'Not peer-reviewed, has lots of flaws': Bharat Biotech on Covishield-Covaxin antibody study
New Delhi | Jagran News Desk: India's own COVID-19 vaccine manufacturer, Bharat Biotech, on Wednesday came out with a statement in connection with the claims of an early study which stated that the Serum Institute of India's (SII) vaccine, Covishield, produces more antibodies against the deadly virus then Covaxin. Bharat Biotech, in its statement, said that the preliminary research has a lot of flaws.
Covaxin manufacturer Bharat Biotech alleged that the research was conducted on an ad hoc basis and was not scientifically designed. The statement further stated that the research has also not been peer-reviewed.
"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", the statement by Bharat Biotech stated.
"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 statement added.
Bharat Biotech also revealed that it will apply for full licensure of its COVID vaccine, Covaxin, from the drug regulator once the phase 3 data of Covaxin's trials will get published in July this year.
"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, adding, "Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for COVAXIN".
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. The vaccine also made headlines for not getting an approval from the WHO, due to which international passengers, who received Covaxin jab, were forced to get vaccinated again in countries like the US.
Posted By: Talibuddin Khan