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Product Development

COVID roundup: Emergency approval in India for Serum Institute, Bharat vaccines; plus Inovio-Advaccine and Moderna

Jan 5, 2021 | 12:30 AM GMT

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.

Inovio, Advaccine development and manufacturing deal
Inovio Pharmaceuticals Inc. (NASDAQ:INO) granted Advaccine Biopharmaceuticals Suzhou Co. Ltd. rights to develop, manufacture and commercialize COVID-19 vaccine INO-4800 in China, Hong Kong, Macau and Taiwan. Inovio gains access to Advaccine’s plasmid manufacturing process for the DNA-based vaccine and its other pipeline candidates, and will receive $3 million up front and up to $108 million in milestones, plus high single-digit percentage royalties. INO-4800 started a Phase II trial in China and a Phase II/III trial in the U.S. in December. 

Moderna predicts billions in potential vaccine revenues
In a Jan. 4 letter to shareholders, Moderna Inc. (NASDAQ:MRNA) said it could have a “multi-billion-dollar revenue in 2021” based on expectations it will be able to produce 500 million to 1 billion doses of Moderna COVID-19 Vaccine (mRNA-1273) per year. The biotech, which has no other marketed products, said the revenue would enable it to invest in R&D and scale its development pipeline “without the need for additional near-term capital raises.”

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