People with a history of significant allergic reactions should not have the Pfizer/BioNTech Covid jab, regulators say.
The UK’s world-first Covid-19 vaccine rollout has hit problems within 24 hours after anyone with a serious allergy to medicines or food was warned not to have the Pfizer jab because two NHS staff fell ill on V-Day.
Both the unnamed healthcare workers, who carried EpiPens, are recovering from anaphylactoid reactions suffered shortly after their injections on the first day of Britain’s biggest ever mass vaccination programme.
This morning the Medicines and Healthcare products Regulatory Agency (MHRA) gave precautionary advice to NHS trusts that anyone who has a history of ‘significant’ allergic reactions should not receive the vaccine.
The number of people set to be barred from having the Pfizer jab is not known, but up to 7million people in Britain have have allergies severe enough to require specialist allergy care, according to the NHS. Around 250,000 people need to carry an EpiPen.
The NHS has said the two workers are ‘recovering well’ and has said a small number of allergy cases like this are ‘common’ when rolling out new vaccines.
It is not known what reaction they suffered, but common and severe reactions include vomiting, swelling or feeling generally unwell.
Professor Stephen Powis, medical director for the NHS in England, said both individuals are recovering well.
“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,” he said.
Dr June Raine, head of the MHRA, said it was only right to take this step now that “we’ve had this experience”.
Reactions like this are uncommon, but do happen with other vaccines, including the annual flu jab.
Similar reactions were not seen in the clinical trials for this drug in which more than 20,000 people were vaccinated, although people with a history of allergic reactions would not have been recruited.
It came hours after Britain’s drug regulator dismissed safety fears over the Pfizer and BioNTech coronavirus vaccine after a report revealed four people in a trial in the US got Bell’s palsy. The condition, which is usually temporary, causes muscles on one side of the face to droop because of nerves not working properly.
Four cases of it were found in a group of 21,720 people who had the Pfizer vaccine in a trial in the US, compared to none among 21,728 people given a placebo vaccine. But this rate of occurrence is no different to how often it would be expected to happen in a random population, the company said.