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.
You may also be interested in...
After Zydus' Historic COVID-19 DNA Vaccine Approval, Inovio To Enter Phase III
Soon after Zydus Cadila won a historic accelerated approval in India for the world’s first plasmid DNA vaccine for human use, in this case against COVID-19, Inovio’s candidate is set to move to Phase III in Brazil. But will the new technology find wide acceptance?
As Delta Plus Variant Identified, Changes To India’s Trials Policy Could Help
As a new Delta plus variant is identified, India’s exemption of bridging trials for imported COVID-19 vaccines could help speed up immunization efforts. The urgency to fully immunize individuals could also prompt a reduction in the interval between Serum/AstraZeneca’s COVID-19 vaccine doses
Supply Concerns As India Fast Tracks COVID-19 Vaccines Approved By Certain Regulators
In an unusual move prompted by an enormous second wave of infections, India is accelerating approvals for COVID-19 vaccines granted emergency use authorizations by other selected regulators or on the WHO’s emergency use list without a local bridging study. While this seems a prelude to permitting private sales, where will the supplies come from?