New Delhi: Zydus Group Director Dr Sharvil Patel on Saturday said that his company will immediately apply to the Approval of the Indian drug regulator to conduct Zycov-D trials in children over 2 years and add that it will take 4-5 months again publish data phase 3 from covid vaccine.
Ahmedabad-based pharmaceutical company based on Ahmedabad has received approval from the Control of Medicine General India (DCGI) for Zycov-D, the first DNA-based vaccine and India developed illegally for Covid-19 which will be given to humans including adults and children 12 years and above.
However, pharmaceutical companies have not issued phase test data 3.
“So, full phase data 3 will show not only the efficacy of vaccines but also the details of the safety and long-term immunogenicity which is at least followed up for the next 3-6 months.
So, for the full report Will be published.
In the peer-reviewed journal, it will take at least four to five months, “said Dr.
Patel Ani.
Asked about the trials carried out in adolescents, he said, “the trial has been carried out at 50 centers throughout the country.
I did not realize the center for only children.
Overall the trial at 28,000 volunteers has been carried out at 50 central.
We have conducted a trial At 1,400 children in the age group 12-18 years.
“The Implementing Director of Zydus Group said that the company did not find severe side effects related to its vaccine in the age group of 12-18 years and adults.
“In the age group of 12-18 years and adults, we have not seen severe side effects related to vaccines.
We have not seen deaths related to vaccines.
We have seen that vaccines and placebo which are not -Vacted have shown the same type of effect Related to the vaccine, “he said.
Asked when the trial in children between 2-12 years will begin, Dr.
Patel said, “In a younger age group, we haven’t started them.
We work now with regulators to work on the program to study for a younger age group Also.
We will file a trial in one or two weeks to start the trial.
But we hope we can test them immediately.
“Responding to questions about the cost of Zycov-D vaccine, he said,” We don’t have a discussion (at price) with Vaccine task force or with the center.
So, once we can do that discussion, we will tell everyone.
“Next, Dr.
Patel explained about getting other producers to increase vaccine production.
“We have spoken with several CMOs that have the potential to make vaccines but they do not have a very large capacity but will use it for some additional capacity.
We also experienced an ongoing discussion outside India where the company with a large capacity on the DNA platform was able to make it and We have a discussion now.
“” So, we hope that we can achieve the target of producing a dose of 4-5 crores at the end of January, “he added.
It will take another 4-5 months to publish the Phase 3 trial data from the Zycov-D vaccine, said Zydus Group MD
