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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, executive director of the Medicines and Health Products Regulatory Agency, or MHRA, told a parliamentary committee that the two people had the allergic reaction shortly after receiving the Covid-19 vaccine and that the regulator was investigating. Both people had a history of severe allergies and were carrying adrenaline pens.
“We know from very large clinical trials that this was not a feature, but we do need to strengthen our advice. . . we sent that advice to the field right away, ”said Dr. Raine, adding that she had discussed the issue with Professor Chris Whitty, England’s chief medical officer, on Tuesday evening.
Professor Stephen Powis, National Medical Director of the NHS in England, said: “As is common with new vaccines, the MHRA has warned as a precaution that people with a significant history of allergic reactions do not receive this vaccine after two people with a The history of major allergic reactions responded negatively yesterday. “
Professor Powis added that the two NHS workers were recovering well.
Pfizer confirmed the temporary change in guidance pending an investigation.
“The MHRA has informed us of two reports of yellow cards that may be associated with an allergic reaction due to the administration of the Covid-19 BNT162b2 vaccine,” the drug manufacturer said.
The company said it was supporting the MHRA in the investigation with its partner BioNTech.
He noted that phase 3 clinical trials showed that the vaccine was “generally well tolerated” without serious safety concerns. More than 44,000 patients have participated in the trials, 42,000 of whom received a second prick, he said. However, the company trial excluded participants with a “history of serious adverse reactions associated with a vaccine.”
The vaccine uses cutting-edge mRNA technology and is the first Covid-19 injection to gain approval for use in Europe or North America.
Data released Tuesday by the US Food and Drug Administration, which is still evaluating the vaccine, showed that it had worked well in trial participants regardless of their race, age or weight.
In what was the most detailed public report yet on the test results, scientists from the US regulator did not raise any significant safety concerns.
However, the report said there was not enough evidence about how safe it was in children, pregnant and lactating women, and people with compromised immune systems, such as those with HIV.
The most common side effects are pain at the injection site, fatigue, and headache. – Copyright The Financial Times Limited 2020
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