Government updates regulations to support the ongoing delivery of Covid and flu vaccinations

The government has taken action to ensure Covid-19 and influenza vaccinations continue to be delivered safely and swiftly following widespread support in a public consultation.

As part of the response to the pandemic, a number of regulations were put in place to enable Covid and flu vaccines to be safely deployed at speed and scale, and to ensure that there is sufficient workforce to administer the vaccines. These regulations were made by making amendments to the Human Medicines Regulations 2012 through the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020.

Two of these regulations - regulation 3A (R3A) and regulation 19 (R19) - are due to lapse on 1 April 2024, while regulation 247A (R247A) is only permitted for use during a pandemic.

Between 7 August and 18 September 2023, the government held a public consultation on proposed amendments to these three regulations to support the ongoing delivery of Covid and flu vaccinations. The three regulations that underwent consultation relate to:

• enabling trained healthcare professionals or staff under the supervision of healthcare professionals to conduct the final stage of assembly, preparation and labelling of Covid-19 vaccines without additional marketing authorisations or manufacturer's licences being required (R3A)

• allowing Covid-19 and influenza vaccines to be moved between premises at the end of the supply chain by providers operating under NHS arrangements or the medical services of His Majesty's Armed Forces, which do not hold wholesale dealer's licences (R19)

• enabling the use of an extended workforce who are legally and safely able to administer a Covid-19 or influenza vaccine without the input of a prescriber, using an approved protocol (R247A)

The consultation received 220 responses, with significant support expressed (over 80%) for each proposal. Several responses highlighted how these regulations have improved the delivery of Covid and flu vaccinations in a safe and effective way, allowing vaccines to be deployed at speed and scale, whilst maintaining patient safety.

The government also heard how the use of an extended workforce has increased flexibility, thereby reducing staff pressures and providing greater opportunities for career development.

The government welcomes the participation of all individuals and organisations who contributed to this consultation.  Given the high level of support expressed in the responses, it is proceeding with the proposed amendments to these three regulations, enabling them to be used until 1 April 2026.