An expert panel of India’s Central drug authority on Saturday recommended granting permission for restricted use of Bharat Biotech-developed indigenous COVID-19 vaccine Covaxin in emergency situation, especially in the context of infection by mutant strains, officials said.
A vaccine demonstration being carried out at RGGGH on Saturday.
New Delhi: The recommendation for Bharat Biotech’s vaccine came a day after the panel cleared the Serum Institute of India’s emergency use athorisation application for the Oxford-AstraZeneca vaccine Covishield, paving the way for the roll-out of COVID-19 shots in the country in the next few days.
The Union Health Ministry on Saturday also confirmed that the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to the Serum Institute of Institute (SII) for restricted emergency use of Covishield in India, subject to multiple regulatory conditionalities.
“The SEC met on January 1 and 2 and made the recommendations for the consideration and final decision of the Drugs Controller General of India (DCGI),” the Ministry said.
According to sources, the committee, however, stated that the firm shall continue the ongoing phase 3 clinical trial and submit data emerging from the trial as and when available. The committee noted that the vaccine is an inactivated whole virion, coronavirus vaccine, having potential to target mutated coronavirus strains, a source said.
Meanwhile, Health Minister Harsh Vardhan said that free vaccine would be provided in the first phase to the most prioritised beneficiaries, including one crore healthcare and two crore frontline workers. He said the details of how 27 crore priority beneficiaries -- those above 50 years of age and those below it having comorbidities -- would be vaccinated until July were being finalised. Across India, the dry run was conducted in in 116 districts across 259 sites. Some 96,000 vaccinators have been trained for this, the Health Ministry had said.
The Union Health Ministry on Saturday also confirmed that the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to the Serum Institute of Institute (SII) for restricted emergency use of Covishield in India, subject to multiple regulatory conditionalities.
“The SEC met on January 1 and 2 and made the recommendations for the consideration and final decision of the Drugs Controller General of India (DCGI),” the Ministry said.
According to sources, the committee, however, stated that the firm shall continue the ongoing phase 3 clinical trial and submit data emerging from the trial as and when available. The committee noted that the vaccine is an inactivated whole virion, coronavirus vaccine, having potential to target mutated coronavirus strains, a source said.
Meanwhile, Health Minister Harsh Vardhan said that free vaccine would be provided in the first phase to the most prioritised beneficiaries, including one crore healthcare and two crore frontline workers. He said the details of how 27 crore priority beneficiaries -- those above 50 years of age and those below it having comorbidities -- would be vaccinated until July were being finalised. Across India, the dry run was conducted in in 116 districts across 259 sites. Some 96,000 vaccinators have been trained for this, the Health Ministry had said.
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