Moderna Inc (NASDAQ:MRNA, ETR:0QF) shares jumped more than 6.5% on Tuesday after the US Food and Drug Administration unveiled a new framework for COVID-19 vaccine approvals that analysts said largely maintains the status quo for the company’s core market.
The FDA’s updated guidance does not change how COVID-19 vaccines are authorized for individuals aged 65 and older or those aged six months to 64 years who are at high risk. These groups, which analysts estimate account for a majority of COVID-19 vaccinations, will continue to receive annual shots without the need for new placebo-controlled trials.
“The stock is up on the new vaccine framework update because essentially it doesn't change anything among those who are 65+ or high-risk 6mos–64yrs—no placebo-controlled trials will be required to approve vaccines every season for these age groups,” Jefferies analysts wrote in a note.
Jefferies said the framework aligns with recent recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), which had leaned toward risk-based vaccination strategies instead of universal guidelines.
The move appeared to ease investor concerns about Moderna’s 2025 outlook, the analysts said, adding that at least 40% to 50% of annual COVID-19 vaccinations are estimated to be among those 65 and older, with additional uptake among younger patients with risk factors such as obesity, asthma, or other comorbidities.
While the updated framework introduces new requirements for placebo-controlled trials in healthy individuals aged six months to 64 years, it remains unclear whether these studies will be needed annually or only for next-generation or combination vaccines. Jefferies noted that running such trials each year could prove difficult given the tight timeline between strain selection in May or June and vaccine rollout in late summer.
For now, vaccines will continue to be approved based on immunogenicity data—how well a vaccine triggers an immune response—rather than infection rates, allowing for a faster pathway to market ahead of the fall and winter respiratory virus season.