People with history of significant allergic reactions ‘should not receive vaccine’
THE UK’S drug regulator has warned that people with a history of “significant” allergic reactions should not receive the Pfizer-biontech vaccine.
The Medicines and Healthcare products Regulatory Agency (MHRA) issued the warning after two NHS staff members who were given doses on Tuesday both suffered an allergic reaction.
NHS England said all trusts involved with the vaccination programme have been informed.
Dr June Raine, chief executive of the MHRA, said the regulatory body was examining the cases.
“We know from the very extensive clinical trials this wasn’t a feature,” she told a parliamentary committee yesterday.
“But if we need to strengthen our advice now that we’ve had this experience in the vulnerable populations — the groups that have been selected as a priority — we get that advice to the field immediately.”
The two NHS staff members, who are understood to have a “strong past history of allergic reactions” and carry an adrenaline auto-injector with them, both recovered after receiving the appropriate treatment. In an NHS email sent out to medical directors on Tuesday evening, authorities said they were “seeking further information and will issue further advice following investigation”.
It remains unclear what element of the vaccine the two staff members were allergic to, while it is understood that officials were not aware this would be an issue.
Professor Stephen Powis, national medical director for NHS 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.”
This means t hat a nyone scheduled to receive the vaccine will now be asked about their history of allergic reactions.
According to Pfizer’s clinical trial protocol, people with a “history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study interventions” were not allowed to take part in the testing. Peter Openshaw, professor of experimental medicine at Imperial College London, said: “As with all food and medications, there is a very small chance of an allergic reaction to any vaccine. However, it is important that we put this risk in perspective.”
He pointed to trial data published by the US Food and Drug Administration earlier this week which showed that a “very small number” of allergic reactions had been reported by researchers.
Prof Openshaw said t he MHRA would investigate Tuesday’s cases to understand if the allergic reactions were linked to the vaccine or were incidental.
A Pfizer spokesperson said: “As a precautionary measure, the MHRA has issued temporary guidance to the NHS while it conducts an investigation in order to fully understand each case and its causes.
“Pfizer and Biontech are supporting the MHRA in the investigation. In the pivotal phase three clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported.”
‘There is a small risk of allergic reaction to vaccine’