Pfizer COVID vaccine under EMA review for younger teens
The European Medicines Agency (EMA) is evaluating an application submitted by Pfizer and BioNTech for use of their COVID-19 vaccine in children aged 12 to 15 years.Pfizer reported that it submitted its application for extension of authorization last week, and EMA announced today that it has undertaken the evaluation of the messenger RNA (mRNA) vaccine. The vaccine has been authorized by the EU for use in people 16 years and up since December 2020.
Trials of the vaccine -- called Comirnaty in Europe -- in the young adolescent population showed similar high efficacy rates to those seen in adult clinical trials of the vaccine. In a 31 March press release, Pfizer shared topline results from its Phase 3 randomized, double-blind, placebo-controlled study of 2,260 adolescents, reporting 100% efficacy at preventing symptomatic disease. No cases of COVID-19 were seen in the vaccinated trial arm, while 18 cases were reported among placebo recipients.
Pfizer also shared antibody responses from the younger age group. At one month after the second dose in the two-dose regimen, participants aged 12 to 15 years had neutralizing antibody geometric mean titers that were numerically higher and statistically non-inferior to those of 16-25 year-olds.
Side effects were also similar between younger adolescents and the older adolescent/young adult age group. The study design includes plans to monitor participants for up to two years after vaccination to track protection against COVID-19 infection and to watch for any additional safety signals.
Studies are also underway in younger school-aged children and preschoolers, with results expected over the summer and by fall 2021, respectively.
“EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets Comirnaty, including results from a large ongoing clinical study involving adolescents from 12 years of age, in order to decide whether to recommend the extension of indication,” wrote EMA in announcing its action. The agency is expected to announce a decision in June “unless supplementary information is needed.”
Meanwhile, the US Food and Drug Administration is reviewing the same data to consider expanding the indication for use of this COVID-19 vaccine in those aged 12 to 15 years as well. In a joint Pfizer and BioNTech statement, the firms wrote on 9 April that they had submitted the data package to FDA in support of the request for use of the vaccine in the younger age group.
“The companies look forward to working closely with the U.S. Food and Drug Administration (FDA) and other worldwide regulatory authorities as part of the companies’ efforts to expand emergency or conditional authorization of their COVID-19 vaccine in 12- to 15-year-olds as quickly as possible,” noted the two companies at that time.
EMA