Bharat Biotech not allowed to conduct simultaneous Phase I, II trials for its intranasal COVID-19 vaccine
The SEC has reportedly refused to consider Bharat Biotech’s request and said it wants the Indian vaccine maker to first conduct the phase I trials and submit the immunogenicity data before moving on to the next stage.
Bharat Biotech has claimed that the non-invasive, single-dose vaccine will be far easier to administer.
Bharat Biotech has not been allowed to conduct simultaneous phase I and phase II trials for its nasal COVID-19 vaccine candidate, reported CNBC-TV18 on January 19.
Sources say SEC did not consider the request of Bharat Biotech to conduct both Phase 1 & 2 trials simultaneously for its nasal #vaccine candidate. SEC wants co to first conduct phase 1 & submit immunogenicity data before seeking approval for phase 2 pic.twitter.com/qNg4kOpGhH
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