Indian Pharmaceutical Giant Manages Emergency Use Of Covid Vaccine

Indian Pharmaceutical Giant Manages Emergency Use Of Covid Vaccine

Indian pharmaceutical company Zydus Cadila has announced that it has applied for an Emergency Use Permit (EUA) with the Drug Controller General of India (DCGI) office for ZyCoV-D. The product is a plasmid DNA vaccine against Covid-19.

UMMATIMES - Zydus Cadila is conducting the largest clinical trial of a Covid-19 vaccine in India so far at more than 50 sites. The study is also the first time a Covid-19 vaccine has been tested in a population of adolescents in the 12-18 year age group in India.

"About 1000 subjects were enrolled in this age group and the vaccine was found to be safe and very well tolerated. The tolerability profile is similar to that seen in the adult population. A 66.6% primer efficacy has been achieved for symptomatic positive RT-PCR," the company said in a statement. a statement reported by Livemint on Thursday (1/7).

Zydus Cadila claims that in the preliminary analysis no moderate cases of Covid-19 disease were observed in the vaccine group after the third dose. It shows 100% efficacy for moderate disease.

"No severe cases or deaths from Covid-19 have occurred following the administration of the second dose of the vaccine," the company said.

Zydus Cadila said ZyCoV-D has demonstrated immunogenicity and tolerability as well as a strong safety profile in previously conducted adaptive Phase I/II clinical trials. Both Phase I/II and Phase III clinical trials have been monitored by an independent Data Security Oversight Board (DSMB).

Zydus Cadila emphasized that the plug and play technology that forms the basis of the plasmid DNA platform is very suitable for dealing with Covid-19 because it can be easily adapted to handle mutations in the virus, as has already happened.

"This breakthrough marks an important milestone in scientific innovation and technological advancement. As the first human-used plasmid DNA vaccine, ZyCoV-D has proven its safety and efficacy profile in our fight against Covid-19," said Managing Director, Cadila Healthcare Ltd., Sharvil. patel.

Patel said that if the vaccine was approved for emergency distribution it would help not only adults but also teenagers in the 12 to 18 year age group. "This was made possible because of the collective support from the government, regulators, volunteers who believe in the process, the scientists who carried out multi-centric trials over these months, the suppliers we work with, and our dedicated team," said Patel.

In another development, the company has also evaluated a two-dose regimen for the ZyCoV-D vaccine using a dose of 3 mg per injection. Its immunogenicity results were found to be equivalent to the current three-dose regimen. These results will further assist in reducing the full duration of vaccination while maintaining the high safety profile of future vaccines.