The expert panel that is advising the Drug Controller General of India (DCGI) on Covid-19 vaccines has given an in-principle nod today to the AstraZeneca-Oxford vaccine candidate, which Pune’s Serum Institute of India will make and market here, say sources in the know.
“Serum Institute’s Covishield vaccine candidate has been given an in-principle nod from the expert panel and now the drug regulator needs to approve it. This would be a restricted emergency use authorisation with some conditions,” said the source.
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While US giant Pfizer did not come to present its case on Friday before the Subject Expert Committee (SEC), Hyderabad-based vaccine major Bharat Biotech has presented its case. The meeting is still on and an official update is expected soon.
Bharat Biotech has sought approval based on data from phase-1 and 2 trials and has also submitted some interim data from their ongoing phase-3 trials. Covaxin, their vaccine candidate, is based on whole inactivated virus vaccine platform, which is an old technology. Covishield, on the other hand, is based on monkey adenoviral (flu) vector candidate.
- Panel clears Covid-19 vaccine manufactured by Serum Institute: Reports [https://www.business-standard.com/article/current-affairs/panel-clears-covid-19-vaccine-manufactured-by-serum-institute-reports-121010100787_1.html]
- India drug regulator approves AstraZeneca COVID vaccine, country’s first – sources [https://www.reuters.com/article/us-health-coronavirus-india-vaccine/india-drug-regulator-approves-astrazeneca-covid-vaccine-countrys-first-sources-idUSKBN296292]
- Covishield vaccine: India’s drug regulator approves AstraZeneca/Oxford vaccine [https://www.khaleejtimes.com/coronavirus-pandemic/covishield-vaccine-indias-drug-regulator-approves-astrazenecaoxford-vaccine]
- Oxford-AstraZeneca ‘Covishield’ vaccine likely to get nod in India [https://www.siasat.com/oxford-astrazeneca-covishield-vaccine-likely-to-get-nod-in-india-2058269/]
- Covid vaccine in India: Expert panel clears Covishield’s emergency use [https://www.khaleejtimes.com/coronavirus-pandemic/covid-vaccine-in-india-expert-panel-clears-covishields-emergency-use]
- AstraZeneca vaccine set to become first to get approval in India AstraZeneca vaccine set to become first to get approval in India [https://tbsnews.net/coronavirus-chronicle/astrazeneca-vaccine-set-become-first-get-approval-india-179515]
- AstraZeneca vaccine set to become first to get approval in India: Sources [https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/astrazeneca-vaccine-set-to-become-first-to-get-approval-in-india-sources/articleshow/80059777.cms]
- AstraZeneca vaccine set to become first to get approval in India: Report [https://www.business-standard.com/article/current-affairs/astrazeneca-vaccine-set-to-become-first-to-get-approval-in-india-report-121010100607_1.html]
- AstraZeneca vaccine set to become first to get approval in India: sources [https://thehimalayantimes.com/world/astrazeneca-vaccine-set-to-become-first-to-get-approval-in-india-sources/]
- AstraZeneca COVID vaccine set to become first one approved in India [https://bdnews24.com/neighbours/2021/01/01/astrazeneca-covid-vaccine-set-to-become-first-one-approved-in-india]