During the first year of the Trump administration, signs of an anti-mRNA slant within the FDA and the Department of Health and Human Services (HHS) became more and more evident. Now, with a refusal-to-file (RTF) letter issued to Moderna over the company’s next-gen flu shot, the situation has been brought into a much clearer focus.
Tuesday, Moderna said it received a RTF letter that flagged the design of the company’s phase 3 trial for its mRNA flu shot, mRNA-1010. The letter specifically took issue with the trial’s control arm, which incorporated a “licensed standard-dose seasonal influenza vaccine,” per Moderna’s press release.
In refusing to take up Moderna’s filing—which had been submitted with a priority review voucher—the FDA flagged that the trial’s control arm “does not reflect the best-available standard of care.”
Neither federal regulations nor FDA guidance stipulate the need for a “best-available standard of care” control arm, according to Moderna’s take on the situation.
In addition, the company says the FDA didn’t flag the standard-dose as a deal-breaker when it was working on phase 3 protocol with the agency.
In a sharply worded statement, Moderna CEO Stéphane Bancel said the decision to issue a RTF letter “does not further our shared goal of enhancing America’s leadership in developing innovative medicines.”
“It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting,” Bancel added, referring to the FDA’s Center for Biologics Evaluation and Research, which oversees vaccines.
The mRNA specialist took the unusual step of publishing the RTF letter (PDF) and says it has requested a meeting with the FDA to determine next steps.
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Meanwhile, the vaccine is under review in the EU, Canada and Australia, and Moderna says more filings are planned this year. The company doesn’t anticipate an impact to its financial guidance for the year based on the RTF letter.
The development comes as Moderna shifts its own R&D priorities to contend with the current vaccine ecosystem in the U.S. Last fall, Kyle Holen, M.D., head of development, therapeutics and oncology, told Fierce that most of the company’s upcoming investigational new drug applications would be in the oncology space.
Last summer, the HHS abruptly ended mRNA vaccine work funded by the Biomedical Advanced Research and Development Authority. The following month, the HHS’ secretary, Robert F. Kennedy Jr., appeared at a Senate hearing and took issue with the rollout of mRNA COVID-19 shots, alongside endorsing false information about the shots’ safety.
In recent weeks and months, there have been indications that certain individuals with influence over U.S. vaccine policy are pushing for the removal of COVID-19 shots from the market.