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Serum Institute files for full CDSCO approval of Covishield

Ruchika SharmaWritten by Ruchika Sharma Published On 2022-01-01T13:01:27+05:30  |  Updated On 1 Jan 2022 1:01 PM IST
Serum Institute files for full CDSCO approval of Covishield
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New Delhi: Serum Institute of India (SII) CEO Adar Poonawala on Friday said the vaccines major has applied to Indian authorities for full market authorisation of Covishield, stating supplies of the COVID-19 vaccine have exceeded 125 crore doses.

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.

Read also: Immunization efforts in India, lower, middle income countries to strengthen with Covovax approval, says SII

serum instituteserum institute of india newscovishieldcoronavirus vaccinecoronaviruscovid19adar poonawala
Source : PTI
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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