Valneva's dual vaccine push faces U.S. setbacks amid global rollouts

French biotech company Valneva is advancing two key vaccines while facing regulatory hurdles in the U.S. Its Lyme disease candidate, VLA15, is progressing through late-stage trials, with results due in early 2026. Meanwhile, its chikungunya vaccine, IXCHIQ, has secured approval in multiple regions but has been withdrawn from the American market following safety concerns.

The company is also rolling out a large-scale vaccination campaign in Brazil, where chikungunya infections have surged in recent years.

Valneva's chikungunya vaccine, IXCHIQ, has now been approved in four regions: Europe, Canada, the UK, and Brazil. Health authorities in these areas have confirmed its safety and effectiveness for travellers to high-risk zones and residents in outbreak-prone regions. Despite this, the U.S. Food and Drug Administration (FDA) placed a clinical hold on the vaccine after a young adult suffered a severe adverse reaction. The patient had received three vaccines at the same time, including IXCHIQ. As a result, Valneva voluntarily pulled the product from the U.S. market.

Brazil has become a focal point for Valneva's efforts. The country reported 254,095 probable chikungunya cases and 161 deaths in 2024 alone. Between January 2019 and July 2024, infections exceeded one million, making Brazil the hardest-hit nation globally. In response, Valneva launched a pilot programme offering up to 500,000 free doses of IXCHIQ. The initiative targets adults aged 18 to 59, aiming for a 20 to 40 percent vaccination rate in selected areas.

On another front, Valneva's Lyme disease vaccine, VLA15, is in Phase 3 trials. Data from these studies are expected in the first half of 2026. Lyme disease affects hundreds of thousands of people in the U.S. each year, presenting a potentially larger commercial opportunity than chikungunya. The company plans to release its 2025 revenue and liquidity update on February 19, followed by full-year results on March 1.

Valneva continues to expand access to IXCHIQ in approved regions while navigating setbacks in the U.S. The Brazilian vaccination drive addresses a critical public health need, given the country's high infection rates. With Lyme disease vaccine trials ongoing, the company's next major milestone will arrive in early 2026 when Phase 3 results are published. Financial updates in the coming weeks will provide further clarity on Valneva's commercial outlook.