The chairman of Bharat Biotech – whose coronavirus vaccine Covaxin has been given “restricted use in emergency situation in public interest” – hit out Monday at critics flagging the lack of Phase III trial data and others questioning the drug’s efficacy, branding it “… safe, like water”.
“We don’t deserve this backlash,” an indignant Dr Krishna Ella declared.
Addressing a virtual presser this evening Dr Ella said his company had carried out “200 per cent honest clinical trials”, had an established track record in producing 16 safe and efficacious vaccines, and was transparent with all data.
“Don’t accuse us of inexperience. We are a global company… have manufactured 16 vaccines. It is not correct to say we are not transparent with data. We conduct clinical trials in many countries, including the UK. The point is we are not an Indian company… but a global one,” he stressed.
“We have published in a lot of journals. We were the first to identify the Zika virus and the first to file a global patent for the Zika vaccine and the Chikungunya vaccine. It is not correct to say that we are not transparent with data… we don’t deserve the backlash,” Dr Ella added.
He also said the company had “the only BSL-3 (bio-safety level 3) production facility in the world”.
On Sunday the Drug Controller General of India granted emergency approval to Covaxin and AstraZeneca-Oxford University’s Covishield, which will be produced by Pune-based Serum Institute.
The decision to green-light Covaxin triggered a row, with critics pointing to a lack of efficacy data at this time. Covaxin has completed only two of three required trial phases; the third – which tests for efficacy – began in November. The two earlier phases only ensured the drug is safe.
Covishield, meanwhile, has completed all three phases, with trials taking place in India and around the world, and submitted data to the DCGI, which said the drug was 70.42 per cent effective.
On Sunday, Serum Institute CEO Adar Poonawalla told NDTV: “… only three vaccines with proven efficacy – Pfizer, Moderna and Oxford-AstraZeneca. Everything else… safe, just like water.”
Today Dr Ella hit back at that remark (although without naming Mr Poonawalla) and said: “We do 200 per cent honest clinical trials and yet we receive backlash. If I am wrong, tell me. Some companies have branded me like ‘water’. I want to deny that. We are scientists.”
He also took on Dr Randeep Guleria, the chief of Delhi’s AIIMS (All India Institute of Medical Sciences), who yesterday suggested Covaxin could be a “back-up”. “It is a vaccine. It is not a backup. People should be responsible before making such statements,” he said.
Earlier the ICMR (Indian Council for Medical Research, the centre’s nodal body in this crisis) acknowledged that it did not have efficacy data for one of two vaccines cleared.
However, when asked to comment on Covaxin, Dr Balram Bhargava, the ICMR’s Director General, told NDTV: “The indicators are it has very high efficacy“. He also said that efficacy data from Phase I and II trials showed ”a tremendous amount of immunogenicity and safety data.”
The centre last week held a day-long trial of the vaccine delivery system to check for problems once the drug is rolled out. The Health Minister, Dr Harsh Vardhan, said that around three crore frontline workers, including doctors, nurses and essential services, will be first to be vaccinated.
(Except for the headline, this story has not been edited by NDTV staff and is published from a press release)