Covaxin is 200% safe, says Dr Krishna Ella CMD Bharat Biotech, slams detractors

After the Modi government announced that Indian Biotechnology Company Bharat Biotech is ready to roll out Covid-19 vaccine – Covaxin, which has been developed in association with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), Dr Krishna Ella the chairman and managing director of Indian Biotechnology Company Bharat Biotech has come out heavily against detractors who have questioned the efficacy of this Indian vaccine. 

Dr Ella in his press conference said that the vaccine is 200 per cent safe and does not require paracetamols to suppress adverse reactions and confirmed data pertaining to the trials will be made available in a week’s time, ANI has reported.

“Covaxin has shown less than 10 per cent adverse reactions, while others have 60-70 per cent adverse reactions. AstraZeneca was giving 4g paracetamol to volunteers to suppress such reactions. We haven’t given paracetamol to any volunteer. I can assure our vaccine is a 200 per cent safe”, Dr Ella has been quoted as saying.

Dr Ella also raised objections over suggestions by ICMR and AIIMS heads terming Covaxin as a backup and got emotional when it was suggested, there was a lack of transparency in vaccine data.

“Many people just gossiping, it’s just a backlash against Indian companies. That is not right for us. We don’t deserve that…I don’t know why Indian companies are always targeted by everyone in the world. It is a global practice to issue emergency medical license. Even the US says that if you have good immunisation data, emergency authorisation can be done”, Dr Ella has been quoted by ANI as saying.

However, this achievement fell under a pall of gloom after several political parties and a section of the medical and media community raised doubts over the efficacy and safety of the Bharat Biotech vaccine after it received restricted emergency use approval from the Drug Controller General of India (DCGI).

Clinical trials for Covaxin have taken place in over 12 countries including the UK and “COVAXIN has generated excellent safety data with robust immune responses to multiple viral proteins that persist”, Dr Ella has been quoted as saying. Also, no placebo has been involved during the trials and every subject has been monitored for the safety and efficacy of the vaccine.

As per reports, 800 subjects were administered the vaccine in Phase I and II of the clinical trials. However, testing for Phase III vaccine was conducted on 22,500 subjects till date.

Dr Ella claimed that Bharat Biotech has “tremendous experience” in developing vaccines and has a presence in 123 countries and it is the only biotechnology company in the world which has a BSL-3 production facility.

As of now, Bharat Biotech has 20 million doses of Covaxin that have been manufactured and the capacity will eventually be scaled up to 700 million. Also, the price of the vaccine may be higher in the introductory period but it will eventually come down, said Dr Ella.

Also, Bharat Biotech has 140 global patents and a product portfolio of more than 16 vaccines, four bio-therapeutics, registrations in more than 116 countries and WHO Pre-qualifications and the has delivered over 4 billion doses of vaccines worldwide.

Bharat Biotech has alsodeveloped vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world’s first tetanus-toxoid conjugated vaccine for Typhoid.