Serum Institute files for full CDSCO approval of Covishield

SII had partnered with the developer of Covishield, AstraZeneca, for the supply of the vaccine to the Indian government, which had in January this year granted emergency use authorisation in the country.

"Supplies of the COVISHIELD vaccine in India, have exceeded 1.25 billion doses. The government of India now has enough data for full market authorisation, and therefore @SerumInstIndia has applied to the @CDSCO_INDIA_INF (DCGI) and @MoHFW_INDIA for this permission," Mr. Poonawala said in a tweet tagging the Central Drugs Standard Control Organisation (CDSCO) and Ministry of Health and Family Welfare.

Covishield, along with Bharat Biotech's Covaxin were the first two vaccines approved by the Drugs Controller General of India (DCGI) in January this year, under emergency use authorisation against the pandemic.

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, transitioning from an earlier emergency use authorisation (EUA) approval.

EUA is granted by authorities during public health emergencies to provide access to medical products after determining that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

In case of full market authorisation, the vaccines need to undergo the standard regulatory process for reviewing the quality, safety and effectiveness of medical products.

In October this year, the Pune-based SII had submitted the final phase 2/3 clinical study report of India with its application for grant of regular market authorization for Covishield.

The firm had also submitted phase-3 clinical study results of 24,244 subjects from the UK, Brazil and South Africa on June 8, 2021, to the CDSCO. Also, phase-3 clinical study results of 32,379 subjects from the US, Chile and Peru were submitted on July 9.

Earlier this week, SII's COVID-19 vaccine Covovax, Biological E's jab Corbevax and anti-COVID pill Molnupiravir were granted emergency use authorisation in India.

Prior to that, six COVID-19 vaccines -- SII's Covishield, Bharat Biotech's Covaxin, Zydus Cadila's ZyCoV-D, Russia's Sputnik V and the US-made Moderna and Johnson and Johnson -- had already received EUA from the Indian drug regulator.