Al Mayadeen English

  • Ar
  • Es
  • x
Al Mayadeen English

Slogan

  • News
    • Politics
    • Economy
    • Sports
    • Arts&Culture
    • Health
    • Miscellaneous
    • Technology
    • Environment
  • Articles
    • Opinion
    • Analysis
    • Blog
    • Features
  • Videos
    • NewsFeed
    • Video Features
    • Explainers
    • TV
    • Digital Series
  • Infographs
  • In Pictures
  • • LIVE
News
  • Politics
  • Economy
  • Sports
  • Arts&Culture
  • Health
  • Miscellaneous
  • Technology
  • Environment
Articles
  • Opinion
  • Analysis
  • Blog
  • Features
Videos
  • NewsFeed
  • Video Features
  • Explainers
  • TV
  • Digital Series
Infographs
In Pictures
  • Africa
  • Asia
  • Asia-Pacific
  • Europe
  • Latin America
  • MENA
  • Palestine
  • US & Canada
BREAKING
The Israeli Walla! website: We are running out of stockpiles, our forces are exhausted, and the lives of the captives are in danger. It is time for a ceasefire deal in Gaza.
Several wounded in an Israeli bombardment of a tent in al-Mawasi, south of Khan Younis in the Gaza Strip.
Israeli media: Three wounded, three killed in an ongoing operation in the Gaza Strip.
Al Mayadeen's correspondent in southern Lebanon: Israeli artillery shelling targets the outskirts of the town of Shebaa
Al-Qassam Brigades: The targeting took place at the intersection of 'Street 5' with the western line north of Khan Younis
Al-Qassam Brigades: A NIMR armored personnel carrier carrying an Israeli soldier was targeted with an Al-Yassin missile north of Khan Younis
Israeli media: At least two soldiers killed by anti-tank missile fired at Israeli army forces in the Gaza Strip
Local Syrian sources: Mortar shells fell on more than nine villages in the Sweida countryside
Local Syrian sources: Dozens of dead and wounded have arrived at Sweida hospitals as a result of ongoing clashes at several locations in the western Sweida countryside
Local sources: Civilians, including children and women, were injured in the al-Maqous neighborhood of Sweida, in Syria, as a result of ongoing clashes

FDA approves Omicron boosters for US citizens as young as 12

  • By Al Mayadeen English
  • Source: Agencies
  • 1 Sep 2022 13:01
5 Min Read

The Biden administration's planned fall COVID-19 booster campaign is now approved by the FDA for shots adapted for the Omicron variant.

  • x
  • Booster shot (AFP)
    Booster shot (AFP)

People in the US could now get the new subvariant booster 2 months after their last shot of the COVID-19 vaccine, with Moderna's new shots authorized for Americans as young as 18, and Pfizer and BioNTech can be given starting from age 12.

According to Dr. Robert Califf, the FDA commissioner, "As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants" - meaning that deliveries of the new doses from Pfizer-BioNTech and Moderna can now begin as multiple states and local health departments have already placed pre-orders last month for the first set of shipments.

Per its spokesperson, Pfizer can ship up to 15 million doses of the new booster by the end of next week, pending "final quality control checks." However, similar to previous COVID-19 vaccine rollouts, vaccine providers will need to wait for the Centers for Disease Control and Prevention's (CDC) own recommendation before administering their first shots, expected by the end of this week, following a two-day meeting of the agency's outside vaccine advisors. 

The new rollouts mark the first significant change to the COVID-19 vaccines since they were provided earlier in the pandemic and Pfizer intends to submit a request to the FDA "in early October" for giving the new booster to children starting at the age of 5 years old and is also working on a submission for boosting kids as young as 6 months old.

By mixing a component from their original "prototype" shots with another, the vials of the so-called "bivalent" shots from each company are intended to target the Omicron subvariants BA.4 and BA.5 - now hitting hard across the US.

Pfizer's CEO Albert Bourla disclosed, "As we head into the fall and winter season, with the potential for greater SARS-CoV-2 spread in schools and at work, it is important to stay up to date with vaccines as a first line of defense against COVID-19 illness."

Earlier this year, scientists are warning that the wide and fast-spreading Omicron is an indicator that it will not be Covid-19's last variant.

