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FDA Plans Rare Advisory Hearing to Debate Moderna’s Flu Shot
Moderna Inc.’s experimental flu shot made with mRNA technology will be reviewed by a Food and Drug Administration advisory panel next month, a sign that the agency may be increasing transparency into its decision-making after several controversies. Advisory panel hearings, once a standard part of the approval process for new medical therapies, have been rare during the second Trump administration. Moderna’s review is scheduled for June 18, according to a notice published Thursday. The FDA is slated to make an approval decision by Aug. 5.
In February, the FDA shocked Wall Street and the biotech industry by initially refusing to review Moderna’s shot, a highly unusual step taken on a tiny minority of applications. It reversed course a few days later. The advisory committee hearing suggests the agency is being more open about how it evaluates drug applications following former Commissioner Marty Makary’s departure last week.
Some biotech companies, including Moderna, complained about being surprised by setbacks in the regulatory review and approval processes under Makary. Acting Commissioner Kyle Diamantas, an attorney, led the agency’s food center before assuming temporary leadership of the agency.
Pfizer Advances Pneumonia Shot After Getting Positive Results in Children
Pfizer Inc. said a new version of its bestselling Prevnar vaccine may provide infants with better protection against common strains of pneumonia than currently available immunizations. The experimental shot was designed to protect against 25 strains of a bacteria that causes pneumonia, five more than the company’s current vaccine. In a mid-stage trial, Pfizer tested it against Prevnar 20, which has been approved for kids since 2023.
After four doses, the newer shot triggered strong immune responses in children up to age 15 months across bacterial strains, Pfizer said on Wednesday. Notably, it also led to a 15-fold higher antibody response to a specific strain that causes more severe disease compared with Prevnar 20, a finding the drugmaker hopes will translate into more durable protection.
Based on the results presented at the International Society of Pneumonia and Pneumococcal Diseases in Copenhagen, Pfizer is moving the vaccine into the final stage of testing. If it succeeds in those trials, the company said it has the potential to protect against about 90% of the disease-causing bacterial strains in children up to age five.
Ebola Vaccine for Bundibugyo Strain Could Take Months Before Human Trials
A vaccine for the Ebola strain driving the outbreak in the Democratic Republic of Congo and Uganda is likely months away from human trials, and there is no guarantee it would work, the World Health Organization said Wednesday. There are currently no approved vaccines for the Bundibugyo strain of the Ebola virus.
There are two potential vaccine candidates, but neither is ready to move into human testing, Dr. Vasee Moorthy, the lead for the WHO’s research and development blueprint, said during a news conference. The more promising of the two could take six to nine months before enough doses are ready for trials, Moorthy said. The other may be available in two to three months but has not yet shown supporting results in animal studies.
“It will depend on the animal data as to whether that is considered a promising candidate vaccine for Bundibugyo,” he said. The timeline has pushed health officials to consider other options, including Merck’s Ebola vaccine, called Ervebo.
‘Wild West’ Peptide Craze Surges Beyond GLP-1s as FDA Faces Pressure to Ease Access
As GLP-1 weight-loss medications gain traction, the peptide market is experiencing a surge in interest. A variety of peptides — commonly marketed for weight loss, muscle building, injury recovery and other uses — have emerged as largely unregulated drugs sold through both licensed compounding pharmacies and unverified vendors. The U.S. Food and Drug Administration is set to evaluate whether to loosen regulations on several peptides during a meeting this summer.
Peptides are short chains of amino acids — the building blocks of proteins — that play key roles in biological functions, according to the National Institutes of Health. Peptide drugs are lab-made versions of natural molecules in the body that are designed to mimic or influence biological signals to treat disease, experts say.
Though the peptide market has been described as the “Wild West,” demand remains strong, potentially challenging pharmaceutical giants that dominate the GLP-1 market.
Dr. Alex Tatem, an Indiana-based board-certified urologist with expertise in men’s health and peptides, discussed how “life-changing” GLP-1s kicked off the rise of peptides.
Experimental Drug Yields Dramatic Weight Loss
An experimental shot helped participants in a large trial lose far more weight than obesity drugs already on the market, Eli Lilly, the maker, announced on Thursday.
Among the heaviest patients in the trial, the results were on par with those seen with gastric bypass surgery, the only effective treatment for most with severe obesity.
The drug, retatrutide, appears to be the most powerful yet in a wave of injections and pills that have transformed the treatment of obesity — so much so that some participants in other research have said they stopped taking retatrutide because they felt they were losing too much weight. If the drug’s effects do not wane with time, and if its results in the real world echo those in the clinical trial, it may extend the notion of what a weight loss drug can accomplish.
