India Prepares 2nd COVID-19 Vaccine Launch Plans

The India Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO) has reportedly recommended the experimental COVID-19 vaccine candidate Covaxin for emergency use authorization, reported news agency ANI on January 2, 2020. The recommendation, along with rollout modalities, will now be taken up by the Drug Controller General of India (DCGI) for a final decision on the matter.

After completing the interim analysis from the Phase 1 & 2 clinical trials of Covaxin, Hyderabad-based Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centers across India. The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's Bio-Safety Level 3, a high-containment facility.

Previously, Bharat Biotech's chairman has claimed that Covaxin can protect against the mutated SARS-CoV-2 coronavirus strain that surfaced in the United Kingdom and several other countries.

"It (coronavirus) is expected to have a lot of mutation, and you can be rest assured this vaccine will also protect against that (mutated) virus because of two hypotheses... So you have these two components in the inactivated vaccine. It will also take care of those mutations," Bharat Biotech Chairman Krihsna Ella said on December 29, 2020, as reported by News18.