Valneva SE (NASDAQ:VALN) gains EMA nod for chikungunya vaccine

Valneva (NASDAQ:VALN), a specialty vaccine company today announced a significant milestone in the fight against the chikungunya virus.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has endorsed Valneva's single-dose vaccine, IXCHIQ®, recommending its approval for the prevention of disease caused by the chikungunya virus in individuals aged 18 and older.

This favorable opinion paves the way for the European Commission (EC) to review the recommendation.

A final decision on the marketing authorization application for IXCHIQ® in the European Union, Norway, Liechtenstein, and Iceland is anticipated in the third quarter of 2024.

If approved, IXCHIQ® will be the first chikungunya vaccine available in Europe, addressing a significant unmet medical need.

Valneva's vaccine has already seen progress internationally, with the U.S. Food and Drug Administration (FDA) granting approval in November 2023.

Additionally, marketing authorization applications are currently under review by Health Canada and the Brazilian Health Regulatory Agency (ANVISA), with potential approvals expected later in 2024.

In line with the International Recognition Procedure (IRP), Valneva is also preparing to submit a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

This step further underscores Valneva’s commitment to providing global access to its vaccine.