FDA approves world’s first vaccine for ’emerging global health threat’: ‘Prevention of a potentially debilitating disease’

Earlier this month, the U.S. Food and Drug Administration (FDA) approved Ixchiq, the world’s first licensed vaccine for the mosquito-borne chikungunya virus.

The single-dose vaccine was developed by Valneva, a French biotech company, and fast-tracked by the FDA via the Accelerated Approval pathway.

Chikungunya — which is spread by mosquito bites — means “to become contorted” or “that which bends up” in the East African language of Kimakonde, referring to the position that infected persons frequently take.

While it is considered non-fatal, affected individuals typically experience fever and severe joint pain that typically lasts for weeks but can persist for years. Other symptoms include headache, rash, nausea, muscle soreness, and fatigue, making chikungunya difficult to differentiate from other mosquito-borne illnesses such as dengue and Zika, both of which have also become increasingly concerning.

Chikungunya is an “emerging global health threat,” per the FDA, and at least 5 million cases have been reported since 2008. According to the European Centre for Disease Prevention and Control, there have been 440,000 cases of chikungunya reported just this year.

The areas most susceptible to the virus include the tropical and subtropical regions of Africa, Southeast Asia, and South and Central America.

However, researchers have theorized that rising temperatures across the globe may increase the geological range of mosquitoes and the diseases they carry, which could potentially expose the United States to the infection.

With the development and approval of Ixchiq, though, the cause for concern has been mitigated.

In Valneva’s press release, the company noted that Ixchiq is geared toward the 60-plus million Americans who travel each year to locations where mosquito-borne diseases are endemic.

Valneva also said it hopes to commercialize the vaccine in the U.S. early next year while securing a vote of approval from the Advisory Committee on Immunization Practices by the end of next February. People over the age of 18 and at risk of exposure to chikungunya are eligible for the shot.

The approval “is an important advancement in the prevention of a potentially debilitating disease with limited treatment options,” said Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research.

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