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FDA Reverses Course, Will Review Moderna’s mRNA Flu Vaccine
Moderna said on Wednesday the U.S. Food and Drug Administration has agreed to review its influenza vaccine, reversing an earlier decision to reject the application, after the company made modifications. The reversal, which comes just a week after the FDA’s surprise decision to not review the company’s experimental flu vaccine application, lifted shares of the vaccine maker more than 3% before the bell.
The FDA has accepted Moderna’s revised approach seeking full approval for the shot for adults aged between 50 and 64, and accelerated approval for those aged 65 and above, the company said, adding that it will also conduct a post-marketing study in older adults.
The mRNA technology used in Moderna’s and most other Covid shots, credited with saving millions of lives, comes with a shift in the national health policy under Health Secretary Robert F. Kennedy Jr., a long-time anti-vaccine activist who has been particularly critical of mRNA vaccines.
Pharma TV Ads Face Rising FDA Enforcement
More FDA enforcement letters are being sent to pharma TV advertisers in 2026, signaling a tougher regulatory posture and a more critical lens on how claims are framed and presented in direct-to-consumer (D2C) ads. In an FDA letter to Johnson & Johnson this month, the FDA called its Tremfya TV ad false or misleading, arguing that its claim that “1 out of 2 patients” achieved remission after a year excluded patients who failed to respond initially.
The agency also objected to the phrase “100% visible healing,” noting that the clinical endpoint measured remission, not total healing. In another February letter, the FDA challenged Novo Nordisk’s Wegovy pill campaign, disputing phrases like “Live Lighter” and “a way forward” as overstating emotional outcomes.
The agency also cited technical noncompliance, including failure to match required on-screen risk text with spoken audio. Federal scrutiny of pharma D2C advertising began ramping up late last year. We estimate that healthcare and pharma marketers spent $5.56 billion on TV advertising in 2025.
Pediatric Obesity Care Evolves as GLP-1 Therapy Expands — With Caution
Pharmacy Practice News reported:
The rapid expansion of obesity medications into pediatric care is reshaping treatment frameworks, but not without ethical complexity, said experts at the ASPEN 2026 Nutrition Science & Practice Conference, in Long Beach, California.
In 2023, the American Academy of Pediatrics released clinical practice guidelines recommending that clinicians offer obesity pharmacotherapy to adolescents 12 years of age and older as an adjunct to health, behavior, and lifestyle treatment, noted Celtina Reinert, PharmD, CSP, a clinical pharmacist specialist at Children’s Mercy Kansas City, in Missouri (Pediatrics 2023;151[2]:e2022060640).
“There is no benefit to watchful waiting. Obesity does not spontaneously resolve; it is a chronic, relapsing-remitting disease,” Dr. Reinert said, noting that it requires longitudinal, patient-centered management that integrates intensive lifestyle treatment with pharmacotherapy when appropriate.
The medication landscape, generally and in the pediatric space, has evolved rapidly. “Options have changed about six times in the 18 months since I joined this clinic,” Dr. Reinert said. “Even though everything we seem to talk about in this world right now is the GLP-1s [glucagon-like peptide-1 receptor agonists], there are also some other oral medications that patients can get benefit from.
Pfizer Retains Top Spot in Vaccine Maker Rankings as Sanofi’s Slide Sparks ‘Code Red’ Call
Pfizer again heads up a physician ranking of vaccine manufacturers, beating Merck & Co. and Moderna to complete an unchanged top three from the last edition of the survey. But, while the rankings held steady, the operating environment has changed quickly to reinforce the value of being in good standing with physicians.
ZoomRx generated the league table by asking 58 U.S.-based healthcare professionals (HCPs) about 14 vaccine manufacturers. Respondents graded the companies’ innovation, patient centricity, reputation, HCP centricity and promotions, generating data that ZoomRx used to give each manufacturer a score out of 100.
As happened when ZoomRx ran a similar survey in 2024, Pfizer took the top spot after achieving strong scores across all five dimensions. The Big Pharma scored 83 out of 100 after HCPs praised its innovation, reliability and sales execution in particular.
Poll Sees Older Adults Skipping Updated COVID-19 Vaccines — ‘They Didn’t Think They Needed Them’
As Michigan sees growing rates of COVID-19 and high rates of influenza, a national poll led by the University of Michigan has found that 42% of individuals over 50 have not received a shot for either illness within the past six months.
In a survey of 2,964 adults over 50, 49% of individuals told the University of Michigan National Poll on Healthy Aging that it’d been more than a year since their last dose of the COVID-19 vaccine, while 15% never received the vaccine. When asked why they hadn’t received an updated dose, the most common reason people gave was that they did not think they needed an updated dose.
Jeffrey Kullgren, a primary care physician at the VA Ann Arbor Healthcare System and the poll’s director, told Michigan Advance that while it’s good news that many older adults have been recently vaccinated against COVID-19 and influenza, many of the answers from individuals on why they didn’t receive the vaccine were in conflict with public health guidances.
WHO Prequalifies New Polio Vaccine to Boost Global Outbreak Response
The World Health Organization said on Feb.13 it had prequalified another novel oral polio vaccine type 2 (nOPV2), a step it said would speed efforts to eradicate the disease. Prequalification certifies that the vaccine meets international standards for quality and safety, allowing U.N. agencies such as UNICEF to buy and distribute it for immunization campaigns.
The nOPV2 shot is designed to be more genetically stable than older oral polio vaccines, lowering the risk of triggering new outbreaks while helping to stop transmission, the WHO said. The move follows a pledge by global leaders in December to provide $1.9 billion to support eradication efforts, aiming to protect 370 million children each year despite recent budget cuts.
Polio, a disabling and potentially life-threatening disease, has been wiped out in many regions but continues to circulate.
