Guidance published earlier this month had suggested that a PGD may not be in place for the start of the programme, raising the prospect that GPs would need to assess each individual patient and authorise for vaccines to be administered under a patient specific direction.
There was concern that this would have had a huge knock-on effect on the general practice workforce as more GPs would need to be available at vaccination sites.
The PGD, published by NHS England and Public Health England on Saturday, provides a legal framework to allow non-prescribers to administer the vaccine. It applies to a defined group of patients, in this case the priority groups identified for the Joint Committee of Vaccination and Immunisation (JCVI) who should be first in line to be vaccinated.
Only registered healthcare professionals are covered by the PGD and NHS England highlighted that PCN sites cannot delegate vaccine administration to unregistered staff. Under the PGD, all vaccinators must have completed the COVID-19 vaccination e-learning programme or locally provided training.
The PGD applies from Monday 14 December, when the first vaccines are due to be delivered by GP-led vaccination sites. It runs until 30 November 2021 and will be reviewed at the start of June next year.
Some sites are expected to begin vaccinating patients later on today, with others starting tomorrow and more joining the programme on Wednesday. Some 280 primary care sites were expected to begin vaccinating patients in the first wave of the programme's roll out in primary care this week.
NHS England said that organisations should 'ensure that staff are familiar with the contents of the PGD and that staff have signed the declaration included prior to starting vaccinating'.
The PGD confirms that patients with a history of immediate-onset anaphylaxis to a vaccine, medicine or food should not be given the vaccine and all vaccine recipients need to be monitored for 15 minutes after vaccination, in line with updated MHRA advice published last week.
The guidance forced GPs into last-minute changes to their vaccination plans, with some sites warning that they may need to pull out of the programme due to a lack of space.
The PGD says that patients who have had a confirmed case of COVID-19 in the previous four weeks should also not receive the vaccine. In these cases patients should postpone the vaccine until they are well and at least four weeks from the onset of symptoms or a positive test result if they were asymptomatic.
Although those under 16 have not been recommended to have the vaccine, the PGD says that any children at 'very high risk of exposure and serious outcomes such as older children with severe neuro-disabilities that require residential care should be referred to specialists for consideration for vaccination, under a patient specific direction'.