Valneva Shares Face Regulatory Setback Despite Promising Pipeline

Valneva SA has encountered a significant regulatory obstacle as US health authorities suspended all distribution and sales of its recently approved chikungunya vaccine, IXCHIQ®. This development represents a substantial setback for the biotechnology firm, which had been addressing initial FDA concerns regarding adverse effects in patients over 60. The complete halt of commercial activities for what was considered a promising product raises questions about the vaccine’s future prospects.

The US Food and Drug Administration’s decisive move on August 25 came in response to four new reports of severe adverse events presenting with chikungunya-like symptoms. Since the vaccine’s initial approval in November 2023, safety monitoring has identified numerous concerning incidents:
– More than 20 cases of serious illness among vaccinated individuals
– Twenty-one... Read more...