FDA refuses to review Moderna’s application for mRNA flu vaccine, company says

The U.S. Food and Drug Administration has refused to accept Moderna’s application to study its first mRNA seasonal flu vaccine. in question On Tuesday, there was another glitch in the technology that has been the target of some health officials from the Trump administration.

The agency told Moderna that its application did not include an “adequate and well-controlled” trial because the control arm did not reflect the “best standard of care available in the United States at the time of the study.” A letter dated February 3 Moderna published online. The company said it did not identify any safety or effectiveness concerns.

Moderna said the rejection was inconsistent with previous feedback from the agency and requested a meeting with FDA officials to understand how to move forward.

Moderna’s president, Dr. “The complete stunner here is, hasn’t anyone ever said this isn’t enough?” Stephen Hoge told CNN on Tuesday. he said.

The U.S. Department of Health and Human Services said that “the FDA generally does not comment on regulatory communications to individual sponsors.” It is rare for the FDA to issue a “refuse to file” letter; A study conducted in 2021 It turned out that only 4% of nearly 2,500 applications to the agency received such letters.

To demonstrate the safety and effectiveness of its experimental mRNA vaccine, Moderna used a standard-dose seasonal flu vaccine called Fluarix as a comparator in a 40,700-person clinical trial. The company said The FDA agreed to that plan in April 2024, but it recommended that the plan also include data comparing its vaccine to the high-dose flu vaccine approved for people over 65, and the company said it did so.

Moderna added that as recently as August, at a meeting before applying for approval of the vaccine, the FDA suggested it would review the application and evaluate issues with the comparator during that process. The agency noted that there may be a “significant problem” with the data “during review” of the application, according to written feedback shared by Moderna.

But last week, the agency refused to conduct the review at all, according to the letter. Dr., director of the FDA’s Center for Biologics Evaluation and Research, which oversees vaccine regulation. Signed by Vinay Prasad.

Prasad, HHS Secretary Robert F. Kennedy Jr. He was an outspoken critic of the government’s response to Covid-19 before being appointed to the FDA under his chairmanship. requested Late last year, he did not provide details about Covid-19 vaccines resulting in the death of 10 children and announced that the institution would change the vaccine approval process.

Moderna is one of three manufacturers of Covid-19 vaccines approved in the US, along with Pfizer and Novavax. Moderna and Pfizer’s vaccines use mRNA technology. Pfizer also has mRNA-based flu vaccines development.

Although the development of mRNA-based Covid-19 vaccines at record speed during the pandemic was one of the main achievements of Trump’s first term, his second administration withdrew its support for mRNA technology in infectious diseases. In August, HHS canceled 22 projects worth about $500 million focused on mRNA vaccine development. claims Against evidence that “these vaccines do not effectively protect against upper respiratory tract infections such as COVID and influenza.”

There are Covid-19 vaccines estimated having saved millions of lives. The hope behind applying mRNA technology to seasonal flu vaccines is that it will make the vaccines work better, allow for tailoring to geographical areas where different strains are circulating, and lead to combinations with Covid-19 vaccines so that people only need a single vaccine to protect against both viruses.

With currently approved technology, experts select flu strains for each fall’s seasonal vaccines the previous February. Hoge pointed out that mRNA vaccines can be produced much faster; He said that it was decided that the design for Covid-19 vaccines would be made in May or June and the shipment would be made in August.

Choosing strains closer to the start of the flu season could potentially lead to a better match with circulating viruses, Hoge said, and “a better match generally equates to better protection.”

Moderna’s phase 3 study showed: results It reported in June that its mRNA-based flu vaccine produced about 27% higher efficacy than Fluarix in adults 50 and older. a separate hearing Moderna said the safety and immune response evaluated included comparison to a high-dose flu vaccine for people 65 and older and showed superiority.

While immune response is evaluated in the laboratory by analyzing blood samples of vaccinated people, effectiveness evaluations often involve seeing how well a vaccine protects against cases of disease.

Hoge said he is waiting for review of the flu vaccine to begin before moving Moderna’s experimental combination flu and Covid-19 mRNA vaccine into the FDA review process. This is currently on hold as the company awaits a meeting and further guidance from the agency.

Meanwhile, the combination vaccine is making progress in other countries as well.

“We expect our first approval will probably be in Europe and this year,” Hoge said. “So this will be a watershed event.”

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