Moderna could face suspension from Britain’s pharmaceutical trade body following a string of breaches of the regulatory code.
The Covid vaccine maker is due to be audited by the Prescription Medicines Code of Practice Authority (PMCPA) over “unacceptable” practices that brought discredit upon the industry.
If found to be lacking adequate compliance systems, Moderna could ultimately be suspended or expelled from the Association of the British Pharmaceutical Industry (APBI).
It follows several code breaches, including representatives of the company offering children £1,500 and teddy bears to take part in Covid vaccine trials.
In a fresh ruling, which is expected to be published in the coming days, the company was also found to have misled regulators about when it first became aware of the financial incentives to children.
Moderna claimed it had taken action as soon as it was notified about the cash offer by the Health Research Agency in January 2024, but it has now emerged that senior executives were informed in August 2023 by the campaign group UsForThem, yet failed to take action.
Under the Medicines for Human Use (Clinical Trials) regulations, it is prohibited for incentives or financial inducements to be given to children or their parents.
The PMCPA ruled the company had shown a lack of transparency that was “completely unacceptable” and brought discredit upon the industry.
A senior employee was also found to have co-authored three articles, including one with Nadhim Zahawi, the former vaccines minister, which promoted Moderna’s Covid vaccine without disclosing he worked for the company. He also sent promotional tweets from a personal account without revealing his role.
The PMCPA said the article and tweets amounted to advertising the vaccine, and viewed the failure to inform readers of links to Moderna as unacceptable.
Molly Kingsley, the founder of UsForThem, said: “Many of the previous judgments against Moderna have revealed how readily it put profit ahead of the health and safety of children.
“Now it has also laid bare just how little regard it has had for the regulatory system that was supposed to keep it honest.
“Never before has a company so new to the pharmaceutical industry been rebuked in this way.”
In two new rulings, Moderna was found to have made ten new breaches of the code. UsforThem said it was particularly worrying as they related to three senior executives at the company.
The PMCPA said that an audit was now necessary to look at whether Moderna’s culture, governance and framework were operating effectively, and said the Appeal Board would then consider whether further sanctions were needed after auditors had reported back.
Suspension of expulsion
The Appeal Board can report a company to the APBI board, which can suspend or expel them from the APBI.
Suspension or expulsion would be a blow for Moderna, which only joined in 2023.
The APBI has taken the measure just nine times in the past 40 years.
The last company to be suspended was Novo Nordisk in 2023. The company manufactures the high-profile weight loss drugs Saxenda and Wegovy, and type 2 diabetes drug Ozempic. Its membership was restored in March.
In the past year, Moderna has been ordered to pay thousands for breaches of the regulations, including for using off-label data to promote its Spikevax vaccine at the European congress of clinical microbiology and infectious diseases in April 2022.
But critics argue the company’s revenue is nearly £7 billion in 2023, so with such small sums it has no incentive to stick to the rules, while being suspended from the APBI only brings reputational damage.
Esther McVey MP, a former member of the all-party parliamentary group on Covid vaccine damage, said: “There have now been six cases over the last few months where the UK Prescription Medicines Code of Practice Authority (PMCPA) have ruled against Moderna regarding multiple breaches of the industry’s Code of Practice.
“The news that the PMCPA is taking the highly unusual step of ordering an audit of Moderna’s culture, governance and compliance framework is reputationally damaging, but it is incredible that the regulator has no real power to impose appropriate fines or other meaningful penalties which might make pharmaceutical companies think twice before breaking the rules.
“They know they can get away with it, and so they do; time and time again. It’s hardly surprising that public trust in the pharmaceutical industry and its regulators is through the floor.”
