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URLhttps://globalnews.ca/news/8226335/pfizer-kids-covid-19-vaccine-data-u-s-fda/
Last Crawled2026-03-23 05:49:48 (24 days ago)
First Indexed2021-09-28 11:37:09 (4 years ago)
HTTP Status Code200
Meta TitlePfizer sends kids’ COVID-19 vaccine trial data to U.S. FDA - National | Globalnews.ca
Meta DescriptionPfizer said a lower dose of its vaccine provided a strong immune response in the target age group in a 2,268-participant clinical trial.
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Posted September 28, 2021 7:35 am Updated September 28, 2021 10:05 pm 1 min read This article is more than 4 years old and some information may not be up to date. 2:07 Some parents push for COVID-19 vaccine approval for children WATCH: Some parents push for COVID-19 vaccine approval for children – Sep 28, 2021 Pfizer Inc. and BioNTech SE on Tuesday submitted initial trial data for their COVID-19 vaccine in children aged 5 to 11 and said they would make a formal request with U.S. regulators for emergency use in the coming weeks. Coronavirus infections have soared in children, hitting their highest point in early September, according to data from the American Academy of Pediatrics. The vaccine, which is already authorized in teens aged 12 to 15 and fully approved for ages 16 and up, induced a strong immune response in the target age group in a 2,268-participant clinical trial, the companies said on Sept. 20. 0:47 U.S. to donate half a billion additional Pfizer COVID-19 vaccines The Pfizer-BioNTech vaccine was authorized in kids aged 12-15 roughly a month after the companies filed for authorization. If the same timeline is followed for this application, younger children could start receiving their shots as soon as late October. Story continues below advertisement A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide. 2:02 Study finds Pfizer vaccine safe and effective for children 5 to 11 years-old While kids are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations that are more at risk of severe illness. Get weekly health news Receive the latest medical news and health information delivered to you every Sunday. The companies said they plan to submit the data to the European Medicines Agency and other regulatory authorities. Data from the companies’ trial showed the two-shot vaccine generated an immune response in children that matched what was previously observed in 16-to-25 year olds. The safety profile was also comparable to the older age group, Pfizer said. Story continues below advertisement The drugmakers are also testing the vaccine in children aged 2-to-5 and those aged 6 months-to-2 years, with data expected in the fourth quarter. Moderna’s COVID-19 vaccine is not yet authorized for use in adolescents in the United States, while it has gained authorization for that age group in Europe. (Reporting by Manas Mishra in Bengaluru; Editing by Saumyadeb Chakrabarty) Ā© 2021 Reuters
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Please read our [Commenting Policy](https://globalnews.ca/pages/global-news-commenting-policy/) first. ### Write a comment ![](https://globalnews.ca/wp-content/uploads/2021/03/globalnews_covid19tagpagebanner_1280x54_v4.jpg?quality=90&strip=all) - [COVID homepage](https://globalnews.ca/tag/covid/) - [COVID vaccines and kids](https://globalnews.ca/news/8396360/covid-vaccine-kids-canada-questions/) - [Omicron FAQ](https://globalnews.ca/news/8453515/omicron-covid-variant-explained/) scroll left scroll right [Video link](https://globalnews.ca/) [Headline link](https://globalnews.ca/) Advertisement Close X Click to scroll back to top of the page Back to top [Health](https://globalnews.ca/health/) # Pfizer sends kids’ COVID-19 vaccine trial data to U.S. FDA By Staff Reuters Posted September 28, 2021 7:35 am Updated September 28, 2021 10:05 pm **1 min read** If you get Global News from Instagram or Facebook - that will be changing. 