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Bharat Biotech Chief Assures COVAXIN's Safety; Promises 'Phase-3 Efficacy Data By March'

Bharat Biotech's CMD Dr. Krishna Ella, lashed out at adverse reactions to COVAXIN by several politicians, experts and social media users after DCGI's nod

A day after massive politicisation occurred over the DCGI's nod to Bharat Biotech (BBL)-ICMR's 'COVAXIN', BBL's CMD Dr. Krishna Ella, lashed out at the adverse reactions to his vaccine by several politicians, experts and social media users. Dr. Ella explained the company's long experience in dealing with vaccines, touting that 123 vaccines have been produced by the company globally. Assuring the safety of COVAXIN, he explained in detail the process of the clinical trials and the data available in the public domain regarding COVAXIN. The DCGI has allowed AstraZeneca - SII's 'COVISHIELD' and Bharat Biotech - ICMR's 'COVAXIN' vaccines for restricted use in an emergency situation.

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Dr Ella: 'We are experienced in vaccines'

"We have tremendous experience in vaccines - touching 123 vaccines globally. Many people accused me of clinical trials only in India. We did it in various countries. In 8-10 months vaccine developed in India. Now that vaccine is being politicized, I want to state very clearly that none of my family members is associated with any political party," he said.

Comparing COVAXIN's publications to the other vaccines developed by Moderna, Pfizer, Dr. Ella said that they were not inferior in any manner. Stating that the authorisation is given to AstraZeneca-SII's 'Covishield' included the UK trials, he said that BBL was the only company with safety data of 25,000 patients. Answering queries of the media, Dr. Ella said that efficacy data of COVAXIN will be available by March and that 20 million doses have been stockpiled by the company for the upcoming national innoculation drive.

"All our samples have been verified by NIV Pune, using the double-blind method. We have published five journals on our vaccine, which is available in the public domain. We are no way inferior to Moderna or Pfizer in terms of our vaccine. Serum vaccine has no publication," he said.

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He added, "Oxford-AstraZeneca gave 4g of Paracetamol for clinical trials before vaccines, but we did not do that. If we did any malpractice in the trials, our Drug controller (DCGI) would have stopped us. The politicisation hurts us as a scientist. Is this type of bashing we deserve from people? Emergency authorization to the other vaccine was given based on UK trial data, but our data is based on India. We have safety data for 25,000 patients, which other company has such data? We are planning to do vaccine trials on children soon".

Talking about the pricing of the vaccine, he said, "We will get Phase-3 efficacy data by March. 20 million doses have been stockpiled. 700 million doses capacity in four facilities -  three in Hyderabad and one in Bengaluru. In beginning, the cost of the vaccine will be high but as the scale of production increases, the price will be controlled by the market. Government is in talks with us. We will unblind our data when 146 cases of Coronavirus positive cases in phase-3 trials and then we can judge efficacy. We will roll out the vaccine as early as possible".

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On Sunday, Drug Controller General of India (DCGI) VG Somani announced that the vaccines of Serum Institue of India (Covishield) and Bharat Biotech (Covaxin) have been granted permission for restricted use in an emergency situation. Covishield - a Recombinant Chimpanzee Adenovirus vector vaccine - has an efficacy of 70.42%, with interim safety and immunogenicity data of Phase-II/III trials submitted to the SEC. Covaxin - a Whole Virion Inactivated Corona Virus Vaccine - 22,500 participants vaccinated in Phase-III trials and was found to be safe as per the data available till date. Meanwhile, Zydus-Cadilla's nCov-Vaccine using DNA platform technology has been allowed to conduct Phase-III clinical trial in 26000 Indian participants.

Union Health Minister Dr. Harsh Vardhan explained that COVAXIN is more likely to work against newer variants like N501Y Variant (UK variant) & any other variant. Citing Phase-I and Phase-II data, Dr. Vardhan stated that no adverse effects were seen after the clinical trials. He also clarified that COVAXIN was given a different approval i.e 'clinical trial mode' - where all COVAXIN recipients will be tracked,monitored as if they’re in trial. COVAXIN is an indigenous COVID-19 vaccine by Bharat Biotech, developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). 

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