Independent report

JCVI statement on the COVID-19 booster vaccination programme for autumn 2022: update 3 September 2022

Updated 3 September 2022

Advice

The primary aim of the COVID-19 autumn booster programme is to increase immunity in those at higher risk of severe COVID-19 during winter 2022 to 2023.

The Joint Committee on Vaccination and immunisation (JCVI) previously advised who would be offered a COVID-19 booster vaccine in autumn 2022. This includes:

• residents in a care home for older adults and staff working in care homes for older adults
• frontline health and social care workers
• all adults aged 50 years and over
• persons aged 5 to 49 years in a clinical risk group, as set out in the Green Book
• persons aged 5 to 49 years who are household contacts of people with immunosuppression
• persons aged 16 to 49 years who are carers, as set out in the Green Book

Following review of vaccine products which may be available for use in the autumn booster programme, JCVI advises the following principles for vaccine deployment:

1. Timeliness of vaccination is more important than the type of booster vaccine used. The key priority of the autumn programme should be for eligible individuals to be offered a booster vaccine dose to increase their immunity against severe COVID-19 (hospitalisation and death) ahead of winter 2022 to 2023, as described in the previous advice of 15 July 2022.

2. Simplicity is central to an efficient vaccination programme. Deployment of a single type of vaccine throughout the autumn booster programme promotes simplicity and is therefore desirable. If sufficient doses of mRNA bivalent Original ‘wild-type’/Omicron BA.1 vaccine become available to complete the autumn booster programme, JCVI considers that it is expedient to aim to offer authorised bivalent vaccines throughout the autumn programme, subject to operational considerations. Where substantial delays might be incurred in deploying a bivalent vaccine, the principle of timeliness should take priority and an alternative UK-approved booster vaccine offered, such as a monovalent Original ‘wild-type’ mRNA vaccine. Individuals offered vaccination should be advised that timely boosting is desirable to increase protection over the winter, and therefore to accept whichever booster vaccine is offered.

3. When there are constraints to vaccine supply or deployment, priority for vaccination should be given to those at higher individual clinical risk of severe COVID-19, such as those of older age.

4. Vaccination of health and social care workers closer to the winter months would optimise the benefits to the NHS arising from vaccine-induced protection against Omicron symptomatic illness and transmission, as such protection is likely to be of relatively short duration. Operational flexibility is however appropriate in delivery of vaccines to health and social care workers.

5. The autumn booster vaccine dose should be offered at least 3 months after the previous dose. Operational flexibility may be applied to maximise timely delivery of the autumn programme and in consideration of individual circumstances.

Considerations

Current (‘wild-type’) mRNA vaccines have been used extensively for booster vaccinations with very good safety profiles observed. These vaccines provide good protection against severe disease from variant strains of SARS-CoV2, including Omicron, although protection against infection and mild disease is lower and relatively short lived (reference 1).

The emergence of SARS-CoV2 variants has led to the development of variant vaccines, with the objective of attaining a better match in vaccine-induced immunity against circulating viral strains. Vaccines that contain 2 different antigens, each based on a different SARS-CoV2 strain, are termed bivalent vaccines. Bivalent vaccines may broaden vaccine induced-immunity and therefore potentially improve protection against some variants of SARS-CoV2. Bivalent Original ‘wild-type’/Omicron BA.1 vaccine is likely to become available for use in the UK in the autumn of 2022. Bivalent Original ‘wild-type’/Omicron BA.4 or 5 vaccines are unlikely to be available for use in autumn 2022, and consideration will be given to the use of such vaccines in due course. JCVI considers that the autumn programme should not be delayed to allow for the potential availability of Omicron BA.4 or BA.5 variant vaccines.

JCVI has reviewed data from studies undertaken by Pfizer-BioNTech and Moderna on bivalent Original ‘wild-type’/Omicron BA.1 mRNA vaccines, and from the COV-BOOST clinical trial. These studies indicate that neutralising antibody levels against Omicron after vaccination with a bivalent or monovalent-Omicron vaccine are marginally higher than after vaccination with a monovalent wild-type vaccine (references 2, 3 and 4). Reactogenic events were similar to those observed in clinical studies of antecedent wild-type mRNA vaccines. There is no data on the clinical efficacy of these variant vaccines against currently circulating strains, or on their durability of protection.

