An expert panel on Covid-19 of the Central Drugs Standard Control Organization (CDSCO) on Friday recommended granting the emergency use authorization for 'Covishield', a Covid-19 vaccine developed by Oxford University and Swedish drug maker AstraZeneca.
However, the Drugs Controller General Of India (DCGI) will take the final call on the matter. The CDSCO had met thrice before, over the approval of vaccines.
The Centre is looking to start giving shots from this month, once the vaccine is cleared for a final time by the DCGI.
This move comes after UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday had approved the Covid-19 vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use.
The Subject Expert Committee (SEC) on Covid-19 of the CDSCO, which had earlier sough additional safety and immunogenicity data from Serum Institute of India (SII),deliberated on its application seeking Emergency Use Authorization (EUA) for the shots on Wednesday, and met again on Friday to review the matter. After SII's application, the SEC has started reviewing the EUA application by Bharat Biotech for its Covid-19 vaccine Covaxin but it yet to take a final decision on the matter.
The Serum Institute of India had earlier said that more than 5 crore doses of the AstraZeneca vaccine have already been stockpiled an the shots could start to be transported from cold storage to all states as early as Saturday.
"For the Government of India, Covishield will be about USED 3 per dose, so USD 6[Rs 440] per person, but for private market it will cost around Rs 700-800",Serum Institute CEO Adar Poonawalla said in a statement.
The Pune-based Serum Institute of India(SII), the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield.
Oxford and AstraZeneca's combined effort for coronavirus vaccine is reported to give around 70 per cent efficacy, which is lesser than the Pfizer's Covid-19 vaccine efficacy at 90 per cent. However, what gives Oxford/AstraZeneca's shot edge is the way it has to be preserved. Unlike Pfizer's Covid-19 vaccine, which has to be kept in ultracold freezers, Oxford-AstraZeneca's Covid-19 vaccine can be preserved in normal refrigeration.
Taking step forward in defeating coronavirus, government has decided to conduct a country wide dry run of the Covid-19 vaccination process in India from January 2.The important decision was taken in the high-level meeting of the Heath Ministry on Thursday. Till now ,Covid-19 vaccination dry run was done in 4 states of the country which are Punjab, Andhra Pradesh, Assam and Gujarat.
"In terms of safety, Covishield was well tolerated with respect to solicited adverse events...majority of solicited reactions were mild in severity and resolved without any after-effect."
"Therefore, Covishield is safe and can be used effectively for prevention Covid-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield",the EUA application signed by Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at Serum Institute of India, had stated.
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