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 Bharat Biotech is close to an accelerated approval of Covaxin in two to 18-year-olds, Zydus Cadila is yet to roll out its COVID-19 vaccine in India. As they head to a face-off in pediatric vaccines, the former faces manufacturing constraints and the latter hesitance over a first of its kind DNA vaccine. Experts speak to Scrip on which one stands a better chance of winning.
A potential decline in mRNA vaccine protection against the Delta variant is raising questions about the need for booster shots in the US. Ocugen Inc. and partner Bharat Biotech hope the changing dynamic of COVID-19 in the US will induce the FDA to reconsider additional clinical trial requirements for Covaxin, an inactivated whole virus vaccine authorized for emergency use in 16 countries.
The companies announced data from their Phase II/III study in children aged 5-11 and intend to take them to regulators to expand Comirnaty's authorization; also, an expert panel advising India's drug regulator endorsed plans for a Phase III trial of a single-dose Russian vaccine, Sputnik Light, and vaccines from other Indian firms progress.