The Food and Drug Administration recently granted approval for Moderna’s latest Covid-19 vaccine, mNexspike, with certain restrictions in place that differentiate it from the company’s existing vaccine, Spikevax. While both vaccines will be available on the market for now, mNexspike is specifically licensed for individuals aged 65 and older and those aged 12 to 64 with underlying medical conditions that increase their risk of severe illness if infected with the SARS-CoV-2 virus. These conditions include diabetes, COPD, and obesity, among others.
Moderna’s CEO, Stéphane Bancel, expressed the significance of the FDA approval for mNexspike in providing additional protection against Covid-19 for high-risk individuals. The company’s statement highlighted the continued threat of the virus, with over 47,000 deaths reported in the US alone last year.
In contrast to the delayed decision on Novavax’s vaccine, the FDA adhered to the agreed-upon deadline for reviewing Moderna’s application, which was May 31st. This timely approval is a positive development for Moderna, especially amidst skepticism surrounding mRNA-based vaccines from certain quarters, including Health Secretary Robert F. Kennedy Jr. and his supporters.
Despite concerns raised by some regarding the safety and efficacy of mRNA technology, billions of doses of mRNA-based vaccines have been administered worldwide since the authorization of Pfizer-BioNTech and Moderna’s vaccines in late 2020. While some cases of myocarditis have been reported in recipients, particularly teenage boys, the overall safety profile of these vaccines remains favorable.
mNexspike represents a next-generation Covid vaccine with a refined target that allows for a smaller dosage compared to Spikevax. In clinical trials, mNexspike demonstrated higher antibody levels, particularly among older adults. Post-marketing studies will be conducted to further evaluate the vaccine’s safety and effectiveness, including an observational study on pregnant individuals and their babies.
The FDA has also requested Moderna to conduct a randomized controlled trial in adults aged 50 to 64 to assess the continued benefits of Covid vaccination in this group. Recent commentary from FDA Commissioner Marty Makary and vaccine division head Vinay Prasad suggests a shift towards targeted vaccine use for high-risk populations and individuals aged 65 and older.
While challenges may arise in conducting these studies, particularly in light of shifting recommendations regarding Covid vaccination for pregnant individuals, ongoing research and surveillance will be crucial in ensuring the continued efficacy and safety of Covid vaccines.
