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| Meta Title | Pfizer sends kidsā COVID-19 vaccine trial data to U.S. FDA - National | Globalnews.ca |
| Meta Description | Pfizer 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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| Boilerpipe Text | 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 ā 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 companiesā 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.
Modernaās 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 |
| Markdown | [SKIP TO MAIN CONTENT](https://globalnews.ca/news/8226335/pfizer-kids-covid-19-vaccine-data-u-s-fda/#content)
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# Pfizer sends kidsā 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**
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2:07
Some parents push for COVID-19 vaccine approval for children
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WATCH: Some parents push for COVID-19 vaccine approval for children ā Sep 28, 2021
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[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.

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
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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.

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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 companiesā 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.
Modernaās 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)*
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| Readable Markdown | 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 ā 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.

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.

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The companies said they plan to submit the data to the European Medicines Agency and other regulatory authorities.
Data from the companiesā 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.
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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.
Modernaās 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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| Root Hash | 18131072723757590355 |
| Unparsed URL | ca,globalnews!/news/8226335/pfizer-kids-covid-19-vaccine-data-u-s-fda/ s443 |