The Indian Council for Medical Research (ICMR) confirmed today that it had not received Phase 3 efficacy or effectiveness data of one of the Covid vaccines that the government’s drug regulator has cleared for emergency use.
Asked specifically to comment on the efficacy of Covaxin, the drug manufactured by Bharat Biotech, Dr Balram Bhargava, the Director General of the Indian Council of Medical Research, told NDTV, ”The indicators are that it has a very high efficacy,” but declined to provide any specific detail. An efficacy report, he said, ”would be (available) within weeks.”
Dr Bhargava did, however, explain that preliminary data for Covaxin had been generated from ”animal studies, small animals and large animals” and that there is efficacy data from Phase 1 and Phase 2 trials which have showcased ”a tremendous amount of immunogenicity and safety data.”
The other drug which has been cleared today is the Oxford/AstraZeneca vaccine being manufactured by the Serum Institute of India.
”Pfizer, Moderna and Astra-Zeneca-Oxford – these are the only three vaccines which have proven to work,” said Adar Poonawalla, the chief of Pune-based Serum Institute. ”Everything else has proven to be safe – just like water is safe. But the efficacy — to know how well a vaccine works — 70%, 90%, 80% – has only been proven in these three vaccines.”
In a statement this evening, Chairman and Managing Director of Bharat Biotech Dr Krishna Ella said, “COVAXIN has generated excellent safety data with robust immune responses to multiple viral proteins that persist.”
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