People with a “significant history of allergic reactions” should not be given the Pfizer/BioNTech coronavirus vaccine, UK health authorities said Wednesday, after two health care workers experienced symptoms after receiving a shot the day before.
The precautionary advice was given after the pair “responded adversely” following their shots on the first day of the mass vaccination rollout in the UK, National Health Service England said Wednesday.
The two staff members — who both carried an adrenaline auto injector and had a history of allergic reactions — developed symptoms of anaphylactoid reaction after receiving the vaccine on Tuesday. Thousands overall were vaccinated in the UK on Tuesday, NHS England told CNN on Wednesday.
“As is common with new vaccines the MHRA [Medicines and Healthcare products Regulatory Agency] 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,” said Stephen Powis, the national medical director for NHS England, in a statement. “Both are recovering well.”
The MHRA issued new advice to health care professionals stating that any person with 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 autoinjector — should not receive the Pfizer/BioNtech vaccine.
The advice also states that vaccines “should only be carried out in facilities where resuscitation measures are available.”
“We are fully investigating the two reports that have been reported to us as a matter of priority,” an MHRA spokesperson said.
“Once all the information has been reviewed we will communicate updated advice,” the spokesperson added.
They advised anyone with a history of a significant allergic reaction due to receive the Pfizer/BioNTech vaccine to speak to the health care professional administering the vaccine.
Pfizer said in a statement that it had been advised by the UK regulator of “two yellow card reports that may be associated with allergic reaction” due to administration of the 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,” the statement said.
“In the pivotal phase 3 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.”
Documents released on Tuesday by the US Food and Drug Administration (FDA) said the Pfizer/BioNTech trial data indicated that there were potentially slightly more adverse responses thought to be allergic reactions among the vaccine group compared with the placebo group, at 0.63% compared with 0.51%.