The healthcare landscape welcomed a significant stride in infection prevention last Thursday, as the first-ever vaccine for the Chikungunya virus, called Ixchiq, received approval from the U.S. Food and Drug Administration (FDA). Specially targeting adults who are at a high risk of exposure, Ixchiq is a single-dose vaccine that marks a monumental step in combating this growing global health concern.
Over the last 15 years, Chikungunya has been omnipresent, racking up approximately five million reported infection cases according to federal records. Tropical and subtropical regions, particularly those in Africa, Southeast Asia, and parts of the Americas, bear the highest infection risk where the Chikungunya virus-carrying mosquitoes are pervasive. Nevertheless, the expanding geographical reach of these vectors due to climate change presents a rising threat to new regions. Prior to 2006, Chikungunya virus detection among U.S. travellers was an anomaly. However, the U.S. Centers for Disease Control and Prevention have noted a marked increase in such instances between 2006 and 2013. By late 2014, transmissions of the virus within U.S. borders were confirmed, specifically within the territories of Florida, Texas, Puerto Rico, and the U.S. Virgin Islands.
The symptoms of Chikungunya infection range from fever and joint pain to headaches, muscle pain, and rashes. In certain cases, joint pain can persist severely for years. For newborns, the repercussions of the infection could be potentially fatal. The Ixchiq vaccine comprises a live but weakened version of the virus which can induce symptoms resembling those of actual infection. Consequently, it carries a cautionary note in its prescribing information pertaining to unknown risks of the vaccine virus being transmitted from pregnant women to their newborns or any potential harm the vaccine might inflict on babies. To ensure the vaccine does not carry serious side effects, postmarket studies have been mandated by the FDA for its creator, Valneva.
In the trials conducted for approval, most common side effects associated with the vaccine included headache, muscle and joint pain, fever, tenderness at the site of the injection, and fatigue. A severe Chikungunya-like adverse reaction requiring medical intervention was observed in only 2 percent of the vaccinated population. Of all trial participants, a mere two out of roughly 3,500 needed hospital care due to a reaction. The green light for Ixchiq was granted to Valneva Austria GmbH.