Moderna secures limited authorization for a fresh Covid-19 vaccine from the Food and Drug Administration (FDA)
Got a scoop for ya! Moderna's latest COVID-19 vaccine, mNEXSPIKE, has received FDA approval this weekend. This bad boy is specifically designed for adults aged 65 and above, and those between 12 to 64 who have a medical condition that ups their risk for severe illness from COVID-19.
Here's the deal with mNEXSPIKE: The vaccine is only for those who've already gotten a COVID-19 vaccine prior, so it ain't a replacement for the existing ones. And guess what? Young, hale, and hearty adults won't be able to get their hands on it, despite participating in the clinical trial.
The FDA's been handing out similar limitations, as seen with Novavax's COVID-19 vaccine approval last month. But this marks the first time the FDA's given the green light to a vaccine since the Trump administration called for tighter restrictions on vaccine eligibility and approvals.
Health officials said they'd limit the approval of updated COVID-19 shots moving forward to older adults and folks with underlying health conditions. And, allegedly, the Centers for Disease Control and Prevention ain't gonna recommend COVID vaccines for healthy children and pregnant women no more. But the CDC website suggests that parents can have a chat with their doctor about vaccinating kids aged 6 months and up.
Now, let's talk science: mNEXSPIKE has been tested using an "active comparator" method, meaning it was compared to Moderna's original COVID-19 vaccine, Spikevax, in a trial of around 11,400 participants ages 12 and up. The results showed that mNEXSPIKE generated higher antibody levels than the original shot, and it had fewer local reactions. However, systemic reactions like fever, headaches, or chills were comparable. The main side effects of mNEXSPIKE include injection-site pain, fatigue, headache, and muscle pain.
Moderna expects mNEXSPIKE to be available for eligible populations in the U.S. during the 2025-2026 respiratory virus season, and the company's also updating its original vaccine to target the LP.8.1 variant this fall.
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This new development pertains to Moderna's mNEXSPIKE vaccine, designed for older adults and those with medical conditions at higher risk for severe COVID-19. In the realm of science, mNEXSPIKE has shown potential benefits, generating higher antibody levels compared to the original shot and fewer local reactions, though systemic reactions remain comparable. The main side effects include injection-site pain, fatigue, headache, and muscle pain.
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