Janssen is the second vaccine to be granted EUA through the fast-track approval route by the Drug Controller General of India. There are six vaccines that have been granted EUA by the DCGI - Covishield, Covaxin, Sputnik V, Moderna, Janssen and ZyCoV-D.
American pharma giant Johnson & Johnson's single-dose vaccine Janssen has arrived for the final round of quality and safety checks at a testing laboratory in Kasauli, Himachal Pradesh. Around 35 lakh doses of the vaccine against COVID-19, which were manufactured by Hyderabad-based Biological E, has been sent in the first batch for testing, a report said.
An official at the Health Ministry told News18 that it will take around two to three weeks for testing at CDL (Central Drugs Laboratory). "After completing the testing, the vaccine will be administered to 100 participants first, as mentioned in the rules for foreign vaccines. After analysing those 100 participants for seven days, the regulator will approve the vaccine for a national rollout," the official told News18.
Janssen is the second vaccine to be granted Emergency Use Authorisation (EUA) through the fast-track approval route by the Drug Controller General of India (DCGI). There are six vaccines that have been granted EUA by the DCGI - Covishield, Covaxin, Sputnik V, Moderna, Janssen and ZyCoV-D.
The Janssen COVID-19 vaccine was approved by FDA under an Emergency-use Authorization in February 2021 for adults. As per the World Health Organisation (WHO), the J&J vaccine has an efficacy of 85.4 percent against severe disease and hospitalisation, observed 28 days after inoculation.