The company needs to carry follow-up studies.
It needs to establish data as to what extent the vaccine provides protection.
After all the news of hue and cry over Covaxin not being approved by some countries, it has now been reported that the vaccine has not yet received approval by Subject Expert Committee (SEC). The vaccine indigenously developed by Bharat Biotech is under phase-3 trial and the trial has not yet ended.
The experts said that the company needs to carry out follow-up studies and it needs to establish data as to what extent the vaccine provides protection. There are all the possibilities that Bharat Biotech may have to wait until next year. However, Covaxin will continue to be available to the public under the earlier emergency authorisation.
An official explained that full license is granted one year after the last trial participant is recruited.
Bharat Biotech had submitted data of phase-3 trials to SEC on Tuesday. The data submitted showed Covaxin demonstrated 77.8 % efficacy in phase-3 trials conducted over more than 25000 participants.
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