The pharmaceutical self-regulatory body has “publicly reprimanded” manufacturer Moderna for not providing “full and frank disclosure of all the facts” about when it became aware of an “unauthorised offer of £1,500” to child participants in a COVID-19 vaccine trial.
In an interim case report published last week (May 1), the PMCPA found that the manufacturer brought “discredit upon…the pharmaceutical industry” and failed to meet high standards.
“The complaint related to the unapproved use of social media to solicit the recruitment of children into a clinical trial using inappropriate and unethical financial incentives,” it said.
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“The core concern was the communication via a group WhatsApp message sent by a paediatrician at a major…NHS trust that had been recruited on behalf of Moderna,” it added.
The doctor offered “an incentive of £1,500 for the purposes of recruiting 12–18-year-old children into Moderna’s phase three clinical trial of a version of its COVID-19 vaccine”, it said.
Moderna said that it “accepts” the regulator’s decision and will work “constructively” to “further strengthen” its compliance. Read its response in full below.
“Plainly false”
When concerns were raised with the manufacturer by parent-led campaign group UsForThem in August 2023, Moderna said the claim that the trial would “pay a lump sum of £1,500 to each child at the completion of the trial [was] incorrect”, the report said.
But two weeks after it received the group’s letter, Moderna “definitively denied” that concerns had been flagged, it added.
Moderna told the PMCPA it was not until January 2024, following a meeting with the Health Research Authority (HRA), that it became aware of a “specific WhatsApp message offering payment of £1,500”.
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“In UsForThem’s August 2023 letter, no details were provided regarding the alleged offer beyond the £1,500 reference, nor that it had been communicated via WhatsApp,” Moderna said.
“Our response to UsForThem reflected Moderna’s genuine understanding at the time, that this was an erroneous reference to the outdated, unapproved version of the trial recruitment materials,” it added.
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But the self-regulator said that it was “not unreasonable to expect that…Moderna should have investigated this allegation and in addition sought additional information” from the campaign group.
“Any suggestion that Moderna was not made aware of the existence of a potential serious breach of ethical and legal rules until January 2024 is plainly false – at least two of the most senior officers…were made aware in August 2023,” it added.
“Most serious breach”
“We assume that in any dealings with the PMCPA, pharmaceutical companies are expected to be not only truthful and accurate, but transparent and candid,” the watchdog said.
“Incidentally, this was one of two PMCPA decisions published in the space of a single week in which the PMCPA found Moderna guilty of a breach of Clause two – upholding confidence in the industry – of the code of practice,” it added.
It stressed that being found “guilty twice in a single week of the most serious breach possible” was “presumably some kind of record even in an industry that seems now routinely to breach its regulatory commitments”.
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“Any suggestion that Moderna may have dealt with the PMCPA other than transparently, candidly and accurately must be a matter of serious concern,” it added.
The regulators’ appeal board “agreed with the panel that the lack of transparency was completely unacceptable”.
It added that the board required “a specific scope audit of Moderna’s procedures”, focusing on the company’s “culture, governance and compliance framework”.
Moderna “accepts decision”
Commenting on the report yesterday (May 6), Moderna told C+D that it “accepts the decision of the PMCPA appeal board and the requirement for a mandatory compliance audit”.
“We view this as an additional opportunity to further strengthen our compliance framework,” it added.
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“We will work constructively with the PMCPA and the Association of the British Pharmaceutical Industry (ABPI) throughout the audit process, reinforcing our commitment to responsible communications and upholding the standards of ethical conduct and integrity,” it said.
Meanwhile in August, the PMCPA revealed that it was “concerned” about “integral” parts of weight loss drug manufacturer Novo Nordisk’s UK pharmacy chain sponsorships.
Read more: Everything you need to know about the Moderna COVID-19 vaccine
It came after a whistleblower claimed Novo Nordisk “had paid significant amounts of sponsorship money to large national pharmacy chains”.
They added that the funding was “used to actively and aggressively promote its services and the prescription medicines” – “specifically” glucagon-like peptide-1 receptor agonist (GLP-1 RA) weight loss drug Saxenda.
The regulator found that “Novo Nordisk…demonstrated a very poor understanding” of its code of conduct.
