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AnkitKumar1635414
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Bharat Biotech's rush to seek approval is of concern as the company had not submitted any data from its phase 3 trial but relied entirely on the interim safety and immunogenicity data of the phase 1 and phase 2 trials; the company had begun phase 3 trials only in mid November. While Serum had submitted interim safety and efficacy data of the Oxford vaccine from the phase 2/3 clinical trials carried out in India and other countries, the safety data of the Indian trial submitted was only till mid November. The phase 3 trials by Serum began on September 21, and since the second dose is administered 28 days after the first, the median follow up after the second dose would have been for just a few weeks, far less than at least two months that the U.S. FDA had stipulated. With the published data of the interim phase 3 trial of the Oxford vaccine raising some concerns, the committee has rightly sought immunogenicity data from the U.K. trial.