US FDA staff says Moderna did not meet all criteria for Covid-19 boosters | The Business Standard
Skip to main content
  • Latest
  • 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

Tuesday
June 10, 2025

Sign In
Subscribe
  • Latest
  • 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
TUESDAY, JUNE 10, 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

  • Aid funding disrupts child vaccinations almost as much as pandemic: UN
  • Trump's White House launches COVID website that criticizes WHO, Fauci and Biden
  • Chinese researchers find bat virus enters human cells via same pathway as Covid
  • US FDA asks fired scientists to return, including some reviewing Musk's Neuralink
  • Forgotten but not gone: Covid keeps killing, five years on

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

  • Chief Adviser Muhammad Yunus leaves for a four-day visit to the United Kingdom from the Dhaka airport on 9 June 2025. Photo: CA Press Wing
    CA Yunus leaves for UK; discussion expected on renewable energy investment, laundered money
  • Donald Trump. Photo: Reuters
    Trump defends sending National Guard to LA as California governor to sue administration
  • California Governor Gavin Newsom. File Photo: REUTERS/Fred Greaves
    California Governor Newsom to sue Trump over National Guard deployment amid LA protests

MOST VIEWED

  • On left, Abdullah Hil Rakib, former senior vice president (SVP) of BGMEA and additional managing director of Team Group; on right, Captain Md Saifuzzaman (Guddu), a Boeing 787 Dreamliner pilot for Biman Bangladesh Airlines. Photos: Collected
    Ex-BGMEA SVP Abdullah Hil Rakib, Biman 787 pilot Saifuzzaman drown in boating accident in Canada
  • A photo showing the former president on his return to Dhaka today (9 June). 
Source: Collected
    Former president Abdul Hamid returns to Bangladesh from Thailand
  • File Photo: British MP Tulip Siddiq attends a news conference with Richard Ratcliffe, the husband of jailed British-Iranian aid worker Nazanin Zaghari-Ratcliffe, in London, Britain October 11, 2019. Photo: REUTERS/Peter Nicholls/File Photo
    Tulip requests CA Yunus for a meeting over corruption allegations: Guardian
  • Representational image. Photo: Reuters
    Bangladesh reports 3 more Covid-19 cases
  • Muhammad Yunus (L) and Narendra Modi. Photo: Collected
    Modi sends Eid-ul-Adha greetings, Yunus calls for continued bilateral cooperation
  • Photo: Reuters
    Trump says Musk relationship over, warns of 'serious consequences' if he funds Democrats

Related News

  • Aid funding disrupts child vaccinations almost as much as pandemic: UN
  • Trump's White House launches COVID website that criticizes WHO, Fauci and Biden
  • Chinese researchers find bat virus enters human cells via same pathway as Covid
  • US FDA asks fired scientists to return, including some reviewing Musk's Neuralink
  • Forgotten but not gone: Covid keeps killing, five years on

Features

File photo of Eid holidaymakers returning to the capital from their country homes/Rajib Dhar

Dhaka: The city we never want to return to, but always do

21h | Features
Photo collage shows political posters in Bagerhat. Photos: Jannatul Naym Pieal

From Sheikh Dynasty to sibling rivalry: Bagerhat signals a turning tide in local politics

2d | Bangladesh
Illustration: TBS

Unbearable weight of the white coat: The mental health crisis in our medical colleges

5d | Panorama
(From left) Sadia Haque, Sylvana Quader Sinha and Tasfia Tasbin. Sketch: TBS

Meet the women driving Bangladesh’s startup revolution

5d | Panorama

More Videos from TBS

US and China to meet in London for trade talks

US and China to meet in London for trade talks

10h | TBS World
The forbidden point on Cox's Bazar beach is like a death trap

The forbidden point on Cox's Bazar beach is like a death trap

12h | TBS Today
Israeli forces seize Gaza aid boat carrying Greta Thunberg

Israeli forces seize Gaza aid boat carrying Greta Thunberg

14h | TBS World
Which way will the anti-immigration campaign in Los Angeles turn?

Which way will the anti-immigration campaign in Los Angeles turn?

14h | TBS World
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