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Breakthrough Moment: FDA Grants Approval for First-Ever Vaccine to Combat Chikungunya Virus

Medical professional's gloved hand about to administer a vaccine | Getty Images

The United States Food and Drug Administration authorized the first vaccination to guard against chikungunya virus infection last Thursday afternoon.

Ixchiq, a single-dose injection, is authorized for use in adults who have a higher chance of contracting the virus.

“Chikungunya virus infection can result in severe disease and protracted health problems, especially for older adults and individuals with underlying medical conditions,” FDA Center for Biologics Evaluation and Research director Dr. Peter Marks stated in a news release announcing the approval. “Today’s approval is a significant step towards the prevention of a potentially crippling disease with limited treatment options and addresses an unmet medical need.”

At least 5 million instances of chikungunya virus infection have been documented during the previous 15 years, making chikungunya a rising global health issue, according to the agency. The areas of Southeast Asia, Africa, and portions of the Americas that are tropical or subtropical and where chikungunya virus-carrying mosquitoes are prevalent have the highest risk of infection. The FDA said, “Unfortunately, climate change has made it possible for the virus to spread to new parts of the world.”

Rarely was the virus found in American tourists, according to the U.S. Centers for Disease Control and Prevention; nevertheless, research has shown a few dozen instances among Americans who traveled there between 2006 and 2013. Local transmission cases were then recorded in Florida, Texas, Puerto Rico, and the United States Virgin Islands towards the end of 2014.

Individuals with chikungunya often experience fever and sometimes joint discomfort. In addition, they can have a rash, headache, and muscular soreness. Some people may experience significant joint discomfort that lasts for years. The FDA stated that chikungunya poses a potentially fatal risk to infants.

Ixchiq may create symptoms that resemble those of a real illness since it includes a live, weakened variant of the virus.

The prescription literature that accompanies the vaccination bears a warning that it is unclear if the vaccine virus may damage an infant, and it is unclear whether the weakened vaccine virus can spread from a pregnant woman to her fetus.

Chikungunya has no known cure, so doctors typically advise patients to control their fever or discomfort with over-the-counter medications, plenty of water, and rest. But for those who are susceptible to the virus, specialists say being vaccinated is the best course of action.

To ensure that there are no major negative effects from the vaccination, the FDA is mandating that Valneva, the company that makes the vaccine, do a post-marketing study.

The most frequently reported adverse effects in trials submitted for approval of the vaccine were fatigue, headache, fever, soreness at the injection site, and muscle and joint discomfort.

According to the FDA, just 2% of vaccination recipients experienced severe adverse responses similar to chikungunya that necessitated medical attention. Out of the approximately 3,500 participants in the trials, only two required hospitalizations due to vaccine-related symptoms.

Chikungunya in the US

The main way that the chikungunya virus spreads to humans is through mosquito bites. Over the past 15 years, at least 5 million instances of chikungunya virus infection have been documented worldwide, making it a growing health danger. In tropical and subtropical regions of Africa, Southeast Asia, and portions of the Americas where chikungunya virus-carrying mosquitoes are prevalent, there is the largest risk of infection. But the chikungunya virus has expanded to new regions, increasing the disease’s incidence all over the world.

Fever and joint discomfort are two of chikungunya’s most typical symptoms. Muscle soreness, headaches, and rashes are possible additional symptoms. Debilitating joint pain can last for months or even years for certain people. Rest, drinks, and over-the-counter pain and fever drugs are all part of the treatment.

1,911 cases of chikungunya had been recorded in the US as of December 2 last year. Prior to this epidemic, 28 tourists with the Chikungunya virus returned to the nation annually on average. According to CDC estimates, nine million people visit the Caribbean and the United States annually.

Meanwhile, the CDC said that the first known local case of chikungunya virus in the Americas was discovered in Caribbean nations and territories at the end of 2013. Local transmission occurs when the virus infects local mosquitoes, who then transmit it to humans. Beginning in 2014, incidences of the Chikungunya virus disease were documented among Americans returning from afflicted regions of the Americas, and Florida, Texas, Puerto Rico, and the United States Virgin Islands were shown to have local transmission. In 2015, the Chikungunya virus illness was declared a national emergency. In the United States, 81 instances of the Chikungunya virus illness had been documented as of 2022.

Travel Health Notices (THNs) are issued by the CDC to advise travelers on precautions they may take to avoid infection or negative health impacts, as well as to advise them about global health risks during epidemics, special events or gatherings, and natural disasters.

A THN may be posted for the following reasons:

  1. An increased number of expected cases of a disease in a nation or region;
  2. Occasional cases of a disease in an uncommon or novel geographic location;
  3. Natural or man-made disasters with serious risks to the environment’s health or infrastructure damage that would restrict access to healthcare services; and
  4. Large-scale gatherings that may trigger disease outbreaks.

Click here for CDC’s list of areas at risk of Chikungunya.

Here is CDC’s travel health notices.

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