Health and Me

Ishita Roy

FDA Refuses To Review Moderna's Flu Vaccine Application

<strong><span rel="noindex">FDA refuses</span> to review Moderna's <span rel="noindex">flu vaccine</span>: </strong>The U.S. Food and Drug Administration (<span>FDA</span>) has declined to begin reviewing Moderna’s application for its experimental <span>flu</span> vaccine. The company made the announcement on Tuesday. The decision marks another signal of stricter vaccine oversight under the Trump administration and has already rattled investor confidence, with Moderna’s stock falling nearly 7% in after-hours trading.

<a href="https://www.healthandme.com/health-news/trump-suggests-changes-in-childhood-vaccines-says-it-is-based-on-what-he-feels-article-152876627" data-type="tilCustomLink">Trump</a> administration, including the Health Secretary RFK Jr. are anti-vaxxers who have pushed vaccine policies so much so that the number of compulsory childhood vaccines have reduced to 11 from 17. Of the six diseases removed from the list included influenza. 

Read: <a href="https://www.healthandme.com/health-news/cdc-vaccine-schedule-coverage-falls-from-17-to-11-diseases-for-children-article-153401712" data-type="tilCustomLink">CDC Vaccine Schedule: Coverage Falls From 17 to 11 Diseases For Children</a>

Moderna said the FDA’s refusal came as a surprise and contradicted feedback the company had received earlier, before it submitted the application and launched phase three trials for the vaccine, known as mRNA-1010. The company has now requested a meeting with the agency to better understand what it described as an unclear “path forward.”

<h2>FDA Refuses: Objections Raised Over Trial Design</h2>

According to Moderna, the FDA did not flag any safety or efficacy concerns with the vaccine itself. Instead, the agency objected to the design of the clinical trial—despite having previously signed off on it. Moderna added that the setback would not affect its financial guidance for 2026.

The experimental flu shot had shown encouraging results in phase three trials last year, successfully meeting all primary trial endpoints. At the time, Moderna positioned the stand-alone flu vaccine as a critical step toward developing a combined influenza and COVID-19 vaccine, a key long-term goal for the company.

<h2>FDA Refuses: Shifting U.S. Vaccine Policy Landscape</h2>

The decision comes amid sweeping changes to U.S. immunisation policy over the past year under Health and Human Services Secretary Robert F. Kennedy Jr., who has long expressed skepticism toward vaccines. Moderna on Tuesday pointed to the FDA’s top vaccine regulator, Vinay Prasad, who returned to the agency in August after being removed earlier.

Prasad currently heads the FDA’s Center for Biologics Evaluation and Research (CBER) and has publicly argued for tighter regulatory standards for vaccines. He has also drawn controversy for comments linking child deaths to COVID-19 vaccines.

<h2>FDA Refuses: FDA Letter Cites Comparator Concerns</h2>

In a letter dated February 3 and signed by Prasad, the FDA stated that its refusal to review Moderna’s application was solely due to concerns about the trial’s design. Specifically, the agency objected to Moderna’s choice of comparator, arguing that comparing the experimental shot to a standard, approved flu vaccine did not represent the “best available standard of care.”

As a result, the FDA concluded that the study did not qualify as an “adequate and well-controlled” trial under its regulatory definition.

Moderna has strongly disputed this interpretation, arguing that FDA rules do not require companies to use the most advanced or highest-dose vaccine as a comparator in clinical trials.

<h2>FDA Refuses: Moderna Pushes Back, Eyes 2026–27 Timeline</h2>

In a statement, Moderna CEO Stéphane Bancel said the decision undermines innovation and fails to advance shared public health goals. He emphasized that the trial design had been discussed and agreed upon with CBER before the study began.

Moderna now expects the earliest possible approval for its flu shot to come in late 2026 or 2027, pending regulatory reviews across the U.S., Europe, Canada, and Australia.

The FDA declined to comment, stating it does not discuss regulatory communications with individual companies, reported <em>CNBC</em>.

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FDA refuses to review Moderna's flu vaccine: The U.S. Food and Drug Administration (FDA) has declined to begin reviewing Moderna’s application for its experimental flu vaccine. The company made the announcement on Tuesday. The decision marks another signal of stricter vaccine oversight under the Trump administration and has already rattled investor confidence, with Moderna’s stock falling nearly 7% in after-hours trading.Trump administration, including the Health Secretary RFK Jr. are anti-vaxxers who have pushed vaccine policies so much so that the number of compulsory childhood vaccines have reduced to 11 from 17. Of the six diseases removed from the list included influenza. Read: CDC Vaccine Schedule: Coverage Falls From 17 to 11 Diseases For ChildrenModerna said the FDA’s refusal came as a surprise and contradicted feedback the company had received earlier, before it submitted the application and launched phase three trials for the vaccine, known as mRNA-1010. The company has now requested a meeting with the agency to better understand what it described as an unclear “path forward.”FDA Refuses: Objections Raised Over Trial DesignAccording to Moderna, the FDA did not flag any safety or efficacy concerns with the vaccine itself. Instead, the agency objected to the design of the clinical trial—despite having previously signed off on it. Moderna added that the setback would not affect its financial guidance for 2026.The experimental flu shot had shown encouraging results in phase three trials last year, successfully meeting all primary trial endpoints. At the time, Moderna positioned the stand-alone flu vaccine as a critical step toward developing a combined influenza and COVID-19 vaccine, a key long-term goal for the company.FDA Refuses: Shifting U.S. Vaccine Policy LandscapeThe decision comes amid sweeping changes to U.S. immunisation policy over the past year under Health and Human Services Secretary Robert F. Kennedy Jr., who has long expressed skepticism toward vaccines. Moderna on Tuesday pointed to the FDA’s top vaccine regulator, Vinay Prasad, who returned to the agency in August after being removed earlier.Prasad currently heads the FDA’s Center for Biologics Evaluation and Research (CBER) and has publicly argued for tighter regulatory standards for vaccines. He has also drawn controversy for comments linking child deaths to COVID-19 vaccines.FDA Refuses: FDA Letter Cites Comparator ConcernsIn a letter dated February 3 and signed by Prasad, the FDA stated that its refusal to review Moderna’s application was solely due to concerns about the trial’s design. Specifically, the agency objected to Moderna’s choice of comparator, arguing that comparing the experimental shot to a standard, approved flu vaccine did not represent the “best available standard of care.”As a result, the FDA concluded that the study did not qualify as an “adequate and well-controlled” trial under its regulatory definition.Moderna has strongly disputed this interpretation, arguing that FDA rules do not require companies to use the most advanced or highest-dose vaccine as a comparator in clinical trials.FDA Refuses: Moderna Pushes Back, Eyes 2026–27 TimelineIn a statement, Moderna CEO Stéphane Bancel said the decision undermines innovation and fails to advance shared public health goals. He emphasized that the trial design had been discussed and agreed upon with CBER before the study began.Moderna now expects the earliest possible approval for its flu shot to come in late 2026 or 2027, pending regulatory reviews across the U.S., Europe, Canada, and Australia.The FDA declined to comment, stating it does not discuss regulatory communications with individual companies, reported CNBC.