Post DCGI nod, Zydus Cadila to start COVID vaccine trial on children aged 3-12 yrs
ZyCoV-D is a three-dose, needle-free vaccine, and is also the world's first plasmid DNA-based medicine. Developed in partnership with the Department of Biotechnology, it is India's second locally developed vaccine to receive EUA after Bharat Biotech's Covaxin
- Aug 22, 2021,
- Updated Aug 22, 2021 10:39 AM IST
Zydus Cadila MD Dr Sharvil Patel said on Saturday that his company is set to apply for the trial of its COVID-19 vaccine ZyCoV-D on children aged 3-12 years. The announcement came a day after the vaccine received the Drugs Controller General of India's (DCGI) approval for emergency use authorisation (EUA) for its three-dose vaccine, becoming the first jab to be approved for children in the 12-18 age group in India.
ZyCoV-D is a three-dose, needle-free vaccine, and is also the world's first plasmid DNA-based medicine. Developed in partnership with the Department of Biotechnology, it is India's second locally developed vaccine to receive EUA after Bharat Biotech's Covaxin.
In an interview with India Today, the Zydus Cadila MD shared details of the company's plan to conduct trials for children in the 3-12 years age group. He also spoke about a potential double-shot vaccine from Zydus Cadila.
"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," said Dr Patel.
"We will now file for a trial in children of age group of 3-12 in the next 7-10 days," he added.
When asked about the availability of the vaccine, he said that the vaccine roll-out is likely to start by mid or end of September. Roll-out in larger quantities, however, will begin in the middle of October.
Patel further stated that no severe side effects related to the vaccine were observed. "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," he said.
Further, when asked about the efficacy of the vaccine against the Delta variant, he said it is at about 66%.
"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," Patel mentioned.
ZyCoV-D is the sixth vaccine to get EUA approval in India after Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, Russian vaccine Sputnik V and the vaccines of Moderna and Johnson and Johnson. Of these, Covishield, Covaxin and Sputnik V are currently in use in India.
These vaccines are being given to only those above 18 years of age and unlike ZyCoV-D, which has three doses, these are administered in two doses.
Also Read: 58 crore Covid vaccine doses administered in India: Govt
Also Read: ZyCov-D vaccine will hit markets soon: Union Health Minister
Zydus Cadila MD Dr Sharvil Patel said on Saturday that his company is set to apply for the trial of its COVID-19 vaccine ZyCoV-D on children aged 3-12 years. The announcement came a day after the vaccine received the Drugs Controller General of India's (DCGI) approval for emergency use authorisation (EUA) for its three-dose vaccine, becoming the first jab to be approved for children in the 12-18 age group in India.
ZyCoV-D is a three-dose, needle-free vaccine, and is also the world's first plasmid DNA-based medicine. Developed in partnership with the Department of Biotechnology, it is India's second locally developed vaccine to receive EUA after Bharat Biotech's Covaxin.
In an interview with India Today, the Zydus Cadila MD shared details of the company's plan to conduct trials for children in the 3-12 years age group. He also spoke about a potential double-shot vaccine from Zydus Cadila.
"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," said Dr Patel.
"We will now file for a trial in children of age group of 3-12 in the next 7-10 days," he added.
When asked about the availability of the vaccine, he said that the vaccine roll-out is likely to start by mid or end of September. Roll-out in larger quantities, however, will begin in the middle of October.
Patel further stated that no severe side effects related to the vaccine were observed. "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," he said.
Further, when asked about the efficacy of the vaccine against the Delta variant, he said it is at about 66%.
"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," Patel mentioned.
ZyCoV-D is the sixth vaccine to get EUA approval in India after Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, Russian vaccine Sputnik V and the vaccines of Moderna and Johnson and Johnson. Of these, Covishield, Covaxin and Sputnik V are currently in use in India.
These vaccines are being given to only those above 18 years of age and unlike ZyCoV-D, which has three doses, these are administered in two doses.
Also Read: 58 crore Covid vaccine doses administered in India: Govt
Also Read: ZyCov-D vaccine will hit markets soon: Union Health Minister