Vaccine developed by Moderna receives green light from the FDA for COVID-19 use
Moderna, a leading pharmaceutical company, has announced that its new COVID-19 vaccine, mNEXSPIKE, will be available in the U.S. for the 2025-2026 respiratory virus season. This vaccine is significant as it provides an additional tool in the ongoing fight against the COVID-19 pandemic.
The FDA's approval of mNEXSPIKE comes after tightened standards for vaccines, requiring more safety tests. This new vaccine has demonstrated a comparable side-effect profile to Moderna's existing offering, Spikevax, with fewer local reactions and similar systemic reactions.
mNEXSPIKE outperforms Spikevax in overall efficacy, achieving a 9.3% higher relative vaccine efficacy (rVE). This improvement is particularly noticeable in older adults, with a 13.5% improvement in efficacy for those over 65.
The Phase 3 clinical trial for mNEXSPIKE involved approximately 11,400 participants aged 12 and older. The trial results also show that mNEXSPIKE is effective against the LP.8.1 variant.
Moderna's CEO, Stéphane Bancel, described the approval as an "important new tool" in safeguarding vulnerable populations against severe outcomes from COVID-19. He also cited more than 47,000 deaths from COVID-19 in the U.S. in the past year as a reason for the urgency in expanding options for COVID-19 vaccination.
The U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE for adults aged 65 and older, as well as individuals aged 12 to 64 with underlying health conditions. The vaccine will be available for the 2025-2026 respiratory season, along with Moderna's other vaccines, such as Spikevax and mRESVIA®, the company's vaccine for respiratory syncytial virus (RSV).
Common side effects of mNEXSPIKE include injection site pain, fatigue, headache, and muscle aches. Regulatory reviews for mNEXSPIKE are underway in multiple international markets, expanding the options for COVID-19 vaccination for high-risk groups.
This marks Moderna's third FDA-approved product, further solidifying the company's position as a major player in the pharmaceutical industry. With the approval of mNEXSPIKE, Moderna is providing a much-needed solution in the fight against COVID-19, offering hope for a safer future.
