May 31 (Reuters) - The U.S. Food and Drug Administration

has approved Moderna's ( MRNA ) next-generation COVID-19 vaccine

for everyone aged 65 and above, the company said on Saturday,

the first endorsement since the regulator tightened

requirements.

The vaccine has also been approved for people aged 12 to 64

with at least one or more underlying risk factors, Moderna ( MRNA ) said

in a statement.

Moderna ( MRNA ) said it expects to have the vaccine, called

mNEXSPIKE, available for the 2025-2026 respiratory virus season.

"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," CEO Stephane Bancel said in the

statement.

The Department of Health and Human Services, under the

leadership of long-time vaccine skeptic Robert F. Kennedy Jr.,

is increasing regulatory scrutiny on vaccines.

The FDA said on May 20 it planned to require drugmakers to

test their COVID booster shots against an inert placebo in

healthy adults under 65 for approval, effectively limiting them

to older adults and those at risk of developing severe illness.

The Moderna ( MRNA ) vaccine, branded mNEXSPIKE, can be stored in

refrigerators rather than freezers, to offer longer shelf life

and make distribution easier, especially in developing countries

where supply-chain issues could hamper vaccination drives.

The Centers for Disease Control and Prevention, which

Kennedy also oversees, said on Thursday that COVID vaccines

remain an option for healthy children when parents and doctors

agree that it is needed, stopping short of Kennedy's

announcement days earlier that the agency would remove the shots

from its immunization schedule.

The CDC announcement eases investor concern to some extent,

analysts say, as it keeps the existing framework for older

adults and at-risk people who generally seek out the shots.

Moderna ( MRNA ) is betting on its newer messenger RNA vaccines as it

grapples with waning demand for its original COVID vaccine

Spikevax and lower-than-expected uptake of its respiratory

syncytial virus vaccine.

The approval for mNEXSPIKE was based on late-stage trial

data, which showed the shot was not inferior in efficacy

compared to Spikevax in individuals aged 12 years and older.

The shot also showed superior efficacy compared to Spikevax

in adults 18 years of age and older in the study.