Video report by ITV News Health Editor Emily Morgan
People with a history of "significant" allergic reactions have been warned not to currently receive the Pfizer/BioNTech Covid-19 vaccine after two people who had the jab on Tuesday had allergic reactions.
Two NHS staff members who received the jab on the first day of the mass vaccination programme suffered an allergic reaction, NHS England has confirmed. Both are recovering, it is understood. NHS England said all trusts involved with the vaccination programme have been informed. It is understood that both the staff members had a significant history of allergic reactions - to the extent where they need to carry an adrenaline auto injector with them. They developed symptoms of "anaphylactoid reaction" shortly after receiving the vaccine and both have recovered after the appropriate treatment.
The Medicines and Healthcare products Regulatory Agency (MHRA) has given precautionary advice to NHS trusts that anyone who has a history of "significant" allergic reactions to medicines, food or vaccines should not receive the vaccine.
Professor Stephen Powis, national medical director for the NHS in 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. Both are recovering well."
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Pfizer said the vaccine was "well tolerated" during the trials with "no serious safety concerns".
A spokeswoman 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."
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Chief executive of the MHRA, Dr June Raine said that careful plans had been made for "real-time vigilance" when monitoring side effects from vaccinations and that any updates to advice for patients would be communicated "immediately".
Appearing at the Commons Science and Technology Committee on Wednesday, she said regulators had been aware that two people who had received the vaccination had experienced allergic reactions.
"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," she said. "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."
The Pfizer vaccine rollout continued across the country on Tuesday, with some elderly care home residents in Northern Ireland given the jab - despite delays in accessing the vaccine for those living in care in England, Wales, and Scotland.
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ITV News understands Northern Ireland's Department of Health has reached an agreement with the UK's vaccinations regulator the MHRA to allow rollout in care homes.
Elderly care homes had been top of the priority list across the UK to receive the vaccine, but this was revised after issues with storing and transporting the jab which needs to be kept at ultra low temperatures.