Hyderabad-based vaccine manufacturer Bharat Biotech will conduct phase 4 trials of Covaxin to check the real-world effectiveness of the vaccine. The company is currently carrying out its phase 3 trial and it will publish the data in July following which it plans to apply for the full licensure of Covaxin.
“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," news agency ANI quoted the company.
“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 told ANI on Wednesday.
On the efficacy of the vaccine, Bharat Biotech said that, “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."
“Whole virus Inactivated vaccines have demonstrated one of the best safety records globally," Bharat Biotech said. There are already several approved inactivated vaccines against Polio, Japanese Encephalitis, Rabies, Hepatitis A, and several vaccines under development such as Chikungunya, Zika, Dengue and Polio.
In a recent preliminary pre-peer-reviewed study about vaccine efficacy report, Bharat Biotech has clarified that it has undergone and will continue to undergo the most intensive safety and efficacy monitoring in Indian vaccines history.
The study had concluded that Serum Institute’s Covishield triggered more antibodies than Bharat Biotech’s Covaxin. A preprint of the first Indian study, by Dr AK Singh and his colleagues, involving doctors and nurses who received both doses of either of the two Covid-19 vaccines states that both vaccines elicited a good immune response.
Countering the claims made by the study, Bharat Biotech said, “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 is a statistically and scientifically designed study. The study design and conduct reflect an ad hoc analysis, rather than a predetermined hypothesis."