Freedom of Information request on the safety of the Pfizer and Moderna COVID-19 vaccines (FOI 22/454)
Published 31 May 2022
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FOI 22/454
14th February 2022
Dear
Thank you for your email.
Regarding the below request, the information requested concerns parts of the quality dossier that are commercially sensitive and so would be exempt from release under Section 41 (Information provided in confidence) and Section 43 (Commercial interests). Section 41 is an absolute exemption and no consideration of the public interest is needed. Section 43 is a conditional exemption and a consideration of the public interest is required. We have considered the balance of the public interest when applying this exemption. In this case, we have not identified any issues which would benefit the public, as a whole, by being brought to their attention. Therefore, there is no public interest that outweighs the commercial harm in releasing information about the manufacturing and control of the Pfizer and Moderna vaccines, which can be used by competitors to overcome regulatory hurdles and inform the development of their own vaccine.
It should be noted that all batches of finished product have to be of suitable quality, as predetermined in the finished product specification for each vaccine. Changes between batches of vaccine that are within the finished product specification are acceptable and should not affect the efficacy of the product.
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