FOI release

Freedom of Information request on clinical trials for the Moderna COVID-19 vaccine (FOI 21/810)

Published 29 December 2021

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-19-july-2021/freedom-of-information-request-on-clinical-trials-for-the-moderna-covid-19-vaccine-foi-21810

22nd July 2021

FOI 21/810

Dear

Thank you for your email.

With regards to your questions, please see MHRA’s response below:

  • Was a blood sugar level and D-dimer blood test carried out as part of the Moderna Phase1 Covid-19 vaccine clinical trials?

This information is available in the public domain, through the data published by the European Medicines Agency (EMA). A link to this is provided below:

https://clinicaldata.ema.europa.eu/web/cdp

  • Was blood lipase measured as part of the Pfizer Phase1 clinical trial?

This information is available in the public domain, through the data published by the European Medicines Agency (EMA). A link to this is provided below:

https://clinicaldata.ema.europa.eu/web/cdp

  • Briefly, with the exception of any personal patient data, is there any chemistry and haematology data i.e. CBC, PLT, blood sugar, WBC, ALT, AST, lipase, Hgb, D-dimer, T.Billi, recorded in the Moderna Covid-19 vaccine Phase1 clinical trial, that the MHRA does not have unhindered access to, this might include certain data, data sets, raw data, meta data etc?

In order to authorise a new medicinal product, MHRA requires that all applicants provide the clinical data from all studies conducted with that product for assessment. We can confirm that the MHRA is able to access all such data mentioned in your question.

  • Briefly, with the exception of any personal patient data, what recourse, is available to the MHRA to gain access to any restricted (3. above) chemistry and haematology recorded test data for the Moderna Phase1 vaccine clinical trial?

Please see our response to Q3 above.

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]

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

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