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Temporary waiver of 15-minute observation period after COVID-19 mRNA vaccines

The Commission on Human Medicines (CHM) and the Medicines and Healthcare products Regulatory Agency (MHRA) have advised that the 15-minute observation period following mRNA vaccines (Pfizer/BioNTech 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. Pharmacists are also advised to refer to the legal mechanism (e.g. PGD) for additional information.

The 15-minute 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. The guidance in the COVID-19: the green book, chapter 14a has also been updated. The Green Book contains guidance for management of individuals with a history of allergy.

The Scottish Government has made further recommendations that all doses of COVID-19 vaccines administered in Scotland be followed by a 5 minute observation period

As fainting can occur following vaccination, all those vaccinated with any of the COVID-19 vaccines individuals should be advised not to drive for 15 minutes after vaccination.

The regulatory documents for both vaccines remain unchanged.

The MHRA Press release has more information on the temporary waiver. For more details on:

The UK Chief Medical Officers' and lead Deputy Chief Medical Officers for vaccines' provided their opinion on the 15-minute wait after vaccination with mRNA vaccine for COVID-19 in an independent report.


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