Covid caution after allergy cases
Britain investigates whether coronavirus vaccine caused reactions in health workers
Britain’s medical regulator warned that people with a history of serious allergic reactions shouldn’t get the Covid-19 vaccine from Pfizer and BioNTech, and investigators looked into whether two reactions on the first day of the UK’s vaccination programme were linked to the shot.
The advice was issued on a “precautionary basis,” and the people who had the reactions had recovered, said Professor Stephen Powis, medical director for National Health Service in England.
Pfizer and BioNTech said they were working with investigators “to better understand each case and its causes.”
The companies also said data on their vaccine were “unlawfully accessed” during a cyberattack on the servers of the European Medicines Agency.
The Amsterdam-based agency, which is considering requests for conditional marketing authorisation for several coronavirus vaccines to be used in the European Union, said yesterday that it had been the target of a cyberattack.
The firms added that no BioNTech or Pfizer systems had been breached in connection with the incident and that they were not aware that any study participants had been identified as a result of the data being accessed.
Britain’s Medical and Healthcare Products Regulatory Agency said people should not receive the shot 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 other similar devices — 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.
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. “One has to remember that even things like Marmite can cause unexpected severe allergic reactions,” he said.
Dr Ashish Jha, dean of the school of public health at Brown University, said he would advise patients who have had severe allergic reactions to other medicines or foods to delay vaccination if they can while the two cases in the UK are investigated. He would extend that advice to people who carry EpiPens.
“The cautionary approach is to say to people who have had severe reactions to other things, ‘just hold’,” Jha said.
He added: “There is going to be a deep dive into these two people who got an allergic reaction” to the vaccine.
Britain is the first country to approve the vaccine’s widespread use. Even in nonemergency 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 one in one million.
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 per cent of those who received the vaccine, compared with 0.51 per cent of those who received the placebo. Reviewers from the US 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.
Dr June Raine, head of the medical regulatory agency, said: “We know from the very extensive clinical trials that this wasn’t a feature” of the vaccine.
Canada’s health regulator yesterday approved Pfizer’s vaccine, days ahead of possible approval in the United States, and say it hopes to start giving the shots next week.
Health Canada said the vaccine has received authorisation.
Canada is set to receive up to 249,000 doses this month and officials expect to start to administer 30,000 doses next week after an initial batch is shipped from
Belgium tomorrow.
“It is encouraging to see that our mRNA vaccine is now authorised in
Canada.
Following UK and Bahrain, it is the third country to approve use of our vaccine within a week,” said Sean Marett, BioNTech’s chief business and chief commercial officer.
Israel said it will begin vaccination on December 27.