Feb. 20 (UPI) — Regulatory predictability is crucial for vaccine makers as they plan trials for future products but shakeups in the United States’ top health agencies are making the process more difficult to navigate.
The U.S. Food and Drug Administration issued a refuse-to-file notice to drugmaker Moderna for its mRNA-1010 influenza vaccine earlier this month. The agency has since changed course, agreeing to review the vaccine, but the initial decision is just the latest signal to the industry that the U.S. market for vaccines has become less receptive.
In a statement to UPI, the FDA said it rejected Moderna’s application “because the company refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy.”
“Moderna exposed participants age 65 and over to increased risk of severe illness by giving them a substandard of care against the recommendation of FDA scientists,” spokesman Andrew Nixon said in a statement. “The most protective flu shots for seniors are a subset of high dose flu shots recommended by the CDC Advisory Committee on Immunization Practices, which would have served as the proper control in this study.”
A refuse-to-file decision is the agency’s way of saying an application is not complete or does not meet the requirements for a review. It is not a dismissal of the application based on an evaluation of its scientific merits or safety.
This refusal-to-file decision was unusual, Richard Hughes IV, a law professor at George Washington University and attorney with Epstein Becker Green, told UPI. He said manufacturers are always in communication with the FDA during the application process. If more is needed from a manufacturer, the FDA will typically request for it, rather than outright refusing the application.
Moderna announced in a press release on Wednesday that the FDA agreed to accept an amended biologics license application. If approved, its mRNA-1010 vaccine would be available for adults 50 and older for the 2026-2027 flu season.
“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Stephane Bancel, CEO of Moderna, said in a statement. “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against the flu.”
The European Union, Canada and Australia have accepted Moderna’s influenza vaccine for review and it expects more countries to do so.
The initial refusal by the FDA did not come as a surprise to Hughes. He is representing the American Academy of Pediatrics in a lawsuit against Kennedy in the U.S. District Court in Massachusetts over Kennedy changing the childhood vaccine schedule last year. The lawsuit is ongoing.
“We’ve seen a steady stream of anti-vaccine actions out of the administration,” Hughes told UPI. “We’ve seen an upheaval at the Advisory Committee on Immunization Practices. We’ve seen the secretary make unilateral changes to the childhood immunization schedule. The platforming of junk science out of the ACIP. All of this has created a really challenging environment for vaccines.”
That challenging environment has sparked some vaccine makers like Moderna to rethink investing vaccines for the American market. Bancel said last month during the World Economic Forum in Davos, Switzerland, that Moderna does not plan to continue investments into new late-stage vaccine trials because of the current environment around vaccines in the United States.
“You cannot make a return on investment if you don’t have access to the U.S. market,” Bancel said.
The rejection of Moderna’s influenza vaccine did not occur in isolation, Hughes said.
Kennedy cast doubt publicly last year about the efficacy of a COVID-19 vaccine produced by Novavax, saying it “never really worked.” Novavax has since transferred its U.S. marketing responsibilities to another company.
The FDA revoked the license for the chikungunya vaccine in August, weeks after lifting a pause on administration of the vaccine and recommending it for high-risk travelers. The vaccine continues to hold licenses in other countries.
Also in August, Kennedy directed the cancellation of a $500 million investment in mRNA vaccine development. Twenty-two government contracts were terminated in the move as Kennedy said mRNA technology “poses more risks than benefits for these respiratory viruses.”
A study published in The New England Journal of Medicine disagreed. The study examined the efficacy and safety of an mRNA influence vaccine made by Pfizer, finding that those who received it had 34.5% fewer flu-like illnesses than those who received the standard flu vaccine. The vaccine had an “acceptable safety profile” in its phase 1 and 2 trial.
Disinformation and mixed signals from the top health officials in the United States may not just cost drug companies, it may deteriorate public health in the future, Hughes said.
“It means we’re going to see decreased immunization uptake. We won’t have certain future vaccines but we’ll see decreased vaccine uptake for current vaccines,” Hughes said. “For some diseases, we’re going to see outbreaks.”
The United States recorded the largest measles outbreak in more than 20 years earlier this year when 789 cases were reported in South Carolina. Measles were declared eradicated in the United States in 2000.
More than a dozen more states have recorded cases of the measles this month.
“We maintain herd immunity by maintaining high vaccine coverage rates,” Hughes said. “We are losing that. What that is going to mean is disease and death. It’s inevitable.”
Hughes acknowledges that the Secretary of Health and Human Services enjoys a great deal of authority over public health policy and vaccine development but the scientific review process plays a critical role as well.
For vaccines to reach the public in the United States, the FDA evaluates clinical trial data to determine if they are safe and effective. Researchers outside the agency are often consulted during this process.
After receiving licensing, the vaccine goes before the Advisory Committee on Immunization Practices within the Centers for Disease Control and Prevention. Evidence of the vaccine’s safety and effectiveness is reviewed and guidance around its distribution is created.
Both steps in this process are supposed to operate separately from each other, though Hughes raised concerns about political influence becoming a factor where it once was not.
The Administrative Procedure Act prohibits agencies from making “arbitrary and capricious” decisions. Hughes is hopeful this will prevent political influences from overshadowing public health interests.
The American Academy of Pediatrics argues that Kennedy acted “arbitrarily and capriciously” when he made changes to the vaccine schedule.
“It is the last sort of safeguard that we have,” he said. “You’re watching this exercise of vast authority but then we have this ability to constrain it with the Administrative Procedure Act and it’s our last, best hope.”
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