Zydus Cadila Apply for Emergency Use of ZyCov-D Vaccine

AHMEDABAD, July 1: Ahmedabad-based pharmaceutical company Zydus Cadila has approached the drug regulator for restricted emergency approval of ZyCov-D, its three-dose Covid-19 vaccine, which if cleared would be the first DNA vaccine available in the world.

The company has also claimed that the vaccine can be administered to the children above 12 years and its two dose regimen was equally useful to prevent severity of the disease and death.

Zydus Cadila expects to produce 100-120 million doses of ZyCov-D, the company said in a statement on Thursday. This would be sufficient for up to 40 million people receiving three doses of the shot.

The vaccine, tested in late-stage human clinical trials involving over 28,000 participants, has been found to have a primary efficacy of 66.6 percent so far– it was able to bring down symptomatic cases of Covid-19 in those who received the vaccine by nearly 67 percent compared with those who did not receive a jab.

The company, which has also been evaluating the possibility of using a two-dose regimen of ZyCov-D, said that the immunogenicity results “had been found to be equivalent to the current three-dose regimen” — two doses of the vaccine were able to prompt an immune response that was just as good as the response in a three-dose regimen.

“This will further help in reducing the full course duration of vaccination while maintaining the high safety profile of the vaccine in the future,” stated the company.

However, the information provided so far suggests that the vaccine may be able to prevent even moderate symptoms of Covid if three doses are provided.

“…no moderate case of COVID-19 disease was observed in the vaccine arm post administration of the third dose, suggesting 100% efficacy for moderate disease,” Zydus Cadila stated.

Meanwhile, two doses of ZyCov-D might be able to prevent severe disease and death, as per the company’s interim analysis of its clinical trial results.

“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,” said Zydus Cadila managing director Dr. Sharvil Patel.

Around 1,000 adolescents in this age group were enrolled in this trial, according to Zydus Cadila.

“The plug and play technology on which the plasmid DNA platform is based is ideally suited for dealing with Covid-19, as it can be easily adapted to deal with mutations in the virus, such as those already occurring,” the company added.

ZyCov-D is among the Covid-19 vaccine candidates that were developed in India using the support of the Department of Biotechnology and the Indian Council of Medical Research.

(Manas Dasgupta)