A 35-year-old healthy male adult who received a shot of Bharat Biotech's vaccine candidate against Covid-19 developed serious side effects and was hospitalised for a week in Nagpur, informed sources confirmed to CNN-News18. Bharat Biotech Chairman and Managing Director Dr Krishna Ella has verified that the adverse event took place and it was duly reported to the CDSCO. "We can't give every adverse reaction to the press," he said at a webinar event where questions were asked about this.
On July 15 during the phase 1 trials of the vaccine, a health volunteer was hospitalised with viral pneumonitis and spent a week in hospital. But it is clear there was no halt in trials even briefly when this adverse event was reported.
In a statement, Bharat Biotech said "the adverse event was not related to the vaccine and as required by the clinical trial guidelines, there was due reporting to the regulatory authorities. The adverse event during phase I clinical trials during August 2020 was reported to the CDSCO-DCGI, within 24 hours of its occurrence and confirmation".
The company also said it was investigated thoroughly and determined as not vaccine-related.
How much time did it take for the PI site to evaluate if the adverse event was not related to the vaccine dose? This is a question that has not been answered. What CNN-News18 has learnt is that the trial was not suspended during this period.
Ella spoke about the Subject Expert Committee (SEC) being kept in the loop but none of the minutes of the meeting indicate the same.
On the contrary, on September 10, the Serum Institute of India (SII), which was conducting the India trials for the coronavirus vaccine being developed by Oxford University, paused it after an adverse event was reported in the UK. The instruction was from the Drugs Controller General of India (DCGI). The drug regulator, however, issued a showcause notice to SII after trials of the AstraZeneca Covid-19 vaccine were halted in the UK and a handful of other countries.
Covaxin India's indigenous vaccine by Bharat Biotech is being developed in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV). Currently the vaccine candidate is in Phase III trials stage.