Can Delta Variant Effectiveness Fill Brazil-Sized Hole In Bharat Biotech’s Prospects?
Ocugen Class Action Suit Could Get Tricky
A study indicates that the Delta variant of SARS-CoV-2 and its sub-lineage Delta Plus can be neutralized by Bharat Biotech’s COVID-19 vaccine, but a federal investigation in Brazil and a class action suit against its US partner have hurt the firm’s global ambitions. Experts weigh in on what the future could possibly hold.
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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.
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.
Company says it is pursuing authorization for 2-18 year-olds due to unmet need and lack of an authorized vaccine in the youngest age group; however, the relatively small size of the safety database, the single-arm design of the pediatric immunobridging study conducted solely in India, and lack of authorized use in adults spell trouble for the request.