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.
Inside the rise of Tracy Beth Høeg, the Covid contrarian shaping FDA vaccine policy
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.
In a Phase 3 trial testing the new vaccine against the existing one, mNexspike generated higher antibody levels, especially among older adults, the company reported.
As it did with the Novavax Covid vaccine, the FDA has asked Moderna to undertake some post-marketing studies to continue to evaluate the safety and effectiveness of the product. Among them is an observational study reporting on the outcomes of pregnant people and their babies when the vaccine was administered during pregnancy. The study is to be submitted by the end of 2032.
Conducting such a study may be challenging, given that Kennedy announced earlier this week that he had unilaterally decided to strike the recommendation that healthy children and healthy pregnant people receive a Covid shot. The establishment of vaccine use recommendations normally falls to the Centers for Disease Control and Prevention, with the assistance of its panel of outside experts, the Advisory Committee on Immunization Practices.
The CDC, on the advice of the ACIP, has recommended pregnant people be vaccinated against Covid, because infection during pregnancy can trigger severe disease. Infectious diseases experts and the professional group representing gynecologists and obstetricians denounced Kennedy’s plan as unsafe and unsupported by scientific evidence.
On Thursday, the CDC’s website page that hosts a schematic of the adult vaccine schedule was changed to remove the recommendation for pregnant people to get Covid vaccines. In its place is a gray bar that indicates there is no guidance for use of Covid vaccine in pregnant people. However, other pages on the agency’s website continue to urge pregnant people to get Covid boosters while pregnant to protect themselves and their fetus. The FDA’s approval letter also asks Moderna to conduct a new randomized controlled trial in adults 50 to 64 to determine if they still benefit from Covid vaccination. In a commentary posted in the New England Journal of Medicine earlier this month, FDA Commissioner Marty Makary and Vinay Prasad, the newly appointed head of the FDA’s vaccines division, argued that it was not clear Covid shots still confer benefits to people who are not at high risk of severe infection, and they announced that going forward, use of the vaccines would be targeted to high-risk groups and adults 65 and older.
