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Chinese Vaccine Approved for Human Testing at Virus Epicenter
CanSino Biologics Inc. said it received Chinese regulatory approval to start human trials of a vaccine against the novel coronavirus, another example of a potential weapon against the illness being fast-tracked for testing as the global death toll escalates and nations impose lockdowns on their citizens.
The vaccine, co-developed by the Hong Kong-listed company and China's Academy of Military Medical Sciences, will undergo clinical trials in Wuhan, CanSino Biologics said in a statement to the Hong Kong Stock Exchange on Wednesday. Wuhan is the epicenter for the pandemic that has spread to all corners of the planet, infecting more than 190,000 people and killing more than 7,800.
Progress is occurring at unprecedented speed in developing vaccines as the highly infectious pathogen that causes the respiratory ailment known as Covid-19 looks unlikely to be stamped out through containment measures alone. U.S. President Donald Trump's administration is pressuring American drugmakers to develop a vaccine: Cambridge, Massachusetts-based Moderna Inc. received regulatory approval to move quickly to human trials last week, skipping the years of animal trials that are the norm in developing vaccines.
"You're planning on administering it to a healthy person who may or may not ever be exposed to the infectious disease agent you're trying to protect them against," said Rajeev Venkayya, president of the global vaccine unit at Japan's Takeda Pharmaceutical Co., said in a separate interview Tuesday. "There's very little margin for a safety problem."
CanSino's trial involves injecting the experimental vaccine into 108 healthy adults, aged 18 to 60, in three different doses, according to data from the Chinese Clinical Trial Registry. Tests will start this month and continue through year's end. The vaccine was tested on animals and proven safe and capable of eliciting immunity against the virus, CanSino said in its statement.
As the outbreak spread around the world, more than 100 clinical trials were launched in China to study the effectiveness of everything from anti-flu drugs and antibody-containing plasma from recovered patients, to traditional Chinese herbal medicine. A smaller number of trials have been announced in countries including the U.S., South Korea and Thailand.
In normal circumstances, a vaccine could take years to reach human clinical trials as scientists conduct substantial amounts of animal testing first before drug regulators greenlight further trials to determine its safety and efficacy on humans.
GlaxoSmithKline Plc said last month it was working with China-based Clover Biopharmaceuticals on an experimental vaccine. Also, the U.S. government's Biomedical Advanced Research and Development Authority is working with Sanofi and Johnson & Johnson on potential vaccines.
Shanghai Fosun Pharmaceutical Group Co. also licensed a vaccine that's now being developed at the pre-clinical stage by Mainz, Germany-based BioNTech SE.
Despite the rapid introduction of human trials, the earliest available vaccine is at least six months away, according to the Chinese Center for Disease Control and Prevention.
Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said it would take about a year-and-a-half to complete trials, scale up production and make a vaccine widely available.
[Source: Bloomberg News, NY, 18Mar20]
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