The coronavirus vaccine is not the only one generating hope. This Thursday, the Franco-Austrian pharmaceutical laboratory Valneva announced positive results for the phase 3 trial of its vaccine against chikungunya. Statements well received on the stock market, the group gaining 4.5% less than an hour after opening.
Tried on 4,115 adults in the United States, the vaccine generated antibodies in 98.5% of those vaccinated with a single dose. The final results of the trial are expected within the next six months. In the meantime, the group has received authorization from the US Food and Drug Administration (FDA) to file a marketing application.
A one-of-a-kind vaccine
Valneva’s serum is the only phase 3 vaccine candidate seeking lasting protection. During phase 1 of clinical development launched in September 2020, the 120 vaccinated patients had retained antibodies for one year. The 98.5% announced this Thursday therefore confirm these initial results and exceed the 70% seroprotection threshold agreed with the FDA.
“The vaccine was also shown to be highly immunogenic, including in elderly participants, who achieved levels of seroprotection and antibody titres as high as younger adults, with an equally good safety profile,” specifies Valneva in a press release.
It was also widely tolerated by patients: the side effects (mentioned on request) are overwhelmingly mild or moderate and ceased within three days. Only 1.6% mentioned side effects of severe intensity, usually headache. Half showed “systemic” effects: fever, headache and muscle pain (more than 20% of vaccinees).
The promise of overcoming a “major public health problem”
“These first results from a Phase 3 trial for a chikungunya vaccine mean that we have taken a further step towards solving this major, growing and unmet public health threat”, welcomes Juan Carlos Jaramillo, Physician Chief hygienist Valneva in the press release. The virus causes clinical illness in 72% to 92% of people infected with a carrier mosquito. While mortality remains low, morbidity is very high.
The Valneva project received last July the status of “Breakthrough program” from the FDA. This status allows research fighting against irreversible diseases to benefit from the support of the administration in order to succeed as quickly as possible. The conduct of clinical development trials is also facilitated, in compliance with the criteria established by the administration. It follows the “Fast Track” statutes of the FDA and “PRIME” of the European Medicines Agency (EMA) received in December 2018 and October 2020, making it possible to accelerate the development and sale of drugs deemed to be priority.
The virus is particularly present in America, as well as in parts of Asia and Africa. In September 2020, the American continent recorded more than a million cases. Valneva has signed an initial agreement with the Brazilian Institute for the future marketing of the vaccine.