FDA Halts Chikungunya Vaccine After Severe Side Effects Reported in Elderly Patients

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The war against the chikungunya virus that claims lives, which is dominant along the country’s coastal towns, has suffered a setback after the U.S. Food and Drug Administration (FDA) suspended the license for its vaccine, Ixchiq, with immediate effect.

A French pharmaceutical company that manufactures the vaccine, confirmed that the suspension followed reports of four serious adverse events consistent with the disease. As a result, the company has been ordered to stop shipping and selling the vaccine in the U.S.

The company added that it was assessing the potential impact of a permanent withdrawal of the drug from the American market but insisted that its financial outlook would remain unchanged, according to Reuters

Chikungunya is spread by the Aedes mosquito species, including the tiger mosquito, which is also known to transmit dengue. The virus causes high fever, severe joint pain, and in some cases, long-term disability.

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An undated photo of the Aedes aegypti mosquito
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The disease was first identified in Tanzania back in 1952. Unlike other mosquitoes, such as the female Anopheles mosquito, which transmits malaria and typically bites at night, these two mosquitoes stand out because they prefer to bite during the day.

Ixchiq was the first preventive vaccine approved for chikungunya in both the U.S. and Europe and works by using a weakened form of the virus to stimulate an immune response in patients.

The vaccine is one of only two approved by the FDA to fight the mosquito-borne virus, which is most common in tropical and subtropical regions but has, in recent years, spread globally.

The French company secured U.S. approval in 2023, but reports of adverse side effects, particularly among elderly patients, triggered ongoing reviews, including one by the European Medicines Agency earlier this year.

According to the company, the FDA suspension is effective immediately, following the discovery of four new cases of severe side effects, three of which involved patients aged between 70 and 82.

Meanwhile, in July, the World Health Organisation (WHO) raised alarm over the deadly mosquito-borne chikungunya virus, calling for action against the virus that is present in Kenya, particularly in areas along the Coast.

The global health body issued the alarm as it aims to prevent a repeat of an epidemic of the chikungunya virus that swept the globe two decades ago, as new outbreaks linked to the Indian Ocean region spread to Europe and other continents.

In Kenya, the disease broke out in June, with 25 people in Mombasa having tested positive for the disease out of the 45 samples that were analysed by the Kenya Medical Research Institute (KEMRI).

According to the Mombasa County government, Mvita, Nyali, Likoni, and Kisauni sub-counties were the most affected by the disease.

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Health Cabinet Secretary Aden Duale flanked with other officials from the Ministry of Health during a meeting with World Health Organisation (WHO) boss Dr. Tedros Adhanom Ghebreyesus.
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