New Delhi: The government panel has recommended marketing authorisation of Oxford COVID-19 vaccine Covishield to Serum Institute of India on Friday.
In a step closer towards India approving its first coronavirus vaccine, the Subject Expert Committee of the Central Drug Standard Control Organisation on Friday recommended emergency use of Oxford-AstraZeneca's 'Covishield' vaccine. The application will be sent to Drugs Controller General of India (DCGI) V.G. Somani for final approval.
Serum Institute of India (SII) is the manufacturing partner for Oxford and AstraZeneca.The SEC deliberated and analysed the additional data and information submitted by SII and Bharat Biotech.
"SEC will make appropriate recommendations to the DCGI. The final decision will be taken by the DCGI," sources told ETV Bharat.
The expert panel had convened a meeting on Friday afternoon to take a call on the emergency use authorisation sought by the Serum Institute of India, which is Covishield's manufacturer, and Bharat Biotech for their coronavirus vaccine candidates.
It may be mentioned here that SII already has a stockpile of 75 million doses of the Oxford vaccine and by January first week it will have 100 million doses.
A decision on Bharat Biotech's Covaxin was still awaited at the meeting which is still underway, the Health Ministry said.
The Pune-based Serum Institute has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing 'Covishield' while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) to make 'Covaxin'.
America's Pfizer was the first one to apply for the accelerated approval on December 4, followed by Serum and Bharat Biotech on December 6 and 7, respectively. Pfizer has, however, sought more time to present the data.
As India awaits for a silver bullet against coronavirus with bated breath, the DCGI, on Thursday, hinted at the approval of vaccine and said that the country will have a "Happy New Year with something in hand".
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The meeting comes a day before dry-run of the vaccine is slated to commence in all the states and Union Territories to equip the administration in management of vaccine supply, storage and logistics, including cold chain management.
The Central government plans to vaccinate nearly 30 crore people in the first phase of the drive. It will be offered to one crore healthcare workers, along with 2 crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities.
SII has already produced around 50 million dosages of the vaccine and plans to scale it up to 100 million by March 2021. The Pune-based company has applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for COVID-19 vaccine in the country.
SII would supply the vaccine to both the government and the private sector players with different cost structures.
SII had applied to DCGI for emergency use authorisation for Covishield on December 6 while the Hyderabad-based Bharat Biotech had sought a similar nod for its indigenously developed Covaxin on December 7.
With agency inputs
READ: CDSCO experts to consider emergency use authorisation for COVID vaccines