The committee considers that the likely clinical benefits arising from only small differences in neutralising antibody levels between bivalent and wild-type vaccines are highly uncertain, with no clear advantage against other non-Omicron variants either. These uncertainties are increased when set in the context of on-going evolution of the SARS-CoV2 virus and the possibility of the emergence of future new variants of concern over winter 2022 to 2023 (reference 5).

There are no head-to-head trials comparing different bivalent Original ‘wild-type’/Omicron BA.1 mRNA vaccines. From the available data, JCVI considers that there are limited differences between bivalent Original ‘wild-type’/Omicron BA.1 mRNA vaccines in relation to immune responses generated against Omicron or wild-type virus (references 2 and 3).

Modelling analyses indicate that in adults aged 65 years and over, there may only be a small additional benefit in terms of the number of hospitalisations prevented by using a variant vaccine compared to a wild-type vaccine. Any potential benefit from a variant vaccine over wild-type vaccine would be abrogated if substantial delay to deployment was incurred as a result of the use of variant vaccines. A summary of the UK Health Security Agency (UKHSA) analysis is in the annex.

These considerations will be kept under review as new data emerges and new vaccine products become available.

Vaccine products for autumn 2022 booster programme

Please refer to the Green Book for more details.

Advised for use in adults aged 18 yea­rs and above:

• Moderna mRNA (Spikevax) bivalent Original ‘wild-type’/Omicron BA.1. Dose: 50 micrograms

• Moderna mRNA (Spikevax) Original ‘wild-type’ vaccine. Dose: 50 micrograms

• Pfizer-BioNTech mRNA (Comirnaty) bivalent Original ‘wild-type’/Omicron BA.1 vaccine. Dose: 30 micrograms

• Pfizer-BioNTech mRNA (Comirnaty) ‘wild-type’ vaccine. Dose: 30 micrograms

Advised for use in persons aged 12 to 17 years:

• Pfizer-BioNTech mRNA (Comirnaty) bivalent Original ‘wild-type’/Omicron BA.1 vaccine. Dose: 30 micrograms

• Pfizer-BioNTech mRNA (Comirnaty) ‘wild-type’ vaccine. Dose: 30 micrograms

Advised for use in persons aged 5 to 11 years:

• Pfizer-BioNTech mRNA (Comirnaty) ‘wild-type’ vaccine paediatric formulation. Dose 10 micrograms. Available for ‘off-label’ use as a booster dose (currently UK approved for primary course vaccination in children aged 5 to 11 years)

Exceptional circumstances:

• Novavax Matrix-M adjuvanted wild-type vaccine (Nuvaxovid), dose 5 micrograms (Spike protein) with 50 micrograms adjuvant, may be used ‘off-label’ as a booster dose for persons aged 18 years and above when no alternative clinically suitable UK-approved COVID-19 vaccine is available (see the Green Book)

In the previous advice published on 15 August it was noted that the Pfizer-BioNTech mRNA bivalent vaccine was under assessment by the Medicines and Healthcare products Regulatory Agency (MHRA). This assessment has now been completed and the vaccine authorised for use as a booster in this age group as of 2 September 2022.

References

1. COVID-19 vaccine effectiveness against the omicron (BA.2) variant in England, 24 May 2022.
2. Vaccines and Related Biological Products Advisory Committee, 28 June 2022 presentation: mRNA-1273.214 Moderna COVID-19 investigational bivalent vaccine (Original + Omicron).
3. Vaccines and Related Biological Products Advisory Committee, 28 June 2022 meeting presentation: Pfizer/BioNTech COVID-19 Omicron-modified vaccine options.
4. Interim COV-BOOST data shared in confidence.
5. Investigation of SARS-CoV-2 variants: technical briefings