FDA Approves New Low-Dose Moderna COVID Vaccine for High-Risk Groups

Late Friday, the FDA approved Moderna’s new COVID-19 vaccine, mNexspike, which provides an updated and lower-dose alternative aimed at safeguarding vulnerable populations against the virus. The vaccine will be limited to specific demographics, specifically targeting adults aged 65 and older, as well as individuals between the ages of 12 and 64 who have underlying health conditions that heighten their risk of severe COVID-19.

The new mNexspike shot, unlike Moderna’s original vaccine Spikevax, which is approved for individuals aged 6 months and older, will not be accessible to the general public. The recent decision reflects the FDA's previous restrictions on another COVID-19 vaccine developed by Novavax.

Stéphane Bancel, CEO of Moderna, expressed his approval of the recent decision, describing it as “an important new tool to help protect people at high risk of severe disease.”

A recent study involving 11,400 individuals aged 12 and older assessed the effectiveness of the vaccine. Recent findings indicate that mNexspike demonstrated safety while matching or surpassing the performance of the original vaccine, all while utilizing only one-fifth of the active ingredient. Moderna credits this enhancement to an improved design of immune targets.

A new lower-dose vaccine has emerged as a significant advancement in the development of next-generation COVID-19 immunizations, focusing on enhancing protection while reducing side effects. Moderna has announced its intention to include both mNexspike and Spikevax in the upcoming fall rollout.

The approval comes amid significant changes in vaccine policy, notably following the Trump administration's recent move to withdraw funding for Moderna's development of a pandemic flu vaccine, despite early promising results against viruses such as H5N1.

In response to the ongoing evolution of COVID-19, federal health agencies are recalibrating their strategies to prioritize protection for the most vulnerable populations. Simultaneously, they are investigating new approaches to enhance overall public health resilience.

‍