by
CNN
–
The American Centers for Disease Control and Prevention is currently investigating five hospital admissions that took place in people who recently received a vaccine that occurs disease caused by the Chikungunya virus.
In a message posted on Tuesday on a vaccine information page for care providers, the CDC said that people, all 65 and older, were admitted to hospital for heart or neurological events after vaccination with IXCHIQ, the only Chikungunya vaccine that is currently a license in the United States.
CNN has contacted the CDC for comment.
Chikungunya virus is usually spread to people through the bite of an infected mosquito. Most adults do not receive the vaccine; it is sometimes Recommended for certain travelers with an increased risk to be exposed to the illness transferred by mosquitoes.
“This subject will be discussed during a coming meeting of the Advisory Committee for Immunization Practices (ACIP). Healthcare suppliers must discuss the benefits and risks of vaccination with individual travelers based on their age, destination, travel time and planned activities, ”said the online notification of the CDC in part.
The Chikungunya vaccine and the surveillance for side effects were originally planned to be discussed in an ACIP meeting on Wednesday, according to a draft meeting agenda, but that meeting was postponed.
Dr. William Schaffner, expert in infectious diseases at Vanderbilt University Medical Center and Acip Liaison, said that the CDC research is an example of the agency’s vaccine monitoring system “who work well and send a signal” in detecting rare events that may deserve further research.
“And of course, the CDC and the locals that take care of these patients are now working on it, which is completely appropriate. That is the way the system should work, “Schaffner said.
“Don’t forget that we are still trying to find out if this is a causal relationship or a casual relationship,” he said about the research, in which he is not immediately involved. ‘Let us not draw conclusions yet. That’s why they do the research. ”
The IXCHIQ vaccine, administered as a single dose in the muscle, contains a living, weakened version of the Chikungunya virus. The vaccine, made by the biotechnology company Valneva, was the first vaccine approved by the American Food and Drug Administration to prevent diseases caused by the Chikungunya virus. The approval, in November 2023, was for people aged 18 and older who run an increased risk of exposure to the Chikungunya virus.
“It is recommended in a very limited way of travelers who go to countries where a current outbreak of Chikungunya is virus infection, and also to travelers who have been going to countries who had experienced an outbreak in the last five years,” Schaffner said. “And also to Laboratori who work with the Chikungunya virus in the laboratory.”
A Valneva spokesperson said on Thursday morning in an e-mail statement that the company is aware that the CDC will assess the safety data of postmarketing as part of his routine vaccine surveillance.
“We understand from the CDC that at least four of these five people had also received other vaccines, and most of them had important underlying medical conditions. Valneva has not identified problems with the safety signal by safety monitoring after marketing, including periodic safety reports and routine signal detection activities, and the safety profile of IXCHIQ remains consistent with data from clinical tests, unchanged and positive, ”said the statement. “No changes have been observed in the established safety profile of clinical test, including participants who are monitored for more than three years after vaccination. Valneva continues to collaborate with health authorities to guarantee the highest standards of vaccine safety. ”
Prescribing information for the vaccine entry: “Vaccination with IXchiq can cause serious or long-term chikungunya-like side effects.”
Chikungunya virus circulates in tropical and subtropical areas. According to the CDC locally, infections have been reported in the United States. But fallen and outbreaks were identified in more than 100 countries in America, Africa, Asia, Europe and the Indian and the Pacific.
Symptoms of chikungunya infections are fever, joint pain, headache, muscle pain, joint growths or rashes, according to the CDC, and the best way to prevent Chikungunya is to avoid mosquito bites. There are currently no medicines to treat chikungunya, but infected people can feel better with rest, liquids and freely available drugs for pain and fever.
In Tuesday’s notification, the CDC said that common side effects after vaccination that took place in more than 10% of vaccinated people in clinical examinations tenderness, headache, fatigue, muscle pain, joint pain, fever and nausea include. In some people, “serious or long-term chikungunya-like side effects occurred”.
Chikungunya-like reactions include “fever, joint pain, headache, rash, and can also include cardiac and neurological disorders that were serious in two cases,” said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, who was not involved in the clinical studies, in an e-mail Wednesday.
The notification of the CDC encouraged care providers to report all the side effects that can be caused by vaccination to the CDC/FDA vaccine processing events Reporting System (VAERS) “, by submitting a report online or using a PDF form.
“The robust vaccine safety monitoring system often identifies extremely rare adverse effects of vaccines after approval,” said Barouch, an expert in the field of infectious diseases that is not involved in the CDC research.
When the vaccine was approved in 2023, the FDA noted that its safety was evaluated in two clinical studies in North America, in which around 3,500 adults received a dose of the vaccine, with one study with around 1,000 participants who received a placebo. Severe Chikungunya-like side effects took place in 1.6% of the IXCHIQ recipients and none of the placebo receivers, according to the FDA.
