Study on antibody levels produced by vax flawed | Economic Times

Hyderabad-based Bharat Biotech said on Wednesday that a report on a recent study that compared the level of antibodies produced by Covishield and Covaxin after their first and second doses contained “flaws.” The company also said it will be conducting phase-4 trials of Covaxin. Phase-4 trials are conducted after regulatory approvals to monitor long-term safety and effectiveness of drugs in real-world usage situations.The recent comparative study was conducted by independent experts, including 29 doctors from across India. As reported by ET on Monday, it found that both vaccines — Covishield and Covaxin — work well. However, it appeared that Covishield may have the ability to produce more antibodies and a higher seropositivity rate amongst recepients. Bharat Biotech told news agency ANI that it was not a peer-reviewed publication, nor a statistically and scientifically designed study. “The study design and conduct reflect an ad-hoc analysis, rather than predetermined hypothesis. Further, the study was not registered on the CTRI website, nor approved by CDSCO and SEC,” it said.AK Singh, the lead author of the study, said that he was “appalled” at the company’s reaction. “I was sensitive enough not to say that Covaxin evoked a timid antibody response after the first dose. It’s not mandatory to register at CTRI for a cross-sectional study nor any prior statistical calculation is required,” he told ET.The company said that once the data from the final analysis of phase-3 studies are available, the company will apply for full licensure for Covaxin.Some experts, on the other hand, said that the study gains significance in the absence of published phase-3 data for Covaxin. Covishield has already published phase-3 data. A public health expert said that an attack by Bharat Biotech is dangerous, and the company “should focus on the integrity of their own research efforts and leave it to independent scientists to critique both their own and others' research”.