Govt panel gives nod to 3-dose Zydus vaccine
NEW DELHI: An expert panel of India’s central drug authority has recommended granting emergency use authorisation to Zydus Cadila’s three-dose coronavirus vaccine which had shown an efficacy of 66.6% in a late-stage trial, officials aware of the developments said.
The Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) deliberated on the application given by Zydus Cadila on Thursday and recommended granting emergency use authorisation (EUA) to its three-dose coronavirus vaccine, ZyCoV-D.
The recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval, which is likely to grant permission for use in the country.
The SEC, however, said that the Ahmedabad-based company needs to submit additional data for the 2-dose regimen of its vaccine, even as Zydus had told the drug regulator that two shots of its vaccine were almost equally effective against Covid-19.
If approved, ZyCoV-D will be the world’s first DNA vaccine against Covid-19, as it makes use of a portion of the genetic code DNA or RNA - in the Sars-CoV-2 virus to stimulate an immune response against its spike protein.
DNA vaccines differ from other approved Covid-19 shots, which are based on new mRNA
technology such as in those from Pfizer and Moderna, and established technology like viral vectors, as with AstraZeneca (manufactured as Covishield in India).
According to the pharma company, the three doses of ZyCoV-D are to be administered on day 0, day 28, and day 56.
ZyCoV-D is an intradermal vaccine that can be applied using a needle-free applicator, which could help significantly reduce side effects. The vaccine is stored at 2-8°C but has shown good stability at temperatures of 25°C for at least three months, the company said.
Zydus vaccine will be the second home-grown shot to get emergency authorisation in India after Bharat Biotech’s Covaxin, and the sixth vaccine which has been approved for use in the country after Serum Institute’s Covishield, Covaxin, Russia’s Sputnik V and the US-made Moderna and Johnson and Johnson.
The generic drugmaker, listed as Cadila Healthcare, had on July 1 applied for emergency use authorisation (EUA) with the DCGI for the vaccine. The company said that it has conducted the largest clinical trial for the vaccine in India in over 50 centres so far.
The clinical trials included 28,000 people who were split into two groups that either received the vaccine or a placebo. Among them were 1,000 volunteers in the 12-18 age group. The company has not yet released data from its previous phases.
According to the company, the tolerability profile among the adolescents was similar to what was seen in the adult population. Primary efficacy of 66.6% was attained for symptomatic RT-PCR positive cases in the interim analysis.
The company said there were no moderate cases of Covid-19 in the vaccine arm, though it did not disclose how many cases the interim analysis was based on.
“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,” Sharvil Patel, managing director of Cadila Healthcare, had said when the company released its late-stage trial data on July 1.
Zydus, which aims to produce up to 120 million doses annually, said its study coincided with the peak of India’s second wave of infections and affirmed its efficacy against new mutants, especially the Delta variant.