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U.S. FDA authorizes first COVID-19 shot for young kids

Published Oct 29, 2021 12:46PM ET Updated Oct 29, 2021 09:00PM ET
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2/2 © Reuters. FILE PHOTO: FILE PHOTO: A woman holds a small bottle labelled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in this illustration taken October 30, 2020. REUTERS/Dado Ruvic/File Photo 2/2
 
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By Manas Mishra and Michael Erman

(Reuters) -The U.S. Food and Drug Administration on Friday authorized the Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) coronavirus vaccine for children aged 5 to 11 years, making it the first COVID-19 shot for young children in the United States.

The shot will not be immediately available to the age group. The U.S. Centers for Disease Control and Prevention still needs to advise on how the shot should be administered, which will be decided after a group of outside advisers discuss the plan on Tuesday.

Pfizer said it will begin shipping pediatric vials of the vaccine on Saturday to pharmacies, pediatricians' offices and other places where the shots may be administered.

The FDA decision is expected to make the vaccine available to 28 million American children, many of whom are back in school for in-person learning.

It comes after a panel of advisers to the regulator voted overwhelmingly to recommend the authorization on Tuesday.

Only a few other countries, including China, Cuba and the United Arab Emirates, have so far cleared COVID-19 vaccines for children in this age group and younger.

The FDA authorized a 10-microgram dose of Pfizer's vaccine in young children, lower than the 30 micrograms in the original vaccine for those age 12 and older.

Advisers on the FDA panel said a lower dose could help mitigate some of the rare side effects after paying close attention to the rate of heart inflammation, or myocarditis, that has been linked to both Pfizer and Moderna (NASDAQ:MRNA) vaccines, especially in young men.

The regulator said on Friday that known and potential benefits of the Pfizer vaccine in individuals aged between 5 and 11 outweigh the risks.

For the pediatric shots, the FDA has authorized a new version of the vaccine, which uses a new buffer and allows them to be stored in refrigerators for up to 10 weeks.

In the United States, around 58% of the population is fully vaccinated, lagging other nations such as the UK and France. Many adults, who have been hesitant to get a vaccine, may be more cautious about giving the shot to their children.

"We certainly hope that as people see children getting vaccinated, and being protected and being able to participate in activities without concern, that more people will get their kids vaccinated," Acting FDA Commissioner Dr. Janet Woodcock said at a press conference.

"And as we accumulate more experience with the vaccine, more comfort with the safety will occur."

Pfizer and BioNTech said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.

"This is a day so many parents, eager to protect their young children from this virus, have been waiting for," Pfizer Chief Executive Albert Bourla said in a statement

The United States started administering the vaccine to teens between ages 12 and 17 in May. Vaccination coverage among the age group is lower than in older groups, according to the CDC.

Pfizer's vaccine was the first to be authorized for emergency use in the United States in December last year for those age 16 and older and was granted full U.S. approval in August.

Earlier this week, Moderna reported interim data showing that its vaccine generated a strong immune response in children ages 6 to 11 years. It is awaiting a U.S. regulatory decision on the authorization for children between ages 12 and 17.

