COVID-19 vaccine: Covaxin reported adverse event during Phase 1 trials

Henrietta Strickland
November 24, 2020

In fact, the company had issued a statement on November 21, Saturday, that a participant of Covaxin's phase I trial had developed an adverse reaction to receiving the vaccine, in August.

Bharat Biotech, the Covaxin vaccine maker in an email response to IE, said the adverse reaction with the participant happened during its first trial with the vaccine that was conducted in August 2020. The participant was hospitalised with viral pneumonitis, a couple of days after being administered the vaccine.

However, in a similar incident, AstraZeneca and Johnson & Johnson had temporarily halted their phase 3 clinical trial immediately after an adverse event was observed in a patient each after being administered vaccines.

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.

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".

"Bharat Biotech is one of the few companies to conduct human challenge studies at Oxford University, United Kingdom while it's is also conducting other clinical trials in U.S. and UK".

The company also claimed that it got approval for the next two phases of trials only after going through a detailed investigation about this adverse event. the company has now started the third and final phase of human trials for Covaxin which will be conducted on almost 26,000 participants which can cost the company approximately Rs. 250 crore.

Developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) Covaxin, Pune, is one of the promising coronavirus vaccine candidates in India. Bharat Biotech Chairman and Managing Director Dr Krishna Ella reportedly confirmed that the adverse event took place and was duly reported to the drug regulator Central Drugs Standard Control Organisation (CDSCO). However, "all treatment costs for the subject was fully paid for by the sponsor, and the subject is safe", Bharat Biotech said.

All Covaxin investigators were not appraised about the incident of a participant being hospitalized.

Covaxin is developed using an inactivated strain of SARS-CoV-2, the virus which causes COVID-19.

Other reports by Click Lancashire

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