COVID roundup: Emergency approval in India for Serum Institute, Bharat vaccines; plus Inovio-Advaccine and Moderna
India grants emergency approval to two vaccines, only one of which has Phase III data
The Drugs Controller General of India (DCGI) granted Serum Institute of India Pvt. Ltd. restricted emergency approval for Covishield, which AstraZeneca plc (LSE:AZN; NASDAQ:AZN) and the University of Oxford are developing elsewhere as COVID-19 Vaccine AstraZeneca (AZD1222). In a press statement, DCGI cited said Serum Institute’s interim readout from an Indian Phase II/III trial of the adenoviral vector vaccine showing safety and efficacy data comparable to AZ and Oxford’s U.K. and Brazilian pivotal trials.
DCGI granted Covaxin, an inactivated SARS-CoV-2 vaccine from Bharat Biotech International Ltd., its first emergency authorization in any territory. Covaxin is in a Phase III trial in India that has yet to read out; as of Jan. 2, the study had enrolled over 23,000 of the planned 26,000 subjects. Phase I and Phase II data published in medRxiv showed prime-boost administration of 3 or 6 µg Covaxin led to neutralization seroconversion rates up to 96.3% at two weeks post-boost and mean neutralizing titers up to 160.1 in microneutralization assays...