Serum Institute of India (SII) CEO Adar Poonawalla on Friday said the vaccine major has applied for full market authorization of Kovishield to the Indian authorities, stating that the COVID-19 vaccine supply will be Rs 125 crore. Dose has been exceeded.
SII had partnered with Covishield, the developer of AstraZeneca, to supply the vaccine to the Indian government, which was granted emergency use authorization in the country in January this year.
“The supply of COVISHIELD vaccine in India has exceeded 1.25 billion. Government of India now has enough data for full market authorization, and hence @SerumInstIndia has applied for this permission to @CDSCO_INDIA_INF (DCGI) and @MoHFW_INDIA,” Mr Poonawalla tagged Central Drugs Standard Control Organization (CDSCO) While saying in a tweet. ) and Ministry of Health and Family Welfare.
Covishield, along with Bharat Biotech’s Covaxin, were the first two vaccines approved under emergency use authorization against the pandemic by the Drug Controller General of India (DCGI) in January this year.
Already in the US, Pfizer-BioNtech’s COVID-19 vaccine has received full USFDA approval for use in individuals 16 years of age and older, infection with an earlier Emergency Use Authority (EUA) approval.
Access to medical products provided by authorities during public health emergencies after the EUA has determined that a product has known and potential benefits, when used to prevent, diagnose or treat disease , exceeds the known and potential risks of the product.
In the case of full market authorization, vaccines have to go through a standard regulatory process to review the quality, safety and effectiveness of medical products.
In October this year, Pune-based SII submitted its final Phase 2/3 clinical study report of India along with its application for grant of regulated market authorization for Covishield.
The firm had submitted the results of a phase-3 clinical study involving 24,244 subjects from the UK, Brazil and South Africa to CDSCO on June 8, 2021. Also, the results of a Phase III clinical study involving 32,379 subjects from the US, Chile and Peru were presented on July 9.
Earlier this week, SII’s COVID-19 vaccine Covovax, Biological E’s jab Corbevax and the anti-COVID pill mollupiravir were granted emergency use in India.
Earlier, six COVID-19 vaccines – SII’s Covishield, Bharat Biotech’s Covaxin, Zydus Cadila’s ZyCoV-D, Russia’s Sputnik V and US-made Moderna and Johnson & Johnson – have already received EUA from the Indian drug regulator. Was.