The move came after the UK's four CMOs advised that maintaining the 15-minute wait 'will cause more harm than it will avert' given the need to accelerate delivery of vaccinations in the face of a surge in COVID-19 cases driven by the highly transmissible Omicron variant.
The CMOs recommended that the 15-minute wait should be suspended immediately for patients receiving first, second or booster jabs with mRNA vaccines. They warned that retaining it would 'significantly reduce the number of people who can be vaccinated over a short period' - at a time when the NHS is aiming to offer a booster jab to all eligible adults by the end of this year.
Suspension of the 15-minute wait has been agreed by ministers after approval from the MHRA and other officials. The MHRA has warned, however, that the observation period should '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'.
15-minute wait
The move will significantly increase the pace at which vaccination sites can work through large numbers of patients, removing the requirement for space to be set aside where people can wait.
The Green Book chapter on COVID-19 vaccinations has been updated to reflect the change in advice - and confirms that dropping the 15-minute wait has also been backed by the Commission on Human Medicines.
Suspension of the 15-minute wait has been recommended by the CMOs as 'a temporary measure on the grounds of public health need to protect as many citizens as possible over a short period of time'.
The CMOs say that the MHRA, the Commission on Human Medicines and the JCVI should make a longer-term decision 'when the current need for extreme speed of vaccination and boosting is over'.
Anaphylaxis risk
Advice from the CMOs says that cases of anaphylaxis in people who have received doses of the Pfizer or Moderna mRNA vaccines being used in the UK booster campaign are 'overall very rare' - and that dropping the 15-minute observation period is therefore justified.
It says: 'All currently deployed vaccines have proven safe with low rates of severe side effects. As with all vaccines occasional cases of anaphylaxis have been reported, and the rates are slightly higher (but still very low) in the case of mRNA vaccines from Pfizer/BioNTech and Moderna but still overall very rare.
'For mRNA vaccines there have been two fatal Yellow Card reports of anaphylaxis linked to primary course vaccination and no deaths from anaphylaxis linked to booster vaccination reported in the UK to date.'
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'.
Health and social care secretary Sajid Javid said earlier this week that the 15-minute wait was under review after an MP warned in parliament that GPs in his constituency had identified the observation period as the number one obstacle to delivering vaccines faster.
Watford GP Dr Simon Hodes told GPonline this week: 'The 15-minute wait post vaccine must be scrapped. It makes no sense as anaphylaxis rates are 4.7 per million and usually immediate.
'The nonsensical 15-minute wait prevent a fast throughput of patients (like a seasonal flu clinic) and prevents many smaller GP sites having the space to do this.'
Commenting on the change, MHRA chief executive Dr June Raine said: 'In light of the rapid spread of the new Omicron variant and the proven effectiveness of booster doses against Omicron, the 15-minute observation period following mRNA vaccines (Pfizer and Moderna) can be waived during the emergency response to the Omicron variant. This advice includes first and second vaccine doses as well as boosters.'
NHS England primary care medical director Dr Nikki Kanani said: 'The updated CMO advice to temporarily suspend the 15-minute wait - where safe and appropriate - will be particularly helpful for smaller vaccination sites, helping get more people protected as quickly as possible.'
