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
Al Mayadeen's correspondent: One was killed, another injured in a raid by an Israeli drone on the city of Khiam in South Lebanon
London views possibility of setting fire to tanker in port of friendly country to Russia to damage port infrastructure, initiate an international probe: Moscow
One of London's scenarios involves setting up accident with 'undesirable' tanker in one of the bottlenecks of maritime communications: Russian foreign intelligence agency
London plans to organize major sabotage with tankers to declare transportation of Russian oil to international shipping: Russian foreign intelligence agency
UK intelligence agencies plan to use NATO allies to launch massive raid on 'Shadow Fleet': Russian foreign intelligence agency
Palestinian Ministry of Health: Two were martyred in Israeli shelling that targeted a besieged house in the town of Qabatiya in Jenin
At least 68 dead in migrant shipwreck off Yemen: IOM
Trump: We want to feed the people in Gaza, we do not want them to starve.
US President Donald Trump: We will impose sanctions on Russia if it does not end the war on Ukraine.
Israeli media: Polls show that 52% oppose Prime Minister Benjamin Netanyahu while only 29% support him.

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

A rescued crew member from the ETERNITY C vessel in a video released by the Yemeni Armed Forces on July 28, 2025 (Yemeni Military Media)

Yemen Navy reveals fate of targeted Eternity C ship crew

  • Politics
  • 28 Jul 2025
An Israeli tank explodes following an ambush by al-Qassam Brigades in Gaza, Occupied Palestine, undated (Al-Qassam Military Media)

Al-Qassam strikes Israeli vehicles in Gaza, inflicts casualties

  • Politics
  • 30 Jul 2025
UAE lodges complaint against Israeli ambassador over 'misbehavior'

UAE lodges complaint against Israeli ambassador over 'misbehavior'

  • Politics
  • 1 Aug 2025
Protesters chant anti-Israeli slogans as they carry a banner that reads:" Freedom for Palestine, Alliance stop the war," during a demonstration in support of Palestinians in Gaza, outside the Israeli embassy, in Athens, Monday, June 9, 2025 (AP)

Athens mayor slams Israeli ambassador over Gaza war, graffiti claim

  • Politics
  • 3 Aug 2025

Coverage

All
The Ummah's Martyrs

Read Next

All
A member of the al-Qassam Brigades, the armed wing of Hamas, takes part in a parade as he celebrates a ceasefire agreement between Hamas and the Israeli regime in Deir al-Balah, Gaza Strip, Sunday, January 19, 2025 (AP)
Politics

Al-Qassam: We’ll allow aid to Israeli captives if Gaza siege ends

Freed Lebanese freedom fighter Georges Abdallah during an interview on Al Mayadeen, which aired on Sunday, August 3, 2025 (Al Mayadeen screengrab)
Politics

Exclusive: Resistance key to building state, Georges Abdallah says

United Nations Secretary General Antonio Guterres gives a statement about the situation in Gaza at UN headquarters, Friday, June 27, 2025 (AP)
Politics

UN warns Gaza faces water crisis, looming famine under Israeli siege

Israeli soldiers drive their armored personnel carrier along the Gaza Strip, in southern occupied Palestine, Wednesday, July 30, 2025 (AP)
Politics

Ex-Israeli general says Gaza starvation campaign isolated 'Israel'

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