Amid row, Bharat Biotech says it will conduct phase 4 trial of Covaxin, phase 3 data to be out in July

Amid the Twitter war between Bharat Biotech's Raches Ella and Kolkata researcher Dr Aswadhesh Kumar Singh over Covaxin versus Covishield, Bharat Biotech on Wednesday informed that the company will conduct a phase 4 trial of its vaccine to check the real-world effectiveness of Covaxin. Its phase 3 trial data will be published in July, the company said, after which it will apply for full licensure.

Covaxin versus Covishield

While the Indian government has said that these two vaccines can not be compared as they are made differently, researchers have not stopped finding out the answer to the question: which vaccine is better between Covaxin and Covishield. A pre-print study, which is yet to peer-reviewed, has recently claimed that both the vaccines showed a good immune response after two doses. But Serum Institute of India's Covishield produced more antibodies than Covaxin.

Bharat Biotech versus researcher

Opposing the reporting of the study, Bharat Biotech's business development head Dr Raches Ella took to social media and said the study has its limitations.

Dr Aswadhesh Kumar Singh, one of the researchers, pointed to the fact that the "whole country is getting vaccinated even without a preprint phase 3 result — lest forget published one".

The company officially issued a statement on Wednesday against the study. "A recent comparative report on an evaluation of immunogenicity responses to spike protein after the first and second dose of Indian manufactured vaccines study had lots of flaws. The journal that stated the comparative report said more antibodies produced by Covishield than COVAXIN®[?]. This is not a peer-reviewed publication, nor do it a statistically and scientifically designed study. The study design and conduct reflect an ad hoc analysis, rather than a predetermined hypothesis," the company said.

Phase 3 data to be out in July

The company on Wednesday said that the data will be out by July. First, the data will be submitted to the Central Drugs Standard Control Organisation, followed by peer-reviewed journals. Then Bharat Biotech will apply for full licensure, the company said.

So far, the vaccine's overall efficacy on 78 per cent and its efficacy against hospitalisation is 100 per cent.

The 4th phase trials will be also be conducted to ensure that Covaxin met every rigorous standard, the company said.