Zydus Cadila applies for EUA for covid-19 vaccine ZyCoV-D
Premium- The company expects to produce 1 crore vaccine doses per month from August after regulatory approvals
Ahmadabad based pharmaceutical firm Zydus Cadila has applied for Emergency Use Authorization (EUA) for ZyCoV-D - its Plasmid DNA Vaccine against covid-19 to the Drug Controller General of India (DCGI), the company announced on Thursday. The company said that it is expecting to produce one crore vaccine doses per month from August after regulatory approvals and manufacturing scale up. If approved, the drugmaker further said, it is ready to roll out the world's first Plasmid DNA shot in 45-60 days.
“Our target is to produce 10-12 crore vaccine doses in a year. We can start from mid-August to have a run rate of around 1 crore 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," Dr Sharvil Patel, Managing Director, Cadila Healthcare Ltd said in a virtual press conference.
When approved, ZyCoV-D will be the India’s second indigenously-developed covid-19 vaccine after Bharat Biotech’s Covaxin. Also, ZyCoV-D will also be the fifth vaccine receiving EUA in India after Covishield, Covaxin, Sputnik V and Moderna’s mRNA-1273 vaccine.
Zydus Cadila has so far invested approximately ₹400 crore to ₹500 crore for the development of the its covid-19 jab. The company said that it is not looking at exports in the near-term as it does not have sufficient quantities to supply to other countries. While the company is focussing on providing the shots to India only, the price of the vaccine remains undisclosed. “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," said Patel.
The drugmaker said that is it waiting for the drug regulator’s approval and has submitted all the required data to the authorities. In the interim analysis, Zydus Cadila said, the primary efficacy of its jab 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 disease 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 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 1000 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.
MINT PREMIUM
See All
“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," Patel 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.
“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 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.
Never miss a story! Stay connected and informed with Mint. Download our App Now!!