Pfizer and BioNTech have reported long-term analysis data from a Phase III clinical trial of their Covid-19 vaccine in adolescents aged 12 to 15 years.

According to the findings, two doses of the vaccine demonstrated to be completely effective against Covid-19, as assessed seven days after more than four months of receiving the second shot.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The US Food and Drug Administration had granted Emergency Use Authorization (EUA) for the vaccine to be used as a preliminary two-dose regimen in children.

Results from the latest analysis, which assessed the safety and efficacy of the vaccine in 2,228 subjects aged 12 to 15 years, showed robust protection against Covid-19 and confirm already reported data.

Furthermore, 30 Covid-19 cases were reported in the placebo arm while no cases were observed in a group of subjects who received the vaccine, signifying 100% efficacy.

In the trial, the adverse event profile of the shot was comparable with existing clinical safety results without any severe safety issues reported in people after a follow-up period of at least six months following the second vaccine.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

BioNTech CEO and co-founder Ugur Sahin said: “These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a Covid-19 vaccine in individuals 12 submitting through 15 years of age.

“The growing body of data we have compiled from clinical trials and real-world surveillance to date strengthen the base of evidence supporting the strong efficacy and favourable safety profile of our Covid-19 vaccine across adolescent and adult populations.”

The companies anticipate submitting these results to the FDA as well as various regulatory agencies.

Pfizer noted that these follow-up results would serve as the foundation for a proposed supplemental Biologics License Application to be filed with the FDA for approval of the vaccine usage in people aged 12 years and above.