British regulator issues allergy warning over COVID-19 vaccine

World
By Editor_1
A nurse prepares a shot of the Pfizer-BioNTech COVID-19 vaccine at Guy's Hospital in London, England -  FRANK AUGSTEIN/AP
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LONDON – The British medicines regulator has advised people with a “significant” history of allergies not to receive the Pfizer/BioNTech COVID-19 vaccine after two front-line health workers suffered allergic reactions to the shot.

The Medicines and Healthcare products Regulatory Agency (MHRA) has given precautionary advice to National Health Service (NHS) trusts that anyone who has a history of “significant” allergic reactions to medicines, food or vaccines should not be given the shot.

This means people who have a previous history of anaphylactic reactions or those who have been told to carry an adrenaline autoinjector should not receive the Pfizer/BioNTech vaccine.

In a statement, the medical director of England’s NHA, Stephen Powis said the advice came after two people with a history of serious allergies had fallen ill. Such precautionary advice from the MHRA was standard practice, he added.

“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,” he said.

Both patients, were “recovering well,” he added.

All hospitals involved with the vaccination program have been informed and patients who are scheduled to receive the vaccine will be asked about their history of allergic reactions before being given the jab.

June Raine, the head of the MHRA, confirmed to the British Parliament’s Science and Technology Committee that two allergic reactions had taken place and that this “wasn’t a feature” during the trials.

Pfizer said both the US drug company and BioNTech are supporting the MHRA while it undertakes an investigation.

“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,” a spokesperson 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.”

The MHRA is continuing to monitor people who have received the vaccine, which has been proven to be highly effective in preventing Covid-19, the respiratory disease linked to the novel coronavirus.

Hospitals and vaccination centres began giving the vaccines to elderly patients and health workers across Britain on Tuesday (8), the first country to administer the Pfizer/BioNTech vaccine as part of a national program, after it received approval from the MHRA for emergency usage last week.

-dpa

 

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