SINGAPORE – Indian drugmaker Cadila Healthcare is about to launch a Phase Three clinical trial for a possible coronavirus vaccine, its chairman told CNBC.
“We are now moving on to phase three, which will start very soon,” Pankaj Patel told CNBC’s “Street Signs Asia” on Tuesday.
He said the trial will involve about 30,000 volunteers and it will take about three to three and a half months.
The pharmaceutical company, also known as Zydus Cadila, said on Sunday that it had received approval from India’s medical regulator to begin phase three clinical trials after earlier studies found that the candidate for DNA vaccine was ‘safe’. is ‘well tolerated and immunogenic’.
“We saw that the antibody response was very, very good, between 20 and 80-fold increase in antibodies occurred after the vaccine was given,” Patel said. Studies have so far been added that volunteers respond well to the vaccine. “We have also seen good virus neutralization with this and we have not seen any side effect that is of concern.”
“Overall, we have very good results and we believe that phase three should actually show us the exact efficacy of the vaccine,” Patel said. Cadila’s candidate is likely to become the second locally developed Covid-19 vaccine if it receives approval after the phase three trial.
Ground staff walk past a container held at Cargo Terminal 2 of Indira Gandhi International Airport, which officials say will be used as a COVID-19 vaccine handling and distribution center in New Delhi, India, on December 22, 2020. word.
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. This will make it easier to spread 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 firm is also in advanced talks with several other countries to provide the possible vaccine once it is ready, but refuses to name the countries.
The largest country in South Asia currently has more than 10.35 million cases of coronavirus infection, which is the second in the United States. According to Johns Hopkins University, just under 150,000 people have died in Covid-19 in India, according to Johns Hopkins University. But official figures suggest that the number of active cases of infection is declining.
India’s medical regulator said on Sunday it approved the limited use of two coronavirus vaccines in emergencies. One of them is a vaccine developed by AstraZeneca and Oxford University, made locally by the Serum Institute of India. The other was developed locally by the Indian Bharat Biotech in collaboration with the state-run Indian Medical Research Council and has obtained emergency clearance while clinical trials continue.