New Delhi: In a major development, the Indian drug regulator’s subject expert committee on Friday recommended emergency use approval for Zydus Cadila’s three-dose COVID-19 vaccine. Moreover, the expert committee added that Zydus needs to submit additional data for the 2-dose regimen of its vaccine.Also Read - Covaxin Faces Further Delay For WHO Clearance Over Technical Queries to Bharat Biotech: Report
It must be noted that the generic drugmaker, listed as Cadila Healthcare Ltd, had applied for the authorisation of the vaccine ZyCoV-D on July 1, based on an efficacy rate of 66.6% in a late-stage trial of more than 28,000 volunteers nationwide. The drugmaker said the vaccine is safe for children between 12 and 18 years of age. However, its trial data is not peer-reviewed yet. Also Read - Russia Says It’s In Sync with United State, China, Pakistan on Taliban | Details Here
Notably, the vaccine will be India’s second indigenous vaccine and the fifth vaccine to be authorised for use in the country if it gets approved by the panel. It must be noted that the country has already approved vaccines from Moderna, AstraZeneca and partner Serum Institute of India, Bharat Biotech, and Russia’s Gamaleya Institute. Also Read - Centre Files Plea Against Allowing 2nd Dose of Covishield After Gap of 4 Weeks
In a statement, Zydus Cadila had earlier stated that they can launch the vaccine within two months of receiving the approval.
It must be noted that ZyCov-D is being developed in partnership with the Department of Biotechnology and the Indian Council of Medical Research and it can be stored at 2-8 degrees Celsius and at 25 degrees Celsius for up to three months.
After it is approved, the vaccine 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.
The company said it has also submitted data evaluating a two-dose regimen for the shot. The SEC is likely to compare the data and make a decision on its go-ahead.