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.”
“The Phase III human clinical trials of COVAXIN began mid-November, targeted to be done in “26,000” volunteers across India, this is India’s first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India. COVAXIN has been evaluated in approximately 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals,” read the statement from Bharat Biotech.
The two vaccines that got approval today could be rolled out within a week, though the health ministry has to take the final call, Dr Bhargava said. The government is yet to announce a date for the vaccine launch.
Asked when the rollout will happen, he said it should happen very soon.
“Both these companies have been stockpiling. Both these companies have been getting their bottling done… It (the vaccination) had a dry run recently. So from that perspective we are ready to roll it out very, very soon,” Mr Bhargava told NDTV.
Pressed for an exact date, he said, “The Health Ministry will be in the best position to comment on the exact date… but I think within a week we should be able to definitely start rolling it out”.
Mr Bhargava said the government has taken a “pro-active and pre-emptive approach” with the UK variant of the virus — believed to be 70 per cent more infectious — surfacing in the country.
Dr Randeep Guleria, the chief of Delhi’s All-India Institute of Medical Sciences, suggested that for the next few weeks, the Serum Institute vaccine that will be the main vaccine and Bharat Biotech will remain as “backup for emergency use”.