SINGAPORE – Indian pharmacist Cadila Healthcare is about to launch a phase three clinical trial for a possible coronavirus vaccine, its president told CNBC.
“Now we move on to the third phase, which will start 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 that it had received approval from India’s drug regulator to start the phase three clinical trial after previous studies found its vaccine candidate against DNA was “safe, well tolerated and immunogenic.”
“We have seen that the antibody response has been very, very good, in a range of 20 to 80 times greater in the antibodies that has occurred after the vaccine was given,” Patel said, adding studies so far indicating that volunteers responded well to the vaccine. “We’ve also seen good neutralization of the virus with this and we haven’t seen any side effects of concern.”
“Overall, we have very good results and we believe that phase three should show us the exact effectiveness of the vaccine,” Patel said. The Cadila candidate is likely to become the second nationally developed Covid-19 vaccine in India if it receives regulatory approval after its phase three trial.
A ground staff passes a container stored at cargo terminal 2 at Indira Gandhi International Airport, which officials say will be used as a COVID-19 vaccine distribution and handling center in New Delhi, India. , on December 22, 2020.
Anushree Fadnavis | Reuters
Unlike some of the other vaccines against Covid-19, which require very cold storage temperatures, Patel said Cadila’s candidate can stay stable at room temperature. This will facilitate distribution to remote areas of India.
Patel explained that the company already has a distribution system available in India and that it has invested in expanding its manufacturing capabilities. He added that the company is also in advanced talks with other countries to supply the potential vaccine once it is ready, but rejected the name of the nations.
Currently, the largest country in South Asia has more than 10.35 million cases of coronavirus infection, according to the United States alone. According to data from Johns Hopkins University, just under 150,000 people are said to have died due to Covid-19 in India. But official figures suggest the number of active infection cases is declining.
India’s drug regulator said Sunday it approved the restricted use of two coronavirus vaccines in emergency situations. One of them is a vaccine developed by AstraZeneca and Oxford University, which is produced locally by the Serum Institute of India. The other was developed locally by India’s Bharat Biotech in collaboration with the State Medical Research Council of India and was granted emergency use authorization while clinical trials continue.