The UK medical regulator has advised that individuals with a significant history of allergies should not receive the Pfizer/BioNTech coronavirus vaccine.
The warning follows news that two NHS staff who received the Covid-19 shot this week experienced an allergic reaction shortly afterwards.
The regulator is looking into the two reports of allergic reactions, June Raine, chief executive for the MHRA, said at a UK parliamentary committee.
She said: “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.â€
Dr Raine also revealed that she and Professor Chris Whitty, chief medical officer for England, discussed the issue last night.
Professor 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. Both are recovering well.â€
Pfizer confirmed the temporary change in guidance while a probe was under way.Â
“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.Â
The company said it was supporting the MHRA in the investigation with its partner BioNTech.Â
It noted that phase 3 clinical trials showed the vaccine was “generally well tolerated†with no serious safety concerns. Over 44,000 patients have taken part in trials, 42,000 of whom had received a second jab, it said.Â
The companies’ trial had excluded participants with a “history of severe adverse reaction associated with a vaccineâ€.
