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FDA says benefits outweigh risks for Pfizer/BioNTech COVID-19 vaccine in children

Stock MarketsOct 23, 2021 12:20AM ET
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© Reuters. FILE PHOTO: A vial labelled with the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine is seen in this illustration picture taken March 19, 2021. REUTERS/Dado Ruvic/Illustration

By Michael Erman

NEW YORK (Reuters) -Scientists at the U.S. Food and Drug Administration (FDA) said on Friday that the likely benefits of giving the Pfizer/BioNTech COVID-19 vaccine to 5 to 11 year olds clearly outweigh the risks of rare cases of heart inflammation.

Earlier on Friday, the vaccine makers said their shot showed 90.7% efficacy against the coronavirus in a clinical trial of children 5 to 11 years old.

The details were in briefing documents published ahead of a meeting of a panel of outside experts scheduled to vote on Tuesday whether to recommend the FDA authorize the shots for the young age group.

If the FDA authorizes the Pfizer/BioNTech immunization for children 5 to 11 years old, it would be the first COVID-19 vaccine for the age group and shots could be available in the United States in early November.

Both the Pfizer/BioNTech and Moderna (NASDAQ:MRNA) Inc vaccines have been linked to rare cases of heart inflammation called myocarditis, especially in young men.

The FDA staff said that, assuming the number of myocarditis cases observed in the younger age group would be similar to that seen in 12 to 15 year olds, the number of COVID-19 related hospitalizations prevented would outnumber myocarditis-related hospitalizations in most scenarios analyzed.

Pfizer (NYSE:PFE) suggested in its own briefing documents that the rate of myocarditis in the age group was likely to be lower than observed in vaccinated 12 to 15 year olds, in part because the younger children were given a lower dose.

The 5 to 11 year olds were given two shots of a 10-microgram dose, a third of what was given to people 12 years and older.

Sixteen children in the trial who had received a placebo got COVID-19, versus three who were vaccinated, Pfizer said in briefing documents submitted to the FDA.

Because more than twice as many children in the 2,268-participant trial were given the vaccine than placebo, that equates to better than 90% efficacy.

Pfizer's clinical trial in those 5 to 11 years old was not primarily designed to measure efficacy against the virus.

Instead, it compared the amount of neutralizing antibodies induced by the vaccine in the children to the response of older recipients in their adult trial.

Based on those results, Pfizer and BioNTech said last month that their COVID-19 vaccine induced a robust immune response in the children. The FDA staff said the vaccine met the agency's criteria for the immune response it generated in the children.

EXPANDED TRIAL

Pfizer also said on Friday that it had expanded its clinical trial to improve its safety data, more than doubling the number of children enrolled.

According to Pfizer, the adverse event profile in the expanded group did not suggest any new safety concerns from the vaccine. The company had said previously that the safety profile in the age group was generally comparable to 16 to 25 year olds.

The second cohort of children have been observed for a shorter time. All of them had received their second dose and more than 70% were more than two weeks post dose two.

The Pfizer/BioNTech vaccine already has U.S. regulatory authorization for people who are at least 12 years old, including full FDA approval in August for those 16 and up.

Around 190 million people in the United States are fully vaccinated, including more than 11 million who are 12 to 17 years old that have received the Pfizer vaccine.

If the FDA authorizes the vaccine for 5 to 11 year olds, a group of advisers to the U.S. Centers for Disease Control and Prevention (CDC) will meet on Nov. 2-3 to make recommendations to the agency on how the shots should be administered.

Most states wait for the CDC to sign off on recommendations for vaccines before they begin administering shots.

FDA says benefits outweigh risks for Pfizer/BioNTech COVID-19 vaccine in children
 

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Comments (15)
Kaveh Sun
Kaveh Sun Oct 23, 2021 1:28PM ET
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what is the death rate if children die from covid vaccine vs unvaccinated kids? If it is not much different, fda is full #
no spin
no spin Oct 23, 2021 3:06AM ET
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Friend got the vaccine the other day left leg still completely numb. Now diagnosed with neurology disorder. He was perfectly fine beforehand.
Edward Chong
Edward Chong Oct 23, 2021 3:06AM ET
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please dont utter rubbish.
Felipe Daniel
Felipe Daniel Oct 23, 2021 3:06AM ET
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Edward Chong how can you deny someone story?
Sam Jennings
Sam Jennings Oct 23, 2021 1:17AM ET
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KIDS ARE PRACTICALLY IMMUNE... so, ANY RISK is too much risk.
László Popescu
László Popescu Oct 23, 2021 1:17AM ET
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Sam Jennings, I cannot agree more! Well writen.
Vesa Saarinen
Vesa Saarinen Oct 23, 2021 12:24AM ET
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when you get bad results from covid shot benefits does not outweigh what happens. 6 days in hospital and now aktive lymfoma. thanks Pfeiser. Nice benefits.
Josh Davis
Josh Davis Oct 22, 2021 1:44PM ET
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So less than 30% since the adult was 95% now its 39% this one will be 30 when its all said and done
Roger Miller
Roger Miller Oct 22, 2021 9:50AM ET
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Soon the children can do their part to protect fearful adults.
Fatchur Rachman
Fatchur Rachman Oct 22, 2021 9:38AM ET
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Thank God Covid-19 gonna end.
Llewellyn Kruger
Llewellyn Kruger Oct 22, 2021 9:27AM ET
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Nuremberg 2.0 is coming to a country near you.
THEE MOTIVATOR
THEE MOTIVATOR Oct 22, 2021 9:17AM ET
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FFS
Francesco Lucchesi
Francesco Lucchesi Oct 22, 2021 8:51AM ET
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scam
Teufel Dog
Teufel Oct 22, 2021 8:44AM ET
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What’s the hospitalization and death rates in children again? Oh yeah…
Jose Cabreja
Jose Cabreja Oct 22, 2021 8:37AM ET
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🤡🤡🤡
Chunki Kim
Chunky Oct 22, 2021 8:26AM ET
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what's covid? Does anyone cares these days?
Steffen vdm
Steffen vdm Oct 22, 2021 8:22AM ET
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Let's vaccinate unborn babies as well!! That should make some profit!!
Jose Cabreja
Jose Cabreja Oct 22, 2021 8:22AM ET
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soon🤣🤣
Felipe Daniel
Felipe Daniel Oct 22, 2021 8:15AM ET
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Children have less than 1% risk these are crimes against humanity all for profit
 
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