One day after the UK began inoculating citizens with Pfizer’s COVID-19 vaccine, their drug regulatory agency warned those that have a history of ‘significant’ allergic reactions should not receive the coronavirus vaccine.
The Medicines and Healthcare Products Regulatory Agency — the UK equivalent of the US FDA — updated its guidance to the National Health Service regarding who should receive the vaccine after two members experienced allergic reactions. Both have had a history of anaphylaxis, both carry epinephrine auto-injectors and both are recovering well according to the national medical director for the NHS.
The guidance states:
Any person with a history of a significant allergic reaction to a vaccine, medicine or food (such as previous history of anaphylactoid reaction or those who have been advised to carry an adrenaline autoinjector) should not receive the Pfizer BioNtech vaccine.
Today, Dr June Raine, Chief Executive of the MHRA, said the agency would maintain “real-time vigilance” in testimony before a government select committee:
Even last evening we were looking at two case reports of allergic reactions. We know from the extensive clinical trials that this was not a feature, but if we need to strengthen our advice now that we have had this experience in vulnerable populations, the groups selected as a priority, we get that advice to the field immediately.
An estimated 2 million people in the UK have food allergies and many of them have had severe reactions and carry an epinephrine auto-injector. The guidance excludes them all from receiving this critical vaccine until the regulator is able to quantify the risk to specific factors.
Another COVID vaccine from Moderna has been submitted for consideration by the MHRA and may have an entirely different safety profile regarding allergic reactions once approved and administered.
Both the Pfizer and Moderna COVID vaccines have been submitted to the US Food and Drug Administration for Emergency Use Authorization.
There is a followup to this article entitled Experts Weigh in on the Guidance That Those with a History of Allergic Reactions Avoid the Pfizer Vaccine.