China has started the first phase of a clinical trial for a novel coronavirus vaccine, records show, as the world’s scientists race to find a way to combat the deadly pathogen.
The Chinese effort began on March 16 – the same day as the US announcement – and is expected to continue until the end of the year, according to a filing in the country’s Clinical Trial Registry, dated March 17.
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.
CanSino Bio and its collaborators at the Academy of Military Medical Sciences’ Institute of Biotechnology secured a quick Chinese regulatory go-ahead to start human testing of their recombinant coronavirus vaccine, the company said in a disclosure (PDF) to the Hong Kong Stock Exchange on Wednesday.
“Thanks to our collaborators and our diligent team, who worked almost around the clock since late January to develop this vaccine candidate with sound scientific data to support IND filing,” CanSino Chairman and CEO Xuefeng Yu said in a statement.
CanSino’s candidate, dubbed Ad5-nCoV, uses its adenovirus-based viral vector vaccine platform. In 2017, the same technology helped the company earn a Chinese nod for its Ebola vaccine, which was the first Ebola shot approved anywhere based on the strain behind the deadly epidemic in West Africa in 2014.
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.
Meanwhile, amid growing numbers of infections in the U.S., the FDA has allowed a phase 1 study of Moderna’s mRNA vaccine without animal data. On Monday, the biotech said researchers at the National Institutes of Health dosed the first subject.
The Moderna candidate, mRNA-1273, contains mRNA encoding for a stabilized form of the spike protein. The phase 1 trial will enroll 45 healthy adults to evaluate the shot’s safety and immunogenicity at three different dose levels, each given twice and 28 days apart.
Moderna previously secured funding from the Coalition for Epidemic Preparedness Innovations (CEPI) to make the first clinical batch. The company said it’s now preparing material for a potential phase 2 trial, which could begin in a few months. In the longer term, Modern is ramping up manufacturing “that could allow for the future manufacture of millions of doses should mRNA-1273 prove to be safe and effective,” the biotech said.
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.
