SINGAPORE – Indian drug company Cadila Healthcare is about to initiate a phase three clinical trial for a possible coronavirus vaccine, the chairman told CNBC.
“We’re now moving into phase three, which will begin very, very soon,” Pankaj Patel told CNBC’s “Street Signs Asia” on Tuesday.
He said the trial will involve about 30,000 volunteers and will take about three to three and a half months to complete.
The pharmaceutical company, also known as Zydus Cadila, said on Sunday it had received approval from the Indian drug regulator to start the phase three clinical trial after previous studies found its DNA vaccine candidate to be “safe, well-tolerated and immunogenic. is.
“We saw that the antibody response was very, very good, in the range of a 20- to 80-fold increase in antibodies after administration of the vaccine,” said Patel, and adding studies to date showed that volunteers responded well. on the vaccine. “We have also seen good virus neutralization with this and we have not seen any side effects that are of concern.”
“Overall, we have very good results and we believe that Phase Three should show us the exact efficacy of the vaccine,” said Patel. Cadila’s candidate is likely to become India’s second domestically developed Covid-19 vaccine if it receives regulatory approval after the phase three study.
A ground crew walks past a container held at Indira Gandhi International Airport’s Cargo Terminal 2, which officials say will be used as a COVID-19 vaccine handling and distribution center in New Delhi, India, on December 22, 2020.
Anushree Fadnavis | Reuters
Unlike some of the other Covid-19 vaccines, which require super-cold storage temperatures, Patel said Cadila’s candidate can be kept stable at room temperature. That would facilitate distribution to remote parts of India.
Patel explained that the company already has a distribution system in India and that it has invested in expanding its manufacturing capabilities. He added that the company is also in advanced talks with several other countries to supply the potential vaccine as soon as it is ready, but declined to name the countries.
South Asia’s largest country currently has more than 10.35 million cases of coronavirus infection, second only to the United States. According to data from Johns Hopkins University, just under 150,000 people have died of Covid-19 in India. But official figures suggest the number of active contamination cases is declining.
The Indian drug regulator said on Sunday it has approved limited use of two coronavirus vaccines in emergencies. One of these is a vaccine developed by AstraZeneca and Oxford University and made locally by the Serum Institute of India. The other was developed locally by India’s Bharat Biotech in conjunction with the state-run Indian Medical Research Council and received emergency use approval as clinical trials continue.