The coronavirus vaccine isn’t the only hope. This Thursday, the Franco-Austrian pharmaceutical laboratory Valneva announced the positive results of the third phase of trials of its chikungunya vaccine. The announcement was well received in the stock market, with the group up 4.5% less than an hour after the opening.
Tested in 4115 adults in the United States, the vaccine produced antibodies in 98.5% of those who were vaccinated with a single dose. The final test results are expected within the next six months. In the meantime, the group has received approval from the US Food and Drug Administration (FDA) to apply for marketing.
Valneva’s serum is the only Phase 3 vaccine candidate requiring long-term protection. During phase 1 clinical development, which began in September 2020, 120 vaccinated patients retained antibodies for one year. The 98.5% announced this Thursday confirm these initial results and exceed the 70% FDA-cleared serological protection threshold.
“In addition, the vaccine has been shown to be highly immunogenic, including in older participants whose seroprotection levels and antibody titers were as high as in younger people, with an equally good safety profile,” Valneva said in a press release. release.
Patients also tolerated it well: side effects (indicated on request) are mostly mild to moderate and disappear within three days. Only 1.6% reported serious side effects, usually headaches. Half showed “systemic” effects: fever, headache and muscle pain (more than 20% of those vaccinated).
The promise to overcome a “major public health problem”
“These first results from the Phase 3 Chikungunya vaccine trial indicate that we have taken another step towards addressing this serious, growing and unmet public health threat,” says Juan Carlos Jaramillo, Valneva’s chief hygienist, in a press release. The virus causes clinical illness in 72–92% of people infected with mosquito vectors. Although mortality remains low, morbidity is very high.
In July last year, Valnev’s project received the status of “Breakthrough Program” from the FDA. This status allows research aimed at combating irreversible diseases to receive support from the administration in order to succeed as quickly as possible. It also facilitates the conduct of clinical trials in accordance with the criteria set by the administration. It complies with the FDA Fast Track and European Medicines Agency (EMA) PRIME guidelines issued in December 2018 and October 2020 to accelerate the development and marketing of priority drugs.
The virus is especially present in America, but also in parts of Asia and Africa. More than a million cases were reported in the Americas in September 2020. Valneva signed an initial agreement with the Brazilian Institute for the future marketing of the vaccine.