US FDA staff says Moderna did not meet all criteria for Covid-19 boosters | The Business Standard
Skip to main content
  • Latest
  • Epaper
  • Economy
    • Banking
    • Stocks
    • Industry
    • Analysis
    • Bazaar
    • RMG
    • Corporates
    • Aviation
  • Videos
    • TBS Today
    • TBS Stories
    • TBS World
    • News of the day
    • TBS Programs
    • Podcast
    • Editor's Pick
  • World+Biz
  • Features
    • Panorama
    • The Big Picture
    • Pursuit
    • Habitat
    • Thoughts
    • Splash
    • Mode
    • Tech
    • Explorer
    • Brands
    • In Focus
    • Book Review
    • Earth
    • Food
    • Luxury
    • Wheels
  • More
    • Sports
    • TBS Graduates
    • Bangladesh
    • Supplement
    • Infograph
    • Archive
    • Gallery
    • Long Read
    • Interviews
    • Offbeat
    • Magazine
    • Climate Change
    • Health
    • Cartoons
  • বাংলা
The Business Standard

Wednesday
June 18, 2025

Sign In
Subscribe
  • Latest
  • Epaper
  • Economy
    • Banking
    • Stocks
    • Industry
    • Analysis
    • Bazaar
    • RMG
    • Corporates
    • Aviation
  • Videos
    • TBS Today
    • TBS Stories
    • TBS World
    • News of the day
    • TBS Programs
    • Podcast
    • Editor's Pick
  • World+Biz
  • Features
    • Panorama
    • The Big Picture
    • Pursuit
    • Habitat
    • Thoughts
    • Splash
    • Mode
    • Tech
    • Explorer
    • Brands
    • In Focus
    • Book Review
    • Earth
    • Food
    • Luxury
    • Wheels
  • More
    • Sports
    • TBS Graduates
    • Bangladesh
    • Supplement
    • Infograph
    • Archive
    • Gallery
    • Long Read
    • Interviews
    • Offbeat
    • Magazine
    • Climate Change
    • Health
    • Cartoons
  • বাংলা
WEDNESDAY, JUNE 18, 2025
US FDA staff says Moderna did not meet all criteria for Covid-19 boosters

Coronavirus chronicle

Reuters
13 October, 2021, 09:40 am
Last modified: 13 October, 2021, 09:43 am

Related News

  • Special health guidelines issued for HSC exams amid covid-19, dengue surge
  • 7 new Covid-19 cases reported in 24hrs
  • Covid hospitals in Chattogram face ICU, testing kit crisis amid rising infections
  • DGHS issues 11-point directive to prevent spread of Covid-19 in Bangladesh
  • Tourist surge raises fresh Covid-19 concerns in Rangamati

US FDA staff says Moderna did not meet all criteria for Covid-19 boosters

Moderna is seeking authorization for a 50-microgram booster dose, half the strength of the original vaccine given in two shots about four weeks apart

Reuters
13 October, 2021, 09:40 am
Last modified: 13 October, 2021, 09:43 am
Syringes filled with a dose of the Moderna Covid-19 vaccine sit on a table during an employee vaccination at the Sarasota Memorial Hospital in Sarasota, Florida, US, September 24, 2021. Photo :Reuters
Syringes filled with a dose of the Moderna Covid-19 vaccine sit on a table during an employee vaccination at the Sarasota Memorial Hospital in Sarasota, Florida, US, September 24, 2021. Photo :Reuters

Scientists at the US Food and Drug Administration said on Tuesday that Moderna Inc had not met all of the agency's criteria to support use of booster doses of its COVID-19 vaccine, possibly because the efficacy of the shot's first two doses has remained strong.

FDA staff said in documents that data for Moderna's vaccine showed that a booster does increase protective antibodies, but the difference in antibody levels before and after the shot was not wide enough, particularly in those whose levels had remained high.

The documents were released ahead of a meeting later this week of the FDA's outside expert advisers to discuss booster doses of the vaccine.

The Business Standard Google News Keep updated, follow The Business Standard's Google news channel

The FDA typically follows the advice of its experts, but is not bound to do so. A panel of advisers to the US Centers for Disease Control and Prevention (CDC) will meet next week to discuss specific recommendations on who can receive the boosters, if the FDA authorizes them.

"There was boosting, sure. Was it enough boosting? Who knows? There's no standard amount of boosting that is known to be needed, and nor is it clear how much boosting happened in the study," John Moore, a professor of microbiology and immunology at Weill Cornell Medical College in New York, said in an email.

Moderna is seeking authorization for a 50-microgram booster dose, half the strength of the original vaccine given in two shots about four weeks apart.

The company has asked regulators to clear a third round of shots for adults aged 65 and over, as well as for high-risk individuals, similar to the authorization gained by rivals Pfizer Inc and German partner BioNTech for their mRNA vaccine.

President Joe Biden's administration announced plans earlier this year to roll out booster doses for most adults, but some FDA scientists later said in an article in journal The Lancet that there was not enough evidence to support boosters for all.

Data on the need for boosters has largely come from Israel, which rolled out the additional shots of the Pfizer/BioNTech vaccine to large swaths of its population, and has provided details on the effectiveness of that effort to US advisers.

