• Contact us
  • Advertise with us
  • Login
Tashi Pharma
  • Home
  • Indian Pharma News
  • Global Pharma News
  • Guideline News
    • All
    • EDQM
    • EMA
    • European Commision
    • Health Canada
    • Medsafe
    • MHRA
    • SAHPRA
    • US FDA
    FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments

    FDA publishes Clinical Trial Guidances for Advancing Development of Cancer Treatments

    Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

    US FDA publishes guidance on Initiation of Voluntary Recalls

    EMA publishes Q & A for Bootstrap methodology for f2 similarity factor

    EMA publishes Q & A on Bootstrap methodology for f2 similarity factor

    US FDA publishes product-specific guidances to facilitate generic drug development

    US FDA publishes product-specific guidances to facilitate generic drug development

    Clinical Trials Regulation comes into effect in the EU

    New Clinical Trials Regulation comes into effect in the EU

    Reflection paper Forecasting demand for medicinal products in the EU_EEA

    EMA publishes reflection paper on forecasting demand for medicinal products in the EU/EEA

    Trending Tags

    • Pharma
    • EMA
    • MHRA
    • TGA
    • US FDA
  • Articles
  • Interview
  • Company Focus
  • Pharma Jobs
    • Quality
    • Regulatory Affairs
    • Production
    • Sales and Marketing
    • Clinical
    • bioanalytical
  • Webinar
No Result
View All Result
  • Home
  • Indian Pharma News
  • Global Pharma News
  • Guideline News
    • All
    • EDQM
    • EMA
    • European Commision
    • Health Canada
    • Medsafe
    • MHRA
    • SAHPRA
    • US FDA
    FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments

    FDA publishes Clinical Trial Guidances for Advancing Development of Cancer Treatments

    Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

    US FDA publishes guidance on Initiation of Voluntary Recalls

    EMA publishes Q & A for Bootstrap methodology for f2 similarity factor

    EMA publishes Q & A on Bootstrap methodology for f2 similarity factor

    US FDA publishes product-specific guidances to facilitate generic drug development

    US FDA publishes product-specific guidances to facilitate generic drug development

    Clinical Trials Regulation comes into effect in the EU

    New Clinical Trials Regulation comes into effect in the EU

    Reflection paper Forecasting demand for medicinal products in the EU_EEA

    EMA publishes reflection paper on forecasting demand for medicinal products in the EU/EEA

    Trending Tags

    • Pharma
    • EMA
    • MHRA
    • TGA
    • US FDA
  • Articles
  • Interview
  • Company Focus
  • Pharma Jobs
    • Quality
    • Regulatory Affairs
    • Production
    • Sales and Marketing
    • Clinical
    • bioanalytical
  • Webinar
No Result
View All Result
No Result
View All Result
Home Global Pharma News

Pfizer Receive First U.S. Authorization for Emergency Use of COVID-19 Vaccine in Adolescents 12 to 15 years of age

PRN by PRN
May 11, 2021
in Global Pharma News
14 0
0
Pfizer Receive First U.S. Authorization for Emergency Use of COVID-19 Vaccine in Adolescents 12 to 15 years of age

Vaccine

9
SHARES
22
VIEWS
  • In a Phase 3 trial, the vaccine was 100% effective and generally well tolerated in participants aged 12 to 15 years
  • Data also submitted to European Medicines Agency (EMA) and other global regulators, with additional authorizations expected in coming weeks

Pfizer Inc. and BioNTech SE announced today that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in the U.S. for use in this age group.

Albert Bourla

“Today’s expansion of our EUA represents a significant step forward in helping the U.S. government broaden its vaccination program and help protect adolescents before the start of the next school year,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We are grateful to all of our clinical trial volunteers and their families, whose courage helped make this milestone possible. Together, we hope to help bring a sense of normalcy back to young people across the country and around the world.”

The FDA based its decision on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. Topline results from this trial, announced on March 31, 2021, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses. In the trial, the vaccine was also generally well tolerated. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

Ugur Sahin

“Since securing the EUA in December for individuals 16 years and older, we have been working tirelessly to get our COVID-19 vaccine authorized around the world so that governments can provide it to as many people as possible,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “Our work is not yet complete, as we continue our research into the use of our vaccine in pediatric populations. Our goal is to submit data for pre-school and school-age children in September.”

As a next step following today’s FDA decision, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss recommendations for use of the Pfizer-BioNTech COVID-19 Vaccine in adolescents 12 to 15 years of age based on the amended EUA.