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Hide message bar This article is more than 4 years old and some information may not be up to date. ![Click to play video: 'Some parents push for COVID-19 vaccine approval for children'](https://i0.wp.com/media.globalnews.ca/videostatic/news/vbhmh15r6a-pqdl4wd3fu/0928_jamie.jpg?w=1040&quality=70&strip=all) 2:07 Some parents push for COVID-19 vaccine approval for children close video mute video unmute video WATCH: Some parents push for COVID-19 vaccine approval for children – Sep 28, 2021 Leave a comment [Share this item on Facebook](https://www.facebook.com/sharer/sharer.php?u=https%3A%2F%2Fglobalnews.ca%2Fnews%2F8226335%2Fpfizer-kids-covid-19-vaccine-data-u-s-fda%2F) [Share this item via WhatsApp](whatsapp://send?text=Pfizer%20sends%20kids%E2%80%99%20COVID-19%20vaccine%20trial%20data%20to%20U.S.%20FDA%20-%20National%20%7C%20Globalnews.ca%20-%20https%3A%2F%2Fglobalnews%2Eca%2Fnews%2F8226335%2Fpfizer-kids-covid-19-vaccine-data-u-s-fda%2F) [Share this item on X](https://twitter.com/intent/tweet?text=Pfizer%20sends%20kids%E2%80%99%20COVID-19%20vaccine%20trial%20data%20to%20U.S.%20FDA%20-%20National%20%7C%20Globalnews.ca%20https%3A%2F%2Fglobalnews.ca%2Fnews%2F8226335%2Fpfizer-kids-covid-19-vaccine-data-u-s-fda%2F) [Send this page to someone via email](mailto:?Subject=Pfizer%20sends%20kids%E2%80%99%20COVID-19%20vaccine%20trial%20data%20to%20U.S.%20FDA%20-%20National%20%7C%20Globalnews.ca&body=%0D%0APfizer%20sends%20kids%E2%80%99%20COVID-19%20vaccine%20trial%20data%20to%20U.S.%20FDA%20-%20National%20%7C%20Globalnews.ca%0D%0Ahttps%3A%2F%2Fglobalnews%2Eca%2Fnews%2F8226335%2Fpfizer-kids-covid-19-vaccine-data-u-s-fda%2F%0D%0A%0D%0A%0D%0A) See more sharing options ## Share Close [Share this item on Facebook facebook](https://www.facebook.com/sharer/sharer.php?u=https%3A%2F%2Fglobalnews.ca%2Fnews%2F8226335%2Fpfizer-kids-covid-19-vaccine-data-u-s-fda%2F) [Share this item on X x](https://twitter.com/intent/tweet?text=Pfizer%20sends%20kids%E2%80%99%20COVID-19%20vaccine%20trial%20data%20to%20U.S.%20FDA%20-%20National%20%7C%20Globalnews.ca%20https%3A%2F%2Fglobalnews.ca%2Fnews%2F8226335%2Fpfizer-kids-covid-19-vaccine-data-u-s-fda%2F) [Send this page to someone via email email](mailto:?Subject=Pfizer%20sends%20kids%E2%80%99%20COVID-19%20vaccine%20trial%20data%20to%20U.S.%20FDA%20-%20National%20%7C%20Globalnews.ca&body=%0D%0APfizer%20sends%20kids%E2%80%99%20COVID-19%20vaccine%20trial%20data%20to%20U.S.%20FDA%20-%20National%20%7C%20Globalnews.ca%0D%0Ahttps%3A%2F%2Fglobalnews%2Eca%2Fnews%2F8226335%2Fpfizer-kids-covid-19-vaccine-data-u-s-fda%2F%0D%0A%0D%0A%0D%0A) [Share this item via WhatsApp whatsapp](whatsapp://send?text=Pfizer%20sends%20kids%E2%80%99%20COVID-19%20vaccine%20trial%20data%20to%20U.S.%20FDA%20-%20National%20%7C%20Globalnews.ca%20-%20https%3A%2F%2Fglobalnews%2Eca%2Fnews%2F8226335%2Fpfizer-kids-covid-19-vaccine-data-u-s-fda%2F) [Share this item via Telegram telegram](https://telegram.me/share/url?url=https%3A%2F%2Fglobalnews.ca%2Fnews%2F8226335%2Fpfizer-kids-covid-19-vaccine-data-u-s-fda%2F&text=Pfizer%20sends%20kids%E2%80%99%20COVID-19%20vaccine%20trial%20data%20to%20U.S.%20FDA%20-%20National%20%7C%20Globalnews.ca) [Share this item on Reddit reddit](https://www.reddit.com/submit?url=https%3A%2F%2Fglobalnews.ca%2Fnews%2F8226335%2Fpfizer-kids-covid-19-vaccine-data-u-s-fda%2F&title=Pfizer%20sends%20kids%E2%80%99%20COVID-19%20vaccine%20trial%20data%20to%20U.S.%20FDA%20-%20National%20%7C%20Globalnews.ca) [Share this item on BlueSky bluesky](https://bsky.app/intent/compose?text=Pfizer%20sends%20kids%E2%80%99%20COVID-19%20vaccine%20trial%20data%20to%20U.S.%20FDA%20-%20National%20%7C%20Globalnews.ca%20https%3A%2F%2Fglobalnews.ca%2Fnews%2F8226335%2Fpfizer-kids-covid-19-vaccine-data-u-s-fda%2F) Copy article link Copy link Descrease article font size Increase article font size [Pfizer Inc. and BioNTech SE](http://globalnews.ca/tag/pfizer-biontech) on Tuesday submitted initial trial data for their [COVID-19 vaccine](http://globalnews.ca/tag/covid) in children aged 5 to 11 and said they would make a formal request with U.S. regulators for emergency use in the coming weeks. ![](https://d21y75miwcfqoq.cloudfront.net/70c8fc80) Coronavirus infections have soared in children, hitting their highest point in early September, according to data from the American Academy of