FDA approves a next-generation Covid vaccine from Moderna, with restrictions

The Food and Drug Administration approved Moderna’s new Covid-19 vaccine late Friday, though it placed restrictions on its use that the company’s existing Covid shot, Spikevax, does not currently face.

The new vaccine, which will be marketed under the name mNexspike, will not immediately replace Spikevax. A statement from the company said both vaccines will be available on the market for the time being.

“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,” Moderna CEO Stéphane Bancel said in the statement. “Covid-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone.”

As it did earlier this month with Novavax’s Covid vaccine, the FDA said the new Moderna shot is licensed for use only in people aged 65 and older and people aged 12 to 64 who have at least one medical condition that puts them at increased risk of becoming seriously ill if they contract the SARS-CoV-2 virus. Such conditions include diabetes, chronic obstructive pulmonary disorder or COPD, and obesity.

Spikevax’s license allows its use in people aged 12 years and older.

Unlike the Novavax decision, in this case the FDA met the agreed-up decision date for ruling on the Moderna application; it was May 31. The Novavax decision came a month and a half after its April 1 due date, with political staff at the agency reportedly raising concerns after FDA career staff recommended approval of the vaccine.

The approval is at least a partial victory for the company, given the skepticism about messenger RNA-based vaccines shared by health secretary Robert F. Kennedy Jr. and his political base, and some of the health department’s recent actions.

Earlier this week Kennedy’s Department of Health and Human Services notified Moderna that it was canceling contracts valued at $766 million for the company to develop, test, and license prototype vaccines against several influenza subtypes that could potentially trigger a pandemic, including H5N1 bird flu. Asked to explain the decision, HHS communications director Andrew Nixon called the mRNA technology “under-tested” and raised vague concerns about the vaccine platform’s safety record.

Billions of doses of mRNA-based vaccines have been administered around the globe since the Pfizer-BioNTech and Moderna Covid vaccines were the first to receive authorization in late 2020, a mere 11 months after the genetic code of the SARS-2 virus was first shared internationally.

That rollout involved close scrutiny by numerous regulatory agencies looking for evidence of adverse events that might have been linked to these vaccines. With the exception of some reports of myocarditis — inflammation of the heart muscle — in some recipients, mostly teenage boys, no significant side effects have been reported. (Covid infection can also trigger myocarditis in this demographic. In fact, it happens at a higher rate, and infection-induced cases are typically more severe than those seen post-vaccination.)

The next-generation Covid vaccine uses a refined target to generate antibodies against the SARS-CoV-2 virus, which allows for the use of a smaller dose — one fifth — than is used in Spikevax.