FOI release

Freedom of Information request on the Novavax and Valneva vaccines, which are not currently authorised for use (FOI 21/1201)

Published 26 May 2022

FOI 21/1201

16th November 2021

Dear,

Thank you for your email.

Regarding your request for information on the Novavax and Valneva vaccines, which are not currently authorised for use, MHRA neither confirms nor denies that it holds information falling within the description specified in your request. The duty in Section 1(1)(a) of the Freedom of Information (FOI) Act 2000 does not apply, by virtue of Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of that Act. This should not be taken as an indication that the information you requested is or is not held by the department.

Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.

Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in alerting competitors what stage of assessment these vaccines are at and can indicate to competitors how close to market these vaccines are. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity.

Regarding AstraZeneca, Pfizer and Moderna, the rolling review process was used by both the EMA and MHRA to assess these vaccines. The timelines that data were received by both regulators would have been the same and the PARs available on the EMA website list the dates that data were received in Section 1.2 ( Steps taken for the assessment of the product).

These can be found at the following links:

[Comirnaty

European Medicines Agency](https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty)

Spikevax (previously COVID-19 Vaccine Moderna European Medicines Agency

Vaxzevria previously COVID-19 Vaccine AstraZeneca- European Medicines Agency

Authorisation of the Pfizer vaccine under Regulation 174 was on 1 December 2020. This information is available in the Regulation 174 PAR. Regulatory approval of Pfizer/BioNTech vaccine for COVID-19 - GOV.UK

Authorisation of the AstraZeneca vaccine under Regulation 174 was on 30 December 2020. Regulatory approval of Vaxzevria-previously COVID-19 Vaccine AstraZeneca)

Authorisation of the Moderna vaccine under Regulation 174 was on 8 January 2021-Regulatory approval of Spikevax-formerly COVID-19 Vaccine Moderna

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.

Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

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 Service Centre