The US Food and Drug Administration (FDA) has granted approval for Pfizer and BioNTech’s supplemental Biologics License Application (sBLA) for their Covid-19 vaccine, Comirnaty, for adolescents aged 12 to 15 years.
Earlier, the regulatory agency granted emergency use authorization (EUA) for the use of the vaccine in this age group and so far over nine million adolescents of this age have received the initial vaccine regimen.
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Comirnaty is the first Covid-19 vaccine to obtain FDA approval for use in adolescents.
The FDA granted approval based on findings from a Phase III clinical trial in 2,260 subjects aged 12 to 15 years.
A two-dose initial vaccine regimen resulted in SARS-CoV-2–neutralising antibody geometric mean titers (GMTs) of 1,239.5, indicating robust immunogenicity in a subset of adolescents a month after the second dose.
Findings showed that this was non-inferior to GMTs elicited by subjects aged 16 to 25 years old in prior analysis.
No cases of confirmed symptomatic Covid-19 were reported in the Comirnaty arm during this time while all 30 cases were seen in the placebo arm.
In both Comirnaty and placebo arms, no cases of severe disease were observed.
A favourable safety profile was reported across six months of safety follow-up data following the second dose with an adverse event profile in line with other clinical findings for the vaccine.
The companies have also submitted these data to the European Medicines Agency (EMA) and other regulatory authorities across the globe.
Comirnaty received FDA EUA for active immunisation for Covid-19 prevention in people aged six months and above.
In June this year, Pfizer and BioNTech signed a $3.2bn vaccine supply deal with the US Government to deliver further doses of their Covid-19 vaccine.
