While it has updated its guidance to include reference to anaphylaxis and allergic reactions, the MHRA re-iterates the vaccine has met safety standards and anaphylaxis is a rare but known side effect with any vaccine. Vaccination in the UK is continuing as scheduled.
Proactively monitoring safety
Yesterday the MHRA (Medicines and Healthcare products Regulatory Agency) convened an Expert Group of the Commission on Human Medicines (CHM), attended by experts in allergy and clinical immunology, to review the three cases which reportedly occurred in health workers who received some of the first doses of the vaccine. The individuals concerned received prompt treatment and are recovering well.
In a statement issued last night, the MHRA updated its guidance for COVID-19 vaccination centres on the management of anaphylaxis, following on from precautionary advice issued on Tuesday.
Any person with a history of immediate-onset anaphylaxis to a vaccine, medicine or food should not receive the Pfizer/BioNTech vaccine, according to the guidance.
A second dose of the Pfizer/BioNTech vaccine should not be given to those who have experienced anaphylaxis to the first dose of Pfizer/BioNTech vaccination.
The guidance also states that vaccine recipients should be monitored for 15 minutes after vaccination, with a longer observation period when indicated after clinical assessment.
A protocol for the management of anaphylaxis and an anaphylaxis pack must always be available whenever the Pfizer/BioNTech vaccine is given. Health professionals overseeing the immunisation service must be trained to recognise and be familiar with techniques for responding to an anaphylactic reaction.
Dr June Raine, chief executive of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said: “Anaphylaxis is a known, although very rare, side effect with any vaccine. Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks.
“Anyone due to receive their vaccine should continue with their appointment and discuss any questions or medical history of serious allergies with the healthcare professional prior to getting the jab.
“You can be completely confident that this vaccine has met the MHRA’s robust standards of safety, quality and effectiveness. The safety data has also been critically assessed by the government’s independent advisory body, the Commission on Human Medicines. No vaccine would be approved unless it meets these stringent standards – on that you can be sure.
“We have in place a robust and proactive safety monitoring strategy for COVID-19 vaccines which allows for rapid, real-time safety monitoring at population level. The fact that these incidents were picked up and reviewed shows that to be the case.
“Members of the public and healthcare professionals are encouraged to report suspected side effects through the Yellow Card scheme. We supplement this form of safety monitoring with analysis of data on national vaccine usage and anonymised GP-based electronic healthcare records, linked to other healthcare data, to proactively monitor safety.”
Pfizer's Phase 3 trial for the vaccine excluded anyone with a history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (such as anaphylaxis).