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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Eight COVID-19 Vaccines Approved In India In 2021, mRNA Addition Awaited
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.
Coronavirus Update: Lukewarm US Panel For Molnupiravir, Inovio, Bharat Look At Omicron
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.
COVID-19 Vaccines: Ocugen’s EUA Request For Covaxin In Kids Faces Steep Climb At US FDA
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.