3 days ago
FDA clears Moderna's new COVID vaccine, but with limits
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The Food and Drug Administration has granted an approval to Moderna's next-generation COVID-19 vaccine, but with limits that will restrict use to older adults and people with preexisting health conditions. The OK is the first since agency leadership rolled out new guidelines for COVID shot approvals.
The new vaccine, which Moderna will sell as mNexspike, is cleared for healthy adults 65 years and older and for individuals aged between 12 years and 64 years with one or more underlying 'risk factors,' the company said Saturday.
Moderna CEO Stéphane Bancel called the shot an 'important new tool' to protect people from COVID, noting in a statement that more than 47,000 people in the U.S. died from the disease last year.
The FDA based its decision on data from a Phase 3 study that pitted mNexspike against Spikevax, Moderna's original vaccine which is cleared for broad use. Results found mNexspike was 'non-inferior' to Spikevax overall and, in people older than 12 years, slightly more effective on a relative basis.
Moderna expects to make mNexspike, which is currently targeted to the JN.1 coronavirus variant, available beginning in the fall.
The FDA granted its approval by a May 31 deadline it had set, despite worries that recent moves by Trump administration officials might jeopardize the shot.
In May, FDA Commissioner Martin Makary and top vaccine official Vinay Prasad said the agency would require placebo-controlled trials before it cleared any new COVID shots in healthy children and adults. Previously, the FDA has accepted comparative immune data for some decisions, such as for boosters.
More recently, Health and Human Services Secretary Robert F. Kennedy Jr. said the Centers for Disease Control and Prevention would remove COVID shots from the recommended immunization schedules for pregnant women and healthy children. The CDC has since confused that messaging with a notice indicating the shots remain an option for children.
MNexspike's approval is similar to what the FDA recently granted Novavax's protein-based shot Nuvaxovid. That vaccine is also cleared for older adults and those at high risk, while the company is required to conduct an additional study.
Messenger RNA shots like Moderna's and Pfizer's Cominarty have appeared to be under higher scrutiny, however. Kennedy has previous questioned the technology, and HHS recently canceled a lucrative contract with Moderna to develop mRNA vaccines for pandemic-prone influenza like bird flu.
MRNA shots can be developed and adapted more quickly, traits that allowed Pfizer and Moderna to quickly deliver safe and effective vaccines early on in the pandemic.
In a note to clients, Jefferies analyst Michael Yee said the on-time approval is an 'incremental positive' for Moderna. It shows FDA leaders are 'still rational so long as the data packages show good efficacy and is well conducted.'
However, there's still some risk Moderna doesn't hit its sales guidance, he added, as vaccination rates remain low.
Advisers to the CDC are set to meet in late June to discuss COVID vaccine use recommendations for the coming fall and winter seasons.
