New Delhi [India]: Managing Director of Zydus Group Dr Sharvil Patel on Saturday said that his firm will soon apply for the Indian drug regulator’s approval to conduct trials of ZyCoV-D on children above 2 years and added that it will take another 4-5 months to publish the phase 3 data of the Covid vaccine. 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 which will be administered in humans including adults and children 12 years and above. However, the pharma company has not published phase 3 data of trials yet. “So, the full phase 3 data will show not only the efficacy of the vaccine but also the safety and long-term immunogenicity details which is at least followed up for the next 3-6 months. So, for the full report to be published in a peer-reviewed journal, it will take at least four to five months,” Dr Patel told ANI. Asked about trials conducted on adolescents, he said, “Trials have been conducted at 50 centres across the country. I am not aware of centres for only children. 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.” The Managing Director of Zydus Group said that the firm did not found any severe side effects related to its vaccine in the 12-18 years age group and adults. “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 said. Asked when the trials on children between 2-12 years will commence, Dr Patel said, “In the younger age group, we have not started them yet. We are working now with the regulators to work on a program to do a study for the younger age group as well. We will be applying for trials in one-two week to start the trials. But we hope that we can conduct trials on them very soon.” 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.” Further, Dr Patel explained about getting other manufacturers to scale up the vaccine production. “We have spoken to a few CMOs who potentially can make the vaccine but they don’t have very large capacities but will use them for some additional capacity. We are also having discussions that are ongoing outside India where companies with large capacities on DNA platform are able to make it and we are having discussions right now.” “So, we are hopeful that we can achieve a target of producing 4-5 crores doses by the end of January,” he added.
