England has temporarily suspended the 15-minute observation period after administering Pfizer and Moderna COVID-19 vaccines, the UK government said on Tuesday.
The move to accelerate the rolling out of booster doses was announced after the UK’s medicines regulator and chief medical officers gave the green light to do so.
The wait time was introduced a year ago, after two National Health Service staff members suffered allergic reactions on the first day of the vaccine rollout.
Dr. June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), said the advice to waive the 15-minute observation period following mRNA vaccines for most people “during the emergency response to the Omicron variant” includes first, second, and booster doses.
But the observation period remains in place for “people who may have previously suffered anaphylaxis or other allergic reactions to a food, insect sting, and most medicines or vaccines.”
“Anaphylaxis and other severe allergic reactions are very rare side effects with the COVID-19 vaccines,” Raine said in a statement.
“During this time when the Omicron variant is spreading rapidly, the benefits of vaccinating as many people as possible, which will be gained from waiving the 15-minute wait, far outweigh the very small risks of anaphylaxis,” she said.
Raine said the MHRA will continue to monitor “both UK and international data” and asked people to report suspected adverse reactions to the agency’s Coronavirus Yellow Card website.
People are asked to inform vaccination centres about their allergy history and stay in the centre if feeling unwell. Those who are vaccinated at home are advised to have someone with them, and dial 999 if there’s tingling or throat tightness.
The latest MHRA summary of Yellow Card data, published on Dec. 9, said the reporting system had received 568 spontaneous adverse reactions associated with anaphylaxis or anaphylactoid reactions following Pfizer-BioNTech COVID-19 vaccination, and 54 reports following Moderna shots.
According to the Department of Health and Social Care, the risk of a serious allergic reaction after vaccination with the mRNA vaccines is around one report per 100,000 vaccine doses.
The Scottish government said it will replace the 15-minute observation period with a five-minute one, reflecting guidance from the Resuscitation Council.
Wales and Northern Ireland are also expected to make decisions on how to implement the advice.
