Bengaluru: India’s drug regulator on Friday approved Zydus Cadila’s three-dose COVID-19 DNA vaccine for emergency use in adults and children aged 12 years and above, bringing in the sixth vaccine authorized for use in the country.
The company said it plans to manufacture 100 million to 120 million doses of ZyCoV-D annually and has started to stockpile the vaccine.
The generic drugmaker, listed as Cadila Healthcare Ltd, applied for the authorization of ZyCoV-D on July 1, based on an efficacy rate of 66.6% in a late-stage trial of over 28,000 volunteers nationwide.
The shot, which Cadila claims works against newer virus strains, including the highly-infectious Delta variant, adds to the country's arsenal in fighting the virus.
Speed is the key to avert future waves
Covid has so far sickened more than 32.3 million in India and killed more than 433,049, especially during a devastating second wave a few months back. Speedier inoculations - known to reduce hospitalisation and deaths - are key to averting future virus waves in the densely-populated country.
The shot is "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," Cadila said in a statement. It also plans to seek approval for a two-dose regimen of the vaccine and make a 100-120 million doses annually.
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How does it work?
ZyCoV-D is the world’s first plasmid DNA vaccine against the coronavirus. It uses a section of genetic material from the virus that gives instructions as either DNA or RNA to make the specific protein that the immune system recognises and responds to.
Tokyo-based AnGes Inc. and the US’s Inovio Pharmaceuticals Inc. are among other companies working on DNA-based vaccines. No DNA vaccine has been widely used against any disease thus far, but they are more stable and easier to store than mRNA shots.
Home to the world’s biggest vaccine-producing industry, India till early this year was seen as a major supplier of vaccines to poorer nations around the world. But those plans went awry amid India’s deadly second wave, vaccine supply shortfalls and consequent export ban from the Indian government.
Zydus Cadila’s vaccine, developed in partnership with the Department of Biotechnology, is the second home-grown shot to get emergency authorisation in India after Bharat Biotech’s Covaxin.
The drugmaker said in July its COVID-19 vaccine was effective against the new coronavirus mutants, especially the Delta variant, and that the shot is administered using a needle-free applicator as opposed to traditional syringes.
How are new vaccines approved?
No vaccine gets into a country without some authorization by the national regulatory authority. Each country has a national regulatory authority, which may be guided by different regulations. The vast majority of them, however, follow internationally-agreed parameters, according to Dr Mariangela Simao, Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals at WHO.
Vaccines that completed Phase 3 clinical trials may be should be given an emergency-use approval, as it’s during Phase 3 trials that efficacy and safety data of vaccines are assessed.
The approving authority assesses the data on both efficacy and safety. But the job is not done yet. After this, in order to authorise at country level, there’s also the need to assess whether the vaccine was “well made”, or if it complied with “good manufacturing practices”, and quality control protocols.
After it comes into the country, it's also monitored for any potential side effects — anything that relates to additional information that didn't come through clinical trials. So by the time it's authorised the country level, a vaccine has gone through a lot of scrutiny.
What are the other vaccines in the making?
There's a whole new batch of vaccines being developed against COVID. We counted at least 32, with more in the pipeline. These vaccines go through rigorous approval process, to ensure they are both safe and effective. The authorised COVID-19 shots around the world are all designed to stimulate your immune system to produce virus-fighting antibodies.
