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STAT+: FDA advisory panel endorses Moderna mRNA flu vaccine that was subject of controversy

An FDA advisory panel has endorsed Moderna's mRNA flu vaccine after it faced controversy earlier this year when a top agency official initially resisted considering it for review. The panel voted unanimously that the benefits of the vaccine outweigh the risks for adults aged 50 to 64 and those 65 and older. The FDA is expected to make a decision soon, with staff presentations suggesting the vaccine could be licensed through a traditional pathway for the younger group and an accelerated pathway for the older group. A former FDA employee who now works for Moderna commented on the situation.

By Ed Silverman

June 18, 2026

Pharmalot Columnist, Senior Writer

And so, another working week will soon draw to a close — at least on this side of the pond where we have a holiday tomorrow. This means we are staring down a longer-than-usual agenda to fill. So far, we plan to manicure the Pharmalot campus and promenade extensively with the official mascots, and we hope to hold still another listening party, where the rotation will likely include this , this , this , this and this . And what about you? The great outdoors, as always, is beckoning, which could mean a jaunt to the beach or perhaps a hike in the woods. Or maybe a stroll along city streets with an iced drink in hand. If the weather fails to cooperate, the great indoors also provides comfort — you can cook a favorite meal, curl up with an e-book, or binge-watch the telly. Well, whatever you do, have a grand time. But be safe, enjoy, and see you soon. And if dad is still around, remember to say hello. …

Johnson & Johnson has no plans to enter the booming obesity market, opting instead to focus on diseases such as cancer, Bloomberg News writes. This sets J&J apart from many of its rivals trying to develop or acquire obesity medicines following blockbuster weight loss drugs from Eli Lilly and Novo Nordisk. J&J chief executive officer Joaquin Duato said the company aims to become the world’s leading cancer company, with oncology as one of its core growth pillars. Last year, J&J paid $3.05 billion in cash for Halda Therapeutics, gaining access to an innovative new type of oral therapy for prostate cancer. His remarks come as J&J continues to reshape itself following the spin off of its Kenvue consumer health business.

The U.S. Food and Drug Administration approved GSK’s oral antibiotic to treat complicated urinary tract ​infections, giving patients a new treatment option ‌against drug-resistant infections , Pharmaphorum notes. While the pill, called Utebzi, does not offer a novel mechanism of action, it provides an alternative to the current intravenously administered carbapenems, which are often used as a last resort for infections resistant to other antibiotics. GSK acquired rights to Utebzi in a $591 million licensing deal in 2022 with Spero Therapeutics, just a few months after the FDA rejected Spero’s first marketing application for the antibiotic with a request for an additional clinical trial.

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Source document: FDA Committee Recommendation

8 reports

NPR NewsIndependentCenter2 days ago
Key FDA committee unanimously recommends its first vaccine since 2023

A key FDA committee has unanimously recommended Moderna's new mRNA influenza vaccine for adults aged 50 and older.

Bias read (Center): The article reports on a unanimous recommendation by an FDA committee regarding a medical product. There is no discernible political framing, slant, or biased language. The content is purely factual and focuses on the approval process without taking a stance or emphasizing any particular perspective

Official sources cited

  • government FDA Committee Recommendation
The HillIndependentCenter2 days ago
FDA panel gives nod to Moderna flu shot

The FDA’s independent vaccine advisory panel voted unanimously 9-0 that the benefits of Moderna’s mFlusiva flu shot outweigh the risks for individuals aged 50 to 64 and those 65 and older.

Bias read (Center): The article presents a factual summary of the FDA panel's decision without apparent bias. It does not include subjective language, one-sided sourcing, or editorializing. The content focuses on the procedural outcome of the vote rather than taking a stance on the vaccine itself.

Official sources cited

  • government FDA’s independent vaccine advisors
The HillIndependentCenter2 days ago
FDA panel recommends mRNA flu vaccine for older adults

An FDA advisory panel has recommended Moderna’s mRNA-based flu vaccine, mFlusiva, for approval for individuals aged 50 to 64 and those 65 and older. The panel voted unanimously 9-0, concluding that the benefits of the vaccine outweigh the risks.

