Zydus Cadila’s three-dose Covid-19 vaccine ZyCoV-D gets DCGI emergency use approval


The three-dose Covid vaccine ZyCoV-D from vaccine manufacturer Zydus Cadila has received DCGI approval for emergency approval. It’s the only needle-free Covid vaccine in the world.

For the first time in India, young people between the ages of 12 and 18 are being vaccinated.

The safety, efficacy and immunogenicity of the vaccine are well established and the company has already started stockpiling vaccines.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSO) had recommended emergency approval (EUA) for Zydus Cadila’s three-dose Covid-19 vaccine ZyCoV-D.

ZyCoV-D is a three-dose intradermal vaccine that is administered with a needle-free system, Tropis, and can also lead to a significant reduction in all types of side effects.

Currently, the Indian government has approved five vaccines against Covid-19, including Covishield, Covaxin, Sputnik V, Moderna’s vaccine and J & J’s single-dose vaccine.

On July 1, Zydus Cadila had applied for approval of his Covid vaccine approved for emergency use. The company conducted the largest clinical trial for its ZyCoV-D vaccine, including on a population in the 12 to 18 age group. It was also the first time a Covid-19 vaccine was tested in the youth population.

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Good performance on exams

The safety profile was similar to that of the adult population. In symptomatic RT-PCR-positive cases, a primary efficacy of 66.6 percent was achieved in the interim analysis.

In contrast, no moderate case of Covid 19 disease was observed in the vaccine arm after administration of the third dose, which suggests 100 percent effectiveness in moderate disease.

ZyCoV-D had already shown a robust immunogenicity, tolerability and safety profile in previous adaptive clinical phase I / II studies. Both the phase I / II and phase III clinical studies were monitored by an independent Data Safety Monitoring Board (DSMB).

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