Dr. June Raine, chief executive of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), said late Wednesday, “You can be completely confident that this vaccine has met the MHRA’s robust standards of safety, quality, and effectiveness.”
“No vaccine would be approved unless it meets these stringent standards—on that you can be sure,” she said in a statement.
“We have in place a robust and proactive safety monitoring strategy for COVID-19 vaccines which allows for rapid, real-time safety monitoring at population level. The fact that these incidents were picked up and reviewed shows that to be the case.”
Earlier on Wednesday, professor Stephen Powis, national medical director for the National Health Service (NHS) in England, confirmed that “two people with a history of significant allergic reactions responded adversely” to the jab on Tuesday, the first day of the vaccine roll-out.
On Wednesday evening, the MHRA said it had received “two reports of anaphylaxis and one report of a possible allergic reaction following immunisation.” Anaphylaxis refers to a severe allergic reaction to venom, food, or medication.
After a meeting of the Expert Group of the Commission on Human Medicines (CHM), the regulator issued updated guidance to vaccination centres.
“Any person with a history of anaphylaxis to a vaccine, medicine, or food should not receive the Pfizer BioNTech vaccine. A second dose should not be given to anyone who has experienced anaphylaxis following administration of the first dose of this vaccine,” Raine said.
“Anaphylaxis is a known, although very rare, side effect with any vaccine. Most people will not get anaphylaxis and the benefits in protecting people against COVID-19 outweigh the risks,” she said.
British Prime Minister Boris Johnson on Tuesday hailed the UK’s vaccine roll-out as a “huge step forward” in the fight against the CCP virus, which caused the COVID-19 pandemic. Health Secretary Matt Hancock said the day would be remembered as “V-day” in Britain’s fight against the pandemic.
The Associated Press contributed to this report.