Participants’ assent yet to be taken for testing vaccine says ICMR head

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The Drugs Controller General of India (DCGI) had on Sunday declared approval of AstraZeneca’ s vaccine Covishield, manufactured by the Serum Institute, and Covaxin for restricted emergency use in the nation. However few pressing questions remained unaddressed.

Balram Bhargava, head of Indian Council of Medical Research (ICMR), said on Tuesday that Bharat Biotech’s Covid-19 immunization has been cleared in the clinical preliminary mode. However, it requires assent of participants to take the pilot testing forward. He responded promptly to the inquiries being raised on the approval given to Covaxin.

“Authorization for restricted use in clinical trial mode has been permitted, which means assent of members must be taken and there must be consistent follow up regarding the development among them,” Bhargava said at a public interview on Tuesday.

Clarifying the method employed in giving green signal to AstraZeneca-Oxford University’s Covid-19 Covishield and natively created Bharat biotech’s Covaxin, Bhargava stated, “The current pandemic circumstance, high mortality, accessible science and absence of complete medicines were considered by the subject expert committee group (SEC) on Covid-19 of CDSCO for conceding quickened endorsement to these vaccines, and that is in our legitimate provision.”

Experts voiced out their opinion that vaccine roll out in the premature stage and overlooking clinical trial data could pose threat to lives of citizens. On the other hand, union health ministry announced that vaccine use for public is likely to commence within 10 days.

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