FOI release

Freedom of Information request (FOI 22/913)

Published 17 January 2024

FOI 22/913

30th September 2022

Dear

Thank you for your information request, dated 18 August 2022. I am pleased to provide you with some of the information requested, see annotations below and the attached file.

1) The full nucleotide base sequence for “Imelasomeran”.

Please refer to attached file named ‘structure’ this document has been redacted due to inclusion of information exempt under section 41 and section 43 (1) of the FOI Act.

2) The conditions attached to this Conditional Marketing Authorisation.

This information is exempt under section 22 (information intended for future publication) of the FOI Act, the list of conditions will be published within the public assessment report (PAR), these can be located close to the end of the document. The PAR is currently undergoing a final review and should be published in the near future.

3) The Public Assessment Report for this approval.

As above.

4) The date and time the application was made.

22 June 2022. Our system does not display the time the data package was received.

5) The date and time the application was approved.

16 August 2022, time: 12.20

In terms of questions 2 and 3, and the exemption of materials due to future publication, given that the PAR should be published very soon. we do not believe that there is a need to provide any further description or clarification about the use of this exemption (S.22). However, in relation to Q.1, most of the information related to the nucleotide sequence is exempt from release under section 41 and section 43 of the FOI Act. You may recall that we commenced a public interest test to consider if the information held for Q.1 should be released. This test is now concluded and details follow beneath the heading of Section 43.

Section 43 – Commercial interests: information where disclosure would be likely to prejudice the commercial interests of any person, including third parties or the public authority that holds the information. Section 43 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information. In favour of disclosure, we consider that there is a general public benefit from:

• Openness and transparency, providing the nucleotide sequence and supportive information may reassure some members of the public about the specific content of genetic material included in the bivalent vaccine.
  • The impact of this factor was considered to be somewhat limited by the release of the full sequence for the original vaccine.
• Ability of a wider range of experts to examine the nucleotide sequence
  • The impact of this factor was lessened by the viewing of the sequence by independent members of the Commission on Human Medicines (CHM), and also by experts that are part of or associated with international regulatory authorities.
• Potential to reduce the incidence of vaccine hesitancy, this point is interconnected with that above; a greater degree of transparency with regard to the genetic material included in the vaccine may help to reassure some members of the public.
  • The magnitude of this factor was somewhat reduced on the basis that many lay members of the public are unlikely to possess the knowledge to interpret the clinical or scientific relevance of the base sequence. Although, it was noted that other experts maybe able to provide further reassurances if the sequence was to be released into the public domain. However, many of the anxieties related to vaccines tend to relate to a suspicion that adverse events are more severe & frequent than the data show. Overall, the consequences of withholding the sequence due to reasons tied to vaccine hesitancy were considered to be very limited, However, we consider that the public interest will be better served by not releasing the information as:
• There is a real risk that the data released for the original Spikevax vaccine (already in the public domain) could be used in conjunction with the bivalent sequence (if it was to be released) to deduce commercially confidential (proprietary) bioinformatics software.
  • The weight of this factor was increased because there is a tendency in the pharmaceutical industry to use similar technology / software in the development of different vaccines / therapies. As such, the commercial harms of release of this document may not be limited to the bivalent vaccine alone, but also likely pose a commercial risk to a far wider range of products.
• The third party is currently involved in legal action related to a claim that their vaccine technology related to their first vaccine has been subject to patent infringement. Therefore, it is understood that the company hold legitimate concerns about the release of sequence data for their bivalent vaccine.

Releasing the information would also prejudice the Agency’s commercial interests in this case and in future. As a market regulator, it is vital that the Agency can freely engage in dialogue with organisations about commercial activities.

Section 41 – Information provided in confidence: information provided to us in confidence, with the expectation that it will not be released, is exempt from disclosure under the FOI Act. Information will be covered by Section 41 if: it was obtained by the authority from any other person; its disclosure would constitute a breach of confidence; a person or organisation could bring a court action for that breach of confidence; and that court action would be likely to succeed.

It is for the reasons given above that we provide a redacted version of the structure document to address Q.1, appended to this response.

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: [email protected]

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,

FOI Team Healthcare Quality and Access