Moderna’s Lower-Dose COVID-19 Vaccine Gets FDA Green Light

Moderna has received U.S. approval for a new COVID-19 vaccine variant, mNexspike. This vaccine is not meant to replace the existing Spikevax but serves as an alternative. With a dosage reduced to a fifth of Spikevax, mNexspike represents a significant advance in vaccine technology.

The FDA allowed its use for adults aged 65 and older, as well as for individuals aged 12 to 64 who have underlying health conditions that increase their COVID-19 risks. This mirrors restrictions placed on another vaccine by Novavax, signaling a notable shift in vaccine accessibility.

Health Secretary Robert F. Kennedy Jr. and other officials are concerned about vaccine hesitancy, influencing these new limitations. Unlike the original vaccine, which is available for individuals aged six months and older, mNexspike will be offered primarily to those at higher risk.

A study involving 11,400 participants aged 12 and older showed that mNexspike is both safe and effective, with performance comparable to the original vaccine. This development follows recent government funding cancellations for Moderna’s research into vaccines for potential pandemic flu viruses, including H5N1.

Moderna’s CEO, Stephane Bancel, emphasized the importance of this new option in safeguarding vulnerable populations against severe COVID-19 outcomes.