India’s drug regulator on Friday approved Zydus Cadila’s three-dose COVID-19 DNA vaccine for emergency use in adults and children aged 12 years and above.
According to CNBC-TV18, the committee also stated that Zydus must provide additional data for its vaccine’s 2-dose regimen.
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ZyCoV-D Three-Dose Covid-19 Vaccine
Zydus Cadila’s vaccine, developed in partnership with the Department of Biotechnology, is the second home-grown shot to receive emergency approval in India.
On July 1, the company applied for emergency use authorisation for its ZyCoV-D three-dose Covid-19 vaccine. Data on a two-dose regimen for the shot was also provided. The SEC will most likely compare the data before deciding on whether or not to proceed.
The company conducted the largest clinical trial for its COVID-19 vaccine in India so far in over 50 centres.
Efficiency Rate
Cadila Healthcare Ltd, sought approval of the ZyCoV-D vaccine on July 1, citing a 66.6 per cent efficacy rate in a late-stage trial involving more than 28,000 volunteers across the country.
ZyCoV-D is the first plasmid DNA vaccination against the coronavirus in the world. It means it uses a section of genetic material from the virus that gives instructions as either DNA or RNA to make the specific protein that the immune system recognises and responds to.
It’s an intradermal vaccine that’s administered with a ‘needle-free injector.’ The needle-free approach, according to Zydus, can reduce side effects significantly.
World’s First DNA Vaccine
This COVID-19 vaccine has been tested in the adolescent population in the 12-18 years age group in India.
India’s drug regulator on Friday approved Zydus Cadila’s three-dose COVID-19 DNA vaccine for emergency use in adults and children aged 12 years and above. In this age group, almost 1000 people were enrolled, and the vaccine was shown to be safe and well-tolerated.
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