Jefferies analysts said the approval was largely expected and an “incremental positive” for Moderna amid questions about the FDA’s attitude toward mRNA and COVID-19 vaccines that have investors worried.
Moderna received FDA approval for its next-generation COVID-19 vaccine Saturday, positioning the biotech to sell the product during the 2025–2026 respiratory virus season. The news comes weeks after the FDA announced a new approval framework for COVID-19 vaccines and less than a week after HHS Secretary Robert F. Kennedy Jr. said that routine COVID-19 vaccination for healthy children and healthy pregnant women will be removed from CDCs guidelines—an announcement that turned out to be only partly true.
The approval of Moderna’s mNEXSPIKE, previously called mRNA-1283, covers all adults aged 65 years and older, as well as people aged 12 to 64 years who have at least one underlying risk factor—the same population targeted by the new COVID framework and for which Novavax’s protein-based vaccine Nuvaxovid was approved last month. Like Moderna’s older COVID-19 vaccine Spikevax, mNEXSPIKE uses mRNA to train the immune system to recognize the virus.
Jefferies analysts said in a note to investors that the FDA approval was “largely expected” and was an “incremental positive” for Moderna. The agency approved the COVID-19 vaccine on time “despite some initial worries given FDA’s sentiment around vaccines,” the analysts said. Novavax’s approval had been delayed from its original PDUFA date of April 1, for example.
“There was some investor nervousness given new FDA and administration have been vocal on mRNA and COVID vaccines,” the analysts wrote. “That said, the PDUFA was approved on-time and shows that despite their views, FDA and CBER are still rational so long as the data packages show good efficacy and is well conducted.”
The analysts said the on-time approval “is a positive read through” to products awaiting authorization, including Moderna’s respiratory syncytial virus (RSV) vaccine and drugs from Denali Therapeutics, Gilead Sciences, Regenxbio and Replimune. The FDA is set to decide whether to approve Moderna’s RSV vaccine in people aged 18 to 59 years by June 12.
Moderna plans to sell mNEXSPIKE alongside Spikevax in the next respiratory virus season. Despite RFK Jr.’s recent announcement last Tuesday indicating that COVID vaccination would be removed from the childhood immunization schedule, updated CDC immunization schedules published late Thursday still list COVID vaccination, stating that healthy children should receive the shots if their parents and doctors agree.
Moderna has differentiated mNEXSPIKE with a design that offers protection at one-fifth of the Spikevax dose and allows storage between 2°C to 8°C for up to 90 days. Spikevax can be stored at those temperatures for up to 60 days. The new vaccine can be kept at 8°C to 25°C for twice as long as Spikevax.
The enhancements stem from a difference in the design of the vaccines. Spikevax encodes the full-length viral spike protein. The new vaccine encodes the receptor binding and N-terminal domains of the virus. A shorter length of mRNA is associated with increased stability.
Jefferies analysts retained their prediction that vaccination rates will fall “given vaccine fatigue and lower public interest in general.” The analysts said the new CDC recommendations and FDA vaccine framework “seem reasonable” but they “still see some risk” to Moderna’s $1.5 billion to $2.5 billion sales guidance. Moderna CEO Stéphane Bancel discussed the U.S. government’s policies at a Bernstein event last week.
“If this administration is going to really try to push vaccination for people at high risk, I’m in, because this is potentially a larger market than some of the confusion we have seen in the past and some of the skepticism that we have seen in the past,” Bancel said. “We are quite pleased that we don’t go into a very dark scenario and actually this scenario has potentially upside for us.”
