The company further said that the vaccine is also safe and very well tolerated in the adolescent population in the 12-18 years age group.
Ahmadabad-based pharmaceutical firm Zydus Cadila has applied for Emergency Use Authorization (EUA) for its three dose ZyCoV-D - its Plasmid DNA Vaccine against covid-19 to the Drug Controller General of India (DCGI), the company announced on Thursday.
In the interim analysis, the pharmaceutical company said, the primary efficacy of the vaccine is 66.6% for symptomatic RT-PCR positive cases. The company further said that the vaccine is also “safe and very well tolerated" in the adolescent population in the 12-18 years age group.
“No moderate case of covid-19 was observed in the vaccine arm post administration of the third dose suggesting 100% efficacy for moderate disease. No severe cases or deaths due to covid-19 occurred in the vaccine arm after administration the second dose of the vaccine," the company said in a statement.
“ZyCoV-D had already exhibited a robust immunogenicity and tolerability and safety profile in the adaptive phase I/II clinical trials carried out earlier. Both the phase I/II and phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB)," the company said, adding that the plug and play technology on which the plasmid DNA platform is based on is ideally suited for dealing with covid-19 as it can be easily adapted to deal with mutations in the virus, such as those already occurring.
Zydus Cadila claimed to have conducted the largest clinical trial for its covid-19 vaccine in India so far in over 50 centers. This was also the first time that any covid-19 vaccine has been tested in adolescent population in the 12-18 years age group in India, the company said in a statement.
Around 1,000 subjects were enrolled in this age group and the vaccine was found to be safe and very well tolerated. The tolerability profile was similar to that seen in the adult population, the company said.
“As the first ever plasmid DNA vaccine for human use, ZyCoV-D has proven its safety and efficacy profile in our fight against covid-19. The vaccine, when approved, will help not only adults but also adolescents in the 12 to 18 years age group," Dr Sharvil Patel, managing director, Cadila Healthcare Ltd said.
In another development, the company has also evaluated a two-dose regimen for ZyCoV-D vaccine using a 3 mg dose per visit and the immunogenicity results had been found to be equivalent to the current three dose regimen. This will further help in reducing the full course duration of vaccination while maintaining the high safety profile of the vaccine in the future.
ZyCoV-D is a plasmid DNA vaccine which when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response mediated by the cellular and humoral arms of the human immune system, which play a vital role in protection from disease as well as viral clearance. Zydus acknowledged the support of National Biopharma Mission, BIRAC, Department of Biotechnology, government of India, National Institute of Virology, Indian Council of Medical Research and PharmaJet in the development of ZyCoV-D vaccine.