Zydus Cadila Seeks Emergency Use Approval For Its Covid-19 Vaccine In India
Cadila Healthcare Ltd. has sought an emergency use approval from the Indian drug regulator for its Covid-19 vaccine amid concerns over a third wave.
Zydus Cadila has applied for emergency use authorisation to the office of Drug Controller General of India for ZyCoV-D, its three-dose intradermal plasmid DNA vaccine, according to an exchange filing. The company, it said, conducted clinical trial in more than 50 centers in India so far.
The primary efficacy has been established at 66.6% for the symptomatic RT-PCR positive cases in the interim analysis, the filing said, adding no moderate case of Covid-19 was observed post administration of the third dose. Also, no severe cases or deaths due to Covid-19 occurred after administration of the second dose. Both phase I/II and phase III clinical trials, it said, have been monitored by an independent data safety monitoring board.
The drugmaker also said that the jab is safe for children in the age group of 12-18 years. “Around 1,000 subjects were enrolled in this age group and the vaccine was found to be safe and very well tolerated.”
The company also claimed that the vaccine can be easily adapted to deal with mutations in the virus.
ZyCoV-D is to be stored at 2-8o Celsius but it has also shown good stability at temperatures of 25o Celsius for at least three months, the filing said. That will help in easy transportation and storage of the vaccine and reduce any cold-chain breakdown leading to wastage. The company plans to manufacture 10-12 crore doses annually.
Two Dose Regimen Evaluated
In a separate development, the company, according to the filing, evaluated the vaccine for a two-dose regimen using a 3 mg dose per visit. The results, it said, were found to be equivalent to the current three-dose regimen.
This came after the Indian drug regulator cleared Cipla Ltd. to import Moderna Inc.’s Covid-19 shot for restricted emergency use. The country is also in talks with Pfizer Inc. to import additional inoculations needed for its immunisation programme.
Shares of Cadila Healthcare were trading 1.26% lower as of 12:30 p.m. on Thursday compared with a 0.15% fall in the Nifty 50 Index.