When will ZyCov-D vaccine be available for children under 12? Company’s MD hopes to start trials ‘very soon’

“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," Zydus Group MD Dr Sharvil Patel said.

The Zydus Group on Saturday said that the company would soon apply to the Indian drug regulator for their approval to conduct trials of ZyCoV-D on children above 2 years of age. The announcement came a day after the Drugs Controller General of India (DCGI) approved the drug for emergency use authorisation against Covid-19 for children and adults above 12 years of age.

ZyCov-D became the sixth vaccine to be approved in India. (Representational image)

“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,” news agency ANI quoted Dr Sharvil Patel, managing director of the Zydus Group, as saying on Saturday evening.

ZyCov-D became the sixth vaccine to be approved in India. The medicine is “the world’s first and India’s indigenously developed DNA-based vaccine for Covid-19 to be administered in humans including children and adults 12 years and above,” news agency PTI quoted the government’s Department of Biotechnology as saying.

While the approval of the vaccine came as a shot in the arm to the country’s immunisation programme against the disease, its phase 3 trials data is yet to be published by the company.

Dr Patel said that the company might take another four or five months to publish the results fully. “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,” ANI quoted him as saying.

When asked about the trials conducted so far on adults, 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,” ANI further reported.

Further, he also said that no severe side effects were observed in the 12 to 18 age group. “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,” Dr Patel said.

So far, more than 57 million doses (576,117,350 to be exact) have been administered under the country’s vaccination drive, the Union ministry of health and family welfare’s dashboard showed.