Covaxin trials not halted
- Bharat Biotech says illness not related
- Now Covaxin in phase 3 trials
New Delhi: A 35-year-old healthy male adult, who received a shot of Bharat Biotech's Covaxin vaccine candidate against Covid-19, developed serious side-effects and was hospitalised for a week in Nagpur, according to reports.
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 Covaxin, a health volunteer was hospitalised with viral pneumonitis and spent a week in hospital. But it is clear that 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 that the illness was not vaccine-related one.