MD Zydus Cadila After getting the DCGI permission for the emergency use authorisation (EUA) for its three-dose ZyCoV-D vaccine, Dr Sharvil Patel announced on Saturday that his company will apply for Covid-19 vaccine studies in children aged 3 to 12.
The ZyCoV-D vaccine, which is the only needle-free Covid vaccine in the world, will also be available for children above the age of 12.
In an interview with India Today’s Sneha Mordani, the Zydus Cadila MD shared the company’s plan for trials in children of age group 3-12. Dr Sharvil Patel also talked about a potential two-shot vaccine from Zydus Cadila.
Q. When will the vaccine be available?
It is a matter of pride for us to get an emergency use authorisation for a vaccine for children. The vaccine roll-out is likely to start by mid or end of September. But in larger quantities, it will begin in the middle of October.
Q. What are your future plans? You have been asked by regulators to provide more data about a double-dose vaccine.
We have done immunogenicity trials for the two-dose vaccine as well which is given on day zero and day 28. Also, we have seen comparable and sometimes significantly better immunogenicity in the double shot vaccine. So we are in discussion with regulators and SECC to see how we can build a two-dose vaccine in the future. We will also at the same time start building for trials in children between the age of three and 12.
Q. When will that happen?
The whole vaccine development journey starts in the way that you try it in the adults first then in the age group of adolescents and then go to the children. As we finished the safety efficacy on this, we will now file for a trial in children of age group of 3-12 in the next 7-10 days
Q. What will be the side effects of this vaccine?
Trials were conducted in 50 centres in the country. Overall, the trials on 28,000 volunteers were conducted. We’ve done the trials on 1400 adolescents of 12-18 yrs. In all the trials, we’ve not seen any severe side effects related to the vaccine.
Q. mRNA-based vaccines have reduced efficacy against the Delta variant which is the most predominant variant in the world right now. What is the efficacy this vaccine is showing against the Delta variant?
Our trial was done at the peak of the second wave. All the positive cases that we saw during the trial were in the period of April, May and June. We did a sero-surveillance of the majority of these positive cases and all of them were found to be Delta variants.
So when we came out with the efficacy of 66 per cent that is definitely against the Delta variant because all our vaccine results came out during the period of April, May and June.
