MHRA revokes approval for Valneva’s Ixchiq due to safety frailties

Pfizer and Valneva's Lyme disease vaccine, LB6V, showed 73.2% efficacy in a phase 3 trial but missed its primary endpoint. The vaccine targets six common serotypes of B. burgdorferi. The trial involved nearly 10,000 participants. Lyme disease affects around 476,000 people annually in the U.S. according to the CDC.

Valneva's (VALN) shares fell after the UK revoked approval for its Ixchiq chikungunya vaccine due to safety and benefit-risk concerns. The decision does not affect other markets and is not expected to significantly impact sales. Valneva will not appeal, focusing on endemic regions instead.

Valneva's shares fell 4.64% to €2.49 after the UK revoked its chikungunya vaccine (Ixchiq) authorization, following a risk-benefit review. The stock is down 8.27% this week and 14% this month, trading below key moving averages. The company had previously refocused Ixchiq on endemic markets and confirmed its 2026 outlook despite geopolitical challenges.

Valneva's shares fell 6.6% to €2.435 after the UK revoked its chikungunya vaccine's marketing authorization. The company stated this was based on known safety data and expects negligible financial impact. Approvals in the EU, Canada, and Brazil remain. The CAC 40 also declined due to rising oil prices and U.S. Treasury yields.

Valneva SE (VALN) shares dropped after the UK revoked approval for its Ixchiq chikungunya vaccine. The decision, based on a benefit-risk assessment, does not affect Ixchiq's licenses in other territories. Valneva expects minimal financial impact and will not appeal. The company cites positive safety data from other regions.

Valneva SE (VALN) shares fell ~5% after the UK revoked the marketing authorization for its chikungunya vaccine, Ixchiq, due to safety concerns, according to the company. The vaccine was launched in 2023 and is the first of its kind. The move impacts Valneva's revenue and market position in the vaccine sector.