India Opens Gates To mRNA COVID-19 Vaccines, Moderna First Out
Moderna’s mRNA COVID-19 vaccine has been cleared in India for restricted emergency use, with expectations building for a go-ahead for Pfizer/BioNTech’s jab too, though it will be important to see how the country deals with the contentious issue of indemnity to vaccine makers.
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India saw a raft of vaccine and drug approvals in 2021, backed by pandemic-related accelerated regulatory processes, and outlined its intent to step up biopharma innovation in the country. Pharma wants some of the regulatory flexibility to stay, though experts are seeking increased transparency in the overall approach.
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.
With an emergency approval, Zydus Cadila has commercialized the world’s first plasmid DNA vaccine for human use and the first COVID-19 vaccine for use in adolescents in India. Will efficacy against the Delta variant help tide over hesitancy towards a new technology or a lack of publicly published data hamper acceptance?