The companies are also planning to file the data with other regulatory authorities in the coming weeks. Food and Drug Administration (FDA) earlier this year as an expansion to the existing EUA for the primary series. The COVID-19 vaccine booster for individuals 12 through 15 years of age was already granted Emergency Use Authorization by the U.S.
No new safety concerns were identified from the data available. The Committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults.
Side effect of pfizer booster trial#
The positive opinion adopted by the CHMP is based on an evaluation of interim safety and efficacy data from a clinical trial of a booster dose of the vaccine in those aged 16 and over, together with published literature and post authorisation data plus real-world evidence from the use of booster doses in young patients in Israel. If the EC grants the variation, the decision will be immediately applicable to all 27 EU member states, making booster vaccines available to everyone 12 years and older. The European Commission (EC) will review the CHMP recommendation and is expected to make a final decision on a variation to the Conditional Marketing Authorization in the near future. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administration of the companies’ COVID-19 vaccine COMIRNATY® as a booster dose (30ug) at least six months after the second dose in adolescents 12 through 17 years of age. NEW YORK AND MAINZ, GERMANY, FebruPfizer Inc. Research and Business Development Partnerships.Unleashing the next wave of scientific innovations
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