In addition, the pediatric study evaluating the safety and efficacy of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to 11 years of age is ongoing. Pfizer and BioNTech expect to have definitive readouts and, subject to the data generated, submit for an EUA or a variation to Conditional Marketing Authorizations for two cohorts, including children 2-5 years of age and 5-11 years of age, in September. The readout and submission for the cohort of children 6 months to 2 years of age are expected in the fourth quarter.

Tags: BioNTechPfizer
Previous Post

MHRA publishes consultation outcome for guidance on the licensing of biosimilar products

Next Post

Novavax Announces Positive Preclinical Data for Combination Influenza and COVID-19 Vaccine Candidate

PRN

PRN

Related Posts

Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine
Global Pharma News

Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine

by admin
February 23, 2022
NDAs of Sandoz Inc have been acquired by ANI Pharmaceuticals
Global Pharma News

Sandoz launches generic lenalidomide in 19 countries across Europe

by admin
February 20, 2022
Revenue of Pfizer up by 95% for year 2021
Global Pharma News

Revenue of Pfizer up by 95% for year 2021

by admin
February 16, 2022
FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant
Global Pharma News

FDA Authorizes New Monoclonal Antibody that Retains Activity Against Omicron Variant

by admin
February 12, 2022
WHO prequalifies first monoclonal antibody - tocilizumab – to treat COVID-19
Global Pharma News

WHO prequalifies first monoclonal antibody – tocilizumab – to treat COVID-19

by admin
February 12, 2022
Next Post
Novavax Announces Positive Preclinical Data for Combination Influenza and COVID-19 Vaccine Candidate

Novavax Announces Positive Preclinical Data for Combination Influenza and COVID-19 Vaccine Candidate

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Recent News

Zydus to launch Oxemia

Zydus to launch Oxemia (Desidustat) a treatment for Anemia in patients with Chronic Kidney Disease (CKD)

March 7, 2022
FDA Urges Companies to be 'Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls

US FDA Urges Companies to be ’Recall Ready’ to Protect Public Health

March 6, 2022
FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments

FDA publishes Clinical Trial Guidances for Advancing Development of Cancer Treatments

March 5, 2022
Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

US FDA publishes guidance on Initiation of Voluntary Recalls

March 5, 2022
Kilitch Drugs Commences Rs. 100 Crore New Facility Expansion Plan

Kilitch Drugs Commences Rs. 100 Crore New Facility Expansion Plan

March 5, 2022

Browse by Category

  • Articles
  • Company Focus
  • EDQM
  • EMA
  • European Commision
  • Global Pharma News
  • Guideline News
  • Health Canada
  • Indian Pharma News
  • Interview
  • Medsafe
  • MHRA
  • SAHPRA
  • US FDA
  • Webinar

Browse by Tags

Abbott Alembic alkem Amgen Amneal AstraZeneca bayer biocon Biogen BioNTech Bristol Myers Squibb cipla covid Daiichi Sankyo drreddy Eli Lilly fda Gilead glenmark gsk Incyte Janssen Jubilant lupin MHRA Moderna Natco Novartis Novavax novo nordisk oncology Panacea Biotech Pfizer pharmacy Pharma News Pharmareg News Remdesivir roche sanofi Sun pharma Teva usfda Vaccine Viatris zydus

Contact us

Address:Pharma Reg News, First floor, Shop no.1 , Plot no 241,242, Near Fire station, GIDC, Ankleshwar, Gujarat - 393002.
Phone:+91 8511586232, +91 9029066605
Email:author@pharmaregnews.com

Browse by Tag

Abbott Alembic alkem Amgen Amneal AstraZeneca bayer biocon Biogen BioNTech Bristol Myers Squibb cipla covid Daiichi Sankyo drreddy Eli Lilly fda Gilead glenmark gsk Incyte Janssen Jubilant lupin MHRA Moderna Natco Novartis Novavax novo nordisk oncology Panacea Biotech Pfizer pharmacy Pharma News Pharmareg News Remdesivir roche sanofi Sun pharma Teva usfda Vaccine Viatris zydus

Advertise with us

© 2021 - Pharmaregnews.com. Developed by YESWEUS.

No Result
View All Result
  • Home
  • Indian Pharma News
  • Global Pharma News
  • Guideline News
    • EMA
    • MHRA
    • TGA
    • US FDA
  • Articles
  • Interview
  • Company Focus
  • Pharma Jobs
    • Quality
    • Regulatory Affairs
    • Production
    • Sales and Marketing
    • bioanalytical
    • Clinical
  • Webinar
  • Contact us
  • Advertise with us
  • Login

© 2021 - Pharmaregnews.com. Developed by YESWEUS.

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In
Are you sure want to unlock this post?
Unlock left : 0
Are you sure want to cancel subscription?