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.
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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.
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By GlobalDataBioNTech 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.
