Bharat Biotech, one of the frontrunners in making a vaccine for COVID-19, had not made public an adverse case event back in August during its phase 1 trial, according to a report.
The incident happened when a 35-year-old patient with no co-morbidities was hospitalised after receiving a dose of the COVID-19 vaccine Covaxin. The patient had viral pneumonitis, a couple of days after being administered the vaccine, and was discharged after a week’s stay in the hospital, according to a report in the Times of India.
But the matter was not made public by either the company or the regulator, Central Drugs Standard Control Organisation and its head Drug Controller General of India (CDSCO-DCGI) VG Somani, the daily reported.
Bharat Biotech, however said the incident was reported to the CDSCO-DCGI within 24 hours of its occurrence.
“The adverse event was investigated thoroughly and determined as not vaccine related,” the company said in a statement.
“All treatment costs for the subject was fully paid for by the sponsor, and the subject is safe,” Bharat Biotech said.
The company says it got an approval for the next two phases of clinical trials only after a detailed investigation of the incident was completed.
The company is now holding stage 3 clinical trials of Covaxin in collaboration with apex bio-research agency the Indian Council of Medical Research.
The tests are being held at Nizam’s Institute of Medical Sciences in Hyderabad and the company is hoping to enrol up to 26,000 participants for this phase which is set to cost the company about ₹150 crore.
AstraZeneca and Johnson & Johnson, the other vaccine contenders, had temporarily halted their phase 3 clinical trial immediately after an adverse event was observed in a patient each after they received their respective vaccines.