My Battle with MHRA for Refusing to Force AstraZeneca to Recall its Jabs

They were distributed to 170 countries!!!

Long Running Battle with MHRA

Since June 2024, I have sent letters to the current and immediate former chair of the MHRA (the current chair was deputy chair of the JCVI!).

Ever since, they have been playing ping pong with me. The ‘customer experience team’ bat back my letters and complaints with ‘nothing to see here.’

This is the Latest

Dear Mr Rees,

Thank you for your reply of 21 October; please accept our apologies for the delay in coming back to you.

On your first point, our Defective Medicines Reporting Centre (DMRC) have confirmed that they do not hold anything that would relate to any non-routine data that has been requested and there have been no non-routine procedures followed for assessment of this medication where complaints have been received; DMRC have followed their routine protocols.

Furthermore, our inspectorate have confirmed that we have not been provided with any relevant data regarding reported distribution anomalies regarding this vaccine.

Turing to your second point: in accordance with Good Pharmacovigilance Practice module VI (as modified by the MHRA Exceptions and Modifications document), section VI.C.2.2.8., the former marketing authorisation holder of the withdrawn product licence is encouraged to continue to collect spontaneous reports of suspected adverse reactions originating within the UK to, for example, facilitate the review of delayed onset adverse reactions or of retrospectively notified cases.

We have also checked with NHS England. NHS England no longer supplies Astra Zeneca as part of the seasonal COVID-19 vaccination campaigns, and are not aware of any supply available in any supply chain in England or the UK.

We hope this information is helpful and we ask that you please consider this response alongside the other replies which we have sent to you.

If you are dissatisfied with the handling of your complaint, you have the right to ask for it to be reviewed by the Administrative Complaints Officer (ACO). The ACO can review the complaint response you have received, determining whether to uphold or not uphold your complaint, but cannot answer additional questions or adjudicate on regulatory matters. ACO review requests should be submitted within two months of receiving a final response to your original complaint and should be sent to aco@mhra.gov.uk

If you are not content with the outcome of the ACO review, you will have the right to apply to the Parliamentary and Health Service Ombudsman (PHSO), via your MP, for a decision.

Kind regards,

Ben

MHRA Customer Experience Centre

Communications and engagement

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

Effectively, they have only considered the UK, forgetting the other 169 countries where the injections were administered to patients.

This is my reply:

Dear Ben,

Thank you for your recent response (MHRA Reference CMPT12025_00979) regarding the AstraZeneca COVID-19 vaccine. I acknowledge the clarifications provided about the scope of the MHRA’s investigation within the UK market.

However, I wish to reiterate and expand upon several critical points:

1. Global Distribution and Oversight
   AstraZeneca’s COVID-19 vaccine was distributed to over 170 countries, with more than two billion doses supplied internationally. This unprecedented scale amplifies the necessity for robust and transparent supply chain oversight, especially given the product’s deployment in low- and middle-income settings where risks may be heightened.​

2. Regulatory Remit and Limitations
   Your reply acknowledges the MHRA’s statutory duties apply only to the UK, yet the wider global context cannot be ignored. Supply chain vulnerabilities and potential safety signals in international markets can have direct repercussions for UK-regulated entities, for the public health reputation of UK authorities, and for global patient safety. The MHRA’s exclusive focus on UK-market data risks insufficient disclosure and coordination with international regulators.​

3. Need for Proactive International Engagement
   Given the global scale and impact of AstraZeneca’s vaccine, I urge the MHRA to:

   • Disclose all available information on supply chain investigations and adverse event reporting linked to UK-distributed products, with transparent acknowledgement of interactions (or lack thereof) with non-UK regulators and international oversight bodies such as the WHO or EMA.​

   • Clarify what steps, if any, have been taken to address or relay supply chain or safety concerns to partner agencies in countries where AstraZeneca’s vaccine was distributed from UK-approved manufacturing locations.

   • Advocate for and participate in cross-border investigations and information sharing on regulatory risks that may affect global supply integrity and patient outcomes.

4. Public Accountability and Next Steps
   Given the magnitude of the global distribution and the established precedent (e.g., historical heparin contamination events), it is incumbent upon the MHRA to adopt a more transparent, proactive stance. I request:

   • A detailed account of communications with international regulators concerning AstraZeneca supply chain issues.

   • Confirmation that supply chain and safety lessons are being actively shared both within the UK and abroad.

   • Explanation of future plans to ensure coordinated international oversight and prevent repeat regulatory failures.

Please confirm receipt of this letter and provide a substantive response addressing each point above. If these matters remain unresolved, I reserve the right to escalate to Parliamentary and Health Service Ombudsman channels and the relevant government and public health committees.

Yours sincerely,

Hedley Rees,

Managing Director, PharmaFlow Ltd

T: +44 7734961726

Author, Wiley’s Transforming the Pharmaceutical Supply Chain, 2025.

Author, Wiley’s Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics, 2011.

LinkedIn: Hedley Rees

The jabs were never approved for the U.S., but countries such as Australia, New Zealand etc will have a strong case against the MHRA.

What’s next

The next reply from MHRA will be in about another month’s time, based on current performance. I’ll keep on batting back the ball until someone, or some president or prime minister, takes action.

If you have any influence to use this information, be my guest.

This is the Daily Sceptic article that promoted the letter and it explains all:

MHRA Cut Corners and Dropped Inspections in the Covid Vaccine Supply Chain, Putting Public at Risk