22 Nov 2020: Bharat Biotech vaccine trials continued despite 'adverse event' in August
The issue had come to light on Saturday after a report in The Economic Times.
It was reported that a 35-year-old trial participant with no co-morbidities was hospitalized after receiving the vaccine shot.
Report: Trial participant was hospitalized with viral pneumonitis
The report stated that the participant had to be hospitalized with viral pneumonitis after receiving a COVAXIN shot in July.
A senior government official told ET that the "serious adverse event" was not vaccine-related, adding that the matter was examined by the Data and Safety Monitoring Board (DSMB) of the sponsor, and the report was shared with the Drug Regulatory Authority.
Issue: Trials weren't stopped; experts concerned
However, the trials were not halted, and there was no public disclosure of this development. Public health experts that ET spoke to found it strange that the trials were not halted.
Notably, pharma companies AstraZeneca and Johnson & Johnson had temporarily halted Phase III clinical trials of their respective COVID-19 vaccine candidates immediately after an adverse event was observed in a patient.
Statement: Bharat Biotech issues statement confirming adverse event
After the report was published, the company issued a statement confirming the development.
It said the participant was hospitalized in August after receiving the dose the previous month.
He was discharged after a week's stay and is safe now, Bharat Biotech said, adding that all treatment costs for the subject were fully paid for by the sponsor.
Statement: Due process was followed, says Bharat Biotech
Further, Bharat Biotech said the adverse event was reported to the CDSCO-DCGI (Central Drugs Standard Control Organisation-Drug Controller General of India) within 24 hours.
It added, "The adverse event was investigated thoroughly, and presented to the CDSCO-DCGI, prior to obtaining permission for Phase II and Phase III clinical trials. The adverse event was investigated thoroughly and determined as not vaccine-related."
Vaccine: COVAXIN undergoing final stage trials; over 60% effective
COVAXIN is being developed by Bharat Biotech in collaboration with India's apex bio-research agency Indian Council of Medical Research.
It is a wholly-inactivated novel coronavirus vaccine which is currently undergoing third and final stage clinical trials at the Nizam's Institute of Medical Sciences, Hyderabad.
Officials told India Today that the vaccine will be over 60% effective and will be launched by Q2 of 2021.