FDA Approves Moderna's Lower-Dose COVID-19 Vaccine for High-Risk Groups

The U.S. Food and Drug Administration (FDA) has approved Moderna's new COVID-19 vaccine, mNEXSPIKE, an mRNA vaccine designed to offer a lower-dose option for specific populations. The vaccine is intended for adults aged 65 and older, as well as individuals aged 12 to 64 with at least one underlying health risk. This approval comes with certain limitations, positioning mNEXSPIKE as an alternative rather than a replacement for Moderna's existing vaccine, Spikevax.

The clinical trials for mNEXSPIKE demonstrated a safety profile similar to that of the original vaccine, with fewer local reactions and comparable systemic effects. The new vaccine contains one-fifth of the dose found in Spikevax, making it a more accessible option for those with underlying health conditions or advanced age. This lower dose is designed to provide the same level of protection while reducing the risk of adverse reactions.

One of the key advantages of mNEXSPIKE is its enhanced storage capabilities. The vaccine can be stored between 2°C to 8°C for up to 90 days, compared to Spikevax's 60-day storage limit at the same temperature range. Additionally, mNEXSPIKE can be kept at 8°C to 25°C for twice as long as Spikevax, offering greater flexibility in distribution and administration.

The design of mNEXSPIKE differs from Spikevax in that it encodes the receptor binding and N-terminal domains of the virus, rather than the full-length viral spike protein. This shorter length of mRNA is associated with increased stability, contributing to the vaccine's improved storage properties.

Moderna plans to offer mNEXSPIKE alongside Spikevax during the next respiratory virus season. The company aims to provide a comprehensive vaccination strategy that caters to different risk groups, ensuring that those most vulnerable to COVID-19 have access to a suitable vaccine option. The approval of mNEXSPIKE is a significant step forward in the ongoing effort to combat the pandemic, offering a tailored solution for high-risk individuals.

Not all children are eligible for the new Moderna COVID shots. The new vaccine is not approved for children under 12 years old, highlighting the need for continued research and development in pediatric vaccination strategies.