BackDecision on Zydus needle-free Covid vaccine in few days. What you need to know
If given approval, the ZyCoV-D would become the fifth vaccine cleared for use in the country after locally produced Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V and the US-made Moderna
PremiumAhmadabad-based drugmaker Zydus Cadila's application for the emergency use authorization of its Covid-19 vaccine will likely be taken up by a Subject Expert Committee (SEC) of India's drug regulator this week, reported news agency Reuters, citing an Economic Times report.
According to the report, the rolling review of the vaccine has already been conducted.
The company had last week submitted an application to the Drugs Controller General of India (DCGI), seeking authorisation for its ZyCoV-D three-dose vaccine.
It also submitted data evaluating a two-dose regimen for the shot. The SEC is now likely to compare the data and make a decision on its go-ahead.
If given approval, the ZyCoV-D would become the fifth vaccine cleared for use in the country after locally produced Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V and the US-made Moderna.
Also, it will become the world’s first DNA vaccine to get the nod in any country.
About the vaccine
ZyCoV-D is a plasmid DNA vaccine that produces the spike protein of the SARS-CoV-2 and elicits an immune response mediated by the cellular (T lymphocytes immunity) and humoral (antibody-mediated immunity) arms of the human immune system.
The vaccine has shown the efficacy of 66.6% against symptomatic Covid cases and 100% for moderate disease.
It is an intradermal vaccine, applied using a ‘needle-free injector’. Zydus claims the needle-free system can lead to a significant reduction in side effects.
Zydus has claimed to have conducted the largest clinical trial for a Covid-19 vaccine in India in over 50 centres. This was also the first time that any Covid-19 vaccine had been tested in the 12-18-year age group in the country.
The vaccine is said to have shown safety and efficacy in a late-stage trial with more than 28,000 volunteers, including 1,000 subjects in the 12-18 year age group.
The tolerability profile of the doses was similar in the adolescent population to that seen in the adult population.
Zydus had last week stated that the immunogenicity data for the adolescent children subset will be submitted in the next four to six weeks.
The company also said that it plans to manufacture 100-120 million doses of ZyCoV-D annually. The plasmid DNA platform provides ease of manufacturing with minimal biosafety requirements (BSL-1).
According to initial reports, it
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