People with a significant history of allergies should not receive the Pfizer/BioNTech coronavirus vaccine, the UK medical regulator has said, after two NHS staff experienced an adverse reaction.
June Raine, chief executive for the Medicines and Healthcare products Regulatory Agency or MHRA, told a parliamentary committee that the two individuals had the allergic reaction shortly after receiving the Covid-19 vaccine and that the regulator was investigating. Both people had a history of serious allergies and carried adrenalin pens.
"We know from the very extensive clinical trials that this wasn't a feature but if we need to strengthen our advice . . . we get that advice to the field immediately," Dr Raine said, adding that she had discussed the issue with Prof Chris Whitty, chief medical officer for England, on Tuesday night.
Prof Stephen Powis, national medical director for the NHS in England, said: "As is common with new vaccines, the MHRA have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination after two people with a history of significant allergic reactions responded adversely yesterday. "
Prof Powis added that the two NHS workers were recovering well.
Pfizer confirmed the temporary change in guidance while a probe was under way.
“We have been advised by MHRA of two yellow card reports that may be associated with allergic reaction due to administration of the Covid-19 BNT162b2 vaccine,” said the drugmaker.
The company said it was supporting the MHRA in the investigation with its partner BioNTech.
It noted that phase 3 clinical trials showed the vaccine was “generally well tolerated” with no serious safety concerns. More than 44,000 patients have taken part in trials, 42,000 of whom had received a second jab, it said. However, the companies’ trial had excluded participants with a “history of severe adverse reaction associated with a vaccine”.
The vaccine uses breakthrough mRNA technology and is the first Covid-19 shot to win approval for use in Europe or North America.
Data released on Tuesday by the US Food and Drug Administration, which is still assessing the vaccine, showed that it had worked well on trial participants whatever their race, age or weight.
In what was the most detailed public report yet on the results of the trials, the US regulator’s scientists did not raise any significant concerns about safety.
However, the report said there was not enough evidence about how safe it was in children, pregnant and breastfeeding 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