CHMP Backs Extended Use of AstraZeneca H5N1 Pandemic Flu Vaccine - Contagion Live
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion on October 15, recommending an extension of indication for AstraZeneca’s H5N1 pandemic influenza vaccine.1 The extension removes the upper age limit from the vaccine’s current indication, which covers children and adolescents aged 12 months to younger than 18 years.2,3Pandemic influenza vaccine H5N1 AstraZeneca (pandemic influenza vaccine [H5N1] [live attenuated, nasal]; AstraZeneca) is an intranasal pandemic preparedness vaccine with conditional EU authorization since 2016.³ It is intended for use only after an official pandemic declaration and in line with official recommendations.¹What the CHMP Indication Extension Means AstraZeneca applied to remove the upper age limit based on efficacy and safety data already submitted in the original marketing authorization application, according to the CHMP agenda.² The revised indication covers active immunisation against influenza in an officially declared pandemic situation, used in accordance with official recommendations.¹ Adults would become eligible alongside children aged 12 months and older once the change
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