New COVID vaccine approved by US FDA: Here's all about it

Just new variants of the coronavirus causing COVID are emerging, the US Food and Drug Administration (US FDA) has approved a new vaccine against COVID. The vaccine has been manufactured by Moderna.

"Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC)," the pharma maker has said in a press release.

COVID killed 47,000 Americans in 2024.

"The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19," said Stéphane Bancel, Chief Executive Officer of Moderna. "COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health."

We announced today that the U.S. FDA has approved mNEXSPIKE®, a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes… pic.twitter.com/RJ1CezICKZ

— Moderna (@moderna_tx) May 31, 2025

What is mNEXSPIKE?
mNEXSPIKE is a COVID-19 vaccine meant for folks who’ve already had a previous COVID shot. It’s mainly for people aged 65 and older, or anyone between 12 and 64 who’s at high risk of getting really sick from the virus. Just a heads-up though—like all vaccines, it’s not a guaranteed shield for everyone, but it does offer an extra layer of protection for those who need it most.


"You should not get mNEXSPIKE if you hada severe allergic reaction after a previous dose of either mNEXSPIKE, SPIKEVAX (COVID-19 Vaccine, mRNA), or any Moderna COVID-19 vaccine or to any ingredient in these vaccines," Moderna has warned. The side effects are trouble breathing, swelling of face and throat, fast heart beat, rashes, dizziness and weakness.

Moderna expects to have mNEXSPIKE available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA, the Company's approved respiratory syncytial virus (RSV) vaccine.