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FDA approves vaccine to prevent infection with the chikungunya virus

By Robin Foster, HealthDay News
The single-dose shot, known as Ixchiq, is approved for adults who are at increased risk of exposure to the virus. File Photo by John Angelillo/UPI
The single-dose shot, known as Ixchiq, is approved for adults who are at increased risk of exposure to the virus. File Photo by John Angelillo/UPI | License Photo

The first vaccine to prevent infection with the chikungunya virus was approved by the U.S. Food and Drug Administration on Thursday.

The single-dose shot, known as Ixchiq, is approved for adults who are at increased risk of exposure to the virus.

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"Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in an agency news release announcing the approval. "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."

Chikungunya is an emerging global health threat, with at least 5 million cases of chikungunya virus infection reported during the past 15 years, the agency said. The highest risk of infection is seen in tropical and subtropical regions of Africa, Southeast Asia and parts of the Americas where chikungunya virus-carrying mosquitos are endemic. Unfortunately, climate change has allowed the virus to spread to new parts of the world, the FDA added.

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Before 2006, the virus was rarely identified in U.S. travelers, according to the U.S. Centers for Disease Control and Prevention, but studies have identified a couple dozen cases in the U.S. travelers between 2006 and 2013. Then, in late 2014, local transmitted cases were reported in Florida, Texas, Puerto Rico and the U.S. Virgin Islands.

People who get sick with chikungunya typically have a fever and can develop joint pain. They may also experience a headache, muscle pain and a rash. For some, the joint pain can be severe and last for years. Among newborns, chikungunya can be a potentially deadly threat, the FDA noted.

Ixchiq contains a live, weakened version of the virus, so it may cause symptoms that mimic an actual infection.

The prescribing information that comes with the vaccine carries a warning that it is not known whether the weakened vaccine virus can be transmitted from a pregnant woman to her newborn, and it is not clear whether the vaccine virus can harm a baby.

Because there's no treatment for chikungunya, doctors usually tell patients to rest, drink lots of fluids and take over-the-counter medication to manage their fever or pain, the FDA said. But experts noted that a vaccine is the best option for people vulnerable to the virus.

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The FDA is requiring that vaccine maker Valneva do a post-market study to make sure there are no serious side effects with the vaccine.

The most common side effects reported in studies submitted for the vaccine's approval included headache, muscle and joint pain, fever, tenderness at the injection site and being tired.

Just 2% of those who got the vaccine had severe chikungunya-like adverse reactions that required medical intervention, the FDA said, and only two of the nearly 3,500 people in the trials had to go to a hospital because of a reaction.

More information

Visit the U.S. Centers for Disease Control and Prevention for more on chikungunya virus.

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