Covaxin phase-3 trial data will be made public next month, says Bharat Biotech
Premium- The submission of the phase-3 trial data is also mandatory to get the World Health Organization's Emergency Use Listing
The phase-3 trial data of the Covid-19 vaccine, Covaxin, will be out in July, the Hyderabad-based Bharat Biotech, which is manufacturing the indigenous vaccine, told ANI on Wednesday.
Once data from the final analysis of phase 3 studies are available, Bharat Biotech will reportedly apply for full licensure for Covaxin.
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"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," the drug firm said.
The submission of the phase-3 trial data is also mandatory to get the World Health Organization's Emergency Use Listing (EUL).
On 24 May, Bharat Biotech had conveyed to the government that it has already submitted 90% of the documents to the WHO for obtaining EUL for Covaxin.
The latest "Status of Covid-19 Vaccines within WHO EUL/PQ evaluation process" guidance document dated May 18 on the WHO website said Bharat Biotech submitted EOI (Expression of Interest) on April 19 and that "more information (is) required".
On Covaxin's efficacy
Regarding the efficacy of the coronavirus vaccine, Bharat Biotech told ANI, "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% and efficacy against hospitalizations is 100%."
The company added, "Whole virus Inactivated vaccines have demonstrated one of the best safety records globally."
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.
"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 company said.
The indigenous whole virion inactivated SARS-Cov-2 virus vaccine company has also said that Covaxin will even undergo phase 4 trials to check 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 vaccine manufacturer said.
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