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

Desperate Plea: Travis Decker ‘Sighting’ Ignored by Police for Weeks, Leaving Me Feeling Unsettled

A NURSE reported that she spent several weeks urging the police to…
Sheriff Cook discusses safety and crime at town hall

Sheriff Cook Talks Crime and Safety Issues at Community Town Hall

During Thursday’s town hall, Sheriff Michelle Cook announced that crime in Clay…
Photo of Carolina Wilga at a petrol station.

Backpacker Carolina Winger, 26, Found Alive After Nearly Two Weeks Lost in Australian Wilderness

A GERMAN backpacker missing for nearly two weeks in the remote Australian…
Carol Reith arrested for animal cruelty, 52 dogs rescued from 200 block of Sky Hill Road, Wauconda police say

Wauconda Police Report: Carol Reith Detained for Animal Cruelty; 52 Dogs Rescued on Sky Hill Road

WAUCONDA, Ill. (WLS) — A woman was arrested for animal cruelty after…
Aryna Sabalenka recalls testy Wimbledon exchange with Amanda Anisimova

Aryna Sabalenka Reflects on Tense Wimbledon Moment with Amanda Anisimova

Aryna Sabalenka is expanding on her perspective following a tense moment Thursday…
Shocking New Report About What Far-Left Mamdani Allies Might Be Planning Against Jeffries, Other Dems

Surprising Insights on Potential Strategies by Far-Left Mamdani Supporters Against Jeffries and Fellow Democrats

Democrats are going off the rails, embracing extremism.  But because it’s Democrats,…
Karen Read asks Massachusetts court to throw out wrongful death lawsuit after murder acquittal

Karen Read Requests Massachusetts Court to Dismiss Wrongful Death Lawsuit Following Her Murder Acquittal

Karen Read, who was exonerated from murder charges last month concerning the…
Alan Dershowitz Drops Bombshells, Says There Is in Fact an Epstein Client List—and He Knows Who's on It

Alan Dershowitz Reveals Shocking News: Confirms the Existence of an Epstein Client List and Claims to Know Who’s Included

Many observers were left dissatisfied with the conclusions, as the department had…
El Chapo's son pleads guilty to US drug trafficking

El Chapo’s Son Admits Guilt in US Drug Trafficking Case

As part of a plea agreement, Guzman Lopez admitted to helping oversee…
Inside the shoe bomb plot that changed airport security and why the rule is now ending

A Look at the Shoe Bomb Plot that Transformed Airport Security and the Reasons Behind the Rule’s End

After nearly two decades of shuffling barefoot through airport security lines, American…
Trump wants mass deportations, but US views of immigration are more positive since he took office

Trump Advocates for Mass Deportations, Yet American Opinions on Immigration Have Grown More Favorable Since His Presidency

WASHINGTON (AP) — Mere months after President Donald Trump’s return to office…
Israel Gaza Concentration Camp: Haaretz Calls Out Rafah Camp

Haaretz Criticizes Rafah Camp in Gaza, Referring to It as a “Concentration Camp”

Israel’s defense minister is promoting a plan to herd Gaza’s entire population…