(CNN) — The United States Food and Drug Administration Unidos said this Thursday that it approved the first vaccine to prevent the disease caused by the chikungunya virus.
The single dose vaccine, Intoxicated , manufactured by Valneva Austria GmbH, is approved for adults who are at increased risk of exposure to the virus. Ixchiq received breakthrough and fast track therapy designations.
Chikungunya, a mosquito-borne disease whose name in the Makonde dialect of Africa means “crouching in pain,” has no specific treatment and can be debilitating and even fatal to newborns. Health experts consider it an emerging global health threat exacerbated by climate change, with at least 5 million cases in the past 15 years, although deaths and serious illnesses are rare, according to the World Health Organization .
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 brought the virus to new parts of the world.
Before 2006, the virus was rarely identified even in American travelers, according to US Centers for Disease Control and Prevention but studies identified a couple dozen cases in American travelers between 2006 and 2013. In late 2014, cases arising from local transmission were reported in warmer parts of the US: Florida, Texas, Port Rico and the US Virgin Islands
People who contract chikungunya usually have a fever and may develop joint pain. They may also have a headache, muscle pain, and rash. For some people, joint pain can be debilitating and can last for years. About 20% to 30% of cases are expected to become chronic, research shows. For newborns, chikungunya can be a life-threatening threat.
Ixchiq contains a live, weakened version of the virus, so it can cause symptoms similar to those of an infection.
The FDA said that in one study, the vaccine virus was detected in people’s blood in the first weeks after they were vaccinated. The prescribing information that comes with the vaccine includes a warning to make sure healthcare providers tell their patients that it is not known whether the virus in the vaccine can be transmitted from a pregnant person to their newborn, and it is not clear whether the virus from the vaccine can be transmitted to and harm a newborn. The warning directs providers to weigh the threat of the virus to the patient, as well as the gestational age and the risks of the disease to the fetus or newborn.
Because there is no specific treatment for chikungunya, doctors usually tell patients to rest, drink plenty of fluids, and take over-the-counter medications to control fever or pain. But scientists say a vaccine is the best option for people vulnerable to the virus.
“Chikungunya virus infection can cause serious illness and long-term health problems, especially in older adults and individuals with underlying medical conditions,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. in a statement from the agency.
“Today’s approval addresses an unmet medical need and is an important advance in the prevention of a potentially debilitating disease with limited treatment options,” he added.
The FDA requires vaccine maker Valneva to conduct a post-marketing study to make sure the vaccine does not pose serious risks.
The most common side effects reported in studies submitted to the FDA for vaccine approval included headache, muscle and joint pain, fever, injection site tenderness, and tiredness. Nearly 2% of people who received the vaccine had serious chikungunya-like adverse reactions that required medical intervention. Only two of the nearly 3,500 people who participated in the trials had to go to a hospital because of the reaction. Some also had a chikungunya-like adverse reaction that lasted at least 30 days. The vaccine comes with a warning to encourage providers to discuss any possible reactions a patient may have to the vaccine.
2023-11-10 06:08:00
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