Zydus Cadila plans to start testing the vaccine on children above 5 years soon
Ahmedabad-based pharma major Cadila Healthcare (Zydus Cadila) is planning to start clinical trials for its DNA-plasmid technology-based COVID-19 vaccine soon on children aged 5 years and above, a senior the officer claimed.
Meanwhile, the company is awaiting approval from the Drug Controller General of India (DCGI) for its vaccine ZyCoV-D. It has sought approval for use in children over the age of 12, and has already submitted safety and tolerability data from Phase 2 clinical trials and 1,000 adolescents (12 to 18 years of age) from its Phase 3 trials. middle) has also prepared data. The 1,000-volunteer data will be submitted to the regulator soon.
Zydus Cadila Managing Director Sharvil Patel said, “If the regulator permits, we are now planning to start testing on children aged five years and above. No other vaccine has yet been approved globally for children under 12 years of age. India’s Bharat Biotech is now in the midst of conducting clinical trials for Covaxin on children above the age of 2 years.
If things go well, ZyCoV-D could be the first approved vaccine for teens. Zydus also claims that its vaccine works against the delta variant; As trials conducted in more than 50 clinical sites spread across the country and during the peak of the second wave of COVID-19 have shown the efficacy of the vaccine against new mutant strains, especially the delta variant.
Currently, DCGI and its expert committee are reviewing data submitted by Zydus from a Phase 3 efficacy trial of 28,000 people. According to sources, the Subject Expert Committee (SEC) may review ZyCoV-D this week. So far, regulators and experts are studying the data collected.
ZyCoV-D has shown 66.6 percent efficacy in an interim analysis of Phase 3 trials, and can be stored at 25°C for three months. It is a three-dose vaccine given on day zero, day 28 and day 56.
No common cases of COVID-19 disease were observed in post-administration of the third dose vaccine, suggesting 100 percent efficacy for moderate disease. The company claimed that there have been no serious cases or deaths due to COVID-19 in the vaccine arm after the administration of the second dose of the vaccine.
Meanwhile, Zydus also presented immunogenicity data from a two-dose regimen (using the 3 mg dose) trial to DCGI, which showed ‘equivalent immunogenicity’ with the three-dose regimen. So Patel expects the approval of the two-dose regimen to be a ‘good discussion point’ with the regulator.
Conventional active vaccines are made from a killed or weakened form of the infectious agent. DNA plasmid vaccine is a relatively new approach where a piece of DNA containing the gene for the antigen is injected. The body then learns to develop an immune response against the antigen, and when the actual pathogen attacks, the body is able to generate specific antibodies against it.
Zydus claims that DNA vaccines have been shown to stimulate a sustained immune response.
The ZyCoV-D efficacy is in the range of Johnson & Johnson’s single dose vaccine which is able to prevent Covid19 disease using the human adenovirus vector Ad26 – 66.3 percent efficacy.
For the Oxford-AstraZeneca vaccine, the WHO notes on its website, “The AZD1222 vaccine against COVID-19 has an efficacy of 63.09 percent against symptomatic SARS-CoV-2 infection.” Bharat Biotech’s Covaxin has shown 77.6 percent efficacy against symptomatic COVID disease from an interim analysis of Phase 3 trials, while Russia’s Sputnik V has shown 97.8 percent efficacy against severe COVID disease in a recent 81,000 subject trial in the UAE .