Indicators are that Covaxin has very high efficacy, said ICMR (Representational)
New Delhi:
The Indian Council for Medical Research (ICMR) confirmed today that it had not received phase 3 efficacy or effectiveness data from one of the Covid vaccines that the government drug regulator authorized for emergency use.
When specifically asked to comment on the efficacy of Covaxin, the drug manufactured by Bharat Biotech, Dr. Balram Bhargava, Director General of the Indian Council of Medical Research, told NDTV: “ The indicators are that it has a very high efficacy ” but he declined to provide specific details. An efficacy report, he said, “would be (available) in a few weeks.”
Dr Bhargava, however, explained that preliminary data for Covaxin had been generated from ” animal, small animal and large animal studies ” and that there are efficacy data from phase 1 and phase 2 trials that have shown “ an enormous amount of immunogenicity and safety data. ”
The other drug that has been approved today is the Oxford / AstraZeneca vaccine that is being manufactured by the Serum Institute of India.
” Pfizer, Moderna and Astra-Zeneca-Oxford: these are the only three vaccines that have been shown to work, ” said Adar Poonawalla, director of the Serum Institute in Pune. ” Everything else has been shown to be safe, just like water is safe. But the efficacy, to know how well a vaccine works, 70%, 90%, 80%, has only been shown in these three vaccines. ”
In a statement tonight, Bharat Biotech President and Managing Director Dr. Krishna Ella said: “COVAXIN has generated excellent safety data with robust immune responses to multiple viral proteins that persist.”
“COVAXIN Phase III human clinical trials began in mid-November, and are targeted to be conducted on” 26,000 “volunteers across India. This is India’s first and only Phase III efficacy study for a vaccine. COVID-19 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 results for safety and immunogenicity, with acceptance in international peer-reviewed scientific journals, “reads the statement from Bharat Biotech.
The two vaccines that got approval today could be implemented in a week, although the Ministry of Health has to take the last call, Dr. Bhargava said. The government has yet to announce a date for the launch of the vaccine.
When asked when the launch will happen, he said it should happen very soon.
“Both companies have been building stocks. Both companies have been bottling their bottling … Recently (the vaccine) had a trial trial. So from that perspective, we are ready to implement it very, very soon,” Bhargava said. he told NDTV.
Pressed for an exact date, he said: “The Ministry of Health will be in the best position to comment on the exact date … but I think that within a week we should be able to definitively begin to implement it.”
Bhargava said the government has taken a “proactive and preventive approach” with the British variant of the virus, which is believed to be 70 percent more infectious, which is showing up in the country.
Dr Randeep Guleria, head of the All India Institute of Medical Sciences in Delhi, suggested that for the next few weeks, the Serum Institute vaccine will be the main vaccine and Bharat Biotech will remain as “backup for emergency use”.
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