Covaxin phase 4 trials to be conducted soon, phase 3 data to be out in July: Bharat Biotech

Bharat Biotech is going to conduct a phase 4 trial of its COVID-19 vaccine, Covaxin, in order to check the real-world effectiveness. The company revealed that the results for the phase 3 trial will be published next month.

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New Delhi: Bharat Biotech, the Hyderabad-based COVID vaccine manufacturer, on Wednesday (June 9, 2021) said that the company is going to conduct a phase 4 trial of its COVID-19 vaccine, Covaxin, in order to check the real-world effectiveness.

The company revealed that the results for the phase 3 trial will be published next month, adding that following which the company will apply for full licensure. 

The statement comes amid a Twitter feud between Bharat Biotech's Raches Ella and Kolkata researcher Dr. Aswadhesh Kumar Singh over Covaxin versus Covishield. 

Even though the Centre has already said that both the COVID-19 vaccines are made differently and hence, cannot be compared, many scientists and researchers have embarked on the journey to find the answer to the question of ‘which vaccine is better between Covaxin and Covishield’. 

A pre-print study has recently claimed that both COVID-19 vaccines showed a good immune response after two doses, but the Serum Institute of India's Covishield produced more antibodies than Covaxin. However, the study is yet to peer-reviewed.

Meanwhile, Bharat Biotech's business development head Dr Raches Ella took it to his Twitter account to reveal that the study has its limitations.

“@Teensthack @singhak_endo surprised that media/researchers are concluding based on non-peer-reviewed work. Limitation 1: Spike-based IgG's are not appropriate when evaluating Covaxin, which induces broad antibody responses to Spike, N, and M. Recommend live virus neutralization,” he wrote on Twitter. 

@Teensthack @singhak_endo surprised that media/researchers are concluding based on non-peer-reviewed work. Limitation 1: Spike-based IgG's are not appropriate when evaluating Covaxin, which induces broad antibody responses to Spike, N, and M. Recommend live virus neutralization. https://t.co/kdCbfjwFbv — Dr. Raches Ella (@RachesElla) June 7, 2021

"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.

Additionally, the company also added that, so far, the vaccine's overall efficacy on 78 percent and its efficacy against hospitalisation is 100 percent. The 4th phase trials will be also be conducted to ensure that the vaccine met every rigorous standard, the company said.

(With agency inputs)