SINGAPORE – Indian drug maker Cadila Healthcare is about to start a Phase 3 clinical trial for a potential coronavirus vaccine, its chairman told CNBC.
“We are now entering the third phase, which will begin very, very soon,” Pankaj Patel told CNBC’s “Street Signs Asia” on Tuesday.
He said the process will involve around 30,000 volunteers and take around three to three and a half months.
The pharmaceutical company, also known as Zydus Cadila, announced on Sunday that it had received approval from India’s Medicines Agency to begin its Phase 3 clinical trial after previous studies found its DNA vaccine candidate was “safe, well tolerated and immunogenic “.
“We saw that the antibody response was very, very good, in the range of 20 to 80-fold increases in antibodies after the vaccine was given,” said Patel, adding studies that so far indicated that the volunteers the vaccine responded well to it. “We also saw good virus neutralization with it and we didn’t see any side effects to be concerned about.”
“Overall, we have had very good results and we believe that phase three should actually show us the exact effectiveness of the vaccine,” said Patel. Cadila’s candidate will likely become India’s second domestically developed Covid-19 vaccine when it receives regulatory approval following its phase three study.
Ground staff walk past a container that is being held at Freight Terminal 2 at Indira Gandhi International Airport and will be used as a COVID-19 center for vaccine handling and distribution on December 22, 2020 in New Delhi, India, according to officials becomes.
Anushree Fadnavis | Reuters
Unlike some other Covid-19 vaccines that require extremely cold storage temperatures, Cadila’s candidate can be kept stable at room temperature, according to Patel. That would make it easier to distribute to remote parts of India.
Patel stated that the company already has a distribution system in India and has invested in expanding its manufacturing capacity. He added that the company is also in advanced talks with several other countries to deliver the potential vaccine once it’s ready, but declined to name the nations.
South Asia’s largest country currently has more than 10.35 million reported cases of coronavirus infection, second only to the US. According to the Johns Hopkins University, almost 150,000 people in India are said to have died of Covid-19. However, official figures suggest that the number of cases of active infections is decreasing.
The Indian Medicines Agency on Sunday approved the restricted use of two coronavirus vaccines in emergency situations. One of them is a vaccine developed by AstraZeneca and Oxford University and made locally by the Serum Institute of India. The other was developed by India’s Bharat Biotech in collaboration with the Indian State Council for Local Medical Research and received emergency approval if clinical trials continue.