Coverage spread: 2 sources — 2 left
Lean ratings via AllSides / Media Bias-Fact-Check. How this works.
Where they agree
- The FDA approved mFlusiva, Moderna’s mRNA-based flu vaccine, for adults 50 and older — the first mRNA flu shot cleared in the U.S.
- The FDA initially refused to review Moderna’s application this year, then reversed course about a week later after Moderna revised its submission.
- Approval for the 65-and-older group is conditional on Moderna running an additional clinical trial in that age group.
- The approval stands in contrast to HHS Secretary Robert F. Kennedy Jr.’s public criticism of mRNA vaccine technology and his cancellation of mRNA research funding.
Where they differ
- CBS News emphasizes the political and regulatory conflict, quoting Moderna’s statement and detailing Dr. Vinay Prasad’s refusal-to-file letter.
- NBC News leans more heavily on clinical and public health context, citing Dr. Ofer Levy and effectiveness statistics from the Mayo Clinic and Infectious Diseases Society of America.
- NBC specifies the trial showed mFlusiva was about 27% more effective than a standard flu shot; CBS does not give this figure.
- NBC includes additional background on Moderna’s separate flu-Covid combination shot approved in the EU but withdrawn from U.S. consideration; CBS omits this.
The FDA on Wednesday approved mFlusiva, Moderna’s flu vaccine built on mRNA technology, making it the first influenza shot of its kind cleared for use in the United States. The approval covers adults 50 and older, with full approval for the 50-to-64 age group and a conditional accelerated approval for those 65 and up, pending an additional clinical trial in that older group. Moderna says it expects mFlusiva to be available for the 2026-27 flu season.
What did the clinical trial show?
The approval rests on a late-stage trial of more than 40,000 adults across 11 countries, including the U.S. In that trial, mFlusiva was found to be about 27% more effective than a standard flu shot at preventing illness in older adults. Side effects — injection-site pain, fatigue, headaches — were reported more often in the mFlusiva group than the comparison group, but were described as mild to moderate. In June, the FDA’s independent vaccine advisory committee unanimously recommended approving the vaccine based on this data.
Why did the FDA initially refuse to review it?
Earlier this year the FDA declined to even accept Moderna’s application for review, then reversed that decision about a week later. The sticking point, laid out in a refusal-to-file letter from FDA vaccine director Dr. Vinay Prasad, was that Moderna’s trial compared mFlusiva to a standard flu shot rather than to the high-dose flu vaccine the CDC specifically recommends for adults 65 and older. Moderna has said the FDA had previously signed off on the trial’s design. To resolve the impasse, Moderna amended its application, splitting its ask into full approval for the 50-64 group and accelerated approval for the 65-and-up group, and agreed to run a further study of the vaccine in older adults. The FDA said it accepted the revised application after discussions led to that new regulatory approach.
How does this fit with HHS Secretary Robert F. Kennedy Jr.’s stance on mRNA vaccines?
The approval comes despite Kennedy’s repeated public criticism of mRNA technology; he has called the mRNA Covid vaccines “the deadliest vaccine ever made.” Last year, HHS under Kennedy canceled roughly 22 mRNA vaccine development projects, representing close to $500 million in canceled research funding. The FDA operates under HHS, so the approval of an mRNA flu shot under Kennedy’s watch is notable given that broader posture toward the technology.
Why does an mRNA flu vaccine matter?
Traditional flu vaccines are manufactured using an egg- or cell-based process that takes roughly six months from strain selection to rollout, forcing manufacturers to guess months in advance which flu strains will circulate. Moderna says its mRNA-based process takes only two to three months, potentially allowing a closer match to the strains actually spreading each season. Dr. Ofer Levy of Boston Children’s Hospital’s Precision Vaccines Program noted that guessing strains half a year out limits how precisely vaccines can be targeted. Traditional flu shots range from about 22% to 56% effective by season, according to the Mayo Clinic, and Levy said public health experts wish that number were higher. The flu hospitalizes hundreds of thousands of Americans annually and can cause tens of thousands of deaths, with young children and older adults most at risk of severe illness.
What’s next for Moderna’s mRNA vaccine plans?
Moderna must still complete the additional trial in adults 65 and older to support full approval in that age group. Separately, the company has been developing a combination flu-and-Covid mRNA vaccine, which the European Union approved in April, but Moderna withdrew its U.S. application for that combination shot last year despite positive late-stage trial results — a sign of the more cautious regulatory climate for mRNA products in the U.S. currently.
How are outlets covering this differently?
CBS News frames the story primarily around the regulatory back-and-forth between Moderna and the FDA and the political tension with Kennedy’s mRNA skepticism. NBC News puts more weight on the clinical and public health case for mRNA flu vaccines, including expert commentary on why faster strain-matching matters and detailed effectiveness comparisons with traditional shots. Both outlets cover the FDA’s initial refusal and reversal, but NBC provides more specific numbers, including the 27% effectiveness edge and the two-to-three-month manufacturing timeline versus six months for standard shots.
Sources
Featured photo: Fletcher via Wikimedia Commons (CC BY 4.0)