FDA approves Moderna's next-generation COVID vaccine for adults 65 or older
Share this @internewscast.com

The US Food and Drug Administration has granted approval for Moderna’s latest COVID-19 vaccine for individuals aged 65 and older, the company announced on Saturday. This is the first authorization following the regulator’s stricter guidelines.

Additionally, the vaccine has been approved for those aged 12 to 64 who have one or more health risk factors as identified by the Centers for Disease Control and Prevention, according to Moderna’s statement.

The company said it expects to have the vaccine, called mNEXSPIKE, available for the 2025-2026 respiratory virus season.

“The FDA’s approval of our third product, mNEXSPIKE, provides a crucial new resource to help shield high-risk individuals from severe COVID-19 illness,” CEO Stephane Bancel remarked in the statement.

The Department of Health and Human Services, under the leadership of long-time vaccine skeptic Robert F. Kennedy Jr., is tightening 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 vaccine 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.

FDA leaders have said 100 million to 200 million Americans would still be eligible for annual shots.

Moderna 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.

Kennedy has kickstarted a major overhaul of health departments, laying off thousands of employees to align with President Donald Trump’s goal of dramatically shrinking the federal government.

This has further ignited worries about potential disruptions to the regulatory review of treatments and vaccines.

The CDC’s outside panel of vaccine experts in April discussed recommending the booster shots only for populations at risk of severe COVID-19 for the upcoming immunization campaign.

The FDA approved Novavax’s COVID vaccine Nuvaxovid this month, limiting its use to older adults and people over the age of 12 with conditions that put them at risk due to the illness.

Conditions that constitute additional risk range from illnesses such as diabetes and heart disease to behaviors like physical inactivity and substance abuse, according to the CDC.

While Moderna’s shots, as well as Pfizer-BioNTech’s Comirnaty, are mRNA-based, Novavax’s vaccine is protein-based and takes longer to manufacture.

Moderna this month withdrew an application seeking approval for its flu-and-COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot.

Share this @internewscast.com
You May Also Like
LSU lands No. 1 college football recruit Lamar Brown in huge get

LSU Secures Top College Football Prospect Lamar Brown in Major Win

The No. 1 recruit in the 2026 recruiting class, according to ESPN’s…
Bikini-clad Sofía Vergara celebrates 53rd birthday in Sardinia

Sofía Vergara Marks Her 53rd Birthday in Sardinia in a Bikini

Buon compleanno! Sofía Vergara celebrated her 53rd birthday in a white bikini…
Satellite image of Ingram Dam in Ingram, Texas before flash flooding.

Before-and-After Photos Highlight the Devastating Impact of Texas Floods and the Heartbreaking Closure of Camp Mystic

SATELLITE images snapped before and after the Texas floods reveal the complete…
Helicopter dropping cash from the sky.

Chaotic Scene Unfolds as Deceased Man’s Life Savings are Released from Helicopter, Leading to Frenzied Cash Grab

THIS is the moment a dead man’s life savings are dropped from…
New Hampshire judge to hear arguments on class action against Trump’s birthright citizenship order

New Hampshire Court to Review Class Action Lawsuit Challenging Trump’s Order on Birthright Citizenship

A federal judge in New Hampshire is set to hear arguments on…
Israel Coalition Against Houthis: Pressuring US for Yemen Strikes

Israel Coalition Advocates for US Intervention: Urging Strikes on Houthis in Yemen

Israel is urging the United States to resume military operations against Yemen’s…
Photo of a smiling baby in a field.

Heartbreaking: 1-Year-Old Dies in Overheated Car as Mom Attends Beauty Appointment

A ONE-year-old boy has died a horrific death after being left in…
Samaritan's Purse volunteers bring faith and supplies to Texans in need

Samaritan’s Purse volunteers deliver faith and aid to struggling Texans

Samaritan’s Purse volunteers are no strangers to disasters, and they are currently…
Canadian police official warns 'traditional values' may be sign a person is becoming 'extremist'

Canadian Police Officer Cautions that ‘Traditional Values’ Could Indicate Emerging Extremism

A spokesperson for the Royal Canadian Mounted Police (RCMP) cautioned on Tuesday…
Chicago crime: Dion Wallace speaks out after son killed in Logan Square stabbing, fire; Wendy Tolbert charged after 3 kids stabbed

Tragedy in Chicago: Father Dion Wallace Shares Loss After Son’s Death in Logan Square; Wendy Tolbert Faces Charges in Stabbing Incident Involving 3 Children

CHICAGO (WLS) — A Chicago father is speaking out after a tragedy…
Man busted with anti-government, anti-Trump documents after Texas ICE ambush suspect phone call, feds say

Federal Authorities Claim Texas ICE Ambush Suspect Found with Anti-Government and Anti-Trump Documents

A man accused of tampering with evidence related to the attack on…
Las Vegas security guard Kegia Mitchell sentenced for killing customer Thomas Martin over COVID-19 protocols

Las Vegas Security Officer Kegia Mitchell Sentenced for Fatal Incident Involving COVID-19 Protocols

A security guard from Las Vegas received a prison sentence ranging from…