Adverse event in phase 1 unrelated to Covaxin: Bharat Biotech

Tribune News Service

New Delhi, November 21

Bharat Biotech which is collaborating with the ICMR on one of India’s two indigenous COVID vaccines, on Saturday said its ongoing trial saw one adverse event in phase one of the trials and it was investigated as “unrelated to the vaccine”.

“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 adverse event was investigated thoroughly and determined as not vaccine related,” the company said in a statement.

Drug Controller General of India VG Somani did not make the adverse event public nor was the Bharat Biotech and ICMR ongoing trial on COVAXIN halted due to the adverse event.

In the past, AstraZenaca and Johnson and Johnson have temporarily halted their COVID vaccine trials after adverse events in one patient each.

Bharat Biotech International had had an adverse event in August during phase 1 trial when a patient without any co-morbidities was hospitalised with viral pneumonitis after a jab of Covaxin.

Covaxin trials have now entered phase 3 in India with “good progress”, according to VK Paul, Member, Health, NITI Aayog and chairman of India’s COVID vaccine task force.