Pediatrics. The vaccine, which is already authorized in teens aged 12 to 15 and fully approved for ages 16 and up, induced a strong immune response in the target age group in a 2,268-participant clinical trial, the companies said on Sept. 20. ![Click to play video: 'U.S. to donate half a billion additional Pfizer COVID-19 vaccines'](https://i2.wp.com/media.globalnews.ca/videostatic/news/p05raibh38-7h38ax9uwo/ONLINE_STILL_BIDEN_.jpg?w=1040&quality=70&strip=all) 0:47 U.S. to donate half a billion additional Pfizer COVID-19 vaccines The Pfizer-BioNTech vaccine was authorized in kids aged 12-15 roughly a month after the companies filed for authorization. If the same timeline is followed for this application, younger children could start receiving their shots as soon as late October. Story continues below advertisement A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide. ![Click to play video: 'Study finds Pfizer vaccine safe and effective for children 5 to 11 years-old'](https://i0.wp.com/media.globalnews.ca/videostatic/news/82jwtmd6fs-l74xytrbdl/Pfizer_for_Kids.jpg?w=1040&quality=70&strip=all) 2:02 Study finds Pfizer vaccine safe and effective for children 5 to 11 years-old More on Health More videos - [Cattle farmers slam N.B. plan to end vet services](https://globalnews.ca/news/11740864/new-brunswick-cattle-farmers-vet-services/) - [Saskatoon woman starts organization for neurological disorder support](https://globalnews.ca/news/11740163/saskatoon-woman-starts-organization-neurological-disorder-support/) - [Personal care home in Winnipeg’s Bridgwater neighbourhood a decade in the making](https://globalnews.ca/news/11739974/personal-care-home-in-winnipegs-bridgwater-neighbourhood-a-decade-in-the-making/) - [Alberta government closing Calgary, Lethbridge supervised drug consumption sites](https://globalnews.ca/news/11739738/alberta-to-shutter-calgary-lethbridge-supervised-drug-consumption-sites/) - [![](https://i2.wp.com/media.globalnews.ca/videostatic/news/kd6716bdwk-98ootollfm/hf.jpg?h=article-hero-560-keepratio&w=article-hero-small-keepratio&crop=1&quality=70&strip=all) UHN researchers exploring how smartwatches help patients living with heart failure detect early warning signs](https://globalnews.ca/video/11739855/uhn-researchers-exploring-how-smartwatches-help-patients-living-with-heart-failure-detect-early-warning-signs/) - [![](https://i0.wp.com/media.globalnews.ca/videostatic/news/q7ym6lj8xr-d7ohuafvgq/DSD.jpg?h=article-hero-560-keepratio&w=article-hero-small-keepratio&crop=1&quality=70&strip=all) B.C. man pays tribute to brother on World Down Syndrome Day](https://globalnews.ca/video/11740329/b-c-man-pays-tribute-to-brother-on-world-down-syndrome-day/) - [![](https://i0.wp.com/media.globalnews.ca/videostatic/news/u1kh9fpt17-8g1nslp9im/web_still_5P_KEL_WATER_RESERVOIR__OM01RTOE.png?h=article-hero-560-keepratio&w=article-hero-small-keepratio&crop=1&quality=70&strip=all) Concerns over potential water contamination after West Kelowna reservoir vandalism](https://globalnews.ca/video/11740279/concerns-over-potential-water-contamination-after-west-kelowna-reservoir-vandalism/) - [![](https://i0.wp.com/media.globalnews.ca/videostatic/news/wywc3g8d3k-ea9vkn0r94/6P_FAMILY_RESIDENCE_PRO_OM01RTLM.jpg?h=article-hero-560-keepratio&w=article-hero-small-keepratio&crop=1&quality=70&strip=all) NDP government quietly changes family accommodation rules](https://globalnews.ca/video/11740266/ndp-government-quietly-changes-family-accommodation-rules/) While kids are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations that are more at risk of severe illness. ![Receive the latest medical news and health information delivered to you every Sunday.](https://globalnews.ca/wp-content/themes/shaw-globalnews/images/skyline/healthiq.jpg) ## Get weekly health news Receive the latest medical news and health information delivered to you every Sunday. By providing your email address, you have read and agree to Global News' [Terms and Conditions](https://www.corusent.com/terms-of-use/) and [Privacy Policy](https://www.corusent.com/privacy-policy/). The companies said they plan to submit the data to the European Medicines