FDA extends review on Valneva chikungunya vaccine by three months

The FDA has pushed its decision deadline on Valneva’s chikungunya vaccine to the end of November, the European vaccine company announced Monday morning.

Originally, the FDA was supposed to decide whether or not to approve the vaccine by the end of August. However, the regulatory agency has now delayed its deadline by three months. The delay was “to allow sufficient time to align and agree on the phase IV program necessary under the accelerated approval pathway,” Valneva said in a press release, adding that the FDA did not request additional clinical data.

Juan Carlos Jaramillo

In a statement, Valneva CMO Juan Carlos Jaramillo said the biotech believes it may be possible for the decision to come earlier than the new deadline. Valneva declined to provide additional details on the delay.

Valneva’s US stock dropped roughly 6% to $13.50 Monday morning on the news.

Chikungunya virus is spread by mosquitoes and causes fever and extreme joint pain. The virus was found primarily in Africa and Asia, though outbreaks have become more widespread in the past two decades, according to the World Health Organization.

There are currently no vaccines or treatments approved specifically for the disease — Valneva’s vaccine is expected to be the first. Valneva is also seeking approval in Canada and planning to submit an application in the EU, positioning its vaccine primarily as a travel vaccine. Valneva is partnered with the Instituto Butantan in Brazil and the Coalition for Epidemic Preparedness Innovations to manufacture the vaccine for low- and middle-income countries.

“We’ve maintained our previous guidance that we still expect to make the product available this year if it is approved,” a Valneva spokesperson said in an email. That still puts it about one year ahead of competitor Bavarian Nordic despite the FDA delay. Last week, following a second successful Phase III readout, Bavarian Nordic announced that it plans to file its chikungunya vaccine for approval in 2024 and launch in 2025.

TD Cowen analyst Boris Peaker noted at the time of Bavarian Nordic’s readout that, while the vaccines showed comparable efficacy in clinical trials, they worked differently. Bavarian Nordic’s vaccine is faster-acting, with peak efficacy at two weeks compared to Valneva’s at one month. The tradeoff is that Bavarian Nordic’s vaccine is less durable in the long term. “We believe that a quicker onset of action is more important for a travel vaccine than duration of coverage, but that there is likely room in the market for both products,” Peaker wrote.

Merck had also been developing a chikungunya vaccine but cut its candidate earlier this year.

Following potential approval, Valneva faces another important milestone in February 2024 — it expects a vote from ACIP, the CDC’s Advisory Committee on Immunization Practices, on recommending its chikungunya vaccine in the US.

For Valneva, the chikungunya vaccine is its latest-stage candidate. The European biotech is also partnered with Pfizer on a Lyme disease vaccine, but Pfizer pushed back its timeline to filing for approval one year to 2026. The delay came after the Big Pharma dropped half of its participants from a Phase III trial following disclosures that a third-party contractor violated clinical trial standards.

This story was updated with comment from Valneva.

vaccines
cmo
biotech
pharma
fda
clinical trials
cdc
world health organization