Ahmedabad-based pharmaceutical company Zydus Cadila will submit additional data on its coronavirus vaccine, ZyCov-D, to the Drugs Controller General of India (DCGI) on July 23, a government official in the know of the development told CNN-News18.
The drug regulator had earlier asked Zydus Cadila to come back with more data related to immunogenicity and safety of ZyCov-D, which is set to become the world’s first plasmid DNA vaccine for human use.
The subject expert committee (SEC) of the DCGI will examine the additional data, and if it is found to be satisfactory, then the final approval from the drug regulatory body could be granted in August, the source said.
Zydus Cadila had earlier said that they can launch the vaccine within two months of receiving the approval. The pharmaceutical firm had applied for an emergency use authorisation for the three-dose DNA vaccine on July 1.
Zydus claims that its vaccine is 66.6% effective against symptomatic coronavirus cases and 100% for moderate Covid-19. It also said the vaccine is safe for children between 12 and 18 years of age. However, its trial data is not peer-reviewed yet.
If approved, the vaccine will be India’s second indigenous vaccine and the fifth vaccine to be authorised for use in the country. India has already approved vaccines from Moderna, AstraZeneca and partner Serum Institute of India, Bharat Biotech, and Russia’s Gamaleya Institute.
ZyCov-D, which is being developed in partnership with the Department of Biotechnology and the Indian Council of Medical Research, can be stored at 2-8 degrees Celsius and at 25 degrees Celsius for up to three months. Once approved, it will be an intra-dermal (between skin and muscles) vaccine administered through a specialised needle-free injector. The currently licensed coronavirus vaccines are administered intra-muscularly.