Freedom of Information request on specifications that are provided to show that the active substance and finished medicinal product are of suitable quality for the Pfizer, AstraZeneca, Moderna or Janssen vaccines (FOI 22/387)
Published 31 May 2022
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FOI 22/387
3rd February 2022
Dear
Thank you for your email.
As part of the Licensing process, satisfactory certificates of analysis are provided for all excipients in the finished product to show that they comply with the agreed specification. Further, methods of manufacture, batch analyses and specifications are provided to show that the active substance and finished medicinal product are of suitable quality and therefore suitable for use. None of the excipients in the Pfizer, AstraZeneca, Moderna or Janssen vaccines contain graphene oxide.
Details of the finished product specification for the finished product, which contains details of impurities and their control in each of the authorised vaccines is exempt from release under S41/S43 of the FOI Act. Details of the manufacturing process is also exempt from release under S41/S43 of the FOI Act.
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 giving manufacturing know-how to competitors who can use this information to inform the development of their own products.
If you have any queries, 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]
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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
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SK9 5AF
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4P