Bias read (Center): The article presents factual information about an FDA recommendation without apparent ideological framing or biased language. It focuses on the procedural outcome of the vote and does not take a stance on the vaccine itself or related policy debates.

Official sources cited

  • government FDA advisory panel
STAT NewsIndependentCenter2 days ago
STAT+: FDA advisory panel endorses Moderna mRNA flu vaccine that was subject of controversy

An FDA advisory panel has endorsed Moderna's mRNA flu vaccine after it faced controversy earlier this year when a top agency official initially resisted considering it for review. The panel voted unanimously that the benefits of the vaccine outweigh the risks for adults aged 50 to 64 and those 65 and older. The FDA is expected to make a decision soon, with staff presentations suggesting the vaccine could be licensed through a traditional pathway for the younger group and an accelerated pathway for the older group. A former FDA employee who now works for Moderna commented on the situation.

Bias read (Center): The article presents the facts of the FDA advisory panel's endorsement of Moderna's vaccine without overtly favoring any side. It mentions the controversy surrounding the vaccine and includes perspectives from multiple stakeholders, including a former FDA employee now working for Moderna. There is a

Official sources cited

  • government Vaccines and Related Biological Products Advisory Committee (VRBPAC)
  • government Food and Drug Administration (FDA)
STAT NewsIndependentCenter3 days ago
STAT+: Pharmalittle: We’re reading about an FDA review of Moderna’s flu shot, J&J’s focus on cancer, and more

The article discusses several pharmaceutical industry updates, including an FDA review of Moderna's flu shot, Johnson & Johnson's decision to focus on cancer research rather than entering the obesity market, and other related developments.

Bias read (Center): The article presents factual updates on pharmaceutical companies without overtly favoring any political perspective. It reports on business decisions and regulatory reviews in a neutral tone.

Official sources cited

  • press release Bloomberg News
The Washington TimesIndependentCenter3 days ago
FDA panel considers a first-of-its-kind flu vaccine using mRNA technology

The FDA advisory committee is considering approval of Moderna's first mRNA-based flu vaccine, mFlusiva, for individuals aged 50 and older. The vaccine showed a 27% reduction in flu cases compared to a commonly used alternative in a study involving 40,000 participants. The FDA has released a positive review of the data with no safety concerns noted. Moderna seeks full approval for the 50–64 age group and conditional authorization for those 65 and older during further testing.

Bias read (Center): The article presents factual information about the development and evaluation of a new medical technology without overtly favoring any political perspective. It focuses on scientific and regulatory processes rather than ideological arguments.

Official sources cited

The HillIndependentCenter3 days ago
FDA vaccine panel set to review Moderna mRNA flu shot

The FDA's vaccine advisory panel is set to review Moderna's mRNA-based flu vaccine candidate. The article mentions that the panel appears open to the candidate ahead of a key meeting.

Bias read (Center): The article provides a factual summary of an upcoming FDA review without apparent ideological framing or biased language. It does not take a stance on the vaccine's merits or the panel's potential decision.

STAT NewsIndependentCenter4 days ago
STAT+: FDA appears open to Moderna’s flu vaccine ahead of adcomm

The FDA has reversed its opposition to an experimental treatment for Huntington's disease, allowing the biotech company UniQure to file for U.S. approval. This development comes amid ongoing discussions about the regulatory landscape for innovative therapies.

Bias read (Center): The article reports on a regulatory decision regarding a medical treatment without taking a stance or using biased language. It focuses on factual updates about the FDA's actions and does not frame the information in a politically charged manner.

Official sources cited

  • government FDA Reverses Opposition to Experimental Treatment for Huntington's Disease

Go to the primary sources (8)

The official sources this coverage is built on. Read them directly to bypass framing.

  • governmentFDA Committee Recommendation
  • governmentFDA’s independent vaccine advisors
  • governmentFDA advisory panel
  • governmentVaccines and Related Biological Products Advisory Committee (VRBPAC)
  • governmentFood and Drug Administration (FDA)
  • press_releaseBloomberg News
  • governmentFDA review of Moderna's data
  • governmentFDA Reverses Opposition to Experimental Treatment for Huntington's Disease