"Happy New Year, All Risks Paid Off': Adar Poonawalla On Vaccine Approval

New Delhi:

All the risks taken by Serum Institute have finally paid off, tweeted Adar Poonawalla, the chief executive of the Pune-based vaccine manufacturer, shortly after the country's drug regulator cleared its Covishield vaccine for emergency approval in India. Mr Poonawalla reiterated that the "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".

Mr Poonawalla, CEO of the Serum Institute, said to be the world's largest vaccine maker, had earlier said the "majority of the first 50 million doses will go to India".

Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks.

- Adar Poonawalla (@adarpoonawalla) January 3, 2021

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".

Serum Institute, the Drug Controller said, has submitted safety, 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.

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.

A decisive turning point to strengthen a spirited fight!

DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation.

Congratulations India.

Congratulations to our hardworking scientists and innovators.

- Narendra Modi (@narendramodi) January 3, 2021

Serum Institute of India's Covishield was the first vaccine to be recommended for "restricted use" by the the government-appointed panel on Friday. Covaxin, the coronavirus vaccine from Hyderabad-based Bharat Biotech, was recommended a day later, on Saturday.

A third vaccine - developed by American pharma giant Pfizer - had also applied for emergency fuse authorisation and is currently being reviewed by the panel. Sources, however, have said that the company has yet to present its data before the panel.

The Pfizer vaccine has already been rolled out in the UK, the US and some other countries.

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.

The approval is expected to kick off one of the world's biggest vaccination drives in the coming days.

A day-long trial run of the vaccine delivery system was held on Saturday to check for potential problems once a vaccine is made available. The Health Ministry said dry runs were held in 116 districts, with nearly one lakh personnel undergoing necessary training.

Source: NDTV

Covishield is ready for "roll-out in the coming weeks", said Adar Poonawalla

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