Despite uncertainties arising from new FDA policies around COVID-19 vaccines, Moderna has cleared the agency's desk with its next-gen shot, mNEXSPIKE.
The FDA has signed off on the company's new COVID-19 vaccine for use in all adults 65 and older, as well as in individuals ages 12 to 64 who have one or more underlying risk factor for severe COVID, such as asthma, diabetes or COPD, Moderna said in a Saturday, May 31 press release.
The vaccine, formerly known as mRNA-1283, proved its merit in a phase 3 study that tested the new shot against Moderna's first approved product, Spikevax.
In the 11,400-participant study, mNEXSPIKE proved its non-inferiority and showed a similar safety profile to Spikevax, according to Moderna. Participants in the study received either a 10 μg dose of mNEXSPIKE or a 50 μg dose of Spikevax.
The next-gen shot showed a 9.3% higher relative vaccine efficacy in participants 12 and older, Moderna said. The number was higher, 13.5%, in a descriptive sub-group analysis of trial participants 65 and older.
With the nod, Moderna expects to make its new vaccine available for the upcoming 2025-2026 respiratory virus season in the U.S.
The approval comes after a period of uncertainty regarding COVID-19 vaccines at the FDA. In early April, the agency missed its decision target date for Novavax's protein-based shot, offering no public explanation at the time.
About a month later, FDA commissioner Marty Makary, M.D., raised eyebrows with his remark to CBS News that the agency was "taking a look" at whether to approve a new set of COVID-19 shots this year.
A few weeks after that, Makary and Center for Biologics Evaluation and Research head Vinay Prasad, M.D., laid out the agency's new approach to COVID shots in an article in The New England Journal of Medicine.
Going forward, the agency expects vaccine developers to produce "randomized, controlled trial data evaluating clinical outcomes" for COVID vaccines before they can be approved for healthy individuals between the ages of six months and 64 years, the FDA leaders wrote.
For people 65 and older and those with risk factors, the officials said that immunogenicity data—those showing the production of antibody titers in people—should be able to support approvals.
As for Novavax, the company eventually picked up its approval in mid-May with usage restrictions similar to Moderna's latest nod.
Meanwhile, U.S. health officials also recently communicated a change in policy regarding the use of COVID-19 vaccines in pregnant women and healthy children. In a social media post, HHS Secretary Robert F. Kennedy, Jr. was joined by Makary and NIH Director Jay Bhattacharya, M.D., Ph.D., to state that the CDC no longer recommends COVID vaccines for those two populations.