Conditional Approval for Serum, Bharat Bio COVID-19 Vaccines In India Amid Uproar
Confusion Over Serum's Exports Of AZ Vaccine
India gave a conditional accelerated approval to AstraZeneca partner Serum Institute and separately, to Bharat Biotech for their COVID-19 vaccines. With the latter’s vaccine still in Phase III trials, the unprecedented decision caused a flutter as the regulator had earlier said an EUA would not be granted unless trials are completed.
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J&J and Pfizer should benefit from India’s unusual move to grant accelerated approvals minus a prior local bridging study for COVID-19 vaccines granted emergency use authorizations by certain regulators or on the WHO’s emergency use list. But while this seems like a prelude to permitting private sales, where will the supplies come from?
AstraZeneca has sent a legal notice to Indian partner Serum Institute for non-delivery of COVID-19 vaccines. Will this and the entry of a new challenger, Sputnik V, in the Indian market affect Serum’s fortunes? Will the EMA and MHRA announcement on clotting incidents related to the AZ vaccine shrink demand for the partnered vaccine?
Bharat Biotech’s COVID-19 vaccine has shown 80.6% efficacy in interim data from Phase III clinical trials, slightly better than the 79.3% reported by Sinopharm and significantly higher than Sinovac’s 50.6% for their vaccines based on similar technology. Supply deals are already on the way, with Brazil having signed up for 200 million doses.