Moderna, GSK, Lykos, Congress updates
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Lots on vaccines this morning: Moderna says its combination shot for Covid and flu works well, and might help improve uptake in the broader population. And the FDA just cleared GSK’s RSV vaccine for younger at-risk adults.
Moderna says data show its combination Covid-flu vaccine generates a strong immune response
Moderna’s combination vaccine for Covid-19 and influenza triggered a stronger immune response in older adults than either individual vaccine — putting it on track to potentially bring one to market as soon as fall 2025.
The hope is that a combination shot would be more widely used than either vaccine on its own. Both are currently under-utilized, even by high-risk groups, STAT’s Helen Branswell writes. In the 2023-2024 season, for instance, only 22.6% of adults got the Covid vaccine and 48.4% got the flu vaccine. Studies have indicated, however, that people would be more willing to take a combination shot.
“We do think that this will do a lot of the work to improve vaccine coverage rates and compliance,” Moderna President Stephen Hoge told STAT.
The inside story of how Lykos’ MDMA work went awry
For months, many onlookers have assumed that MDMA-assisted therapy would sail through its expedited regulatory process. But a dramatic advisory committee meeting last week on Lykos Therapeutics’ treatment highlighted major issues with the data — which, as STAT’s Olivia Goldhill reports, underscore what former employees saw as disorganization and a broader pattern of failings at the company.
Lykos’ origins as a nonprofit meant the company developed a “cult side,” as one former employee characterized it, and interfered with its efforts to grow as a scientific company. Another former employee, Christina Faulk, told STAT she was “relieved” the FDA ad comm asked so many questions about patient safety and data integrity.
FDA allows GSK’s RSV vaccine to be used in at-risk adults over 50
The FDA expanded its approval of GSK’s vaccine for RSV, authorizing it for use by at-risk adults who are 50 and older — and not pregnant. Before, Arexvy was only licensed for use in people over the age 60.
“When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider,” an RSV researcher said in a statement circulated by GSK. “Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions.”
Pfizer said in April that it would file for a license extension on its competing RSV vaccine, Abrysvo, so that the company might market its shot to at-risk adults older than 18.
Calling on Congress to help rare disease drug development
The FDA’s rare disease priority review voucher program is set to expire this September. This has rare disease advocates very worried, since these vouchers help accelerate the development of much-needed orphan drugs. The program was established in 2012 and gives vouchers to companies that successfully develop drugs for rare pediatric diseases. They can be used for priority review of other products, hastening drug development timelines — or they can be sold to other companies.
“Without swift action by Congress, the difficult task of curing and treating rare childhood diseases will get even harder,” opine Joe and Courtney Dion, parents of two children with limb-girdle muscular dystrophy and the founders of the Dion Foundation for Children with Rare Diseases.
More reads
- AbbVie’s tight grip on Humira market raises concerns about biosimilars, Reuters
- Ex-staffer pleads guilty to scamming Takeda out of $2.3M through fake consulting firm, FierceBiotech
