There are about 20 million doses of Covaxin from Bharat Biotech ready, Dr. Ella said Monday.
New Delhi:
The president of Bharat Biotech, whose Covaxin coronavirus vaccine received “restricted use in emergency situations of public interest,” yesterday attacked critics who question the lack of data from Phase III trials and others who question the drug’s efficacy. , calling it “… sure, like water”.
An outraged Dr. Krishna Ella turned to a virtual presser and said that his company had conducted “200% honest clinical trials”, had an established track record of producing safe and effective vaccines and was transparent with all the data. “We don’t deserve this backlash,” he declared.
“Do not accuse us of inexperience. We are a global company … we have manufactured 16 vaccines. It is not correct to say that we are not transparent with the data. We conduct clinical trials in many countries, including the UK. The point is we are not a company Indian … but global, “said Dr. Ella.
“We have published in many journals. We were the first to identify the Zika virus and the first to file a worldwide patent for the Zika vaccine and the chikungunya vaccine. It is not correct to say that we are not transparent with the data. .. we don’t deserve the reaction, “he added.
“We have the only BSL-3 (biosafety level 3) production facility in the world, even the United States does not have it. We are here to help with public health emergencies anywhere in the world,” stated Dr. Ella.
On Sunday, India’s Comptroller General of Drugs granted emergency approval to two Covid vaccines – Covaxin from Bharat Biotech and Covishield from AstraZeneca-Oxford University, to be manufactured in India by the Pune-based Serum Institute.
The decision to greenlight Covaxin sparked a dispute, with critics pointing to a lack of efficacy data at this time. Covaxin has completed only two of the three required testing phases; the third, which tests efficacy, started in November. The previous two phases only ensured that the drug is safe.
Covishield, meanwhile, completed all three phases and submitted data to DCGI.
On Sunday, Serum Institute CEO Adar Poonawalla told NDTV that “there are only three vaccines with proven efficacy: Pfizer, Moderna and Oxford-AstraZeneca. Everything else has been shown to be safe, like water.”
Today, Mr. Ella responded to that comment (though without naming Mr. Poonawalla) and said: “We do 200% honest clinical trials and yet we get backlash. If I’m wrong, tell me. Some companies have labeled me as ‘Water'”. . “
Previously, the ICMR (Indian Council for Medical Research, the center’s nodal body in this crisis) acknowledged that it had no efficacy data for one of the two vaccines licensed for emergency use.
However, when asked to comment on Covaxin, ICMR Director General Dr. Balram Bhargava told NDTV: “The indicators are that it has a very high efficacy.” He also said that the efficacy data from the Phase I and II trials showed “an enormous amount of immunogenicity and safety data.”
Dr. Ella today defended the decision to grant Covaxin emergency approval, noting that “even the US government says that an emergency clearance can be granted if a company has good immunization data.”
(Except for the headline, this story has not been edited by NDTV staff and was released from a press release)
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