FDA Approves Moderna's next-generation COVID-19 vaccine
The FDA has *gasp*, approved Moderna's new mRNA vaccines called mNexspike, a next-generation COVID-19 vaccine that represents a significant advancement in mRNA vaccine technology. Unlike the original Spikevax vaccine you might have received already, mNexspike targets a refined portion of the SARS-CoV-2 spike protein, allowing for a dramatically reduced dose of just 10 micrograms compared to Spikevax's 50 micrograms—one-fifth the amount. I’m hoping this produces less side effects for people, too.
The vaccine's precision design focuses the immune response on the most critical regions of the spike protein for virus neutralization (specifically the N-terminal domain and receptor-binding domain of the spike protein). Clinical trials involving 11,400 participants demonstrated that mNexspike achieved 9.3% higher relative vaccine efficacy in preventing infections overall compared to Spikevax, with a notable 13.5% higher efficacy in adults 65 and older.
The FDA approval is limited to adults 65 and older and people aged 12-64 with underlying health conditions that increase their risk of severe COVID-19. The vaccine is potentially refrigerator-stable, which could simplify distribution and expand access to high-risk populations. Moderna expects mNexspike to be available for this coming respiratory virus season alongside the existing Spikevax vaccine. I think both will target LP.8.1. Confusion exists about FDA approval without RCTs.