FDA bans Ixchiq within the US, sending Valneva shares plummeting
The US Meals and Drug Administration (FDA) has suspended the licence for Valneva’s chikungunya vaccine Ixchiq, simply two weeks after lifting a partial pause on the jab’s use after investigating security issues.
The U-turn by the FDA comes amid new studies of significant antagonistic occasions (SAEs) in people administered with Ixchiq.
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Shares in Paris-listed Valneva had been buying and selling 25.5% down in comparison with market open on 22 August, the day the FDA issued its resolution after market shut.
The company acknowledged its verdict, made by way of the Heart for Biologics Analysis and Analysis (CBER), is “primarily based on critical security issues associated to the vaccine, which seems to be inflicting chikungunya-like sickness in vaccine recipients”.
The company cited studies of 21 hospitalisations and three deaths linked to the vaccine. This consists of one dying from encephalitis instantly attributable to the vaccine.
The CBER stated its benefit-risk is not in favour of the drug beneath most believable situations. The FDA division stated it due to this fact “believes this vaccine isn’t protected” and that “continued administration to the general public would pose a hazard to well being”.
The choice to revoke the vaccine’s licence means it could possibly not be used within the US. In an announcement, Valneva stated it’s now mandated to cease transport and promoting Ixchiq within the nation.
“Valneva is dedicated to upholding the very best security requirements and can proceed to interact proactively with well being authorities in all territories the place Ixchiq is licensed,” the French vaccine specialist added in its assertion.
Including extra readability to the security occasions, Valneva highlighted that three of the 4 deaths – all of which occurred outdoors the US – occurred in aged sufferers.
The corporate acknowledged: “Valneva believes all instances describe signs in line with these beforehand reported throughout scientific trials and post-marketing expertise, notably among the many aged people for whom the vaccine’s Prescribing Info (PI) consists of warnings and precautions.”
Valneva’s CEO Thomas Lingelbach confirmed that Ixchiq will nonetheless be offered in all nations the place the product is licensed.
Ixchiq contributed €7.5m to Valneva’s €91m whole product gross sales in H1 2025. The corporate says it’s at present evaluating the monetary influence of the US suspension.
In an electronic mail to Pharmaceutical Expertise, a Valneva spokesperson stated the corporate is “persevering with to analyze these instances intimately and if warranted will pursue additional steps in reference to FDA’s resolution in accordance with relevant statutory procedures.”
The shot’s ban within the US is the newest undulation in a rocky regulatory highway Ixchiq has traversed up to now month. In Could 2025, the FDA and the US Facilities for Illness Management and Prevention (CDC) collectively advisable a pause within the vaccine’s use in these aged 60 and over after post-marketing studies of significant antagonistic occasions. Nevertheless, this partial pause was lifted on 8 August after the FDA reevaluated the vaccine’s benefit-risk profile as a part of its investigation.
The FDA suspension of Ixchiq’s licence leaves Bavarian Nordic’s Vimkunya as the only chikungunya vaccine accredited within the US. In contrast to Ixchiq, which was solely accredited for adults, Vimkunya is licensed for immunisation in these aged 12 years and above.
It’s unclear whether or not the European Medicines Company (EMA), which has made related selections to the FDA up to now month concerning Ixchiq, can even, in flip, droop advertising authorisation.
Attributable to its namesake virus, chikungunya is a mosquito-borne illness primarily present in tropical areas. Though instances will not be prevalent in North America or Europe, there’s a danger of illness transmission to travellers visiting outbreak-affected nations in Africa and South America, together with islands within the Indian and Pacific Oceans.
Certainly, the CDC has issued a substantial variety of chikungunya-related journey alerts amid a new wave of outbreaks in nations, together with China, Kenya, and Bolivia.
The CBER reversals with Ixchiq mirror related selections with Sarepta’s gene remedy Elevidys in July.
Even the company’s director Vinay Prasad was concerned in a reversal. Prasad stepped down from his function as CBER director in late July, solely to rejoin the division in the identical function two weeks later.
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