The Government's Chief Medical Officers (CMOs) made the decision to temporarily suspend the observation period in order to speed up the delivery of vaccinations in response to surging numbers of COVID-19 cases attributable to the highly transmissible Omicron variant. This decision applies to people receiving a first, second or third (booster) dose of an mRNA vaccine (BioNTech-Pfizer, Moderna).
Further informationView COVID-19 vaccine records
The observation period after vaccination will remain in place for the small number of people who may have previously suffered anaphylaxis or other allergic reactions to a food, insect sting and most medicines or vaccines.
Discussing their decision, the CMOs stated that a continuing requirement for each patient to remain in a vaccination centre for 15 minutes after being jabbed would 'significantly reduce the number of people who can be vaccinated over a short period.' It will also remove the requirement for space to be set aside at vaccine centres where people can wait.
The CMOs added that 'swift action is needed to tackle the rapid increase in cases of the Omicron variant of COVID-19 and the increasing risk to the public and healthcare services. This temporary measure will assist in the major task of vaccinating the nation ahead of the end of the year.'
Green Book amended
The chapter on COVID-19 vaccinations in the Green Book has been amended to reflect the updated recommendations, confirming that the move to waive the observation period has also been backed by the Commission on Human Medicines (CHM).
The CMOs state that the measure is a temporary one made on the 'grounds of public health need to protect as many citizens as possible over a short period of time'. They add that the Medicines and Healthcare products Regulatory Agency (MHRA), the CHM and the Joint Committee on Vaccination and Immunisation (JCVI) should make a longer term decision once the 'current need for extreme speed of vaccination and boosting is over.'
Rare risk of anaphylaxis
The risk of a serious allergic reaction after vaccination with an mRNA vaccine is low – around one report per 100,000 vaccine doses.
Chair of the CHM, Professor Sir Munir Pirmohamed, said: 'The decision to temporarily waive the post mRNA observation period in specific circumstances comes after the CHM considered and reviewed the available Yellow Card data on anaphylaxis after the primary course and after boosters. The data show that anaphylaxis and other severe allergic reactions are an extremely rare side effect with the COVID-19 vaccine'.
Overall, the CMOs argue that the change 'will lead to a marginal increase in risk for a very small number of people, but substantially fewer than would be harmed by a slower vaccine rollout in the current public health emergency leading to some citizens not getting boosted or vaccinated prior to exposure to Omicron'.