Those with a history of “significant” allergic reactions have been told not to take the Pfizer/BioNTech Covid vaccine following two allergic reactions.
Those with a history of “significant” allergic reactions have been told not to take the Pfizer/BioNTech Covid vaccine following two NHS workers’ allergic reactions.
Two reactions to Covid vaccine
NHS England confirmed that two staff members who received jabs on Tuesday suffered an allergic reaction.
Both staff members have a significant history of allergic reactions and carry an adrenaline auto-injector with them. Both went into anaphylactic shock shortly after receiving the vaccine, but both recovered after being treated.
In the aftermath, the Medicines and Healthcare products Regulatory Agency (MHRA) told NHS trusts that anyone who has a history of “significant” allergic reactions to medicines, food or vaccines should not receive the vaccine.
Anyone scheduled to receive the vaccine from now on will be asked about their history of allergic reactions.
National medical director for the NHS in England, Professor Stephen Powis, 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. Both are recovering well.”
Dr June Raine, chief executive of the MHRA, which approved the Pfizer/BioNTech jab, told the Commons Science and Technology Committee:
“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. As an illustration to this, I may share with the committee that even last evening we were looking at two case reports of allergic reaction. We know from the very extensive clinical trials that this wasn’t a feature but if we need to strengthen our advice now that we have had this experience in the vulnerable populations … we will get that advice to the field immediately.”
A Pfizer spokesperson said:
“We have been advised by MHRA of two yellow card reports that may be associated with allergic reaction due to administration of the Covid-19 BNT162b2 vaccine. 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 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.”
The yellow card scheme is the system for collecting and monitoring information on suspected safety concerns or incidents involving medicines and medical devices. The MHRA advice 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 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.”