FDA approves Moderna’s new lower-dose COVID-19 vaccine
- The FDA approved Moderna's new COVID-19 vaccine, mNexspike, late Friday for adults 65 and older and high-risk people ages 12 to 64.
- This approval follows a clinical trial of 11,400 people comparing mNexspike with Moderna's existing vaccine, and introduces new FDA limits on who can use it.
- MNexspike uses a dose one-fifth the size of Spikevax, Moderna's current vaccine, and targets the immune response more precisely as a next-generation option.
- Moderna CEO Stéphane Bancel stated that the FDA's authorization of their third vaccine, mNEXSPIKE, provides a valuable option aimed at safeguarding individuals most vulnerable to severe COVID-19 illness.
- Because of the FDA restrictions, mNexspike will supplement rather than replace Spikevax, suggesting a more targeted approach to vaccine use in high-risk groups.
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What you need to know about Moderna's new COVID vaccine, just approved by the FDA
Moderna, over the weekend, announced that the U.S. Food and Drug Administration had approved its second-generation COVID vaccine, but only for specific populations: all adults 65 and over and those between 12 and 64 with at least one underlying risk factor as defined by the Centers for Disease Control and Prevention. Moderna’s COVID shot had previously been approved for everyone 12 and older. The narrower approval follows the FDA announcing it w…
The new vaccine, called mNEXSPIKE, was approved Saturday for adults 65 and older, as well as for people ages 12 to 64 with at least one medical condition that puts them at higher risk for COVID-19.
Broadcom Up Ahead of Earnings, Moderna Higher, Disney Slides on Layoffs - Stock Movers
Broadcom (AVGO) is up today ahead of earnings this week. Bloomberg Intelligence analysts are expecting the software giant to post slightly better results and guidance led by strength in AI. Moderna (MRNA) share rose after the drugmaker won FDA approval for its second-generation Covid vaccine. The company’s second-generation vaccine is cleared for all adults over 65 and anyone over 12 who has at least one risk factor for severe disease, Moderna s…


FDA Approves Moderna’s New COVID-19 Vaccine
The national emergency response in the U.S. to COVID-19 ended in April 2023.
Moderna wins narrower US approval for new COVID vaccine
Moderna Inc. gained U.S. approval for a new COVID vaccine for a narrower group of people, in the latest sign that regulators are restricting access to immunizations under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr.
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