ZyCoV-D, a three-dose Covid-19 vaccine by Ahmedabad-based pharmaceutical firm Cadila Healthcare (Zydus Cadila), was on Friday received approval for Emergency Use Authorisation from the Drug Controller General of India (DCGI) and it will be administered to people 12 years and above.
Hours before, the Indian drug regulator’s subject expert committee (SEC) had given recommendation for its emergency use approval in the country.
The government’s Department of Biotechnology (DBT) said that 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. “Zydus Cadila has received approval for Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D today i.e. 20/08/2021, the world’s first and India’s indigenously developed DNA-based vaccine for COVID-19 to be administered in humans including children and adults 12 years and above,” it said.
According to reports, the drug regulator has asked Zydus to submit additional data for the two-dose regimen of its vaccine against coronavirus infection.
Zydus Cadila’s vaccine has become the second homegrown jab to get emergency authorisation in India after Hyderabad-based Bharat Biotech’s Covaxin.
Zydus Cadila had earlier said that they can launch their three-dose plasmid DNA Covid-19 vaccine within two months of receiving the approval.
Here’s all you need to know about ZyCoV-D vaccine:
• ZyCov-D becomes the world’s first plasmid DNA vaccine for human use against SARS-CoV-2 infection.
• Unlike most other coronavirus vaccines, which need two doses for full immunity, ZyCoV-D is administered in three doses.
• Zydus claims that its vaccine is 66.6 per cent effective against symptomatic coronavirus cases and 100 per cent for moderate Covid-19. It also said the vaccine is safe for children between 12 and 18 years of age.
• The firm had applied for the authorisation of the vaccine ZyCoV-D on July 1, based on an efficacy rate of 66.6% in a late-stage trial of more than 28,000 volunteers nationwide.
• ZyCov-D, which is being developed in partnership with the Department of Biotechnology and the Indian Council of Medical Research (ICMR), can be stored at 2-8 degrees Celsius and at 25 degrees Celsius for up to three months.
• It will be an intra-dermal (between skin and muscles) vaccine administered through a specialised needle-free injector. The currently licensed coronavirus vaccines are administered intra-muscularly.
• ZyCoV-D is India’s first DNA plasmid vaccine which was developed at Ahmedabad’s Vaccine Technology Center.
• According to a media report, Zydus Group chairman Pankaj R Patel had in December 2020 said that the first two phases of the trial showed that the vaccine was “safe and immunogenic”.
What is a DNA plasmid vaccine?
As per a report published in Business Standard, DNA plasmid is a relatively new vaccine technology and is also considered cost-effective for scaling up. Cells have DNAs in their chromosomes and also outside the chromosomes in a form called plasmids. It works by injecting genetically engineered plasmids that trigger the body to produce antibodies and immune response to protect against the virus.
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