Vaccine group directions: what you need to know as a clinical pharmacy practitioner

Prior to December 2020 and the inception of the national protocol for influenza and COVID-19 vaccines, pharmacy involvement in vaccination was limited to either pharmacist administration under a patient group direction (PGD) or individualised assessment by a medical/non-medical prescriber, followed by delegation to an appropriately trained (pharmacy) practitioner^​1​. Since then, the contribution made by the community pharmacy sector to both COVID-19 and influenza vaccination campaigns have been significant^​2​. PGD legislation changes to include pharmacy technicians in June 2024^​3​ further allowed opportunities for pharmacy involvement, as well as the recent offer of the meningococcal B disease vaccine to school leavers being exclusively delivered by community pharmacists^​4​. 

Until 1 April 2026, there were several legal mechanisms to support non-prescribers to vaccinate those eligible under the national immunisation programmes, such as influenza and COVID-19. These included: 

• PGDs; 
• National protocols (exclusively for COVID-19 and influenza)^​1​.

During the COVID-19 pandemic, there were several alterations to the Human Medicines Regulations 2012 legislation to support greater workforce flexibility around COVID-19 and influenza vaccination. These amendments were reflected in the Human Medicines Regulations (Coronavirus and Influenza), which took effect in October 2020^​5​. One of the principal changes was the creation of Reg 247A: protocols relating to coronavirus and influenza vaccinations and immunisations. The creation of a coronavirus occupational health vaccinator afforded additional professional responsibilities to nursing associates and operating department practitioners, to ensure that frontline healthcare workers were vaccinated against flu and COVID-19. Another important enabler was the introduction of Reg 174A, which detailed the specific conditions under which unlicensed medicines — such as the first COVID-19 vaccines — could be supplied in a pandemic. These two amendments facilitated rapid COVID-19 vaccine uptake in a mass vaccination delivery model from December 2020^​5​.

Up to this point, the entire patient vaccination journey would have been undertaken by the same practitioner — under a PGD — or the vaccine would be prescribed under a patient specific direction, such as a written direction to supply in the patient’s GP record, to be administered by a registered healthcare professional or non-registrant, such as a healthcare assistant. 

The national protocol enabled the vaccination process to be broken down into tasks. After a patient gives consent for the vaccine to a registered healthcare professional, or a coronavirus occupational health vaccinator or medical/non-medical prescriber, enabled to work under a PGD, up to three additional practitioners — who could be non-registrants, such as members of the public — could proceed with vaccine preparation, administration and record keeping. Specifically for pharmacists, they were one of just three named professions able to clinically supervise COVID-19 or flu operations when a protocol was in use^​5​. Until June 2024, pharmacy technicians were excluded from using PGDs, so the protocol represented an opportunity for the pharmacy sector as a whole to support the two largest vaccination programmes in the UK^​3​. 

There was a drive to harness the efficiencies realised through the national protocol through delegating parts of the vaccine process, leading to the proposal for a more permanent legislative framework. This culminated in a public consultation reviewing the temporary legislative changes brought about by COVID-19^​6​. 

This article explores the fundamental principles of the different commonly used legal mechanisms to support vaccine delivery and how that has changed since COVID-19. 

Vaccine group direction changes

After Reg 247A lapsed on 31 March 2026, Reg 235a of the VGD took effect on 1 April 2026 as the primary replacement^​7​. 

There are some notable changes from the national protocol (see, Table 1^​7,8​). 

A summary of the features of the key prescribing mechanisms are outlined in Table 2^​1,7,8​, which builds on the information from Table 1 by comparing and contrasting the VGD and protocol with a PGD and patient specific direction (PSD). 

These changes offer multiple potential benefits to the pharmacy sector, which include: 

• Opportunity for pharmacy technicians and pharmacists to develop and further enhance clinical supervision skills in vaccination;
• Supporting all pharmacy staff in expanding their knowledge and involvement in vaccination and the wider public health agenda;
• Opportunities for pharmacists and pharmacy technicians to explore public health as a clinical specialism; 
• Upskilling all members of the pharmacy team — including counter assistants and non-registered medicines technicians/ assistant technical officers — to be involved in the process of vaccination; 
• Improving national vaccination uptake, through community pharmacy staff being easily accessible by the public, through no routine need for appointments and late night/ weekend opening hours; 
• Increasing patient choice of NHS provider when accessing vaccinations.

The VGD retains the benefits of workforce expansion, including to non-registrants, provided that they are suitably trained and competent to deliver the tasks to which they have been allocated. However, a separate regulation that was introduced during COVID-19, Regulation 3A, lapsed on 31 March 2026. This regulation previously allowed delegation of mass vaccine manufacture and assembly under the supervision of a doctor, nurse or pharmacist, such as exemplified in the mass vaccination setting of COVID-19 when the protocol was in use^​9​. Therefore, delegation of just vaccine preparation as a standalone activity is no longer permitted. For this reason, vaccine preparation and administration must be completed by the same individual^​7​.

This important deviation from how the national protocol operated may prove to be temporarily problematic, particularly when more complex vaccine manipulations are required. For example, reconstitution of vaccine using a separate diluent, needing to use of a vial connector/ adaptor or where the vaccine contents, such as freeze-dried powders, have to be delicately handled during reconstitution. Considering that recent COVID-19 vaccines are straight draw-ups (from solution in a vial) and flu vaccines are in prefilled syringes, there may be a proportion of the vaccine workforce as yet unfamiliar with these preparation techniques, representing a training need^​10​. 

