The Damning Moderna Audit Report That We’re Not Allowed to See

A recent UK regulator’s report on the culture, governance and compliance framework of pharmaceutical company Moderna has revealed “numerous and varied issues”. Is this company still a suitable choice for a multi-billion-pound mRNA vaccines ‘strategic partnership’ with His Majesty’s Government? Should it have been chosen in the first place? Why all the secrecy?

Earlier this year, the UK’s pharmaceutical industry’s self-regulatory body the PMCPA (the Prescription Medicines Code of Practice Authority) ordered a mandatory audit of the UK operation of the pharmaceutical company Moderna. The audit team was told to focus on the company’s “culture, governance and compliance framework” This audit was imposed following several months, indeed years, during which Moderna had been found guilty by the PMCPA of breaking the UK pharmaceutical industry’s Code of Practice on numerous occasions. These breaches came to light as a result of complaints about practices relating to the development and promotion of its mRNA Covid vaccines and communications with healthcare professionals and the general public about those vaccines. Many of these breaches were very serious indeed. They not only include multiple findings of misleading claims about the safety and efficacy of their vaccines, but also of permitting the offer of inappropriate payments to healthcare professionals and targeting advertisements at children. Also included were several findings in which the breaches were so egregious as to be deemed to have “brought discredit on, and reduced confidence in the pharmaceutical industry”. 

Things came to head earlier this year when the PMCPA judged that Moderna had permitted the offer of illegal payments to children for participation in a COVID-19 vaccine study. The self-regulatory body subsequently discovered that Moderna had also misled it in the statements it had submitted in its attempt to defend this behaviour. Around the same time the PMCPA had also found Moderna guilty of concealing its involvement in newspaper and online articles written by a previous government vaccines minister Nadim Zahawi, extolling the virtues of how the Covid pandemic was handled and praising the role of the COVID-19 vaccines (the articles were co-written by a Moderna employee who was previously a member of the government’s vaccine taskforce). As a result of this litany of breaches of the industry code, earlier this year the PMCPA decided that enough was enough and took the unusual step of imposing an audit on Moderna. The audit was commenced in July this year and the top-line results have just been published as an addendum to PMCPA case 0316/10/24. Here are those top-line results from that audit. (I say top-line results; the truth is that the detailed results of the audit are unlikely to ever see the light of day in terms of being available for public scrutiny. Furthermore, the PMCPA is not a public body and therefore does not have to respond to Freedom of Information Act requests for information.)

These Moderna cases and the audit findings are interesting in their own right, and particularly so for those of us who are still seeking to understand what exactly happened to the world during those Covid years and to learn from the experience. However, they are particularly interesting when one considers that Moderna is the UK Government’s chosen principal partner for the development and commercialisation of vaccines based on mRNA technology. Back in 2022, Moderna and the Conservative government trumpeted this new 10-year “strategic partnership” as a “major boost for vaccines and research”. However, anyone looking for more details as to exactly what this partnership entailed was going to be disappointed. The government press release announcing the agreement on the DHSC website concluded with the words

NOTES TO EDITORS: the details of the strategic partnership between the government and Moderna are commercially sensitive.

This partnership, entered into by Rishi Sunak, has been enthusiastically embraced by our current Labour Government. Earlier this year, Moderna and an impressive array of Labour politicians, Government advisors and civil servants lined up with Moderna Directors and employees to celebrate the opening of their new state-of-the-art mRNA facility in Harwell, Oxfordshire. Unfortunately, the secrecy surrounding the details of the arrangements between the government and Moderna remains impervious to enquiry. I myself have made an FOIA request of the DHSC for information about how much taxpayers’ cash and how many non-financial government resources have been promised to Moderna. I also asked for information on any regulatory concessions given to Moderna as part of this deal. The DHSC response was to admit that it had some of the information but refused to supply it, using what is called a section 12 exemption on the grounds of excessive costs associated with the search. When I significantly reduced the scope of my request and resubmitted, it was nevertheless still refused, again using a section 12 exemption.

Whilst the UK Government is stonewalling information requests, we may be able to get an idea of the kind of concessions which might be on offer to Moderna if we look beyond our shores. The UK is not alone in entering into partnerships with Moderna. Similar deals have apparently been struck with the governments of Canada and Australia. Last year, concerns were raised in Australia when it was revealed that, as a result of a deal with the Australian government, Moderna’s mRNA vaccines will be exempt from assessment by the country’s Pharmaceutical Benefits Advisory Committee. The switch to a seemingly parallel approval system just for Moderna, which had not been publicly explained, apparently raised concerns in the health sector. The Australian Moderna deal is currently the subject of an ongoing Australian National Audit Office probe which was announced in November 2024, the report of which is expected shortly.

Back to the PMCPA’s audit report. Even with an attempted gloss of mitigation due to a lack of experience of self-regulation, the PMCPA’s conclusions about Moderna are stark and damning. “Numerous and varied issues” were identified, and apparently Moderna’s response to the audit report indicated that it required 18 months to “comprehensively address its compliance gaps”. Eighteen months! That would put Moderna halfway through its 10-year deal with the Government. So, half of the timeframe of the deal will have been spent with the Government’s chosen partner having “compliance gaps” requiring significant improvements. What are the public to make of any outputs from Moderna in general, and Harwell in particular, during that time? Is our Government not worried by the damage these findings have done to the credibility of its ‘strategic partnership’? When it comes to this secretive deal, why should we now believe a word either it or Moderna says?

Although we are apparently not to be told exactly what they are, surely many of Moderna’s shortcomings in terms of culture, governance and compliance, which were identified in this report, should have been apparent when the UK government did its due diligence in advance of entering into this partnership with Moderna. Even if this was not the case, the company’s behaviour over the next few years, as evidenced by the number and seriousness of the PMCPA findings described above, should have triggered a whole parade of red flags for the government, and particularly the UKHSA which is supposedly responsible for managing this partnership on its behalf. The PMCPA’s Appeal Board decided that it did not want to wait 18 months for Moderna to close its “compliance gaps” but that it should be reaudited in 12-15 months, at which point it expected the company to demonstrate “significant progress” against each recommendation in the report. Notice that Moderna only needs to have made “significant progress” (what that means we have no way of knowing) and not to have fully achieved the required standard (but again, we have no way of knowing what that is either). On receipt of the re-audit report the Appeal Board will then decide whether future sanctions are necessary. What those future sanctions might be is not stated.

The British public now deserve to know more details about our Government’s deal with Moderna if both the Government and Moderna expect us to have any trust or confidence in anything coming out of Harwell once it starts conducting its clinical trials and trying to sell its mRNA vaccines (possibly as early as next year). This is particularly true when we now have a report – limited though it is – of a recent detailed audit, conducted by Moderna’s own industry self-regulatory body: a report which throws into question whether that company is, or ever was, a fit and proper commercial partner for His Majesty’s Government.

Dr Alan Black is a retired pharmaceutical physician, having worked in and for the pharmaceutical industry for around 30 years. Prior to that he spent a number of years in laboratory and clinical medicine.