Warning after two NHS workers have allergic reaction to Pfizer/BioNTech Covid vaccine

People with a history of life-threatening allergic reactions to a vaccine or food should not get the Pfizer/BioNTech Covid-19 vaccine, the head of the UK’s medicine regulator has warned, after two NHS workers who received the jab had “adverse" reactions. 

NHS England confirmed that two staff members who were administered doses on Tuesday – on the first day of the mass vaccination programme – suffered an allergic reaction.

Both staff members have a significant history of allergic reactions, to the extent where they need to carry an adrenaline auto-injector with them, it is understood.

They developed symptoms of “anaphylactoid reaction” shortly after receiving the vaccine, but both recovered after the appropriate treatment.

The NHS in England said all trusts involved with the vaccination programme had been informed. This means that anyone scheduled to receive the vaccine will be asked about their history of allergic reactions.

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.”

Dr June Raine , head of the MHRA, which approved the vaccine, said anaphylaxis was a “known … very rare side effect with any vaccine”.

She said a group including experts on allergy and clinical immunology was convened on Wednesday to consider any possible mitigation.

She said: “Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine. A second dose should not be given to anyone who has experienced anaphylaxis following administration of the first dose of this vaccine.

“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.”

On Thursday, Professor David Salisbury, a former Department of Health director of immunisation, said these reactions are only discovered after clinical trials.

“When you do clinical trials, you very often screen out people who might have a reaction,” he told BBC Radio 4’s Today programme.

“So you only discover this sort of event in the surveillance that goes on after the programme runs out.”

He added that adverse reactions happen “of the order of about one in a million doses”.

“Severe adverse reactions, allergic ones to vaccines, do happen but they are very rare,” he told BBC Radio 4’s Today programme.

“They happen of the order of about one in a million doses. And everybody who administers vaccines in this country is trained to deal with them.”

Peter Openshaw, past-president of the British Society for Immunology and professor of experimental medicine at Imperial College London, said it was important to “put the risk in perspective”.

“As with all food and medications, there is a very small chance of an allergic reaction to any vaccinem" he said. 

“However, it is important that we put this risk in perspective. The occurrence of any allergic reaction was one of the factors monitored in the phase three clinical trial of this Pfizer/BioNTech Covid-19 vaccine, the detailed data from which was released yesterday.

“In this, they reported a very small number of allergic reactions in both the vaccine and placebo groups (0.63 per cent and 0.51 per cent).

“Similar to the rollout of all new vaccines and medications, this new Covid-19 vaccine is being monitored closely by the MHRA.

“They will now investigate these cases in more detail to understand if the allergic reactions were linked to the vaccine or were incidental.

“The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well.”

Pfizer said on Tuesday that 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.”

The yellow card scheme is the UK system for collecting and monitoring information on suspected safety concerns or incidents involving medicines and medical devices.

It came as Professor Chris Whitty, chief medical officer for England, told MPs that the NHS and the MHRA are in a “very good position” to pick up issues with any vaccine.

He said that “inevitably you accrue more information over time”.

“The NHS through to the MHRA is in a very good position to make sure that we can pick things up quickly, identifying them, communicate them widely, ensure that we improve practice", he added.

Dr Raine also said that regulators in the US are looking to conclude their review of the vaccine shortly.

“It is my understanding that the Food and Drug Administration will be looking this week to conclude their review, and the European Medicines Agency fairly shortly thereafter,” she said.

Thousands received the vaccine at 70 hospital hubs across the UK on Tuesday – dubbed “V-Day” by Health Secretary Matt Hancock.

Among the health staff, care home workers and elderly who got the jab was 90-year-old Margaret Keenan who said she felt “so privileged” to be the first person in the world given the Pfizer vaccine against Covid-19 outside clinical trials.

Amid the jubilance, Mr Hancock cautioned that the guidance still needs to be followed, as the vaccine is rolled out over the coming months.

He told MPs in the Commons that people must “temper our joy and enthusiasm” at the beginning of the rollout “with the need to keep each other safe”.

He added: “Let’s not blow it since we can see the answer is on the horizon.”

The Government’s chief scientific adviser Sir Patrick Vallance has said the UK is unlikely to get back to a semblance of normality before spring, and that we might still need face masks next winter.