FDA Greenlights Moderna's Next-Gen COVID-19 Vaccine for Seniors, High-Risk Patients

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FDA Greenlights Moderna’s Next-Gen COVID-19 Vaccine for Seniors, High-Risk Patients
In this photo illustration, Pfizer-BioNTech COVID-19 (L) and Moderna COVID-19 vaccines sit in boxes at Borinquen Health Care Center on May 29, 2025 in Miami, Florida. Joe Raedle/Getty Images/Getty Images

The US Food and Drug Administration (FDA) has given the green light to Moderna's new COVID-19 vaccine, named mNexspike.

This vaccine is designed to protect people at higher risk from severe COVID-19 illness, especially seniors and those with certain health conditions.

However, it is not meant to replace Moderna's current vaccine but to provide another option for protection.

Moderna's new vaccine contains a smaller dose, using only one-fifth of the amount found in their current vaccine, Spikevax.

This lower dose is possible because the vaccine targets the virus more precisely, helping the immune system respond better.

According to AP News, Moderna's CEO, Stephane Bancel, said the approval "adds an important new tool to help protect people at high risk of severe disease from COVID-19."

The FDA has approved mNexspike for adults 65 and older, and for those aged 12 to 64 with at least one health condition that raises their risk from COVID-19.

These conditions can include things like diabetes, heart disease, or a weakened immune system. The same age and risk limits were set when the FDA approved a COVID-19 vaccine from Novavax.

Moderna to Launch Two COVID Vaccines This Fall, Including Low-Dose Option

This new restriction marks a change in how COVID-19 vaccines have been approved so far. Moderna's original vaccine, Spikevax, is still available and recommended for everyone 6 months and older without restrictions. The company expects both vaccines to be offered this fall.

The FDA's approval came after a study that included 11,400 participants aged 12 and older, CBS News said.

The study found that the new lower-dose vaccine was safe and worked at least as well — sometimes better — than the current vaccine.

This announcement came just days after funding for Moderna's development of vaccines against other flu viruses, including the bird flu, was canceled by the previous administration despite early success in studies.

At the same time, the Centers for Disease Control and Prevention (CDC) updated its guidance on COVID-19 vaccines for children, recommending them only for kids with moderate to severe immune problems.

This change was influenced by Health Secretary Robert F. Kennedy Jr., who expressed concerns about vaccine risks outweighing benefits for healthy children and pregnant women.

One federal health official criticized this change, calling it "vibe-based decision making," comparing it to setting a plane's flying altitude without expert advice.

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