Bharat Biotech has provided additional data sought by WHO and the vaccine Covaxin is closer to WHO emergency use listing.
An interim analysis of Covaxin’s Phase-3 trials, conducted on 25,800 volunteers across India, had indicated an overall efficacy of 78%. Earlier, Bharat Biotech said scientific standards and commitment of the indigenously-developed Covid-19 vaccine Covaxin are transparent, and the company has so far published nine research studies on its safety and efficacy.
The complete data for Phase I and II, and partial data for Phase III trials of Covaxin have been thoroughly scrutinised by the regulators in India, Bharat Biotech said in a statement.
Covid-19 -related deaths worldwide passed a grim milestone of 4 million on Thursday, as many countries struggle to procure enough vaccines to inoculate their populations. While the number of new cases and deaths have abated in countries like the US and Britain, several nations have vaccine shortages as the Delta variant becomes the dominant strain around the world.
WHO’s seal of approval would be a major booster for the Indian vaccine that has found itself mired in controversy ever since the Drugas Controller General of India granted an emergency use nod on January 3 this year while its phase-3 trials were under way.
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