(CercleFinance.com) – Pfizer and its partner BioNTech today announced that they have submitted to the European Medicines Agency (EMA) longer-term follow-up data on 2,228 young people aged 12 to 15 from a trial phase III clinical trial, in order to support the safety and favorable efficacy profile of Comirnaty, its Covid vaccine, in this age group.
In the trial, the two doses of Comirnaty (30 µg per dose) were found to be 100% effective against Covid, from seven days to more than four months after the second dose, supports the laboratory. If thirty symptomatic cases of Covid were confirmed during the trial, they all concerned patients who received the placebo.
Pfizer and BioNTech say they have also submitted this data to the United States Food and Drug Administration (FDA) and plan to present it to other regulatory authorities in the coming weeks.
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