HomeIndiaCovid jabs get market approval for use in adults, with conditions

Covid jabs get market approval for use in adults, with conditions

More than a year after it granted permission for restricted emergency use of Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin vaccines against Covid-19, the country’s drug regulator on Thursday upgraded the two vaccines by granting market authorisation in adult population, with certain conditions.

While India continues to report a surge in new cases, the Health Ministry on Thursday said “there is an early indication of plateau” in Covid-19 cases being reported in certain geographies. It said six states are recording a decline in cases and positivity: Maharashtra, Uttar Pradesh, Delhi, Odisha, Haryana, and West Bengal.  It, however, emphasised that required precautions need to be continued.  It said six states continue to record high cases and increase in positivity rate: Karnataka, Kerala, Tamil Nadu, Gujarat, Andhra Pradesh, and Rajasthan.

With the Drugs Controller General of India approving upgrade of status for Covishield and Covaxin, the two vaccines will have to comply with three broad conditions. The manufacturers will have to submit data of ongoing clinical trials overseas with due analysis on six-monthly basis.  Second, they will have to submit the safety data, including adverse event following immunisation, with due analysis on six-monthly basis. Third, the two vaccines will be supplied for “programmatic setting”, and all vaccinations done within the country to be recorded on CoWIN platform and Adverse Event Following Immunization, Adverse Event of Special Interest shall continue to be monitored, the ministry said.

Centre urges caution on lifting curbs

New Delhi: The Centre has asked states to exercise caution while lifting Covid-19 restrictions, as cases still remain high. On Thursday, the Union Home Ministry issued an order under Disaster Management Act, extending its earlier order of December 27 for covid containment till February 28.

In a letter to chief secretaries of all states, Home Secretary Ajay Bhalla wrote, “…there has been a steady increase in number of cases…active cases have increased to over 22 lakh. Though a majority of active cases are recovering fast and a low percentage of cases are in hospitals, it is still a matter of concern that 407 districts in 34 States & UTs are reporting a positivity rate of more than 10%….there is a need to exercise caution and vigilance.”

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