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People with a significant history of allergies should not receive the Pfizer / BioNTech coronavirus vaccine, the UK medical regulator said after two NHS staff members experienced an adverse reaction.
June Raine, chief executive of the Medicines and Healthcare Products Regulatory Agency (MHRA), told the UK parliamentary committee that the two people had an allergic reaction shortly after the vaccination and that the regulator was investigating. Both people had a history of severe allergies and carried an adrenaline pen.
“We know from very extensive clinical trials that this was not typical, but if we need to confirm our advice … we will get that advice immediately in the field,” Dr. Raine said.
An allergic reaction to the vaccine is not uncommon and independent scientists have stressed that there is no need for immediate alert.
Professor Stephen Powis, National Medical Director for the NHS in England, said: “As is customary with new vaccines, the MHRA has advised as a precaution that people with a significant allergic reaction will not receive this vaccine in two cases. a history of significant allergic reactions reacted poorly yesterday. “
Professor Powis added that the two NHS workers had recovered well.
Pfizer confirmed a temporary change of control while a probe was flowing. “The MHRA has given us two yellow flat reports that could cause an allergic reaction due to the administration of the Covid-19 BNT162b2 vaccine,” the drugmaker said.
The company said it is supporting MHRA with its partner, BioNTech, in the investigation.
Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said: “For the general public, this does not mean they have to worry about vaccinations … An allergic reaction occurs with many vaccines. perhaps even more often with drugs, so not unexpected. “
Professor Evans added that data from the BioNTech / Pfizer study showed that 0.5 percent of placebo-treated participants experienced an allergic reaction, compared with 0.6 percent of those who received the actual vaccine.
According to Pfizer, Phase 3 clinical trials have shown that the vaccine is “generally well tolerated” without serious safety concerns. More than 44,000 patients took part in the studies, 42,000 of whom received a second blow, he says. However, the study of the companies excluded participants who had “serious vaccine-related side effects in the past”.
The vaccine uses breakthrough mRNA technology and was the first COVID-19 shot to be licensed in Europe or North America earlier this month. It was also approved for use on Wednesday in Canada, where the regulator smoothly reviewed the shot. It has also received regulatory approval in Bahrain.
Data released Tuesday by the U.S. Food and Drug Administration, which is still evaluating the vaccine, showed that they performed well in the experimental participants, regardless of their breed, age, or weight.
In the most detailed public report on the results of the investigations, U.S. regulatory scientists did not raise significant safety concerns. However, the report says there is insufficient evidence of how safe children, pregnant and breastfeeding women, and people with compromised immune systems, such as people living with HIV, are. The most common side effects were pain, tiredness and headache at the injection site.
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