FDA approves Moderna's mNEXSPIKE for seniors amid new rules
The U.S. Food and Drug Administration (FDA) has approved Moderna's new mNEXSPIKE vaccine, targeting the elderly and those with comorbidities. This new version is expected to be available before the 2025-2026 fall-winter season.
What do you need to know?
- Who can receive the new vaccine? The mNEXSPIKE vaccine is intended for adults aged 65 and older.
- When will it be available? Moderna plans to launch the mNEXSPIKE vaccine before the 2025-2026 fall-winter season.
- Why is it important? The new vaccine has higher efficacy than previous versions, making it a crucial tool in protecting against severe COVID-19.
The new Moderna mNEXSPIKE vaccine has been approved by the FDA in response to the federal government's tightening of COVID-19 vaccination rules.
This vaccine targets those most vulnerable to severe disease, including the elderly and those with comorbidities.
What are the benefits of the new mNEXSPIKE vaccine?
The mNEXSPIKE vaccine has been developed to more effectively stimulate the body to produce antibodies against the SARS-CoV-2 virus. Moderna highlights that one dose contains five times less active substance than the current Spikevax vaccine, which could mean fewer side effects.
Clinical trials have shown that mNEXSPIKE has a 9.3% higher efficacy compared to the previous version of the vaccine in people over 12 years old, and the efficacy in older individuals increased by 13.5%.
What are the potential side effects?
As with other vaccines, mNEXSPIKE may cause some side effects. The most common are pain at the injection site, fatigue, headaches, and muscle aches, which usually resolve within a few days. Moderna notes that the risk of a severe allergic reaction is very low and usually occurs within the first hour after vaccination.
Moderna's CEO, Stéphane Bancel, emphasized the importance of the new vaccine as a protective tool for those most at risk of severe COVID-19. Bancel added that COVID-19 remains a serious threat, and last year the virus contributed to the deaths of over 47,000 people in the U.S.
