BackZydus Cadila jab shows 66.6% efficacy, seeks regulatory nod
Zydus Cadila said if the vaccine gets emergency use authorization from the DGCI, it could begin manufacturing in 45-60 days and scale production up to 10 million doses a month later
PremiumDrugmaker Zydus Cadila on Thursday applied for regulatory approval for ZyCoV-D, India’s second indigenously developed covid-19 vaccine after Bharat Biotech’s Covaxin.
Early analysis showed an efficacy of 66.6% for the three-dose vaccine, the Ahmedabad-based company said, adding it is “safe and very well tolerated" among 12-18-year-olds and works against the delta variant of SARS-CoV-2.
The company said if the vaccine gets emergency use authorization from the Drugs Controller General of India, it could begin manufacturing in 45-60 days and scale production up to 10 million doses a month later.
“Our target is to produce 100-120 million vaccine doses in a year. We can start from mid-August to have a run rate of around 10 million doses per month. A new facility to manufacture this vaccine will come up by the end of July, which will start producing ZyCoV-D at scale," managing director Sharvil Patel said in a virtual press conference.
ZyCoV-D is the world’s first plasmid DNA vaccine, which produces the SARS-CoV-2 virus’s spike protein in the body, triggering an immune response. If it gets emergency approval, ZyCoV-D will be India’s fifth vaccine in the fight against covid-19, after Covishield, Covaxin, Sputnik V and Moderna’s mRNA-1273 vaccine.
Zydus Cadila has invested ₹400-500 crore in developing its vaccine candidate. It is not looking at exports in the near term as it does not have sufficient quantities to supply other countries.
The company did not disclose the price of its vaccine. “We are only currently focusing our efforts on making sure we can make these doses available for India. It is too early to talk about pricing. We have not stockpiled any doses currently, and we will announce it before the commercial launch," Patel said.
The company said it submitted all the required data to the authorities.
“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 of the second dose of the vaccine," the company said in a statement.
Zydus Cadila claimed to have conducted the largest clinical trial for its covid-19 vaccine in India so far in more than 50 centres.
This was also the first time that any covid-19 vaccine had been tested in the 12-18 years age group in India, the company said.
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 12-18 years age group," Patel said.
The company has also evaluated a two-dose regimen for ZyCoV-D vaccine using a 3mg 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.
Zydus Cadila acknowledged the support of the National Biopharma Mission, Biotechnology Industry Research Assistance Council, the Department of Biotechnology, the National Institute of Virology, the Indian Council of Medical Research and PharmaJet in the development of ZyCoV-D.
“ZyCoV-D had already exhibited 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," the company said, adding that the plug-and-play technology on which the plasmid DNA platform is based 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.
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