The company also said that the phase 3 trials of Covaxin will be published in July
Bharat Biotech, the manufacturer of COVID-19 vaccine Covaxin, on Wednesday, slammed a recent study that showed Serum Institute’s Covishield has a significantly higher seropositivity rate and antibody response against the spike protein. Bharat Biotech said that the study had “lots of flaws”
In a statement to ANI, the Hyderabad-based company said “A recent comparative report on the evaluation of immunogenicity responses to spike protein after the first and second dose of Indian manufactured vaccines study had lots of flaws.”
It's not a peer-reviewed publication, nor statistically & scientifically designed study, the study design & conduct reflect an ad hoc analysis, rather than predetermined hypothesis. Further, the study was not registered on CTRI website, nor approved by CDSCO & SEC: Bharat Biotech
— ANI (@ANI) June 9, 2021
The statement also said that the study was not registered on the CTRI website, nor approved by Central Drugs Standard Control Organisation (CDSCO) and the Subject Expert Committee (SEC).
“It’s not a peer-reviewed publication, nor statistically and scientifically designed study. The study design and conduct reflect an ad hoc analysis, rather than a predetermined hypothesis. Further, the study was not registered on CTRI website, nor approved by CDSCO and SEC,” the company said
Dr. Raches Ella, Project Lead of COVID-19 Vaccines at Bharat Biotech, the makers of Covaxin, too, called out the coverage given to the study on Twitter and said, “Spike-based IgG’s are not appropriate when evaluating Covaxin, which induces broad antibody responses to Spike, N, and M. Recommend live virus neutralization.”
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Bharat Biotech further said, “It is critical to understand the Phase-3 data will first be submitted to CDSCO, followed by peer-reviewed journals, with a timeline of 3 months for publication, and as communicated earlier COVAXIN phase 3 results full trial data will be made public during July.”
It’s important to note that Bharat Biotech’s Covaxin hasn’t been recognized internationally by WHO yet and the vaccine’s final phase trial yet to be published.
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