Hope to start Covid vaccine trials for children aged 2-12 years very soon: Zydus Cadila MD
Zydus Cadila has received approval from the Drugs Controller General of India (DCGI) for ZyCOV-D, the world's first and India's indigenously developed DNA-based vaccine for Covid-19
Zydus Cadila will soon apply for the Indian drug regulator's approval to conduct trials of ZyCoV-D on children above 2 years, said Dr Sharvil Patel, the managing director of the company.
"We have not started studies for the younger age group (2-12 years). We are working with regulators to work on a program to do a study in the group. We are going to the regulator with the proposed trial in the next five to seven days. We hope to do trials very soon," Patel was quoted as saying by news agency ANI.
Speaking about the trials of ZyCOV-D on adolescents, he said that no severe side effects related to the vaccine were seen in the 12-18 years age group.
"Overall the trials on 28,000 volunteers have been conducted at 50 centres. We have conducted the trials on 1,400 children in the 12-18 years age group," said Patel.
"In the age group of 12-18 years and adults, we have not seen severe side effects related to the vaccine. We haven't seen any deaths related to the vaccine. We have seen that the vaccine and the placebo which is the non-vaccinated have shown the same kind of mild effects related to the vaccine," he added.
The Ahmedabad-based pharma company has received approval from the Drugs Controller General of India (DCGI) for ZyCOV-D, the world's first and India's indigenously developed DNA-based vaccine for Covid-19.
However, the phase 3 data of trials has not been published yet. As per Patel, it will take another 4-5 months to publish the phase 3 data of the vaccine.
"The full phase 3 data does not only show efficacy but also means safety and long-term immunogenicity, which is at least followed up for the next three to six months. So, for the full report to be published in a peer-reviewed journal, it will take at least four to five months," said the Zydus Group MD.
Responding to a question on the cost of ZyCoV-D vaccine, he said, "We have not had that discussion yet (on pricing) with the vaccine task force or with the Centre. So, once we are able to have that discussion, we will apprise everybody."
He said that there will be more clarity on the price of the vaccine next week.
"There will be more clarity about the price of the ZyCOV-D vaccine by next week," Patel said.
Asked about the mass supply of the vaccine, he said, "The supply of vaccine will begin by mid-September and from October onwards, the supply will be scaled up to one crore doses per month."
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