FDA Grants ‘Accelerated Approval’ for Vaccine Against Life-Threatening Mosquito-Borne Virus Once Unheard of in US

FDA Grants ‘Accelerated Approval’ for Vaccine Against Life-Threatening Mosquito-Borne Virus Once Unheard of in US

The Food and Drug Administration has given its approval for a vaccine against a disease few Americans ever heard of 20 years ago.

Under its “accelerated approval” rules, the FDA approved a drug called Ixchiq, which is the first vaccine against chikungunya. The shots are for adults “18 years of age and older who are at increased risk of exposure to chikungunya virus,” according to an FDA news release on its website.

The virus is spread by the bite of an infected mosquito.

At least 5 million cases of the virus have been reported in the past 15 years, mostly in tropical and subtropical areas of Africa, Southeast Asia, and parts of the Americas, leading the FDA to classify it as “an emerging global health threat.” The virus can be fatal to newborn babies.

Through September, there were about 440,000 chikungunya cases globally, with about 350 dead from the virus, the European Center for Disease Prevention and Control reported, according to Forbes.

Countries with the most cases were located in South and Central America.


Headache, fatigue, muscle pain, joint pain, fever and nausea were among the most common side effects of the shot, the FDA said, noting that 1.6 percent of drug trial recipients who got the shot had adverse reactions, with two being hospitalized. For some, reactions to the shot lasted for 30 days.

“Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“Today’s approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options,” he said.

Fever and joint pain are the most common symptoms of chikungunya.

Chikungunya has been on the global radar screen since it was identified in 1952 in Tanzania, according to Forbes. It now exists on every continent except Antarctica.

The virus was rarely noticed among U.S. travelers before 2006, according to the federal Centers for Disease Control and Prevention.

Between 2006 and 2013, only about 28 cases a year were reported in Americans who had traveled to places where the virus was prevalent.

The virus reached the Americas in 2013, and in 2014, it began to be spread by mosquitoes in Florida, Texas, Puerto Rico, and the U.S. Virgin Islands.

Since 2015, the CDC said no locally acquired infections have been reported. In 2022, 81 cases were reported in Americans who travel abroad.

The drug is made by Valneva Austria GmbH.


This article appeared originally on The Western Journal.

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