U.S. FDA authorizes first COVID-19 shot for young kids
 

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Comments (9)
Roger Miller
Roger Miller Oct 30, 2021 2:53AM ET
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Finally, the kids will learn what it means to sacrifice for others. Probabally no harm to them, but not much benefit either. I wonder how many have had it so don’t even need the vaccine.
Kris GE
Kris GE Oct 29, 2021 11:50PM ET
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Parents, if you love your children DO NOT do this to them. Protect them and under no circumstances allow this jab to be administered to your child. There is no benefit, but potential for REAL harm .This is an experiment. Tell these people to experiment on rats, or mice not on humans. Tell them to go and pound sand.
David David
David9 Oct 29, 2021 11:50PM ET
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the vaccine is safe....billions have already got it.
Roger Miller
Roger Miller Oct 29, 2021 11:50PM ET
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David David …safe but unnecesary for children.
James Johannsen
James Johannsen Oct 29, 2021 11:50PM ET
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have you seen the VAERS Data? these injections are far from safe
Daniel Martin
Daniel Martin Oct 29, 2021 11:50PM ET
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It’s impossible to have that date at this point in time. But I can tell you there’s not a pandemic of people dropping dead from taking the vaccine like there was from contracting Covid or previously the Spanish flu worldwide. The number of people that had antibodies to Covid or symptoms from contracting Covid far outweigh what taking a vaccine would entail even. They’ve been used for decades. For instance, the polio vaccine. It helped eradicate what was a major issue worldwide and still is in some areas d/t the shortage of the vaccine. But the simplest one, the flu vaccine, helps prevent what happened with Covid. Spreading from one continent to the next, them one state to the next.
David David
David9 Oct 29, 2021 11:45PM ET
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everybody, adult or children need to get the vaccined so we can end this. if not, it will go on and on forever.
Roger Miller
Roger Miller Oct 29, 2021 11:45PM ET
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…until it evolves into a common cold virus in a year or two.
Lesko Brandon
Lesko Brandon Oct 29, 2021 8:23PM ET
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Now that they got it approved through the government bureaucracy that has gone against advisory panel guidance several times they just have to come up with a reason to give children these shots that are correlated with heart inflammation/auto-immune disease/sudden death, only last a few months, does not prevent spread of the virus, and the pharma companies have complete legal immunity...I am sure the media and politicians who receive advertising budget and donations from pharma companies will do their part to their corporate overlords.
Lesko Brandon
Lesko Brandon Oct 29, 2021 8:23PM ET
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Statistically children have a higher likelihood of having adverse event from the vaccine than from COVID. Children have lower risk with COVID than the common flu. Statistically a child is more likely to die in a car accident while on the way to get the vaccine than from COVID itself.
Thomas DeVito
Thomas DeVito Oct 29, 2021 8:23PM ET
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don't worry they will be required for profits
Lesko Brandon
Lesko Brandon Oct 29, 2021 8:23PM ET
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Statistically children have a higher likelihood of having adverse event from the vaccine than from COVID. Children have lower risk with COVID than the common flu.
Ac Tektrader
Ac Tektrader Oct 29, 2021 5:15PM ET
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here we have a lot of posts by people who think children and their families dying of covid-19 is OK.
Lesko Brandon
Lesko Brandon Oct 29, 2021 5:15PM ET
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"It's for your safety" "Think of the children"...the same rhetoric tyrants and fascists have used throughout history. The same way Adolph got his population to be afraid of Je.wish people and put them in concentration camps. Children have lower risk with COVID than the common flu, the vaccines do not prevent the spread of the virus and only last a few months, and some countries have already banned the use of COVID vaccines in children since there it has been proven to be linked to heart inflammation and sudden death in otherwise healthy children and young adults. Meanwhile, you are trusting the media and politicians who are sponsored by the pharma companies who have received complete legal immunity for their vaccines.
Kevin Avila
Kevin Avila Oct 29, 2021 5:15PM ET
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Then get the damn shot! Stop forcing it on others!
Co Gonz
Co Gonz Oct 29, 2021 4:08PM ET
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other countries have moved the other way- Sweden, norway, U.K. how is the u.s. more progressive?
Marvin McEwen
Marvin McEwen Oct 29, 2021 3:42PM ET
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In the US, a significant number of media outlets are sponsored by pharmaceutical companies and politicians receive large donations from pharmaceutical companies...I am sure completely unrelated to the fact that the US is trying to push these experimental jabs on children while other countries are banning them from being used in younger people due to adverse events such as heart inflammation and sudden death that have been observed related to the vaccines.
Lesko Brandon
Lesko Brandon Oct 29, 2021 2:46PM ET
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Even threatening adults with loss of their jobs did not get enough people to take the experimental jab, so to make the pharma companies money they want to give your kids heart inflammation for something less deadly to them than the common flu. No long term safety data, complete legal immunity to pharma companies, and many countries have already banned use in children due to cardia risks. Meanwhile US pushing for it with the pharma donations to politicians and their media mo.uthpieces, and Fauci literally involved in gross science experiments and funding the lab that created the virus.
Ac Tektrader
Ac Tektrader Oct 29, 2021 2:46PM ET
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I guess you and your supporters will have to learn the hard way.
Lesko Brandon
Lesko Brandon Oct 29, 2021 2:46PM ET
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Ac Tektrader  The vaccines you got a few months ago have already worn off buddy, better take a break from posting here to get your heart inflammation booster.
Felipe Daniel
Felipe Daniel Oct 29, 2021 1:15PM ET
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Crimes against humanity
 
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