HomeHealthAdar Poonawalla hails DCGI's approval to Covishield, ensures it's 'safe and effective'

Adar Poonawalla hails DCGI’s approval to Covishield, ensures it’s ‘safe and effective’

As the year has arrived the people across the globe have positive expectations for the treatment of Covid-19 and the vaccination that follows. For India there is also good news as the “Covishield” vaccine has been approved in India for emergency use.

Adar Poonawalla, the chief of the Pune-based vaccine manufacturer, tweeted that “Covishield” vaccine — developed by Serum Institute of India in partnership with the Oxford University and pharma major AstraZeneca – is “safe and effective” against coronavirus and added that the vaccine “is ready to roll out in the coming weeks”.

Shortly after the drug regulatory body of India cleared the vaccine for emergency uses in India. Apart from Covishield, Bharat Biotech’s Covaxin has been granted permission for “restricted use”. Restricted use approval is normally granted if there is sufficient evidence to suggest the drug is both safe and effective.
“We’ll never approve anything if there is slightest of safety concern. The vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergy are common for every vaccine,” Drug Controller General of India VG Somani said while granting permission to the vaccine makers for “restricted use”.
Minutes later, Prime Minister Narendra Modi tweeted to say that it would make every Indian proud that the two were “made in India”. “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion,” the Prime Minister tweeted.
According the Serum Institute, immunogencity and efficacy data of over 73,000 participants and found 70.42 per cent efficacy. The firm is conducting Phase 2 and Phase 3 trials on 1,600 participants in India. They submitted data of trials abroad also. Recommendation was made for restricted use and the trials will continue, he added.
Bharat Biotech’s Covaxin, meanwhile, has conducted Phase I and Phase II trials in around 800 subjects and the results demonstrated that the vaccine is safe and provides a robust immune response. The Phase III trial was initiated in India in 25,800 volunteers and till date, 22,500 participants have been vaccinated.
India is the world’s second most-infected nation with more than 1.03 crore cases and almost 150,000 deaths, although its rate of infection has come down significantly from a mid-September peak of more than 90,000 cases daily.
This approval is expected to start on the world’s biggest vaccination drives in coming days.

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