People who have had serious allergic reactions in the past should not receive the COVID-19 vaccine developed by Pfizer and BioNTech, British health regulators have warned after two reactions were recorded on the first day of the UK’s much-heralded vaccination program.
Trials of the vaccine did not find any serious safety concerns, yet two of the thousands who received the shot yesterday suffered allergic reactions.
The British medical regulator, Medicines and Healthcare products Regulatory Agency, said the updated advice applies to those who have had significant allergic reactions to medicines, food or vaccines, such as those who have been told to carry an adrenaline shot or who have had potentially fatal allergic reactions.
The medical director of Britain’s National Health Service says both patients have recovered, and both had histories of serious allergies and carried adrenaline pens.
The new advice is being given on a “precautionary basis”, according to a report from the ABC.
Both Pfizer and BioNTech, the developers of the vaccine, say they are working with investigators to better understand what occurred.
The regulator also said vaccinations should be carried out only in facilities where resuscitation equipment is available
Professor Stephen Powis, medical director of the NHS, said it was “common” with new vaccines to issue such a warning, according to a report from the BBC.
It is also common practice for doctors to be on the alert for reactions to medication or vaccines, especially when they are being taken for the first time.
Several vaccines already in circulation also carry warnings about allergic reactions, the ABC has reported.
Several thousand people were vaccinated on Tuesday, although the exact numbers have not been released, as the vaccine is rolled out in hospitals around Britain, targeting those over 80, nursing home staff and selected healthcare workers.
Prof Peter Openshaw, an expert in immunology at Imperial College London, said, “The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well,” the BBC has reported.
“Two people, out of thousands vaccinated yesterday, had an allergic reaction which they recovered from,” wrote James Gallagher, the BBC’s health and science correspondent.
“Such reactions can happen with any vaccine and are treated with drugs such as steroids or adrenaline.
“The MHRA has given targeted advice to those most at risk, but for the overwhelming majority of people, this changes nothing.”
Britain has struggled to contain COVID-19. The virus has caused 1.7 million people to become infected and killed more than 62,000.
Data from the vaccine’s trials showed potential allergic reactions in 0.63 per cent of those who received the vaccine, compared with 0.51 per cent of those who received the placebo, the ABC has reported.
