- Vaccine by Bharat Biotech was approved for emergency use in India
- Critics questioned approval over lack of Phase III trial data
- Company's chairman says, "we don't deserve this backlash".
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 questioning the drug's efficacy. "We don't deserve this backlash," Dr Krishna Ella said.
Addressing a virtual presser, 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" and referred to vaccines for other illnesses that were approved without finishing Phase III trials.
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 that the drug is safe.
Covishield, meanwhile, has submitted data for all three phases, with trials taking place in India and around the world, and the DCGI has said the drug is 70.42 per cent effective.
In response, Dr Ella cited a 2019 CDCSO notification that said "good quality immunogenicity data" from Phase I and II trials could be presented, among other data, to get an emergency license.
He also said Bharat Biotech would be "ready with Phase III data in some days", pointing out that a massive trial (nearly 24,000 volunteers so far) was underway.
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.''
Dr Ella 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 back-up. People should be responsible before making such statements," he said.
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.
While the date of vaccine roll-out has not yet been confirmed, Dr Bhargava told NDTV it could happen "very, very soon". Serum Institute CEO Adar Poonawalla has said a majority of 50 million Covishield doses produced so far are for India. Dr Ella said 20 million doses of Covaxin are currently ready.
India has a little over 2.4 lakh active Covid cases, data from Monday morning showed.