Health
ZyCoV-D: Needle-free Covid-19 vaccine gets approval in India
New Delhi: The Indian drug regulator’s subject expert committee (SEC) Friday recommended emergency approval to Zydus Cadila's three-dose COVID-19 vaccine ‘ZyCoV-D’, sources revealed.
On July 1, the Ahmedabad-based pharmaceutical firm had applied for emergency use authorization of its ZyCoV-D 3-dose coronavirus vaccine.
The generic drug maker administered over 28,000 volunteers in a late-stage trial nationwide. The volunteers included around 1,000 children aged 12-18.
Reportedly, the vaccine demonstrated a 66.6% efficacy against symptomatic RT-PCR positive cases in the interim analysis. Following which, the company had filed the application with the Drug Controller General of India (DCGI) for an emergency use authorization (EUA) for ZyCoV-D.
Moreover, the concerned authorities had directed the company to submit additional data for the 2-dose regimen of its vaccine.
Zydus said it also evaluated a two-dose regimen for ZyCoV-D vaccine using a 3 mg dose per visit and the immunogenicity results had been found to be equivalent to the current three-dose regimen.
If approved, Zydus Cadila's vaccine will be the second home-grown shot to get emergency authorization in India after Bharat Biotech's Covaxin.
Zydus Cadila has stated that it plans to manufacture 120 million doses annually.
ZyCoV-D is a plasmid-based vaccine and the three doses— offering sustained immunity with a longer antibody response.
The cycle will be 0-28-56-days. It is an intra-dermal vaccine and it will be administered without a syringe.
The shot can be stored at a normal refrigeration temperature of 2 to 8 degrees.