The U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine against a dangerous tropical disease, developed by Narva native Tartu University researchers. It is the first vaccine developed in Estonia that has approval for human application.
The chikungunya virus is primarily transmitted to people through the bite of an infected mosquito. Chikungunya is an emerging global health threat with at least 5 million cases reported during the past 15 years. The highest risk of infection is in tropical and subtropical regions, but the virus has now spread to other areas causing a rise in global prevalence, the U.S agency reports.
The vaccine was approved using the so called accelerated approval pathway. Accelerated approval allows the FDA to approve certain products for serious or life-threatening conditions based on evidence of a product’s effectiveness.
Ixchiq was granted “Fast Track” and “Breakthrough Therapy” designations in the United States.
The FDA granted approval of Ixchiq to Valneva Austria GmbH.
The initial vaccine against the Chikungunya virus, the first in the world, was developed by virologist Andres Merits in collaboration with virologists Alexei and Valeria Lulla at the University of Tartu.
Valeria administers her own laboratory in Cambridge, England, where the couple, originally from Narva, currently resides.
“We are Narva natives. We earned our doctoral degrees from the University of Tartu and continued to work there as members of Andres Meritsa’s research group for about a decade,” Valeria Lulla said.
The vaccine, which was developed in Tartu, has already undergone testing on primates and rodents by an international group of researchers, and the Austrian company carried out first clinical trials on humans.
“Ours was the initial phase; we were tasked with designing and testing about 20 vaccine candidates in cell culture. This was the earliest and most critical stage, which ultimately determined the course of the entire undertaking,” Aleksei Lulla explained their part.
The development of a vaccine for the virus in Tartu was initiated with the support of EU funding a decade ago.
“Réunion [an island in the Indian Ocean that is an overseas department and region of France], where the first mass outbreak of the virus occurred, is part of the European Union, which, although on the wrong side of the equator, is part of France.About a quarter or a third of the people who had the virus on that island became ill within a few months, putting a huge strain on the hospital system. In addition, this virus has the property of causing chronic, long-lasting arthritis-like symptoms in about half or more of the cases,” Merits said.
Merits said the largest market for the vaccine is likely to be Brazil and other South American countries, as well as Southeast Asia, where the spread of the virus is a major concern.
“There are not that many human vaccines overall, and this is the first one against the alphavirus. It is essential for a tropical virus vaccine to work in a single injection, and this is the only vaccine that does so and gives the protection. This is an amazing achievement for humanity, not just for us,” Valeria Lulla said.
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