Agency and other regulatory authorities. Read more: [Pfizer launches large study of oral COVID-19 prevention drug](https://globalnews.ca/news/8223650/pfizer-study-oral-covid-drug/ "Pfizer launches large study of oral COVID-19 prevention drug") Data from the companies’ trial showed the two-shot vaccine generated an immune response in children that matched what was previously observed in 16-to-25 year olds. The safety profile was also comparable to the older age group, Pfizer said. Story continues below advertisement The drugmakers are also testing the vaccine in children aged 2-to-5 and those aged 6 months-to-2 years, with data expected in the fourth quarter. 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Posted September 28, 2021 7:35 am Updated September 28, 2021 10:05 pm **1 min read** This article is more than 4 years old and some information may not be up to date. ![Click to play video: 'Some parents push for COVID-19 vaccine approval for children'](https://i0.wp.com/media.globalnews.ca/videostatic/news/vbhmh15r6a-pqdl4wd3fu/0928_jamie.jpg?w=1040&quality=70&strip=all) 2:07 Some parents push for COVID-19 vaccine approval for children WATCH: Some parents push for COVID-19 vaccine approval for children – Sep 28, 2021 [Pfizer Inc. and BioNTech SE](http://globalnews.ca/tag/pfizer-biontech) on Tuesday submitted initial trial data for their [COVID-19 vaccine](http://globalnews.ca/tag/covid) in children aged 5 to 11 and said they would make a formal request with U.S. regulators for emergency use in the coming weeks. ![](https://d21y75miwcfqoq.cloudfront.net/70c8fc80) Coronavirus infections have soared in children, hitting their highest point in early September, according to data from the American Academy of Pediatrics. The vaccine, which is already authorized in teens aged 12 to 15 and fully approved for ages 16 and up, induced a strong immune response in the target age group in a 2,268-participant clinical trial, the companies said on Sept. 20. ![Click to play video: 'U.S. to donate half a billion additional Pfizer COVID-19 vaccines'](https://i2.wp.com/media.globalnews.ca/videostatic/news/p05raibh38-7h38ax9uwo/ONLINE_STILL_BIDEN_.jpg?w=1040&quality=70&strip=all) 0:47 U.S. to donate half a billion additional Pfizer COVID-19 vaccines The Pfizer-BioNTech vaccine was authorized in kids aged 12-15 roughly a month after the companies filed for authorization. If the same timeline is followed for this application, younger children could start receiving their shots as soon as late October. Story continues below advertisement A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide. ![Click to play video: 'Study finds Pfizer vaccine safe and effective for children 5 to 11 years-old'](https://i0.wp.com/media.globalnews.ca/videostatic/news/82jwtmd6fs-l74xytrbdl/Pfizer_for_Kids.jpg?w=1040&quality=70&strip=all) 2:02 Study finds Pfizer vaccine safe and effective for children 5 to 11 years-old While kids are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations that are more at risk of severe illness. ![Receive the latest medical news and health information delivered to you every Sunday.](https://globalnews.ca/wp-content/themes/shaw-globalnews/images/skyline/healthiq.jpg) ## Get weekly health news Receive the latest medical news and health information delivered to you every Sunday. The companies said they plan to submit the data to the European Medicines Agency and other regulatory authorities. Data from the companies’ trial showed the two-shot vaccine generated an immune response in children that matched what was previously observed in 16-to-25 year olds. The safety profile was also comparable to the older age group, Pfizer said. Story continues below advertisement The drugmakers are also testing the vaccine in children aged 2-to-5 and those aged 6 months-to-2 years, with data expected in the fourth quarter. Moderna’s COVID-19 vaccine is not yet authorized for use in adolescents in the United States, while it has gained authorization for that age group in Europe. *(Reporting by Manas Mishra in Bengaluru; Editing by Saumyadeb Chakrabarty)* Ā© 2021 Reuters
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