In a statement that has generated optimism and curiosity in the medical fraternity, Bharat Biotech said Sunday that its COVID-19
The ‘Covaxin’ vaccine will be at least 60% effective, according to trial data.
The President of Quality Operations of Bharat Biotech Sai D Prasad said that the World Health Organization (WHO), the United States Food and Drug Administration (USFDA) and the Central Organization for Standard Drug Control of India ( CDSCO) approved a respiratory disease vaccine if it was at least 50% effective.
The firm said that while it had aimed to achieve at least 60% effectiveness, a minimum set of criteria, it was now trying to reach an even higher rate. “The chances of the vaccine being less than 50% effective are remote, as the results of our trials so far suggest,” he said.
In your target product profile for COVID-19 vaccines, WHO suggested that a “clear demonstration of efficacy (on a population basis) ideally with a point estimate of ~ 50%” should be a minimum criterion for any acceptable candidate. The agency also said that efficacy can be evaluated against “disease, serious illness and / or spread.”
With the efficacy of the vaccine passing the 50% mark, the news hits an optimistic note in the country as it continues to reel under the effects of the ongoing pandemic.
Bharat Biotech has also said that the vaccine implementation process is planned for mid-2021 after receiving approvals. “If we get all approvals after establishing robust experimental data and evidence, and efficacy and safety data in our last phase of trials, we aim to launch the vaccine in the second quarter of 2021,” the company said. News18.
Bharat Biotech, which manufactures India’s first indigenous vaccine against COVID-19 had started Phase III trials earlier this month. The trials, involving 26,000 volunteers at 25 centers in India, are being carried out in partnership with the Indian Council for Medical Research. It is the largest clinical trial being conducted for a coronavirus vaccine candidate in India.
However, the announcements also attracted attention. AIDAN co-convener Malini Aisola said in a tweet: “It has not shared the results of Phase 1 and 2. It does not clarify adverse events. The detailed protocols for Phases 1/2 and 3 are not in the public domain (sic ). “
But Dr. VK Paul, a member of the Center’s vaccine expert group, said News18 Trial data will be available only after the completion of Phase III trials, ruling out the claim that there was something unusual about the data being kept hidden from the public for now.
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