Drive BC says to avoid the area until the road is clear

Osoyoos chef Murray McDonald was ecstatic upon realizing he scored the $1 million guaranteed prize in the June 2, 2021 Lotto 6/49 draw. (Contributed)
Osoyoos chef ecstatic after bagging $1 million Lotto 6/49 win

Chef Murray McDonald was at home and ready to doze off to sleep when he got a text from his wife

The border crossing into the United States is seen during the COVID-19 pandemic in Lacolle, Que. on February 12, 2021. THE CANADIAN PRESS/Paul Chiasson
VIDEO: Border quarantine to soon lift for fully vaccinated Canadians

Eligible travellers must still take multiple COVID-19 tests

Chilliwack secondary school’s principal is apologizing after a quote equating graduation with the end of slavery in the U.S. was included in the 2020-2021 yearbook. (Screenshot from submitted SnapChat)
B.C. student’s yearbook quote equates grad to end of slavery; principal cites editing error

Black former student ‘disgusted’ as CSS principal apologizes for what is called an editing error

A coroner’s inquest will be taking place at the Capitol Theatre in Port Alberni for the next week. (ELENA RARDON / ALBERNI VALLEY NEWS)
Teen B.C. mom who died following police custody recalled as ‘friend to many’

Police sent Jocelyn George to hospital after intoxication had gone ‘beyond the realm’ of normal detox

FILE - In this Nov. 29, 2020, file photo, Las Vegas Raiders defensive end Carl Nassib leaves the field after an NFL football game against the Atlanta Falcons in Atlanta. Nassib on Monday, June 21, 2021, became the first active NFL player to come out as gay. Nassib announced the news on Instagram, saying he was not doing it for the attention but because “I just think that representation and visibility are so important.” (AP Photo/John Bazemore, File)
Nassib becomes first active NFL player to come out as gay

More than a dozen NFL players have come out as gay after their careers were over

Photograph By MICHAEL POTESTIO.KTW
Former Kamloops security gaurd wants job back after kicking incident caught on video

Rick Eldridge quit when a video surfaced of him kicking a man outside a facility for homeless

People participated in a walk to honour the 215 children found at a former Kamloops residential school, as well as residential school survivors. (Twila Amato/Black Press Media)
Kelowna marks National Indigenous Peoples’ Day with walk to remember Kamloops 215

“Let’s speak the truth and deal with the truth, and heal.”

COVID-19 daily cases reported to B.C. public health, seven-day moving average to June 17, 2021. (B.C. Centre for Disease Control)
B.C.’s COVID-19 infections drop to 90 on Sunday, 45 Monday

Pandemic spread dwindles as 77% of adults receive vaccine

A home on Cameo Drive sustained major damage due to an early morning fire Monday, June 21. (Roger Knox - Morning Star)
UPDATE: Fire sparked during Vernon home renovation

Heavy black smoke from Cameo Drive home, no one inside

The new Civic Memorial Park will incorporate pieces of the 80-year-old arena it replaces. (Artists rendering)
Pieces of Civic Arena reclaimed for new Vernon park

City centre space to incorporate wood from the historic arena

Most Read