India has approved Zydus Cadila’s First Covid-19 vaccine for children
Zydus Cadila’s ZyCoV-D Covid-19 vaccine is the world’s first plasmid DNA vaccine against the coronavirus.
Indian drug regulator DCGI 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.
India has now approved its first vaccine for children, a timely move amid warnings of an upcoming third wave in the country, which some experts have warned could be deadlier towards children. While the Union Health Ministry has refuted that the next wave of the pandemic would prove more serious to the ‘vulnerable and unvaccinated’ population comprising children, it has, at the same time, augmented pediatric services across the nation as a preventive measure.
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 drug maker, 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.
“Interim results from Phase-III Clinical Trials, in over 28,000 volunteers, showed primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases,” said a government release, adding that 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 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),” it said.
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 recognizes and responds to.
Zydus Cadila’s vaccine, developed in partnership with the Department of Biotechnology, is the second home-grown shot to get emergency authorization in India after Bharat Biotech’s Covaxin.
The drug maker 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.
Earlier today, the Indian drug regulator’s subject expert committee had recommended emergency use approval for the vaccine. The committee had added that Zydus needs to submit additional data for the 2-dose regimen of its vaccine.
Covishield, Covaxin and Sputnik V vaccines are being given to only those above 18 years and unlike ZyCoV-D, which is three-dose, these are administered in two doses.
The Department of Biotechnology (DBT) has said that ZyCoV-D is the world’s first DNA-based vaccine against the coronavirus and when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from the disease as well as viral clearance.
The vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive phase one and two clinical trials. Both Phase one/two and Phase three clinical trials have been monitored by an independent data safety monitoring board, it added.
The Union government is expecting Zydus Cadila’s needle-free COVID-19 vaccine ZyCoV-D to be available from the first week of October in India.