May 23, 2025 – Moderna Inc. on Friday submitted a marketing application for its updated COVID-19 vaccine, branded as Spikevax to the U.S. Food and Drug Administration (FDA). This updated vaccine targets SARS-CoV-2 variant LP.8.1 of the JN.1 lineage.
Moderna’s application aligns with new FDA policies requiring more rigorous clinical trials for COVID-19 vaccines intended for healthy individuals under 65. The FDA had previously advised vaccine manufacturers to update their formulations to target strains within the JN.1 lineage, with a preference for the LP.8.1 variant.
Moderna anticipates launching the updated vaccine by mid-August 2025. Spikevax targets LP.8.1 subvariant of the JN.1 lineage, which currently accounts for about 70% of COVID-19 cases in the U.S., as per government data.
Earlier this week, FDA announced plans to require new clinical trials for the approval of annual COVID-19 boosters for healthy Americans under the age of 65. This move would effectively limit booster access to older adults and individuals at higher risk of severe illness.
Vinay Prasad, top U.S. vaccines regulator stated that all COVID-19 vaccine manufacturers will be required to conduct placebo-controlled trials involving healthy individuals aged 50 to 64. He also mentioned that companies will be encouraged to carry out similar trials in very young children.
Moderna did not reveal the age range the updated vaccine will target. It also did not indicate whether any additional clinical trials were conducted. Once approved, the new vaccine will be Moderna’s first COVID-19 formulation specifically designed to meet the FDA’s updated guidance for targeting emerging variants like LP.8.1.
Such product launches and approvals are expected to boost COVID vaccine industry. According to Coherent Market Insights (CMI), the global coronavirus vaccine market size is forecast to total from US$ 50.64 Bn in 2025 and USD 83.47 Bn by 2032. Global demand for coronavirus vaccine will likely surge at a CAGR of 7.4% during the forecast period.
“Moderna’s updated coronavirus vaccine, Spikevax—targeting the LP.8.1 subvariant of the JN.1 lineage—reflects an evolving approach to COVID-19 management,” said a senior analyst at Coherent Market Insights (CMI). “This move underscores how vaccine manufacturers are adapting to updated regulatory guidance and responding to the dynamic nature of the virus.”
Cases of COVID-19 cases are rising significantly across nations like India and the United States. This is expected to create lucrative growth avenues for coronavirus vaccine manufacturers in the coming years.
Top players are focusing on introducing updated versions, such as that of Moderna’s Spikevax, to capitalize on emerging opportunities as well as comply with evolving regulations. Other vaccine manufacturers may follow Moderna’s suit by developing updated COVID-19 vaccines. This will bode well for the coronavirus vaccine industry.
Source:
News Outlet: Reuters
Company: Moderna Inc.
