ZyCoV-D Covid Vaccine gets approval in India; 12+ Children can get the Dose

The vaccine from Ahmadabad based pharmaceutical company is now the world’s first and India’s indigenously developed DNA based vaccine for Covid-19.

Insight Bureau:  The Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation  has recommended an emergency use authorisation (EUA)  for Zydus Cadila’s three-dose COVID-19 vaccine -ZyCoV-D for children above 12 years.

The vaccine from Ahmadabad based pharmaceutical company is the world’s first and India’s indigenously developed DNA based vaccine for Covid-19.

Zydus Cadila plans to manufacture 100 million to 120 million doses of ZyCoV-D annually and has started to stockpile the vaccine.

In India, the firm performed the largest clinical study for its COVID-19 vaccine in over 50 centres nationwide. This was also the first time in India that any COVID-19 vaccine was tested in the adolescent population aged 12 to 18. In this age range, almost 1000 people were enrolled, and the vaccination was shown to be generally well tolerated.

The committee added that Zydus needs to submit additional data for the 2-dose regimen of its vaccine.

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After domestically created Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V, US-made Moderna and Johnson & Johnson,  ZyCoV-D  would become the latest vaccine authorised for use in India. It will also be the world’s first DNA vaccination to receive approval in any country.

On July 1, the Ahmedabad-based pharmaceutical company filed an emergency use authorization application for its ZyCoV-D three-dose Covid-19 vaccine. Data on a two-dose regimen for the shot was also provided by the firm. The SEC will most likely compare the data before making a judgement on whether or not to proceed.

ZyCoV-D is a plasmid DNA vaccine that generates the SARS-CoV-2 spike protein and elicits an immunological response mediated by the human immune system’s cellular (T lymphocyte immunity) and humoral (antibody-mediated immunity) arms. It’s an intradermal vaccination that’s administered with a ‘needle-free injector.’ The needle-free method, according to Zydus, can reduce side effects significantly.

The profile of tolerability was comparable to that of the adult population. In the interim study, primary efficacy of 66.6 percent was achieved for symptomatic RT-PCR positive patients. After the third dosage, no moderate cases of COVID-19 infection was found in the vaccination arm, suggesting that the vaccine is 100 percent effective against moderate disease.

In previous adaptive Phase I/II clinical studies, ZyCoV-D has demonstrated a strong immunogenicity, tolerance, and safety profile. An independent Data Safety Monitoring Board oversaw both the Phase I/II and Phase III clinical trials.

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