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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Multiple COVID-19 vaccines, including from J&J, Pfizer and RDIF, are seen gaining approvals in India in 2021, following on from a raft of R&D, manufacturing and marketing tie-ups, as well as other developments, in the action-packed field last year.
No one wants to take away from India’s flair and prowess in the vaccines segment, but there should be no place for doubt when it comes to rigor in scientific and regulatory processes. Experts have raised questions around the restricted emergency use clearance of two COVID-19 vaccines in India.
Could Serum Institute or Bharat Biotech be the first company to have a COVID-19 vaccine for children under 12 years of age? While Pfizer and Moderna have begun pediatric trials for children 12 years and above, Serum plans to begin testing its indigenous vaccine and Bharat Biotech its Covaxin in children under 12