The vaccine’s design differs from Spikevax, Moderna’s shot that has been available.
The Food and Drug Administration has approved Moderna’s next-generation COVID-19 vaccine.
The FDA licensed the vaccine for adults aged 65 and up as well as people aged 12 to 64 who have at least one condition that
puts them at higher risk for severe COVID-19, the agency
said on May 31. The vaccine is meant for “active immunization to prevent” COVID-19 for people who have been previously vaccinated with any COVID-19 vaccine.
“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,” Stéphane Bancel, Moderna’s CEO,
said in a statement.
People who suffered a severe allergic reaction after receiving any Moderna COVID-19 vaccine, or after receiving any ingredient of mNEXSPIKE, should not get the new vaccine, the FDA
said in a package insert.
The vaccine, also known as mRNA-1283, utilizes messenger ribonucleic acid (mRNA), just like Moderna’s already-available COVID-19 vaccine, Spikevax. But it contains just 10 micrograms of mRNA per dose, compared to 50 micrograms in the available vaccine.
Moderna scientists have said that the new vaccine encodes epitopes, or portions of the COVID-19 spike protein, rather than the full-length spike protein.
In a clinical trial of 11,417 people, about half of whom received mNEXSPIKE, the immunogenicity triggered by the new vaccine was the same or better than that prompted by Spikevax, the company told a government advisory panel in April. A lower percentage of mNEXSPIKE recipients contracted COVID-19 or severe COVID-19, the company said.
Other clinical and nonclinical data support the new vaccine, Moderna told a government advisory panel in April.
“What remains consistent throughout all those investigations is this consistent pattern that mRNA 1283 outperforms Spikevax in terms of its ability to induce higher neutralizing antibodies,” Bishoy Rizkalla, a Moderna official,
told the committee.
Moderna has not yet published the results in a journal, according to
ClinicalTrials.gov, a government database.
FDA officials announced
on May 20 that the regulator would approve COVID-19 vaccines only if companies provided clinical trial data showing the shots provided protection against symptomatic COVID-19 and other clinical endpoints.
The exceptions were for elderly adults and people with underlying risk conditions putting them at higher risk of severe COVID-19 outcomes, as defined by the Centers for Disease Control and Prevention. Those risk conditions include diabetes and obesity.
For those groups, immunogenicity data would be sufficient, the officials said.
More recently, FDA officials encouraged Moderna, Pfizer, and Novavax to update their COVID-19 vaccines to target LP.8.1, a subvariant of the JN.1 strain of the disease. Moderna on May 23 said it had filed for clearance for an updated version of Spikevax that targets LP.8.1.
Moderna said on May 31 that it expects to have mNEXSPIKE available later in 2025, alongside Spikevax.
Pfizer’s vaccine also uses mRNA technology. Novavax’s vaccine is protein-based.
As part of the approval process, the FDA is requiring Moderna to carry out two post-approval studies, including an observational study of outcomes in women and infants following receipt of the shot in pregnancy, the FDA
said in an approval letter.
The Department of Health and Human Services, the FDA’s parent agency, has expressed doubt about the mRNA platform. In a statement about canceling funding for Moderna’s vaccine candidate against avian influenza, a spokesperson
told The Epoch Times in an email that “mRNA technology remains under-tested” and has been linked to “legitimate safety concerns,” including heart inflammation.
None of the mNEXSPIKE recipients in the trial for the vaccine experienced heart inflammation or died, according to Moderna. Adverse events were similar among the trial’s two arms, the company said.
