FDA approves first vaccine to prevent chikungunya virus
The US Food and Drug Administration has approved the first vaccine to prevent disease caused by the chikungunya virus. The single-dose vaccine, Ixchiq, made by Valneva Austria GmbH, is approved for adults who are at an increased risk of exposure to the virus. Ixchiq was granted fast track and breakthrough therapy designations.
Chikungunya is a mosquito-borne disease that has no specific treatment and can be debilitating and even deadly for newborns. Health experts consider it to be an emerging threat to global health made worse by climate change, with at least 5 million cases in the past 15 years. Although deaths and severe illness are rare, the virus poses a significant risk to those who are infected.
People most at risk of infection live in Africa, Southeast Asia, and parts of the Americas, where chikungunya-carrying mosquitoes are endemic, but the climate crisis has driven the virus to new parts of the world. Before 2006, the virus was rarely identified even in US travelers, but cases stemming from local transmission were reported in warmer parts of the US in recent years.
Symptoms of chikungunya typically include fever, joint pain, headache, muscle pain, and a rash. The joint pain can be debilitating and may last for years. Around 20% to 30% of cases are expected to become chronic, and for newborns, chikungunya can be a potentially deadly threat.
Ixchiq contains a live, weakened version of the virus, and the FDA is requiring vaccine maker Valneva to conduct a postmarket study to ensure there are no serious risks associated with the vaccine. The most common side effects reported in studies submitted to the FDA for the vaccine’s approval included headache, muscle and joint pain, fever, tenderness at the injection site, and fatigue. However, nearly 2% of people who received the vaccine had severe chikungunya-like adverse reactions that required medical intervention.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, stated, “Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions. 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.”
While Ixchiq may cause symptoms similar to an infection, doctors say that a vaccine is the best option for people vulnerable to the virus. The prescribing information that comes with the vaccine carries a warning to make sure health care providers tell their patients that it is not known whether the vaccine virus can be transmitted from a pregnant person to their newborn and it is not clear whether the vaccine virus can harm a newborn. Providers are encouraged to discuss any potential reactions a patient may have to the vaccine.
This new vaccine approval is a significant step towards preventing the spread of chikungunya and protecting those most at risk of the virus.