The UK's medical regulator has issued a notification that anyone who has a history of significant allergic reactions to medicines, food or vaccines should not receive the Pfizer/BioNTech vaccine currently used in the country to vaccinate people.
Medicines and Healthcare products Regulatory Agency (MHRA) Wednesday's precautionary advice has come after a day when two National Health Service staff members experienced allergic reactions after being vaccinated.
The MHRA's advisory said that any person with a significant allergic reaction to a vaccine, medicine or food, such as the previous history of anaphylactoid reaction, or those who have been advised to carry an adrenaline autoinjector, should not receive the Pfizer/BioNtech vaccine.
The notification added 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."
"Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks. You can be completely confident that this vaccine has met the MHRA's robust standards of safety, quality and effectiveness."
Meanwhile, Stephen Powis, the national medical director for NHS England, said in a statement on Wednesday: "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," Powis added
The UK had approved the Covid-19 vaccine developed jointly by US Pfizer and German partner BioNTech and began vaccination on Tuesday.
Allergic Reaction
MHRA chief Raine informed the lawmakers that such allergic reactions were not seen during Pfizer’s clinical trials.
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Pfizer stated that people with a history of severe adverse allergic reactions to vaccines or the candidate's ingredients were not included in the late-stage clinical trials, which is reflected in the MHRA's emergency approval protocol. The allergic reactions, however, might have been generated by a component of Pfizer's vaccine called polyethylene glycol, or PEG, which helps stabilise the shot and is not in other types of vaccines.
Reacting to the development, Pfizer said that it had been advised by the UK regulator of "two yellow card reports that may be associated with the allergic reaction" due to administration of the vaccine, adding that it was "supporting the MHRA in the investigation".