COVAXIN Phase 3 trial data to be out in July, says Bharat Biotech

Days after an early study claimed that the Covishield vaccine produces more antibodies against coronavirus infection than Covaxin, the latter’s manufacturer on Wednesday came out with a statement and said that the preliminary research has “a lot of flaws”.

Bharat Biotech, which manufactures indigenously-developed Covaxin, said the study has not been peer-reviewed. It also alleged that the research was not scientifically designed and was conducted on an ad hoc basis.

A recent comparative report on the evaluation of immunogenicity responses to spike protein after 1st and 2nd dose of Indian manufactured vaccines study had a lot of flaws. The journal that stated the comparative report said more antibodies were produced by Covishield than Covaxin.

“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 the CTRI website, nor approved by CDSCO and SEC,” Bharat Biotech said in its statement.

The pharma firm also revealed that the Phase 3 data of Covaxin’s trial will be published in July and the firm will then apply for full licensure of the Indian vaccine.

“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,” Bharat Biotech said.

“Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for COVAXIN,” it added.

It may be noted that Bharat Biotech has been facing a lot of flak for delaying the publication of the Phase 3 data, despite the fact that its vaccine was granted emergency use approval way back in January.

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