While an mRNA vaccine is still missing, 2021 saw Indian companies strike alliances, battle legal action and gain funding while the regulator played a crucial enabling role in the run up to the approval of eight COVID-19 vaccines from zero in 2020.

Availability of emergency authorization route in US depends upon lack of 'adequate, approved and available alternatives,' but as more vaccines make their way through the BLA process sponsors may find the EUA door slowly closing.

Ocugen’s mutation-agnostic candidate for retinitis pigmentosa and leber congenital amaurosis is set for Phase I trials in the US. In this exclusive audio interview, founder and CEO Shankar Musunuri speaks to Scrip about seeking partners beyond CanSino Biologics for the candidate while stressing Bharat Biotech’s COVID-19 vaccine could hold promise against the Omicron variant.

A US FDA review panel has given a lukewarm reception to molnupiravir, while Inovio is assessing its vaccine candidates against the new omicron variant, J&J nears a South African vaccine deal with Aspen, and South Korea brings in new COVID-19 measures. Meanwhile, Serum exports Novavax vaccine, Bharat looks at Covaxin in Omicron and Ocugen's Covaxin trial put on hold.