FDA reverses course, will review Moderna's mRNA flu vaccine

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FDA reverses course, will review Modernas mRNA flu vaccine candidate

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The Food and Drug Administration reversed its decision and agreed to review Moderna's mRNA influenza vaccine application after initially declining to consider it earlier this month. Following a Type A meeting between the company and the agency, Moderna proposed full approval for adults aged 50 to 64 and accelerated approval for those 65 and older.

The Food and Drug Administration reversed its decision and agreed to review Moderna's mRNA influenza vaccine application after initially declining to consider it earlier this month. Following a Type A meeting between the company and the agency, Moderna proposed full approval for adults aged 50 to 64 and accelerated approval for those 65 and older.

The FDA assigned a target action date of August 5, 2026, for completing its review of the vaccine. If approved, the vaccine would be available for the 2026-2027 flu season, potentially providing a new option for adults 50 years and older to protect themselves against influenza.

The FDA assigned a target action date of August 5, 2026, for completing its review of the vaccine. If approved, the vaccine would be available for the 2026-2027 flu season, potentially providing a new option for adults 50 years and older to protect themselves against influenza.

The initial refusal stemmed from FDA concerns that Moderna's clinical trial did not compare the vaccine against high-dose flu vaccines recommended for older adults. The agency stated that Moderna should have used a comparator vaccine that better represented the standard of care for that population.

The initial refusal stemmed from FDA concerns that Moderna's clinical trial did not compare the vaccine against high-dose flu vaccines recommended for older adults. The agency stated that Moderna should have used a comparator vaccine that better represented the standard of care for that population.

Moderna's vaccine uses mRNA technology, the same method employed in COVID-19 vaccines that has been credited with saving millions of lives. The company conducted a clinical trial involving more than 40,000 adults aged 50 and older to evaluate the vaccine's efficacy.

Moderna's vaccine uses mRNA technology, the same method employed in COVID-19 vaccines that has been credited with saving millions of lives. The company conducted a clinical trial involving more than 40,000 adults aged 50 and older to evaluate the vaccine's efficacy.

Health and Human Services Secretary Robert F. Kennedy Jr. has been critical of mRNA vaccines for respiratory viruses. Under his leadership, the FDA has terminated nearly $500 million in federal funding for mRNA vaccine development, impacting projects at companies including Moderna and Pfizer.

Health and Human Services Secretary Robert F. Kennedy Jr. has been critical of mRNA vaccines for respiratory viruses. Under his leadership, the FDA has terminated nearly $500 million in federal funding for mRNA vaccine development, impacting projects at companies including Moderna and Pfizer.

Moderna's application has been accepted for review in multiple countries, including the United States, Canada, Australia and the European Union. The company expects the first potential approvals for the vaccine in 2026, subject to ongoing regulatory reviews in these jurisdictions.

Moderna's application has been accepted for review in multiple countries, including the United States, Canada, Australia and the European Union. The company expects the first potential approvals for the vaccine in 2026, subject to ongoing regulatory reviews in these jurisdictions.

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Gain-of-Function Research and the COVID Origins Debate

FDA will review Moderna mRNA vaccine

FDA will review Moderna mRNA vaccine

FDA Reverses Course, Will Review Moderna's mRNA Flu Vaccine

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FDA Reverses Course, Will Review Moderna's mRNA Flu Vaccine

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