India Grants Controversial Conditional Approvals To Serum, Bharat COVID-19 Vaccines
Confusion Over Serum's Exports Of AZ Vaccine
India has given conditional accelerated approval to AstraZeneca partner Serum Institute, and separately to Bharat Biotech, for their COVID-19 vaccines. With the latter’s candidate still in Phase III trials, the unprecedented decision has caused controversy given the national regulator had earlier said an EUA would not be granted unless trials are completed.
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A round up of COVID-19 developments, including the CDC advising that it is "prudent" to start testing variant vaccines in case the South African B.1.351 strain gains a foothold in the US.
Multiple COVID-19 vaccines, including from RDIF and Novavax, could get accelerated approvals in India in the first half of calendar 2021, expanding the range at the country’s disposal. J&J's vaccine is expected to follow although it still hasn’t begun local trials, while Pfizer has temporarily withdrawn an application.
AstraZeneca is expected to apply for the EU approval of its COVID-19 vaccine next week. The vaccine was developed in partnership with the University of Oxford.