Valneva: submits vaccine application to FDA
(CercleFinance.com) - Valneva has announced that it has submitted an indication extension request for its IXCHIQ chikungunya vaccine to the US FDA to potentially expand the use of its vaccine to adolescents aged 12 to 17.
The submission also includes a request to include data on antibody persistence for up to two years, a key differentiator of the IXCHIQ vaccine, in the summary of product characteristics.
This submission to the FDA follows applications for extension of indication submitted to the European Medicines Agency (EMA) and Health Canada two months ago.
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The submission also includes a request to include data on antibody persistence for up to two years, a key differentiator of the IXCHIQ vaccine, in the summary of product characteristics.
This submission to the FDA follows applications for extension of indication submitted to the European Medicines Agency (EMA) and Health Canada two months ago.
Copyright (c) 2024 CercleFinance.com. All rights reserved.