The Food and Drug Administration has given its stamp of approval to Moderna’s latest Covid-19 vaccine, mNexspike, in a late Friday announcement. This new vaccine will not immediately replace Moderna’s existing Spikevax shot, as both will be available on the market for the time being.
Moderna’s CEO, Stéphane Bancel, expressed the importance of this new tool in the fight against Covid-19, especially for individuals at high risk of severe illness. The FDA has specified that mNexspike is licensed for use in individuals aged 65 and older, as well as those aged 12 to 64 with certain underlying medical conditions such as diabetes, COPD, and obesity. In contrast, Spikevax is approved for individuals aged 12 years and older.
The FDA’s decision regarding the new Moderna vaccine was reached on the agreed-upon date of May 31, unlike the delayed ruling on Novavax’s vaccine. The approval comes amidst skepticism surrounding mRNA-based vaccines, with concerns raised by health secretary Robert F. Kennedy Jr. and his supporters. The Department of Health and Human Services recently canceled contracts with Moderna for influenza prototype vaccines, citing concerns about the mRNA technology.
Despite these challenges, mRNA-based vaccines have been widely administered globally, with no significant side effects reported aside from rare cases of myocarditis, primarily in teenage boys. The mNexspike vaccine offers a refined target for generating antibodies against SARS-CoV-2, allowing for a smaller dosage compared to Spikevax. In clinical trials, mNexspike demonstrated higher antibody levels, especially in older adults.
The FDA has requested post-marketing studies from Moderna to further evaluate the safety and efficacy of mNexspike, including a study on pregnant individuals. This study may face obstacles following Kennedy’s decision to revoke recommendations for healthy children and pregnant people to receive the Covid vaccine. The CDC and ACIP continue to recommend Covid vaccination for pregnant individuals due to the risks associated with infection during pregnancy.
In addition to these studies, Moderna has been asked to conduct a new trial in adults aged 50 to 64 to assess the continued benefits of Covid vaccination in this group. FDA Commissioner Marty Makary and vaccines division head Vinay Prasad have emphasized the importance of targeted vaccine use for high-risk groups and older adults. As the fight against Covid-19 continues, the approval of Moderna’s mNexspike vaccine represents a significant step forward in protecting vulnerable populations from the virus.
