Covid caution after two allergy cases
Britain investigates whether Covid-19 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 advicewas issued on a “precautionary basis,” and the people whohad 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 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 thosewhohave been told to carry an adrenaline shot— such as an Epipen or other similar devices— or otherswhohave 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’tuncommon; several vaccines already on the market carry warnings about allergic reactions, and doctorsknowto watch forthemwhenpeople who’ve had reactions to drugs or vaccines in the past are givennewproducts. The two peoplewhoreported reactions were Nhsstaffmemberswhohad ahistory of significant allergies and carried adrenaline shots. Both had serious reactions but recovered after treatment, thenhssaid.
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 toremember that even things like Marmite can cause unexpected severe allergic reactions,” he said. Dr Ashish Jha, dean of the school of public health atbrownuniversity, said he would advise patientswhohave had severe allergic reactions to other medicines or foods to delay vaccination if they can while the two cases in theukare investigated. Hewould extend that advice to peoplewhocarry Epipens.
“The cautionary approach is to say to peoplewhohave had severe reactions to other things, ‘just hold’,” Jha said.
Headded: “There is going to be a deep dive into these two peoplewho 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 monitornewvaccines 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.
Morethan 42,000 people have received two doses of the shot during those trials.
Detailed data from the vaccine’s trials showedpotential allergic reactions in 0.63 per cent of those whoreceived the vaccine, compared with 0.51 per cent of thosewho received the placebo. Reviewers from theusfood and Drug Administration called this a “slight numerical imbalance.”
Documents published by the two companiesshowed that people with ahistory of severe allergic reactions were excluded from the trials, and doctors were advised to look out for such reactions in trial participants whoweren’t previouslyknownto have severe allergies.
Dr June Raine, head of the medical regulatory agency, said:“weknow 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 receiveupto 249,000 doses thismonthand officials expect to start to administer 30,000 doses next weekafter an initial batch is shipped from Belgium tomorrow.
“It is encouraging to see that our mrnavaccine isnowauthorised in Canada. Followingukand Bahrain, it is the third country to approve use of our vaccine within aweek,” said Sean Marett, Biontech’s chief business and chief commercial officer.