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Pfizer-BioNTech COVID-19 vaccine 100% effective in adolescents 12 to 15

By Brian Buntz | November 23, 2021

Pfizer-BioNTechPfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) shared new data from their Phase 3 study of the Comirnaty vaccine, concluding that two 30-µg doses were 100% effective against COVID-19 between seven days and four months after the second dose.

The safety profile of the vaccine in the study was broadly consistent with other clinical safety data. In addition, clinical trial investigators reported no serious safety concerns in participants in the six months following receipt of the second dose.

Data from 2,228 individuals were included in the analysis.

In the U.S., the Comirnaty vaccine is available under emergency use authorization for adolescents 12 to 15. The FDA approved the vaccine for individuals at least 16 years of age in August. In late October, the companies received emergency use authorization for the vaccine in children 5 to 11.

Pfizer and BioNTech plan on including the recent data in a planned supplemental Biologics License Application (sBLA) to extend approval of the vaccine to include individuals 12 and older.

Pfizer and BioNTech received permission from the FDA to allow the use of their vaccine as a booster in all individuals 18 and older at least six months after receiving the second dose of the vaccine.

Given the expanding use of the Comirnaty vaccine, SVB Leerink analyst Geoffrey Porges recently projected that it would generate global sales of up to $59 billion in 2021 and $48 billion in 2022.


Filed Under: clinical trials, Drug Discovery, Infectious Disease
Tagged With: Biologics License Application, BioNTech, Comirnaty, coronavirus, covid-19, COVID-19 vaccine, COVID-19 vaccines, FDA, Pfizer
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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