Bharat Biotech, a vaccine manufacturer located in Hyderabad, lambasted a recent comparative study of antibodies produced by its vaccine Covaxin and Serum Institute of India’s locally produced Covishield vaccine on Wednesday, claiming the report has “plenty of faults.” “There were numerous errors in a recent comparison analysis on the examination of immunogenicity responses to spike protein after the first and second doses of Indian made vaccines. According to the journal that published the comparative analysis, Covishield produces more antibodies than Covaxin “In a statement, Bharat Biotech noted. The vaccine maker further noted that the pan-India survey, which gathered reactions from healthcare personnel who had received both doses of the preventives, was “neither a peer-reviewed publication nor a statistically & scientifically planned study.” “The study design and methods represent an ad hoc analysis, rather than a predefined hypothesis because it is not a peer-reviewed publication or a statistically and scientifically designed study.
The study was also not registered on the CTRI website, nor was it approved by CDSCO or the SEC “According to the firm. It is crucial to realize that Phase-3 data will be submitted to CDSCO first, followed by peer-reviewed journals, with a publication timeframe of 3 months, and that COVAXIN phase 3 results full trial data will be made public during July, as previously stated According to Bharat Biotech.
“Once data from the final analysis of phase III studies are available, Bharat Biotech will file for a full license for COVAXIN,” the company added.
Raches Ella, Bharat Biotech’s head of business development and advocacy, questioned why “non-peer-reviewed material” was published in tweets on Monday. Ella responded to a media story with a series of tweets “I’m surprised that the media and researchers are reaching conclusions based on non-peer-reviewed research.
Limitation 1: When testing Covaxin, which elicits wide antibody responses to Spike, N, and M, spike-based IgGs are not acceptable.
Live virus neutralization is recommended.” According to a recent pan-India study, Covishield vaccination creates more antibodies than Covaxin, although both vaccines create an “excellent immunological response.”
The study, which was released on the online website MedRxiv on June 4 but has yet to be published, included 515 healthcare workers (HCW) — 305 men and 210 women — from 22 locations across 13 states. The Serum Institute of India in Pune manufactures Covishield, a product of the Oxford-AstraZeneca stable.
Bharat Biotech, situated in Hyderabad, developed Covaxin in partnership with the ICMR and the National Institute of Virology (NIV).
According to a report by the news agency PTI, the number of antibodies produced and levels of specific antibodies directed to the virus’s spike protein, which is regarded as a surrogate for protection, were evaluated in the blood samples of participants who took part in the study. “After two doses of both vaccinations, 95 percent of the 515 HCW demonstrated seropositivity.
“Seropositivity was found in 98.1 percent of the 425 Covishield users and 80 percent of the 90 Covaxin recipients, respectively,” according to the study authors.
The development of antibodies in a person is referred to as seropositivity. Researchers from the Vijayratna Diabetes Centre in Ahmedabad, Kolkata’s GD Hospital and Diabetes Institute, Dhanbad’s Diabetes and Heart Research Centre, and the Rajasthan Hospital and Mahatma Gandhi Medical College and Hospital in Jaipur participated in the study.
The rise in anti-spike antibodies was also “much larger in Covishield vs Covaxin recipients,” with 127 AU/mL and 53 AU/mL, respectively, according to the investigators. Covaxin is a live viral vaccination that has been inactivated.
Covaxin has an effectiveness rate of 81 percent according to preliminary data from Phase 3 trials.
There is a 28-day interval between the two dosages.
Covishield is made from a weakened variant of a common cold virus found in chimps and is based on the viral vector platform.
Covishield is given in two doses, each 12 weeks apart.
It has a 70 percent effectiveness rate.
