Moderna has suffered its second PMCPA rebuke in quick succession. Days after ruling Moderna had brought discredit on the industry, the U.K. self-regulatory body reached the same damning conclusion in a separate case.
The second case focused on a Moderna presentation at the European Congress of Clinical Microbiology and Infectious Diseases in April 2022. According to the complainant, the session’s title suggested a balanced presentation covering mRNA technologies in a pandemic scenario, but the content actually promoted Moderna’s Spikevax and included off-label data on the vaccine.
When the PMCPA put the accusations to Moderna, the biotech said the event took place many months before it became a member of the Association of the British Pharmaceutical Industry (ABPI) and had accepted the jurisdiction of the self-regulatory body. The biotech didn’t agree it could reasonably be expected to have been in compliance with the ABPI code before becoming a member.
“If the PMCPA’s position is that the ABPI Code does apply retrospectively to all members on joining the ABPI, this needs to be made clear to companies before they decide to join. This would have materially impacted Moderna UK’s decision as to when to join the ABPI,” the biotech said.
The PMCPA told Moderna it does accept complaints about activities that predate a company’s agreeing to comply with the code. Moderna could ask to refer the matter to the MHRA, the PMCPA said, but getting the U.K. regulator involved wouldn’t stop it from making its own assessment. Moderna agreed to the PMCPA’s handling of the case.
As well as arguing that the code shouldn’t apply, Moderna made the case that the presentation wasn’t promoting Spikevax to U.K. healthcare professionals outside the product’s U.K. license. The event took place in Portugal, but a U.K. healthcare professional gave the presentation. Moderna said the clinical data shared in the presentation was of “genuine scientific interest for the attendees.”
The PMCPA reached different conclusions. The body said the presentation was within its remit because it was delivered by a U.K. speaker to an audience that included U.K. health professionals. That established, the PMCPA panel turned its attention to the question of whether the presentation was promotional.
“The panel noted that only four of the 23 slides, including the title slide, made no direct reference to Spikevax; the panel was therefore concerned that Moderna had submitted that the presentation was not promotional. In the panel’s view, the presentation could not be seen as anything other than promotion of Spikevax,” the PMCPA said.
Moderna was found to have breached three clauses of the code. The panel ruled Moderna promoted Spikevax in a manner that was inconsistent with the summary of product characteristics, resulting in one breach. Moderna’s second charge—failing to maintain high standards—stemmed from the presentation of efficacy and safety claims based on a different dose than that licensed in the U.K.
“Taking everything into account, the panel considered that the promotion of off-label information about dosage in association with claims such as ‘safe’, ‘most immunogenic’ and ‘the best’, meant that Moderna had brought discredit upon and reduced confidence in the pharmaceutical industry and a breach of Clause 2 was ruled,” the PMCPA said.
The ruling marks the second time in a matter of days that Moderna has been found to bring discredit to the pharma industry. The earlier ruling related to an unapproved WhatsApp message that offered children around $2,000 to participate in a COVID-19 booster vaccine trial.