US health authorities have suspended approval of the chikungunya vaccine developed by the Franco-Austrian laboratory Valneva, basing their decision on new reports of side effects, the group announced on August 25. This suspension is effective immediately and involves a cessation of the shipment and sale of Ixchiq.", trade name of the vaccine, " in the United States", Valneva detailed in a press release.
This vaccine is one of the first to be developed against chikungunya, a viral disease transmitted from human to human by mosquito bites. But its deployment has been disrupted by reports of several serious side effects, particularly during a major outbreak in the spring in Réunion.
French health authorities had made Ixchiq a central tool in the fight against the disease in the overseas department, but around twenty serious effects were recorded, all in elderly people. According to the latest report, one death there is very likely linked to the vaccine.
In this context, the vaccine had been suspended by France, then the European Union for those over 65, before the United States followed suit. But the EU reauthorized the vaccine in July, judging that these side effects did not call into question the vaccine's benefits against a disease that is particularly risky for older people.
A suspension " sudden", according to the laboratory
Conversely, the United States, through its Food and Drug Administration (FDA), has therefore decided to suspend the vaccine for everyone, explaining this decision by the reporting of new serious side effects in the United States. This choice " is based on serious concerns about the safety of the vaccine, which appears to cause disorders similar to chikungunya", states the FDA on its website, assuring that " the benefits of the vaccine do not outweigh its risks, according to the most plausible scenarios“.
The decision comes at a time when many researchers are concerned that US health policy is taking a vaccine-sceptic turn under the leadership of Robert Kennedy Jr., appointed to head the Department of Health by President Donald Trump. Without directly criticizing the FDA's decision, Valneva mentioned a suspension " sudden " and judged that the new reported effects, affecting four people aged 55 to 82, were " comparable » to those already known.
The group has not yet revised its financial forecasts accordingly, but says it is assessing the financial impact that a definitive withdrawal of the vaccine in the United States could have.
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