Siphiwe Sibeko/Pool via AP
- Two recipients of the Pfizer-BioNTech COVID-19 vaccine had adverse reactions Tuesday, the UK’s national health service (NHS) said Wednesday morning.
- Both had a history of “significant” allergic reactions, but are recovering.
- As a result, the UK drug regulator has warned people with a history of significant allergic reactions to food, medicine, or vaccines to avoid the Pfizer vaccine in its current state.
- “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,” Professor Stephen Powis, national medical director for the NHS in England, said.
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The UK’s drug regulator has warned that people with a history of “significant” allergic reactions should not receive Pfizer and BioNTech’s COVID-19 vaccine in its current state, after two recipients had reactions.
The UK began rolling out the vaccine on Tuesday, following approval on December 2.
“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,” Professor Stephen Powis, national medical director for the national health service in England, said.
This includes reactions to medicines, food, and vaccines, the MHRA said.
The people who suffered the reactions were NHS staff members who received the shot on Tuesday and developed “anaphylactoid reaction” symptoms shortly after.
Both have a "strong past history of allergic reactions," and have to carry an adrenaline auto injector with them.
"Both are recovering well," Powis added.
Authorities have not yet said which element of the vaccine the staff members were allergic to.
All regions involved with the vaccination programme have been alerted, NHS England said, and from Wednesday all patients receiving the vaccine will be asked beforehand if they have a history of allergic reactions.
"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 autoinjector) should not receive the Pfizer/BioNtech vaccine," according to advice issued by the MHRA.
Vaccination should only be carried out in facilities where resuscitation measures are available, the regulator added.
A Pfizer spokesperson told Sky its vaccine was "well tolerated" during trials with over 44,000 participants, with "no serious safety concerns."
"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," the spokesperson said.
"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 US could approve the vaccine as early as Thursday.
This is a breaking news story.