Related News

FDA to suspend food testing as staff cuts bite into safety program

US FDA finds widely used asthma drug impacts the brain: Reuters

Why are the booster shots being changed?

The decision was the result of meetings of the FDA's vaccine advisors earlier this year to weigh the issue, which at the time, a majority of the committee leaned toward an approach close to that of Pfizer and BioNTech to expedite the authorization of new shots that might boost their effectiveness ahead of another feared deadly winter wave of the virus.

Although the FDA said it would not require lengthy clinical trials of the Omicron shots before authorization, it would rely largely on trial data collected from testing the immune response triggered by the new shots in animals, as well as data from other formulas trialed by the vaccine makers.

Dr. Califf added on the Public Health On Call podcast on Tuesday, "In the midst of a pandemic, if you wait for all that data to come in, you've missed the boat. And so you have to be preemptive," comparing the authorization to updating the annual flu vaccine, citing "the totality of the evidence" supporting their decision.

CDC Director Dr. Rochelle Walensky indicated her approval of signing off on the new booster shots and pointed to her agency's calculations, which show the BA.4 and BA.5 subvariants making up virtually all new infections across the US right now.

"The strategy now is to tailor vaccine for giving us the largest breadth of response, ideally one that would have less waning over time," Walensky told the Conversations on Health Care radio program.

But even with the presence of the approval, the two vaccine makers disclosed plans to complete human clinical trials of these new shots, with federal health officials asking for these trials to track the vaccine's ability to curb future virus variants later this year, which might look very different from the strains circulating now. 

Amid annual flu shots and a current monkeypox vaccine rollout, twenty million doses were made available for vaccine providers to pre-order, from states to pharmacies, according to a spokesperson for the Department of Health and Human Services - all 50 states and the District of Columbia have requested shots.

According to CDC statistics, the US is currently averaging less than 40,000 first doses a day and the CDC last month urged state and local health departments to prepare for distributing the early shipments to providers to serve "those at highest risk for severe COVID-19 disease" first, like in nursing homes. They also announced that not all providers will continue to have stock of the primary series COVID-19 vaccines. 

  • FDA
  • COVID-19
  • US
  • Omicron
  • Biden
  • Moderna
  • Pfizer

Most Read

Hezbollah SG reveals war details on Al Mayadeen for the first time

Hezbollah SG reveals war details on Al Mayadeen for the first time

  • Politics
  • 8 Jul 2025
Major ambush in Gaza kills 6 Israeli troops, injures dozens

Major ambush in Gaza kills 5 Israeli troops, injures 14

  • Politics
  • 8 Jul 2025
Israeli soldiers are seen in Beit Hanoun ahead of an operation by the al-Qassam Brigades, undated (Al-Qassam Brigades Military Media)

'Israel' on blast as media exposes report discrepancies in Gaza ambush

  • Palestine
  • 8 Jul 2025
Yemen Navy sinks ETERNITY C ship, shares footage of operation

Yemen Navy sinks ETERNITY C ship, shares footage of operation

  • Politics
  • 9 Jul 2025

Coverage

All
The Ummah's Martyrs

Read Next

All
The Freedom Flotilla ship Handala as it departs for Gaza, where it aims to break the maritime blockade at a port in Syracuse, Sicily in southern Italy on July 13, 2025. (AFP)
Palestine

Freedom Flotilla's Handala departs Sicily in bid to break Gaza siege

The container ship CMA CGM Laperouse, left, docks at the Georgia Ports Authority's Port of Savannah, Sept. 29, 2021, in Savannah, Ga (AP)
Politics

US shipbuilding woes deepen as tariffs, outdated policies backfire

Gaza war raises ethical questions for ex-Obama, Biden officials
Politics

Mercenary firm tied to Gaza war crimes hires Obama-Biden PR operatives

'Israel' targets children in Gaza collecting water
Palestine

'Israel' strikes Gaza kids fetching water, blames it on 'malfunction'

Al Mayadeen English

Al Mayadeen is an Arab Independent Media Satellite Channel.

All Rights Reserved

  • x
  • Privacy Policy
  • About Us
  • Contact Us
  • Authors
Android
iOS