The regulator has asked Bharat Biotech to keep providing trial data (File)
New Delhi:
Covaxin – Bharat Biotech’s homegrown vaccine against the coronavirus – has been taken off the clinical trial mode, which means beneficiaries will not have to sign consent forms before taking the drug. This comes a day after a subject expert committee that has been monitoring the development of the drug made a recommendation in this regard to the country’s drug regulator, DCGI.
“…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 – which had been linked to vaccine hesitancy as it was approved for emergency use without efficacy data being made public – is 81 percent effective in preventing COVID-19 and can work against the UK variant of the virus, Bharat Biotech said 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.
The DCGI decision is based on the interim efficacy data released by the company.
The regulator has asked Bharat Biotech to keep providing it 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 consent form waiver, 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 earlier today.
On Tuesday, medical journal Lancet declared the drug “safe, immunogenic with no serious side effects”. It, however, said efficacy cannot be determined by phase 2 trials.