Potential issues with implementation 

The questions fielded at UK Health Security Agency (UKHSA) to date enquiring about VGD use in practice imply that some providers had historically relied upon advanced preparation/ draw-up of vaccine, when vaccine preparation was a separate step under the national protocol, as enabled by Regulation 3A above. 

For example: 

• “Does vaccine preparation under the VGD also include drawing up the vaccine? We usually get our nurses to do this in advance.”
• “We would welcome guidance on whether drawing down vaccines from multidose vials is classed as preparation as it is neither reconstitution or dilution.”

Legalities aside, mass vaccine preparation ahead of patient attendance is not advised on multiple grounds: 

• Vaccine stability data refers to when the vaccine is in its original container. Where a dose is drawn up from a multidose vial and into a syringe, which is stored for a prolonged period, the manufacturer’s data no longer holds and use of the vaccine would be considered off-label;
• Potential for microbiological spoilage from incorrectly stored vials and deterioration of the syringe contents over time; 
• The vaccinator cannot positively validate if the vaccine dose is contained in the syringe, unless they have supervised the draw up (which then questions any operational advantage of having a separate practitioner complete the preparation)^​10​. 

Using a VGD places supervisor responsibilities on the registered healthcare professional involved in the patient journey, whereas with the national protocol, an oversighting doctor/nurse/pharmacist could preside over operations without having to be involved in any part of the process^​7​. Under a VGD, this professional must be physically present, where they have chosen to delegate any part of the process downstream from clinical assessment and consent, even if those they have delegated to are themselves capable of autonomously operating under a PGD^​7​. In this particular situation, the supervision requirement may feel like a retrograde step for both parties involved, but it ensures that there are clear lines of accountability placed on both the delegator and delegatee, to try to safeguard patient care. Conversely, the registered healthcare professional may decide they lack sufficient experience or confidence to intervene in the patient’s care, in which case it is entirely appropriate to carry out all steps of the vaccination process as they would under a PGD. 

Further questions have been asked about the erosion of responsibility assigned to registered nursing associates, who  — alongside operating department practitioners — are no longer able to conduct the consent and clinical assessment step of a VGD, as they were previously able to do under a national protocol. With the presence of a clinical supervisor, both these professional groups were previously able to independently carry out all stages of vaccination^​1​. 

Although not an area explicit to VGDs, the UKHSA has received a number of recent queries asking about the validity of consent that’s given ahead of time and in writing by the patient or carer. The Green Book Chapter 2 (Consent) makes it clear that written consent bypasses the ability to check and confirm understanding of both the healthcare professional and patient^​11​. Arguably, consent that is sought only in writing cannot have been gained on a fully informed basis. The VGD has not been designed for the stages to occur over several days of contact. From a governance perspective, consider the scenario where the patient or their carer changed their mind or wanted to ask more questions before proceeding, particularly if it is a non-registered practitioner who is administering the vaccine. Referral back to the consenting practitioner would be the only clinically safe and viable option. The perceived economy of scale of operating a clinic in this manner, which is non-compliant with a VGD, is lost. 

Historically, the regular questions asked of the UKHSA are how to operationalise the framework and legal frameworks generally, including staff eligibility to work under them, highlighting that this is potentially a poorly understood topic.

Conclusions and future direction of travel

The legal responsibilities placed upon the national public health authorities to develop VGDs is not an alien concept; such organisations have developed immunisation PGDs for many years. It does, however, place further onus on the principle of getting it right the first time, and it should be recognised that there will be natural variation in service delivery to suit the local population and workforce. At the UKHSA, the immediate priority has been to create a legally compliant framework that clearly outlines training requirements, restrictions to task delegation, patient eligibility and key vaccine and programme characteristics, all with patient safety at the forefront. 

Potential challenges lie with shifting clinical landscapes, variation of commissioning models and the providers delivering services from one NHS region to the next, and lack of standard benchmarking in reference to postgraduate education and support. An article, published in April 2026, articulates the challenge facing emerging pharmacists, particularly those employed or engaged in a community pharmacy setting, where patchy training and supervision capacity, lack of protected postgraduate training time and limited opportunities to access funded courses mean the potential of this emergent prescribing workforce may be squandered^​12​. This is notable, as it is the community pharmacy sector where large ambitions are being placed to expand uptake of vaccines in general. While there is no doubt that there are many capable clinical practitioners who work in this sector — pharmacists and pharmacy technicians alike — operational and day-to-day pressures remain, representing the opportunity cost and a governance risk, as inexperienced vaccinators require protected time to expand their skillset^​13​. The item of service fee payable to GP practices for 2026/2027 is £10.06^​14​, but this offer has remained static since 2019/2020, causing some GPs to consider no longer offering a flu programme^​15​. Further reliance may be placed upon the community pharmacy sector, with the potential to encounter very complex patients and needs, whose medical histories may not be available to view via GP Connect, such as consultant visits^​16​.

Resources developed by the NHS Specialist Prescribing Services team for further reading can be found in Box 1.