Indications of an anti-mRNA bias in the FDA and the Department of Health and Human Services (HHS) would continue to emerge during the first year of the Trump administration. The situation is now in much clearer focus, now that a refusal-to-file (RTF) letter was issued to Moderna regarding the company’s next-gen flu shot.
Moderna disclosed that it had obtained an RTF letter, which had raised concerns about the design of the phase 3 trial of its mRNA flu shot, mRNA-1010. The letter specifically objected to the control arm of the trial, which involved a so-called licensed standard-dose seasonal influenza vaccine, according to the press release issued by Moderna.
The FDA indicated that the control arm of the trial does not represent the best-available standard of care, when the refusal to accept the filing of Moderna, which was made with a priority review voucher.
According to the Moderna interpretation of the situation, neither federal control nor FDA directions presupposes the presence of a control arm that constitutes the best-available standard of care.
Besides this, the firm claims that the FDA did not indicate the standard-dose as a deal-killer when it was developing the phase 3 protocol with the agency.
Moderna CEO Stéphane Bancel asserted in a letter that the move to release an RTF letter does not advance our common interest of increasing the leadership of America in creating innovative medicines.
Bancel had added, referring to the FDA and its Center for Biologics Evaluation and Research, which regulates vaccines, that it should not be controversial to do a comprehensive review of a submission of a flu vaccine that uses an FDA-approved vaccine as a comparator in a study that had been discussed and agreed on with CBER before the study was initiated.
The mRNA expert went to the extreme of releasing the RTF letter (PDF) and that it has sought an audience with the FDA to discuss the way forward. The letter was signed personally by CBER director Vinay Prasad, and led the process of deciding to disallow the filing, vetoing agency employees.
Analysts at Citi said in an email to clients that there is no surprise regarding the change in approach of the agency, but the changing regulatory environment. The RTF letter potentially spells doom to the Moderna combo flu-COVID vaccine, the analysts indicated, because the program will be based on the data package of the stand-alone flu vaccine. The two shots would have earned 750 million dollars in the year 2028, and thus, the future sales might have been left in limbo as anticipated by the Citi team.
Generally, the Citi analysts said that the development provides a wrench to the seasonal dependency of the company on the use of vaccines to achieve its 2028 break-even goal of cash.
Notably, the analysts contended that it ought to have been evident that the FDA also desired Moderna to utilize a high-dose vaccine as the comparator in the trial. Although the FDA signed onto the plan of standard dose comparator two years ago, during the term of President Joe Biden, Citi mentioned that the regulatory environment has changed since then and that the writing has been on the wall long before our time.
In the meantime, the vaccine has been reviewed in the EU, Canada, and Australia, and Moderna has stated that additional filings are planned this year. According to the RTF letter, the company does not expect to be affected by the financial guidance for the year.
The shift is accompanied by Moderna changing its personal R&D priorities to be able to compete with the existing vaccine ecosystem within the U.S. Late last year, the head of development, therapeutics and oncology, Kyle Holen, said that the majority of the future investigational new drug submissions of the company would be done in the oncology area.
In the summer before, the HHS called off an mRNA vaccine project financed by the Biomedical Advanced Research and Development Authority at the last minute. The HHS secretary, Robert F. Kennedy Jr., then testified in a Senate committee the next month and objected to the implementation of mRNA COVID-19 vaccines, as well as supported false statements regarding the safety of the shots.
Over the past few months, some people who have influence over the vaccine policy in the U.S. have been hinting at the possibility of removing COVID-19 shots from the market.
FDA Issues Refusal to File Letter for Moderna’s mRNA Flu Vaccine
The U.S. Food and Drug Administration (FDA) has delivered a refusal to file (RTF) letter to Moderna regarding its investigational mRNA-based seasonal influenza vaccine, creating a new regulatory hurdle for Moderna as it seeks to expand its respiratory vaccine portfolio.
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