Moderna gains as FDA nod for next-gen COVID-19 vaccine

Investing.com -- Moderna (NASDAQ:MRNA) saw its shares rose nearly 5% in premarket trading Monday after the U.S. Food and Drug Administration (FDA) has approved the drugmaker’s next-generation COVID-19 vaccine, mNEXSPIKE, for adults 65 and older, as well as individuals aged 12 to 64 with at least one underlying condition that increases their risk of severe illness.

This is the FDA’s first COVID-19 vaccine approval since it introduced stricter criteria for authorization.

In a statement on May 20, the agency said it would now require vaccine makers to conduct placebo-controlled trials in healthy adults under 65, making approvals more limited to higher-risk groups.

Moderna said it expects to have mNEXSPIKE ready for use during the 2025–2026 respiratory virus season.

“The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,” said Moderna CEO Stephane Bancel in a statement.

Unlike the original Spikevax, mNEXSPIKE can be stored in standard refrigerators, offering a longer shelf life and improving logistical flexibility, particularly in low-resource settings where distribution has been a challenge.

The vaccine received approval based on late-stage trial results showing it was not inferior to Spikevax in individuals aged 12 and up. Among adults 18 and older, the new shot showed superior efficacy in the same trial.

William Blair analyst Myles R. Minter said the approval of mNEXSPIKE “is an incremental win for Moderna, especially considering HHS Secretary Robert F. Kennedy Jr.’s negative public opinion on mRNA COVID-19 vaccines, and we continue to see autonomy and data-driven decisions at the FDA.”

Mintar does not view the approval “as a massive boost to Moderna’s COVID-19 vaccine sales,” noting that demand is still largely influenced by overall sentiment toward the vaccination market.

However, he emphasized that the approval marks an important regulatory milestone for the company’s combo flu/COVID vaccine candidate, mRNA-1083, which incorporates mNEXSPIKE as its COVID-19 component.

Separately, TD Cowen analysts said they are “somewhat surprised that the FDA did not grant full approval to the 12+ patient population.”

Moderna is increasingly relying on its next-generation mRNA vaccines amid slowing demand for Spikevax and weaker-than-anticipated uptake of its RSV vaccine. Earlier this month, the company withdrew an application for its flu-and-COVID combination vaccine, opting to wait for more data from a separate trial of its flu candidate.