Home |Covid Vaccination | Indian regulators have given authorization to Covaxin even before its Phase 3 trial results were out. How do we explain this?

Indian regulators have given authorization to Covaxin even before its Phase 3 trial results were out. How do we explain this?

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Citizen Helpdesk, Curated Answers from Government Sources
Answered on April 27,2021
We are passing through COVID-19 pandemic. COVID-19 has caused social disruption, economic downturn and significant number of deaths. To control this pandemic, the society as well as the system may have to take steps which may also be termed as drastic. Both pre-clinical and clinical data (complete data for Phase I and II, and partial data for Phase III) of Covaxin have been thoroughly scrutinized by the regulators. This data shows that the vaccine is safe and induces a robust antibody response. However, to what extent the vaccine will protect the recipients from getting the disease is not fully known yet. Therefore, the regulators have allowed its use in trial mode. Source: This answer is sourced from Ministry of Health and Family Welfare portal.
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