MHRA warns patients with history of significant allergic reactions not to receive Pfizer/BioNTech COVID-19 vaccine

pharmafile | December 9, 2020 | News story | Research and Development COVID-19, MHRA, UK, Vaccine 

While the rolling out of Pfizer and BioNTech’s COVID-19 in the UK this week marked a historic moment in a year dominated by the pandemic, reports of allergic reactions to the injection have prompted warnings over what populations may be unsafe to receive it.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which approved the vaccine for emergency use last week, issued precautionary advice to NHS trusts after two workers for the health service had an “anaphylactoid reaction” to the therapy.

“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,” the MHRA said in a statement. “Pfizer and BioNTech are supporting the MHRA in the investigation.”

The advice stated: “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 auto-injector) should not receive the Pfizer/BioNtech vaccine. Resuscitation facilities should be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available.”

Both affected NHS workers fall into this group, each having a history of allergic reactions that require them to carry an adrenaline auto-injector. Both have received appropriate treatment for their reactions and both are said to be “recovering well”.   

Pfizer also stepped in to defend its product, stressing the robustness of the clinical testing it had been put through pre-approval: “In the pivotal phase three clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee. The trial has enrolled over 44,000 participants to date, over 42,000 of whom have received a second vaccination.”

Dr June Raine, Chief Executive at the MHRA, stressed that the agency’s work will continue to evaluate the vaccine’s safety as it is rolled out: “Now that we’ve had this experience in the vulnerable populations – the groups that have been selected as a priority – we [will] get that advice to the field immediately”, adding: “The role is before, during and after and there is a true end to end – looking from the scientific laboratory bench through to the patient who yesterday first received the vaccine.”

Matt Fellows

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