FOI release

Freedom of Information request (FOI 22/1026)

Published 17 January 2024

FOI 22/1026

5th December 2022

Dear

We sincerely apologise for the delay that you have experienced whilst we addressed your request for information, and we thank you for your patience.

Thank you for your information request, dated 7 October 2022, where you asked for

Question 1:

What are the full names/unique reference codes for each vaccine currently being offered during autumn 2022?

A. A list of the COVID-19 vaccines authorised is available here with their full names:

Covid-19 Vaccination information - electronic medicines compendium (emc) *

*list reflects vaccines upon which a regulatory decision had been made occurring on or before your FOI request was received.

Please also refer to the JCVI’s statement on autumn 2022 COVID-19 vaccines: JCVI statement on the COVID-19 booster vaccination programme for autumn 2022: update 3 September 2022 - GOV.UK (www.gov.uk)

In terms of unique reference codes MHRA does not apply a reference code system, this is a data not held response.

Question 2:

Which of these vaccines are issued MHRA license categories of:

standard / normal; license; emergency use; license

yellow highlighted text indicates the manner that supply is presently designated. The temporary authorisations under R174 have not been withdrawn. For further detail see below.

A. COVID-19 Pfizer/BioNTech Original – R174, CMA COVID-19 Moderna (Spikevax) Original – R174, CMA

COVID-19 Moderna Spikevax Original / Omicron booster vaccine – NI R174 GB, CMA

Nuvaxovid – CMA (product not currently available) – also being used off-label as autumn booster

COVID-19 AstraZeneca – R174, CMA (product not currently available)

COVID-19 Janssen – CMA (product not currently available)

COVID-19 Valneva – CMA (product not currently available)

For information, none of the R174 emergency use authorisations have been withdrawn (although R174 product can no longer be supplied in the UK).

Except for those COVID-19 vaccines with a marketing authorisation, the majority of the COVID-19 vaccines have conditional MAs and as the conditions get fulfilled, the CMAs get converted into standard MAs. The EMA has already converted the Comirnaty CMA and the Spikevax CMA into standard MAs and they apply in Northern Ireland. The equivalent change may be made in GB in due course.

Question 3; For each of these vaccines, what is the most recent Coronavirus variant(s) that the vaccine was developed to combat against? tested against?

A. This is described in the JCVI statement

JCVI statement on the COVID-19 booster vaccination programme for autumn 2022: update 3 September 2022 - GOV.UK (www.gov.uk).

Please note, since receiving your request, new vaccines have been authorised e.g. Original/Omicron BA.4/5 bivalent vaccines. However, FOI terms state that FOI requests need only cover data and information held at the time of receiving the request. To be helpful and for your interest, we have, however, included the below.

Second Pfizer/BioNTech bivalent COVID-19 booster vaccine approved by UK medicines regulator - GOV.UK (www.gov.uk)

The PARS for the BA,4/5 vaccines are also provided in our response to Q.4.

Question 4: Please provide (links to access) the formal trial results that were provided to the regulatory approval body (MHRA) that show efficacy against the most recent Omicron variants i.e. BA.1/2/3/4/5 etc)

A. These data will be presented in the public assessment reports for each vaccine, in some cases, conclusions relied upon in vitro (lab testing data) including immunogenicity data and the bridging of data and experience gained from earlier versions of a vaccine/s, as well as, clinical data from on-going trial/s. To see a summary of the data submitted refer to the section of the PAR ‘What benefits of [product name] have been shown in studies?’ for each vaccine. Please note for some of the COVID-19 vaccines additional data are pending, and will be included in the relevant PAR/s in due course.

Please refer to the first two PARs in the results which will appear when accessing the below, PARs for the other products for earlier variant vaccines can be searched in the same manner:

[MHRA Products

Search results](https://products.mhra.gov.uk/search/?search=BA.4&page=1&doc=Par&rerouteType=0)

Question 5: Do these trial results show difference in efficacy between patients who are :have had Covid-19 infection have not had a Covid-19 infection This question will require a product specific answer which will be dependent on the design of the trial conducted. Therefore, we would be grateful if you could refine this question to cite one or two of the COVID-19 vaccines.

Question 6: What was the most prevalent Omicron Variant in England in during July 2022.” A. According to sequencing data analysis published by UK-HSA the Omicron Variant BA.5 was most prevalent in July 2022.

Source: SARS-CoV-2 variants of concern and variants under investigation: technical briefing 44 (22 July 2022) (publishing.service.gov.uk)

The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this email

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely,

HQA FOI Team