Phase 4 trials for Covaxin to be conducted by Bharat Biotech to confirm real effectiveness

All data derived from the phase 3 trials of Covaxin will be submitted to the Central Drugs Standard Control Organization (CDSCO) with peer-reviewed journals which will be available to the public by July.

Bharat Biotech International Limited, an Indian multinational biotechnology company based out of Hyderabad, will start conducting phase-4 clinical trials on Covaxin, the indigenously developed vaccine. These trials are being conducted to check the real-world effectiveness of the vaccine. They have said that they will only apply for full licensure for Covaxin after the final analysis data of the phase 3 trials have been analysed.

The company has mentioned that the phase 4 trial will not only corroborate the real-world effectiveness but will also make sure that the vaccine matches every ‘rigorous scientific standard’ in order to ensure that safety, effectiveness and manufacturing quality is equivalent for emergency use authorization (EUA).

The company said, “It is important to note, the inoculation drive which began in mid-January and with several million doses administered, we will have credible and sizable data soon”. In addition to that, it also mentioned that all data derived from the phase 3 trials of Covaxin will be submitted to the Central Drugs Standard Control Organization (CDSCO) with peer-reviewed journals which will be available to the public by July.

According to the data announced by the Indian Council of Medical Research (ICMR) and Bharat Biotech, emergency use authorized Covaxin has an efficacy of 78% and a 100% efficiency against hospitalizations.

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