Covaxin taken off clinical trial mode, no consent forms required

The decision by the Drugs Controller General of India (DCGI) comes a day after a subject expert committee that has been monitoring the development of the drug made a recommendation in this regard.

"...after detailed deliberation the committee recommended for omission 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 DCGI said in a letter to the Hyderabad-based company.

"Further, the ongoing phase 3 clinical trial should be continued as per the approved protocol," it added.

Covaxin has been declared to be an 81 per cent success.

The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research.

The DCGI decision is based on the interim efficacy rate data released by the company.

The regulator has asked Bharat Biotech to keep providing its data from the ongoing phase 3 trials. It has also directed the company to submit a revised summary of the characteristics of the drug. 

Apart from the waiver to consent form, those who take the vaccine will now not be needed to go through seven-day monitoring by medical teams.

"Covaxin is now in regular emergency use authorisation. This has taken the authorisation for Covaxin to another level. Both vaccines (Covaxin and Covishield) now have the same intensity of licensure. Therefore, it is a great day. Covaxin has now been given to more than 19 lakh people and there have been only 311 cases of side-effects. Covaxin has stood the test of time," Dr VK Paul, Head of India's Vaccine administration Committee, said on Thursday.