FOI release

Freedom of Information request (FOI 22/1004)

Published 17 January 2024

31st October 2022

FOI 22/1004

Dear

Thank you for your request under FOIA.

We are pleased to provide some of the requested information.

Please find attached the nucleotide sequences for the bivalent vaccine PLGB 53720/0004. Please note, the first document related to the Omicron variant includes redactions and it is for the reasons given below that we provide a redacted version of the structure document.

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.

In terms of the remainder of the requested portions of the active substance dossier; in particular sections S.4.1, S.4.2 and P.5.2. We consider the information contained within to be exempt from release under the same Sections of FOIA as described above (S.41 and S.43). This is because these part of the product dossier include the specifications, analytical procedures and details of the pharmaceutical development of this vaccine; data and information that are considered to be commercially confidential.

Please note, the HMA/EMA guidelines also stipulate that these sections of the dossier are commercially confidential, and we do not believe that these data are available online or have been published by other regulators. While we appreciate there is a public interest in the COVID-19 vaccines including the Spikevax Bivalent vaccine, because this information relates to aspects of manufacturing and controls there is a clear and tangible risk of commercial harm i.e. that from competitors using the data to create the same or a similar product, or due to competitors using the scientific insights gained to advance development of other mRNA products. This exemption is conditional on the public interest in releasing it not outweighing the company’s/commercial enterprise’s right to confidentiality and the probable damage that the company/commercial enterprise could suffer as a result of the information being released. In this case we have not identified any issues which would benefit the public as a whole by being brought to their attention (examples of issues would be a major public health risk or a major procedural failure or irregularity). Overall, we do not believe that the public interest would be better served by a release of these data.

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

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

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

MHRA Customer Experience Centre