COVID-19 vaccine trials for ages 3-12 soon: Zydus Cadila MD
After receiving emergency use approval for its COVID-19 vaccine, Zydus Cadila will now submit an application to start vaccine trials for children aged 3-12 years, Managing Director Dr. Sharvil Patel said Saturday. Known as ZyCoV-D, the three-shot vaccine is the world's first plasmid DNA-based COVID-19 vaccine that is applied using a needle-free system. Notably, ZyCoV-D is the second approved COVID-19 vaccine made in India.
Dr. Patil informed India Today that Zydus Cadila is planning for trials in the 3-12 age group. ZyCoV-D is already set to be India's first COVID-19 vaccine for those aged 12-18 years. Explaining that vaccines are first approved in older populations, Dr. Patil said, "We will now file for a trial in children of the age group of 3-12 in the next 7-10 days."
Zydus Cadila is also planning for a two-shot vaccine, Dr. Patil said, adding that it has already completed immunogenicity trials for the same. "We have seen comparable and sometimes significantly better immunogenicity in the double shot vaccine. So, we are in discussion with regulators and SEC to see how we can build a two-dose vaccine in the future," Dr. Patil told India Today.
On the efficacy of the vaccine against the Delta variant, Dr. Patil explained their trial was done at the peak of the second wave in April, May, and June. He said a "sero-surveillance" had found that a majority of positive cases they witnessed during the trial were Delta variants. "So, when we came out with 66% efficacy, that is definitely against the Delta variant."
Zydus Cadila's vaccine is being developed in partnership with the Department of Biotechnology and the Indian Council of Medical Research (ICMR). The second and third doses are required to be given 28 and 56 days after the first, respectively. It is India's first intra-dermal (between skin and muscles) vaccine administered through a specialized needle-free injector. Other COVID-19 vaccines approved in India are administered intramuscularly.
According to Dr. Patil, the vaccine will be rolled out in mid to late September. However, doses will be available in larger quantities only from the middle of October. Meanwhile, the price of the vaccine has not been finalized yet.