FDA Approves Moderna's New Low-Dose COVID-19 Vaccine with Usage Restrictions
The FDA has approved Moderna's mNexspike vaccine for specific high-risk groups, marking a shift in COVID-19 vaccination strategy.
Overview
The FDA has approved Moderna's new low-dose COVID-19 vaccine, mNexspike, for adults 65 and older and those aged 12-64 with health conditions. This vaccine is not a replacement for the existing Spikevax but offers a lower dose option. The approval reflects a cautious approach amid skepticism from health officials. The decision follows a study showing mNexspike's safety and effectiveness. Moderna plans to provide both vaccine options this fall, despite recent funding cuts for pandemic flu vaccine development by the Trump administration.
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Analysis
- The articles present a balanced view on Moderna's new COVID-19 vaccine approval, noting both benefits and limitations.
- There is cautious optimism about advancements in vaccine options, despite ongoing debates about vaccine safety.
- The approval aims to protect high-risk individuals, but skepticism about vaccines remains among some officials.
Articles (3)
"…The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines."
ABC News·1M·"…The approval "adds an important new tool to help protect people at high risk of severe disease from COVID-19.""
CBS News·1M·"…The approval adds an important new tool to help protect people at high risk of severe disease from COVID-19."
Boston Herald·1M·FAQ
Individuals aged 12-64 qualify for the new Moderna mNexspike vaccine if they have at least one underlying condition that puts them at increased risk of severe COVID-19 infection. Examples commonly include chronic illnesses such as asthma, diabetes, or cancer, though official lists may be updated and should be confirmed with healthcare providers or the FDA.
In Phase 3 clinical trials, the mNexspike vaccine demonstrated a 9.3% higher relative efficacy compared to Moderna's original Spikevax in people aged 12 and older, and a 13.5% greater efficacy in those 65 and older. Safety data from these trials supported its approval[2].
The FDA, under new leadership, has tightened standards and no longer recommends COVID-19 vaccines for healthy children and healthy pregnant women, citing a shift toward a more targeted vaccination strategy focused on those at highest risk of severe disease or complications.
Moderna expects the mNexspike vaccine to be available for the 2025-2026 respiratory virus season. Both mNexspike and Spikevax will be available for high-risk groups this fall, giving healthcare providers and patients a choice of vaccine options[2].
The FDA’s approval was based on safety and efficacy data from a Phase 3 clinical trial involving approximately 11,400 participants. The trial showed that mNexspike is safer and more effective than the original Spikevax vaccine, especially in high-risk groups[2].
History
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