Covaxin To Be Moved Out Of Clinical Trial, What It Means For Bharat Biotech's COVID Vaccine
Covaxin, the COVID-19 vaccine co-developed by Hyderabad-based Bharat Biotech and ICMR, which recently published the results of its Phase-3 trials has cleared another hurdle.
The vaccine which was given emergency authorization despite not completing clinical trials can now be moved out of that phase.
What the DGCI said?
The Subject expert committee (SEC) of Drugs Controller General of India (DCGI) on Wednesday recommended removing the "clinical trial mode" condition on Covaxin.
SEC recommended a nod for Emergency Use Authorisation for Covaxin with the vaccine no longer needed to be administered in clinical trial mode.
They said the decision was taken after going through interim phase three trial data of the vaccine.
The company had earlier this month announced Phase 3 results of Covaxin, stating that the vaccine demonstrates interim clinical efficacy of 81 per cent.
Lancet study said it is 'safe'
Lancet, a top medical journal, which published phase 2 results of Covaxin, has said it was "safe, immunogenic with no serious side effects".
The reactogenicity assessments reported in this study were substantially better in the phase 2 trial than the phase 1?trial?and other trials with a placebo group. Additionally, the proportion of participants reporting adverse events in the phase 2 trial were lower than in the phase 1 trial," it said.?
Covaxin had also got emergency licensure in January but the authorisation was in clinical trial mode which made it mandatory for every beneficiary to sign an informed consent while getting the vaccine.
This however doesn't make much of a difference in the way how it has been administered in India so far.
The only practical difference now will be that the recipients will not be required to sign a consent form to take the indigenous COVID-19 vaccine.
This is a big relief for Bharat Biotech and the government which had come under heavy criticism over the vaccine's lack of data.
Criticism early on
Many had even criticized the emergency use authorisation given to Covaxin and the world's largest clinical trial of a COVID-19 vaccine without properly informing the recipients that they are part of an experiment.
Adding fuel to the skepticism was how the government rolled out two vaccines, Covishield and Covaxin, out of which the recipients had no option to choose, and only at the vaccination facility they were told which jab they are to receive.
Despite all the criticism, the government continued its support for the indigenous vaccine and even PM Modi and other minsters took the same jab earlier this month.
Covaxin, like Covishield is a two-dose vaccine administered to an individual in a gap of 28 days.
