Covaxin gets approval to lift clinical trial mode

The Drug Controller General of India (DCGI) has approved the Central Drugs Standard Control Organisation (CDSCO)'s recommendation to remove Bharat Biotech's Covid-19 vaccine COVAXIN from the clinical trial mode.

New Delhi: A day after the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) recommended removal of "clinical trial mode" for the use of Bharat Biotech's Covid-19 vaccine COVAXIN, the Drug Controller General of India (DCGI) on Thursday has accepted the recommendations.

Following the approval, COVAXIN got the approval for restricted use in an emergency situation without "clinical trial mode."

The Hyderabad based company, last week has claimed that COVAXIN has shown an interim efficacy of 81 percent in its phase 3 clinical trial.

Following the findings, the company approached the DCGI for the removal of the clinical trial method. In January COVAXIN was given EUA under clinical trial mode due to incomplete data on the vaccine's efficacy.

Recently, a global medical journal 'The Lancet' has said that BBV152 (COVAXIN) was safe, immunogenic with no serious side effects.

In its meeting that took place on Wednesday, the SEC recommended ommission of the condition of the use of the vaccine in clinical trial mode.

"However, the vaccine should be continued to be used under restricted use in emergency situation condition," the SEC said.

Bharat Biotech had presented, to the SEC, updated interim safety data of its phase III clinical trial of the Whole Virion, Inactivated Coronavirus vaccine (BBV152) in the country.

Reacting to the development, senior health expert and Indian Council of Medical Research (ICMR) advisor Dr Suneela Garg told ETV Bharat that the approval was much expected.

"This development will certainly promote make in India vaccine. Bharat Biotech is well known for producing good vaccines not only for India but also for other countries," said Dr Garg.

She feels that the development will also end vaccine hesitancy among the people.

Another senior health expert and president of the Asian Society for Emergency Medicine Dr Tamorish Kole said that it was the right step in the right direction.

Kole, however, said that India needs more vaccines to inoculate the huge population of the country.

"Giving approval to COVAXIN for EUA without clinical trial mode will definitely inspire the vaccine manufacturers as India need more vaccines to fight the Covid-19 pandemic," Dr Kole added.