Zydus covid-19 vaccine to be launched by September
- Zydus is working closely with the Indian regulatory authorities on the pricing of the vaccine, which is likely to be announced in a week or two
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NEW DELHI: Indian pharmaceutical company Zydus Cadila on Saturday indicated that it will launch its three-shot covid-19 vaccine ZyCov-D by September. The statement comes a day after the vaccine received emergency use authorisation (EUA) from the Drug Controller General of India (DCGI).
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“We plan to supply about 30 lakh to 40 lakh doses of ZyCov-D vaccine by September and aim to scale up the supply to 3 crore to 4 crore by December," said Dr Sharvil Patel, managing director, Zydus Cadila.
The company said that it is working closely with the Indian regulatory authorities on the pricing of the vaccine, which is likely to be announced in a week or two. "Pricing will depend on technology, delivery and volumes, and also we have a benchmark pricing," Patel said.
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Zydus will supply the vaccine to the government as well as the private sector. Around 50 lakh doses have been stocked at their facilities. They will go through testing and various clearances before starting the supply. The company is having discussions with potential partners for scaling up the production in the coming months.
"The company is working with partners and we have requests from overseas for transfer of technology," Patel said.
ZyCoV-D is the world’s first plasmid DNA vaccine. It is a three-dose vaccine to be administered first on day zero, day 28th and then on the 56th day.
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India now has its first covid-19 vaccine for adolescents in the 12-18 age group, besides the adult population. ZyCoV-D is a needle-free vaccine administered using PharmaJet, a needle-free applicator, which ensures painless intradermal vaccine delivery. The company also plans to seek approval for the two-dose regimen of the vaccine.
Developed in partnership with the Department of Biotechnology, Government of India and implemented by Biotechnology Industry Research Assistance Council (BIRAC), ZyCoV-D has been supported under covid-19 Research Consortia through National Biopharma Mission for Preclinical studies, Phase-1 and Phase-2 clinical trials and under the Mission Covid Suraksha for Phase-3 clinical trial.
When injected, the vaccine produces spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from disease as well as viral clearance. The plug-and-play technology on which the plasmid DNA platform is based can be easily adapted to deal with mutations in the virus, such as those already occurring.
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Interim results from Phase-3 trials, in over 28,000 volunteers, showed primary efficacy of 66.6% for symptomatic RT-PCR positive cases. This has been the largest vaccine trial so far in India for covid-19. This vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase-1 & -2 clinical trials carried out earlier. Both the Phase-1, -2 and Phase-3 clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB).
The final clinical trial data will be available in three to six months.
“The efficacy of the vaccine in adolescents was found similar to adults. Since our trials began April and May onwards, and Delta variant dominated most covid cases, the vaccine shows efficacy against this variant," said Patel adding that the few breakthrough infections we recorded were of delta variant.
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“Major raw material and applicator for the vaccine have been imported from the United States of America and Singapore," said Patel.
Zydus has the capacity to manufacture 10-12 crore doses of ZyCoV-D per year.
Appreciating the move, in response to a tweet by CDSCO India Info, Prime Minister Narendra Modi said, "India is fighting Covid-19 with full vigour. The approval for world’s first DNA based ‘ZyCov-D’ vaccine of @ZydusUniverse is a testimony to the innovative zeal of India’s scientists. A momentous feat indeed."
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