GPs told to observe patients given COVID-19 vaccine for 15 minutes

10 December 2020

The MHRA has issued new advice to COVID-19 vaccination centres following two reports of anaphylaxis and one report of a possible allergic reaction in patients who received the jab.

GP-led COVID-19 vaccination sites will have to ensure they have the physical space to allow patients to remain on-site for 15 minutes. | GETTY IMAGES

According to the updated guidance, patients receiving the Pfizer/BioNTech COVID-19 vaccine need to be monitored for 15 minutes after vaccination, 'with a longer observation period when indicated after clinical assessment'.

Practices were previously advised that a 15-minute observation period would not be necessary and that patients could be told simply not to drive for that period.

The new recommendation comes after the MHRA advised yesterday that the vaccine should not be administered to patients with a history of allergic reactions.

Anaphylaxis

MHRA chief executive Dr June Raine said: 'We convened an expert group of the Commission on Human Medicines (CHM), attended by experts in allergy and clinical immunology, to robustly review these reports to consider any possible mitigation on the rare risk of anaphylaxis.

'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.'

All vaccination sites are expected to have a protocol for managing anaphylaxis and 'an anaphylaxis pack must always be available whenever the Pfizer/BioNTech vaccine is given'. Immediate treatment should include early treatment with 0.5mg intramuscular adrenaline (0.5ml of 1:1000 or 1mg/ml adrenaline), with an early call for help and further IM adrenaline every 5 minutes.

Health professionals managing vaccination sites should be trained to recognise an anaphylactic reaction and know how to resuscitate a patient experiencing one.

Some 280 designated primary care sites are due to start administering the Pfizer/BioNTech vaccine next week, receiving their first batches on either 14 or 15 December. The sites will be expected to begin vaccinating patients the day after the delivery. The sites will initially focus on patients in the over-80 cohort who are able to attend for a vaccination.