Zydus Cadila set to seek nod for its Covid vaccine
If approved by the Drugs Controller General of India, it will become the fourth vaccine to be cleared for use against the viral infection in India
Indian pharmaceutical company Zydus Cadila is likely to apply for an emergency use authorisation for its Covid-19 vaccine ZyCoV-D to the central drugs regulator next week, people aware of the developments said on Saturday.
If approved by the Drugs Controller General of India, it will become the fourth vaccine to be cleared for use against the viral infection in India. The company has so far not released any data from its trials.
Currently, the country’s vaccination programme is using the Oxford-AstraZeneca vaccine, locally manufactured as Covishield, Bharat Biotech’s Covaxin, and Russian vaccine Sputnik V.
“We are hoping that they will apply in the near future. Most of their study is complete. They have enrolled more than 28,000 in their phase III study. We expect they will submit the results very soon,” Dr VK Paul, member (health) NITI Aayog told ANI.
Once ZyCoV-D is approved, it will be the second indigenously developed vaccine to receive clearance in the country and the first DNA vaccine in the world to be authorised. So far, about 18 vaccines are in use across the world, with many using the inactivated virus technology.
DNA-Plasmid based ZyCoV-D will be a three-dose vaccine and is to be administered intradermally. It can be stored at two to four degrees Celsius and does not require cold chains, making transportation to remote parts of the country easy.
With the vaccine being tested even in the 12-18 year age group, the firm could seek approval for use in children as well, people aware of the developments said. So far, no vaccine has been approved for use in children in India. Bharat Biotech is also conducting trials for Covaxin in children between the ages of 6 and 18 years.
Globally, only Pfizer’s vaccine is approved for use in children.
An official aware of the matter told news agency PTI: “The analysis of the phase-three trial data is almost ready and the company has informed the government that it could apply for emergency use licensure for its Covid-19 vaccine next week.”
The vaccine candidate has been supported by the National Biopharma Mission (NBM) under the aegis of Biotechnology Industry Research Assistance Council (BIRAC), a PSU under the department of biotechnology.
With inputs from agencies