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FDA refuses to review Modernas mRNA flu vaccine application

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"This decision protects children, respects families, and rebuilds trust in public health."

"This [2026] decision recommits HHS to all three [transparency, rigorous science, and respect for families]."

"This decision commits NIH, CDC, and FDA to gold standard science, greater transparency, and ongoing reassessment as new data emerge."

"No family will lose access.This [2026] framework empowers parents and physicians to make individualized decisions based on risk, while maintaining strong protection against serious disease."

"The data support a more focused schedule that protects children from the most serious infectious diseases while improving clarity, adherence, and public confidence."

“I think that a reduced schedule is going to endanger children and lay the groundwork for a resurgence in preventable disease.”

“Changing the pediatric vaccine schedule based on no scientific input on safety risks and little transparency will cause unnecessary fear for patients and doctors, and will make America sicker.”

"This wildly irresponsible decision will put lives at risk."

“There will be more diseases, more infection, more hospitalizations.”

Will Secretary Kennedy's U.S. Childhood Vaccine Schedule Overhaul Risk Public Health?

Pharmaceutical maker Moderna announced Tuesday that the U.S. Food and Drug Administration (FDA) issued a refusal-to-file letter regarding its application for an mRNA-based influenza vaccine, mRNA-1010. The FDA's Center for Biologics Evaluation and Research cited concerns about the trial design.

Pharmaceutical maker Moderna announced Tuesday that the U.S. Food and Drug Administration (FDA) issued a refusal-to-file letter regarding its application for an mRNA-based influenza vaccine, mRNA-1010. The FDA's Center for Biologics Evaluation and Research cited concerns about the trial design.

The letter, signed by the Director of the Center for Biologics Evaluation and Research (CBER) at the FDA Vinay Prasad, stated that the trial lacked an adequate and well-controlled study because the comparator arm did not reflect the best-available standard of care. The letter did not identify any specific safety or efficacy concerns.

The letter, signed by the Director of the Center for Biologics Evaluation and Research (CBER) at the FDA Vinay Prasad, stated that the trial lacked an adequate and well-controlled study because the comparator arm did not reflect the best-available standard of care. The letter did not identify any specific safety or efficacy concerns.

Moderna's Phase 3 trial compared its experimental vaccine against Fluarix Quadrivalent, a licensed standard-dose seasonal influenza vaccine sold by GSK, in a study of approximately 40,000 adults aged 50 and older. The trial concluded the new vaccine was more effective.

Moderna's Phase 3 trial compared its experimental vaccine against Fluarix Quadrivalent, a licensed standard-dose seasonal influenza vaccine sold by GSK, in a study of approximately 40,000 adults aged 50 and older. The trial concluded the new vaccine was more effective.

In April 2024, Moderna submitted its Phase 3 study protocol to the FDA for review, and the agency provided written guidance stating that it would be acceptable to use a licensed standard-dose influenza vaccine as the comparator, though a vaccine for older adults was recommended.

In April 2024, Moderna submitted its Phase 3 study protocol to the FDA for review, and the agency provided written guidance stating that it would be acceptable to use a licensed standard-dose influenza vaccine as the comparator, though a vaccine for older adults was recommended.

Moderna CEO Stéphane Bancel stated that the FDA's decision does not further the "shared goal of enhancing America's leadership in developing innovative medicines." The company has requested a meeting with the FDA to understand the path forward and noted the vaccine is under review in Europe.

Moderna CEO Stéphane Bancel stated that the FDA's decision does not further the "shared goal of enhancing America's leadership in developing innovative medicines." The company has requested a meeting with the FDA to understand the path forward and noted the vaccine is under review in Europe.

This decision comes amid increased scrutiny of vaccines under Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., who has criticized mRNA technology. In 2025, Kennedy announced the cancellation of over $500 million in contracts and funding for mRNA vaccine development.

This decision comes amid increased scrutiny of vaccines under Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., who has criticized mRNA technology. In 2025, Kennedy announced the cancellation of over $500 million in contracts and funding for mRNA vaccine development.

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Requiring rigorous trials with proper controls strengthens vaccine trust and regulatory integrity. The FDA should demand higher standards for approval, especially for drugs treating common conditions, and Prasad is making sure those standards are met. Forcing industry to fund more robust studies improves the entire system.

Requiring rigorous trials with proper controls strengthens vaccine trust and regulatory integrity. The FDA should demand higher standards for approval, especially for drugs treating common conditions, and Prasad is making sure those standards are met. Forcing industry to fund more robust studies improves the entire system.

Dr. Angela Rasmussen

John Mandrola, MD

Moderna invested $750 million in trials proving mRNA-1010 beats traditional vaccines by 25% for vulnerable seniors, yet the FDA invented impossible demands that crashed stocks 18% and halted 150 million lifesaving doses. This political sabotage forces reliance on slower, weaker egg-based shots while punishing innovation.

Moderna invested $750 million in trials proving mRNA-1010 beats traditional vaccines by 25% for vulnerable seniors, yet the FDA invented impossible demands that crashed stocks 18% and halted 150 million lifesaving doses. This political sabotage forces reliance on slower, weaker egg-based shots while punishing innovation.

White House Xray

Joseph Allen

There's an 80% chance that a new tuberculosis vaccine will be approved by the U.S. FDA, EU EMA or Japan's PMDA before Jan. 1, 2028, according to the Metaculus prediction community.

There's an 80% chance that a new tuberculosis vaccine will be approved by the U.S. FDA, EU EMA or Japan's PMDA before Jan. 1, 2028, according to the Metaculus prediction community.

FDA Rejects Moderna's mRNA Flu Vaccine Over Trial Design

FDA Rejects Moderna's mRNA Flu Vaccine Over Trial Design

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FDA Rejects Moderna's mRNA Flu Vaccine Over Trial Design

FDA Rejects Moderna's mRNA Flu Vaccine Over Trial Design

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