FOI release

Module 4 of the CTD for zapomeran (Kostaive) mRNA COVID-19 vaccine

Some or all of the information requested may not have been provided because we determined that the request was vexatious.

Case reference FOI2026/00006

Received 3 January 2026

Published 5 May 2026

Request

Dear Medicines and Healthcare Products Regulatory Agency, please provide me with the following parts of Module 4 of the CTD for zapomeran (Kostaive) mRNA COVID-19 vaccine which you recently approved: 4.1 Table of Contents 4.2 Study Reports (the actual results from nonclinical studies, including: Pharmacology, with special regard to the proposed mechanism of action. Pharmacokinetics (ADME - Absorption, Distribution, Metabolism, Excretion). Toxicology (acute, subchronic, chronic toxicity, genotoxicity, carcinogenicity, reproductive toxicity, etc.).

Response

See attached

Documents

• FOI2026_00006 (redacted).pdf (985.2 KB)

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