Photo credit: www.yahoo.com
The US Centers for Disease Control and Prevention (CDC) is currently looking into five hospitalizations that have occurred among individuals who recently received the chikungunya vaccine designed to prevent disease caused by this virus.
As per a notice published on Tuesday aimed at healthcare providers, the affected individuals, all aged 65 and older, were hospitalized due to cardiac or neurological issues following vaccination with IXCHIQ, currently the only licensed chikungunya vaccine in the United States.
CNN has sought further information from the CDC regarding this investigation.
Chikungunya virus is primarily transmitted through the bite of infected mosquitoes. The vaccine is not broadly administered to the general population; instead, it is recommended for particular travelers who face an elevated risk of exposure due to their travel plans.
The CDC indicated that the situation would be included in discussions at an upcoming meeting of the Advisory Committee on Immunization Practices (ACIP). The agency emphasized that healthcare providers should thoroughly review the benefits and risks associated with the vaccine based on individual patient circumstances including age, travel destination, duration of stay, and activities planned.
Originally, the evaluation of the chikungunya vaccine and monitoring for adverse effects were on the agenda for discussion at an ACIP meeting this Wednesday. However, that meeting has been postponed.
Dr. William Schaffner, a specialist in infectious diseases at Vanderbilt University Medical Center and an ACIP liaison, stated that the current investigation represents the effective functioning of the CDC’s vaccine surveillance system, which is adept at identifying rare events that may warrant deeper examination.
“The CDC and local healthcare professionals are appropriately addressing this situation. This is precisely how the system is designed to operate,” Schaffner remarked.
He acknowledged that the ongoing investigation aims to ascertain whether there is a causal relationship between the vaccine and the reported events, urging caution against drawing premature conclusions.
The IXCHIQ vaccine is administered as a single intramuscular dose and contains a live, attenuated form of the chikungunya virus. This vaccine, developed by the biotechnology firm Valneva, was the first to gain approval from the US Food and Drug Administration for the prevention of chikungunya virus disease, receiving authorization in November 2023 for individuals aged 18 and older who are at heightened risk of exposure.
“Its usage is highly restricted, primarily recommended for travelers heading to areas experiencing current chikungunya outbreaks or those who have had outbreaks in the past five years,” Schaffner clarified. “It’s also advised for laboratory personnel handling the chikungunya virus.”
CNN has also attempted to obtain a response from Valneva. As per the prescribing information for IXCHIQ, vaccination may lead to severe or prolonged adverse reactions resembling chikungunya symptoms.
The chikungunya virus is prevalent in tropical and subtropical regions. According to CDC data, there have been no locally acquired cases reported in the United States since 2019. However, outbreaks have been documented in over 100 countries across the Americas, Africa, Asia, Europe, and the Indian and Pacific Oceans.
Typical symptoms of chikungunya infections include fever, joint pain, headache, muscular discomfort, and sometimes skin rashes. Preventive measures focus primarily on minimizing mosquito bites, as there are presently no specific treatments for chikungunya. Symptomatic relief can be achieved through rest, fluid intake, and the use of over-the-counter medications.
According to the CDC’s notice issued on Tuesday, common side effects reported in more than 10% of those vaccinated during clinical trials included tenderness, headaches, fatigue, muscle soreness, joint pain, fevers, and nausea. In select cases, serious or extended chikungunya-like adverse reactions were documented.
Chikungunya-like reactions encompassed symptoms such as fever, joint pain, headaches, rashes, and in some instances, serious cardiac and neurological complications. Dr. Dan Barouch, who leads the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, commented on this matter in an email, noting that he was not directly involved in the clinical trials.
The CDC has advised healthcare providers to report any adverse events potentially linked to vaccination through the CDC/FDA Vaccine Adverse Events Reporting System (VAERS) by submitting an online report or utilizing a PDF form.
“The comprehensive vaccine safety surveillance system often uncovers very rare adverse effects post-approval,” Barouch remarked, speaking to the importance of ongoing monitoring.
When IXCHIQ’s approval was granted in 2023, the FDA highlighted that its safety profile was evaluated in two clinical trials in North America involving around 3,500 adults, one of which included about 1,000 participants who received a placebo. Reportedly, severe chikungunya-like adverse reactions were observed in 1.6% of those receiving IXCHIQ, in contrast to none among the placebo group, as noted by the FDA.
Source
www.yahoo.com