The UK investigates whether the COVID-19 vaccine caused an allergic reaction

London (AP) — UK medical regulators warned on Wednesday that people with a history of severe allergic reactions should not be vaccinated with COVID-19 from Pfizer and BioNTech, investigators vaccinated in the UK The two reactions on the first day of the program are linked to the shots.

The advice was issued “preventively” and those who responded recovered, said Professor Stephen Pawis, director of health care at the United Kingdom’s National Health Service.

Pfizer and BioNTech said they are working with investigators “to better understand each case and its causes.”

Also on Wednesday, Canadian health regulators approved the vaccine, which Dr. Supriya Sharma, Health Canada’s chief medical adviser, called it a “significant opportunity.”

Canada will receive up to 249,000 doses this month, and Canadian authorities will begin next week shortly after shipping from Belgium on Friday.

The UK Medicines and Healthcare Products Regulatory Agency should not take injections if they have a serious allergic reaction to a vaccine, drug, or food, such as someone who has been told to give an adrenaline injection such as EpiPen. Stated. Similar devices — or other devices that can cause a fatal allergic reaction. Medical regulators also said vaccination should only be given in facilities equipped with resuscitation equipment.

Such advice is not uncommon. Some vaccines already on the market warn of allergic reactions, and doctors know that people who have responded to drugs or vaccines in the past will be monitored when new products are given. I have.

The two who reported the reaction were NHS staff who had a history of serious allergies and received adrenaline injections. Both responded seriously, according to the NHS, but recovered after treatment.

Stephen Evans, a professor of pharmacoepidemiology at the London School of Economics and Tropical Medicine, said regulators did the right thing, but the general public shouldn’t be worried about vaccination. ..

“For the general public, this does not mean that they need to worry about getting vaccinated. Remember that even things like marmite can cause unexpected and severe allergic reactions. Must be kept, “he said, referring to food spreads made from brewing yeast.

Dr. Ashish Jha, Dean of Public Health at Brown University, postponed vaccination if possible while investigating two cases in the UK for patients with severe allergic reactions to other drugs and foods. He said he would advise him to do so. He extended that advice to those who have EpiPen.

“A careful approach is to say’just wait’to those who have had a serious reaction to something else,” Jha said. “You will sneak deep into these two people who have allergic reactions. I added. vaccine.

He said that vaccines are getting so much attention that “everything that happens all the time will expand. You should discuss it and be honest with people, but put it in the context of people. We should help. ” Understand … Very few people have an allergic reaction to almost any drug. “

Comments came the day after the UK launched its mass vaccination program in an effort to control a pandemic that killed more than 62,000 people nationwide. MHRA last week granted an emergency permit to the Pfizer-BioNTech vaccine, making it the first country in the UK to approve its widespread use.

Even in non-urgent situations, tens of thousands of studies cannot detect the rare risk of affecting 1 in 1 million, so health authorities need to closely monitor new vaccines and drugs. Authorities haven’t said how many people were shot in the UK so far, but 800,000 in the first phase, targeting people over the age of 80, nursing home staff, and some NHS workers. I will give a dose.

Late-stage trials of the vaccine found “no serious safety concerns,” Pfizer and BioNTech said. Over 42,000 people received two shots during these trials.

Detailed data from the vaccine trial showed a potential allergic reaction in 0.63% of those who received the vaccine, compared to 0.51% of those who received the placebo. US Food and Drug Administration reviewers call this a “small numerical imbalance.”

According to documents released by both companies, people with a history of severe allergic reactions will be excluded from the study, and doctors will be aware of such reactions in study participants who are not previously known to have severe allergies. I was advised to do it.

As part of an emergency vaccine permit, MHRA has required healthcare professionals to report side effects so that regulators can collect more information on safety and efficacy.

Authorities are closely monitoring the development of the vaccine and will investigate these cases in more detail to understand whether the allergic reaction was vaccine-related or accidental. “Powis said. “The fact that we quickly learned about these two allergic reactions and that regulators acted on them to issue preventative advice shows that this surveillance system is working well.”

Dr. June Rain, Head of Medical Regulatory Authority, has informed Parliamentary Commission of the reaction during the previously planned pandemic testimony.

“Very extensive clinical trials have shown that this was not a feature of the vaccine,” she said. “But if you need to strengthen your advice, we’ve gained this experience with a vulnerable group of priorities and we’ll give you that advice right away.”

Margaret Keenan, the first vaccinated person in the UK, was discharged from the university hospital Coventry on Wednesday. She had a heart test at the time of firing.

In a statement released by the NHS, a 90-year-old former clerk said, “I feel very good to be able to go home and spend a fulfilling time with my family.”

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Contributed by Associated Press writer Frank Jordan of Berlin, Laurent Neilgard of Alexandria, Virginia, Rob Gillies of Toronto, and David König of Dallas.

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