Moderna mNEXSPIKE: Everything To Know About The New Covid Vaccine

As new variants of COVID-19 continue to trigger concern worldwide, the U.S. Food and Drug Administration (FDA) has approved a new vaccine, mNEXSPIKE, manufactured by Moderna.

The pharmaceutical company made the announcement on X (formerly Twitter) on Saturday, May 31.
The post read: “We announced today that the U.S. FDA has approved mNEXSPIKE®, a new vaccine against COVID-19, for use in all adults aged 65 and older, as well as individuals aged 12 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.”

In a statement, Moderna CEO Stéphane Bancel said: “The FDA approval for mNEXSPIKE, our third product, adds an important new tool to help protect people at high risk of severe disease from COVID-19.”

Calling COVID-19 a serious public health threat, the company highlighted that more than 47,000 Americans died from the virus in 2024 alone.

The FDA’s approval of mNEXSPIKE is based on results from a randomized, observer-blind, active-controlled Phase 3 clinical trial, which enrolled approximately 11,400 participants aged 12 years and older.

Who is eligible?

Individuals who have previously received a COVID-19 vaccine are eligible to receive the mNEXSPIKE vaccine.
Those aged 65 years and older are eligible.
Those aged 12 to 64 years with at least one underlying condition that puts them at high risk of severe COVID-19 are also eligible.

What are the likely side effects?

There is a very small chance that mNEXSPIKE could cause a severe allergic reaction. This would typically occur within a few minutes to one hour after receiving a dose.
Signs of a severe allergic reaction include:

• Trouble breathing
• Swelling of the face and throat
• A fast heartbeat
• A rash all over the body
• Dizziness and weakness

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some individuals who received mRNA COVID-19 vaccines. These side effects have most commonly been reported in males aged 12 to 24 years.

Seek medical attention immediately if you or your child experience any of the following symptoms within two weeks of vaccination:

• Chest pain
• Shortness of breath
• A fast-beating, fluttering, or pounding heart

Side effects reported in clinical trials:

Injection site reactions: Pain, tenderness, swelling of lymph nodes in the same arm as the injection, swelling (hardness), redness

General side effects: Fatigue, headache, muscle pain, joint pain, chills, nausea or vomiting, fever

Who should not take the mNEXSPIKE vaccine?

Individuals who had a severe allergic reaction to a previous dose of mNEXSPIKE, SPIKEVAX (COVID-19 Vaccine, mRNA), any other Moderna COVID-19 vaccine or any ingredient in these vaccines are advised not to receive the mNEXSPIKE vaccine.

When will mNEXSPIKE be available?

Moderna expects to make mNEXSPIKE available to 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.