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INSIDE PHARMA

Re: Outstanding risks and possible breaches concerning AstraZeneca SARS-CoV-2 sterile injectables supply chain

Open letter to MHRA Chair, receipt acknowledged, looking forward to some remediation

Hedley Rees's avatar
Hedley Rees
Jul 31, 2025
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Open Letter to Dr Anthony Harnden, Chair, MHRA

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This is the text of an open letter I have sent to MHRAs Chair:

“To:
Dr. Anthony Harnden, Chair, MHRA.
Medicines and Healthcare products Regulatory Agency
10 South Colonnade
Canary Wharf
London
E14 4PU
United Kingdom

Re: Outstanding risks and possible breaches concerning AstraZeneca SARS-CoV-2 sterile injectables supply chain

Dear Dr. Harnden,

I write to you, having previously written to the former Chair of the MHRA, Professor Cooke. This letter follows both my open letter, dated June 6, 2024, and the subsequent response from MHRA Customer Experience Centre (Ref: CEC 189744, September 18, 2024)

While your reply outlines MHRA’s routine regulatory procedures relating to approval and monitoring, it does not materially engage with the supply chain vulnerabilities or the specific risks I raised in my original correspondence.

I remain gravely concerned that, in light of the market withdrawal—but not recall—of AstraZeneca SARS-CoV-2 sterile injectables, a rigo…

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