Moderna’s New COVID-19 Vaccine Approved by FDA

The FDA has given the green light to Moderna’s latest COVID-19 vaccine, known as Mnexspike.

This new option is specifically aimed at adults aged 65 and older, along with younger individuals, ages 12 to 64, who have at least one underlying medical condition that puts them at higher risk for severe COVID-19.

However, it’s worth noting that Mnexspike isn’t a substitute for Moderna’s existing COVID-19 vaccine, Spikevax. Instead, it offers a lower-dose alternative for patients who prefer that option.

“The FDA approval of Mnexspike adds an important new tool to protect people at risk of severe illness from COVID-19,” said Stéphane Bancel, CEO of Moderna.

This approval is somewhat restricted to those who have already received a COVID vaccine in the past.

Compared to the SpikeVax vaccine, which has been available for individuals over six months, the new Mnexspike is a more limited offering.

Interestingly, this is the first vaccine approved under the Trump administration after Health and Human Services Secretary Robert F. Kennedy Jr. introduced a new policy aimed at reinforcing the standards of scientific research. This involves requiring pharmaceutical companies to conduct placebo clinical trials for new vaccines.

In clinical trials, which involved approximately 11,400 participants aged 12 and older, Mnexspike was shown to produce higher levels of antibodies than previously approved versions. It seems to be a promising option headed into the fall.