The Central Drug Standard Control Organization through circular dated 15, April, 2021 has issued Guidance for approval of Covid vaccines for restricted use in emergency situations. The vaccines with emergency approval shall be administered as per the following guidelines for use:
- Vaccines shall be used as per the guidelines prescribed under National Covid-19 vaccination program.
- Post approval bridging clinical trials shall be conducted shall be conducted within 30 days of approval.
- First 100 beneficiaries shall be assessed for 7 days.
