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Pfizer COVID-19 vaccine safe, effective on adolescents in trial, companies say

Published 03/31/2021, 06:52 AM
Updated 03/31/2021, 12:25 PM
© Reuters. FILE PHOTO: A medical worker fills a syringe with Pfizer-BioNTech vaccine in Nis, Serbia

© Reuters. FILE PHOTO: A medical worker fills a syringe with Pfizer-BioNTech vaccine in Nis, Serbia

By Julie Steenhuysen

CHICAGO (Reuters) -Pfizer Inc and BioNTech SE (NASDAQ:BNTX) said on Wednesday their COVID-19 vaccine was safe and effective and produced robust antibody responses in 12 to 15-year olds, paving the way for them to seek approval in the United States and Europe in weeks.

The read-out, which puts the pair ahead of other western vaccine developers in the quest to also protect children, will likely allow for the use of the vaccine in that group before the next school year, Albert Bourla, Pfizer (NYSE:PFE)'s chief executive, said in a statement.

Pfizer's vaccine is already authorized for use in people starting at age 16. The new study offers the first evidence of how the vaccine will also work in school-age adolescents.

In the trial of 2,260 adolescents aged 12 to 15, there were 18 cases of COVID-19 in the group that got a placebo shot and none in the group that got the vaccine, resulting in 100% efficacy in preventing COVID-19, the companies said in a statement.

The vaccine was well tolerated, with side effects in line with those seen among those aged 16 to 25 in the adult trial. It did not list the side effects for the younger group, but the adult trial's side effects generally were mild to moderate and included injection-site pain, headaches, fever and fatigue.

The companies also studied a subset of teens to measure the level of virus-neutralizing antibodies a month after the second dose and found it was comparable to study participants aged 16 to 25 in the pivotal trial in adults.

Bourla said the company planned to seek emergency authorization from the U.S. Food and Drug Administration "in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year."

Last week, the companies gave the first vaccine doses in a series of trials testing the vaccine in younger children, that will eventually go to those as young as 6 months of age.

The Pfizer/BioNTech vaccine was authorized by U.S. regulators in late December for people aged 16 and older.

A trial by Moderna (NASDAQ:MRNA) Inc to test its COVID-19 vaccine in children aged six months to less than 12 years was launched this month, while Johnson & Johnson (NYSE:JNJ), which recently won approval for its vaccine in adults, has yet to begin a planned trial https://clinicaltrials.gov/ct2/show/NCT04505722 on children.

AstraZeneca (NASDAQ:AZN) in December removed children from a mid-to-late stage trial of its COVID-19 vaccine in Britain.

© Reuters. FILE PHOTO: A medical worker fills a syringe with Pfizer-BioNTech vaccine in Nis, Serbia

The British drugmaker's vaccine has been linked this year with a very rare form of blood clotting in the brain, prompting some European countries to halt its use in younger adults even though the cause of the condition remains unclear.

Top U.S. infectious disease expert Anthony Fauci in January raised the prospect of a U.S. vaccination campaign for children by late spring or early summer.

Latest comments

emergency authorization means you can't sue them of your child dies or has any other harmful effects from this jab. No thanks.
Based on Pfizer numbers the placebo was 99.2% effective against preventing COVID-19 as well. I'll take the placebo as there are no cancer causing PED's in them.
One can't conclude that with these numbers. There isn't 3rd group that didn't take the placebo
No reason to inject children this is criminal
they need the profits, they don't care
Kids don't die from covid ( very low number  ) so why they need this toxic staff ? How many vaccines do American babies get? Currently, 16 vaccines – some requiring multiple doses at specific ages and times – are recommended from birth to 18 years old. Recommended vaccines include: Influenza (annual flu shot) Diphtheria, tetanus and pertussis (DTaP)
because a virus left to spread will morph and we will never be rid of it
how did that work out for the common flu? Its a coin toss which vaccine they decide to go with every year. The Kung Flu isnt going anywhere, but at least it cured everything else you can die from.
How about  flu ! Hundreds of million useless vaccines every year and the flu is still around ! Now flu changed its name to covid ,lol.
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