SINGAPORE – Indian pharmacist Cadila Healthcare is about to start a phase three clinical trial for a potential coronavirus vaccine, its president told CNBC.
“We are now entering phase three, which is going to start very, very soon,” Pankaj Patel told CNBC’s “Street Signs Asia” on Tuesday.
He said the test will involve about 30,000 volunteers and will take about three to three and a half months to complete.
The pharmaceutical company, which is also known as Zydus Cadila, said on Sunday that it received approval from the Indian drug regulator to start phase three of the clinical trial after previous studies found that its candidate DNA vaccine is “safe, well tolerated. and immunogenic “.
“We saw that the antibody response has been very, very good, in the range of 20 to 80 times the increase in antibodies occurred after the vaccine was administered,” said Patel, adding studies so far indicated that the volunteers responded well to the vaccine. “We have also seen good virus neutralization with this and have not seen any side effects that are of concern.”
“Overall, we have very good results and we believe that phase three should really show us the exact effectiveness of the vaccine,” said Patel. The Cadila candidate is likely to become the second Covid-19 vaccine developed domestically in India if she receives regulatory approval after her phase three trial.
A ground crew passes through a container held at Cargo Terminal 2 at Indira Gandhi International Airport, which according to officials will be used as a COVID-19 vaccine handling and distribution center in New Delhi, India, on 22 December 2020.
Anushree Fadnavis | Reuters
Unlike some of the other Covid-19 vaccines, which require super-cold storage temperatures, Patel said the Cadila candidate can be kept stable at room temperature. This would facilitate distribution to remote parts of India.
Patel explained that the company already has a distribution system available in India and that it has invested in expanding its manufacturing capacity. He added that the company is also in advanced negotiations with several other countries to supply the potential vaccine as soon as it is ready, but declined to name the nations.
The largest country in South Asia currently has more than 10.35 million reported cases of coronavirus infection, second only to the United States. There are reports that just under 150,000 people died from Covid-19 in India, according to data from Johns Hopkins University. But official figures suggest that the number of cases of active infection is decreasing.
India’s drug regulator said on Sunday that it had approved the restricted use of two coronavirus vaccines in emergency situations. One is a vaccine developed by AstraZeneca and Oxford University, which is being produced locally by the Serum Institute of India. The other was developed locally by Bharat Biotech of India in collaboration with the state-run Indian Medical Research Council and has received emergency use authorization as clinical trials continue.