Medicines and Healthcare products Regulatory Agency
- Date 3 September 2025
- Sector Health, Regulators
- Decision(s) FOI 10: Upheld, FOI 17: Upheld, FOI 22A: Not upheld
The complainant has requested MHRA to disclose the Suspected Unexpected Serious Adverse Reactions (SUSARs) reports concerning the Moderna products mRNA-1345 and mRNA-1365. MHRA refused to disclose the requested information citing section 22A (research information), 38(1)(a) (health and safety) and 44 (prohibitions on disclosure) of FOIA. The Commissioner’s decision is that MHRA is entitled to rely on section 22A of FOIA. It however breached section 10 and 17 of FOIA by failing to respond to the request within 20 working days of receipt. The Commissioner does not require further steps to be taken.