No similar real-world study populations exist for the Moderna or Johnson & Johnson vaccines.

The evidence for Moderna's booster appears to have "a lot of holes," said Dr. Eric Topol, a professor of molecular medicine and director of the Scripps Research Translational Institute in La Jolla, California, noting that the data provided was limited and offers no insight into how the boosters actually perform in people.

"That is fairly short of what Pfizer had from Israel, where they had the full restoration of the vaccine effectiveness from the booster," Topol said.

The FDA's advisers will also consider booster doses for J&J's single-dose vaccine on Friday. The FDA has not yet released its briefing documents on those shots.

J&J has asked the FDA to authorize a booster at least two months after the initial shot. It said data suggests high-risk adults should receive boosters earlier, but that lower-risk individuals could benefit from waiting at least six months for their second shot.

Top News / World+Biz

Moderna / Covid -19 / booster / US FDA

Comments

While most comments will be posted if they are on-topic and not abusive, moderation decisions are subjective. Published comments are readers’ own views and The Business Standard does not endorse any of the readers’ comments.

Top Stories

  • US President Donald Trump points a finger as he departs for Canada to attend the G7 Leaders' Summit, from Joint Base Andrews in Maryland, US, June 15, 2025. Photo: REUTERS/Kevin Lamarque
    Trump demands Iran's 'unconditional surrender', says US won't kill supreme leader 'for now'
  • Infographics: Duniya Jahan/TBS
    How Israel's secret nuclear arsenal comes under spotlight amid attacks on Iran
  • Representational image. Photo: Collected
    17 banks in Tk1.77 lakh crore provision shortfall amid soaring NPLs

MOST VIEWED

  • Former Bangladesh High Commissioner to the UK Saida Muna Tasneem. Photo: Collected
    ACC launches inquiry against ex-Bangladesh envoy Saida Muna, husband over laundering Tk2,000cr
  • Infograph: TBS
    Ship congestion at Ctg port lingers as berthing time rises
  • A view of Iranian missiles across the sky as seen by Biman pilot Enam Talukder. Photo: Enam Talukder
    Biman pilot witnessed Iran's missiles flying towards Israel
  • Power Division wants Tk56,000cr PDB loans turned into subsidy
    Power Division wants Tk56,000cr PDB loans turned into subsidy
  • BNP leader Ishraque Hossain held a view-exchange meeting with waste management officials and Dhaka South City Corporation staff inside Nagar Bhaban on 16 June 2025. Photos: Hasan Mehedi
    Ishraque holds Nagar Bhaban meeting as 'Dhaka South mayor', says it’s people’s demand
  • Bangladesh gains bigger share in US apparel market as China loses ground, sees 29% export growth in Jan-Apr
    Bangladesh gains bigger share in US apparel market as China loses ground, sees 29% export growth in Jan-Apr

Related News

  • Special health guidelines issued for HSC exams amid covid-19, dengue surge
  • 7 new Covid-19 cases reported in 24hrs
  • Covid hospitals in Chattogram face ICU, testing kit crisis amid rising infections
  • DGHS issues 11-point directive to prevent spread of Covid-19 in Bangladesh
  • Tourist surge raises fresh Covid-19 concerns in Rangamati

Features

The Kallyanpur Canal is burdened with more than 600,000 kilograms of waste every month. Photo: Courtesy

Kallyanpur canal project shows how to combat plastic pollution in Dhaka

5h | Panorama
The GLS600 overall has a curvaceous nature, with seamless blends across every panel. PHOTO: Arfin Kazi

Mercedes Maybach GLS600: Definitive Luxury

1d | Wheels
Renowned authors Imdadul Haque Milon, Mohit Kamal, and poet–children’s writer Rashed Rouf seen at Current Book Centre, alongside the store's proprietor, Shahin. Photo: Collected

From ‘Screen and Culture’ to ‘Current Book House’: Chattogram’s oldest surviving bookstore

2d | Panorama
Photos: Collected

Kurtis that make a great office wear

4d | Mode

More Videos from TBS

What's behind the animosity between former allies Iran and Israel?

What's behind the animosity between former allies Iran and Israel?

1h | Others
21 Muslim countries condemn Israeli attack on Iran

21 Muslim countries condemn Israeli attack on Iran

1h | TBS World
News of The Day, 17 JUNE 2025

News of The Day, 17 JUNE 2025

4h | TBS News of the day
Rising default loans threaten jobs, growth, trade

Rising default loans threaten jobs, growth, trade

6h | TBS Insight
EMAIL US
contact@tbsnews.net
FOLLOW US
WHATSAPP
+880 1847416158
The Business Standard
  • About Us
  • Contact us
  • Sitemap
  • Advertisement
  • Privacy Policy
  • Comment Policy
Copyright © 2025
The Business Standard All rights reserved
Technical Partner: RSI Lab

Contact Us

The Business Standard

Main Office -4/A, Eskaton Garden, Dhaka- 1000

Phone: +8801847 416158 - 59

Send Opinion articles to - oped.tbs@gmail.com

For advertisement- sales@tbsnews.net