Britain’s medicine regulator on Wednesday, 9 December, issued a detailed warning over the Pfizer-BioNTech COVID-19 vaccine, asking anyone with a history of anaphylaxis to a medicine or food to avoid taking the shot, Reuters reported.
On Tuesday, the UK had begun a mass vaccination programme aimed to protect the elderly and allowing life to return to normal amid the worldwide pandemic that has lasted for a year now.
According to Reuters, the Medicines and Healthcare Products Regulatory Agency (MHRA) referred to two reports of anaphylaxis and one report of a possible allergic reaction that have emerged since rollout of the vaccine began.
However, even while issuing the warning, the agency asserted that the vaccine was safe and had met requisite standards.
“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.”MHRA Chief Executive June Raine
Earlier, the MHRA had issued an advisory for those with a "significant allergic reaction", which it has now clarified and sharpened. According to Reuters, Pfizer and BioNTech have said that they are supporting the MHRA's investigation.
The report also said that allergic reactions had not been a feature of Pfizer's clinical trials, adding that people with a history of severe adverse allergic reactions to vaccines or the candidate's ingredients were not a part of the late stage trials.
Reuters also reported that the allergic reactions may have been caused by a component of Pfizer's vaccine – polyethylene glycol, or PEG – which helps stabilise the vaccine and is not present in others.
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