Ahmedabad: Homegrown Healthcare and Pharmaceutical Major Zydus Cadila has submitted a request for emergency use (EUA) to the Indian drug controller office for Zycov-D, Plasmid DNA vaccine against Covid-19.
“As the first plasmid DNA vaccine for human use, Zycov-D has proven its safety and efficacy profiles in our fight against Covid-19.
Vaccines, when approved, will help not only adults but also adolescents in 12-year age group , “said Dr.
Sharvil Patel, MD, Cadila Healthcare Ltd, the flagship Zydus Cadila Group based in Ahmedabad.
Zycov-D is a plasmid DNA vaccine which, when injected, produces a protein surge in the SARS-COV-2 virus and raises the immune response mediated by the cellular and humoral arm of the human immune system, which plays a vital role in the protection of disease and viral permits.
Zycov-D has also been tested for teenagers between 12 and 18 years in India.
About 1,000 subjects in this age group are registered and the vaccine is found safe and tolerated very well.
The tolerability profile is similar to what is seen in the adult population.
Zydus is currently preparing a new facility to produce its Covid-19 vaccine.
“Once the facilities are assigned at the end of this month, we can produce about one dose of crore from the vaccine,” added Patel, who refrained from giving a certain time line to launch vaccines but stated that it could be done aggressively.
Within 45-60 days after getting regulatory approval.
Zydus Cadila has so far invested up to RS 500 Crore in the development of this vaccine, including the cost of forming new manufacturing facilities.
According to Zydus, plug-and-play technology where Plasmid DNA platform is based ideally to deal with Covid-19 because it can be easily adjusted to handle virus mutations.
The company has also evaluated a two-dose regimen for Zycov-D using a 3mg dose per visit.
Immunogenicity results have been found equivalent to the current three-dose regimen.
“This will then help reduce the duration of full vaccination roads while maintaining a high security profile of the vaccine in the future,” Patel added.