No consent form required to take Covaxin coronavirus vaccine

New Delhi : Bharat Biotech's vaccine for coronavirus – COVAXIN – has been taken out from clinical trials and from now onwards there will be no requirement of consent form to take the vaccine.

"...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 drug regulator 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 is more than 81 per cent effective for the treatment of coronavirus, it has also been found effective against the UK strain, said Bharat Biotech on March 4.

Its 81 per cent success or efficacy rate was based on this: the trial had a little over 25,000 people. Among this sample, 43 people contracted COVID-19 - of them, 36 had been given a placebo and seven had been given Covaxin.

Interestingly, people taking Covaxin will not be monitored by the team of doctors for seven days.

"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 earlier today.

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