NEW DELHI: Bharat Biotech, the Hyderabad-based COVID vaccine producer, has categorically rejected a latest study that claimed that Covaxin is considerably less effective in opposition to the B.1.617.2 variant, the pressure largely chargeable for the ferocious second wave of the pandemic within the nation.
The firm additionally dismissed claims that its Covaxin is less effective than Serum Institute of India’s (SII) Covishield.
“A recent comparative report on an evaluation of immunogenicity responses to spike protein after the first and second dose of Indian manufactured vaccines study had lots of flaws. The journal that stated the comparative report said more antibodies produced by Covishield than COVAXIN. This is not a peer-reviewed publication, nor do it a statistically and scientifically designed study. The study design and conduct reflect an ad hoc analysis, rather than a predetermined hypothesis,” the corporate stated.
Â
A latest comparative report on analysis of immunogenicity responses to spike protein after 1st & 2nd dose of Indian manufactured vaccines study had plenty of flaws. The journal that acknowledged comparative report stated extra antibodies produced by Covishield than Covaxin: Bharat Biotech
— ANI (@ANI) June 9, 2021
Â
 The Hyderabad-based COVID vaccine manufacturer additionally stated that it is going to publish the section 3 trial knowledge in July and after that, it is going to be making use of for the total licensure of COVAXIN.
“It is critical to understand, and further emphasise the Phase-3 data will first be submitted to Central Drugs Standard Control Organisation (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. Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for COVAXIN,” Bharat Biotech was quoted as saying by ANI on Wednesday.
Â
It is crucial to know the Phase-3 knowledge will first be submitted to CDSCO, adopted by peer reviewed journals, with a timeline of ~ 3 months for publication, and as communicated earlier COVAXIN section 3 outcomes full trial knowledge might be made public throughout July: Bharat Biotech
— ANI (@ANI) June 9, 2021
Â
Regarding the efficacy of the vaccine, the corporate stated, “Vaccine efficacy refers to the ability of a vaccine to bring about the intended beneficial effects on vaccinated individuals in a defined population under ideal conditions of use. When it comes to efficacy and safety, the efficacy data of Covaxin have been reported at overall efficacy is 78 per cent and efficacy against hospitalizations is 100 per cent.”
The firm stated, “Whole virus Inactivated vaccines have demonstrated one of the best safety records globally.” There are already a number of authorized inactivated vaccines in opposition to Polio, Japanese Encephalitis, Rabies, Hepatitis A, and several other vaccines below improvement equivalent to Chikungunya, Zika, Dengue and Polio.
In a latest preliminary pre- peer-reviewed study about vaccine efficacy report, Bharat Biotech has clarified that it has undergone and can proceed to bear essentially the most intensive security and efficacy monitoring in Indian vaccines historical past.
The indigenous entire virion inactivated SARS-Cov-2 virus vaccine firm has additionally stated that Covaxin will even bear section 4 trials to test the real-world effectiveness of the vaccines.
“Bharat Biotech is also doing phase 4 trials to check on the real-world effectiveness of the vaccines, and to ensure its vaccine met every rigorous scientific standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” the corporate added.
(With ANI inputs)
 Live TV
