Zydus Cadila had submitted an application for it. Post that, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) deliberated on it and has recommended granting emergency use authorisation to its three-dose coronavirus vaccine. The Drugs Controller General of India (DCGI) will give final approval to the recommendation.
Zydus Cadila is an Ahmedabad-based pharma major. On July 1, it had applied for emergency use authorisation (EUA) with the DCGI for the vaccine, as per
sources.
According to the company, it has conducted the largest clinical trial for the vaccine in India in over 50 centres so far.
It conducted a late-stage trial of more than 28,000 volunteers nationwide and showed an efficacy rate of 66.6%. It also claims the vaccine to be safe for children between 12 and 18 years of age. Its trial data, however, needs peer-reviewing.
If given approval, the vaccine will become India’s second indigenous vaccine. It will also be the fifth vaccine to be authorised for use in the country.
US pharma giant Johnson & Johnson (J&J) is also looking forward to conduct clinical trials of its single shot Janssen vaccine against Covid-19 on adolescents aged 12-17 years. It has moved an application to the Central Drugs Standard Control Organisation (CDSCO) in India seeking permission for the same.
The vaccine's single shot has shown 85% efficiency in preventing severe effects of the virus. It was given emergency use approval in India earlier in August. The Union Health Minister had said this will further strengthen India’s collective fight against COVID infection Read more about it here
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