Incorrect To Criticise Transparency With Data, Clinical Trials Are Honest, Says Bharat Biotech Chairman

In a major reaction to criticism against the vaccine maker, the chairman of Bharat Biotech Dr Krishna Ella has come out strongly against critics saying “We don’t deserve this backlash”. Bharat Biotech’s Covaxin has got approval for “restricted use in emergency situation in public interest” .  Apart from Bharat Biotech, Drug Controller General of India also granted emergency approval to AstraZeneca-Oxford University’s Covishield, which will be produced by Pune-based Serum Institute. Also Read: Bird Flu Outbreak Confirmed In 4 Indian States: 40,000 Birds To Be Culled In Kerala, Alert Sounded In Rajasthan

What is Bharat Biotech response to critics?

Addressing a virtual press conference, Dr Ella has mentioned that his company had carried out “200 per cent honest clinical trials”, and 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 pointed out.

While elaborating on it further Dr Ella said, “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.”

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.

While pointing out at the trial done by AstraZeneca-Oxford, he said if his firm had done a vaccine trial like AstraZeneca, the Indian regulator would have “shut down the company’’. The chairman was referring to the inadvertent dosing error in case of the Oxford-AstraZeneca vaccine in the UK, where a group received a half-dose and full dose regimen instead of two full doses.

How did the vaccine war was triggered?

The decision to give approval to Covaxin led to this vaccine war with critics pointing to a lack of efficacy data at this time. As per report, 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.

On the other hand Covishield, 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.

On this, he said, it was not uncommon for regulators to give emergency use approvals after successful phase 2 trials in the midst of an epidemic or a pandemic, he pointed out. Such a thing had happened during the H1N1 swine flu as well, he claimed.

While reacting to this, 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.

Dr Ella also took on Dr Randeep Guleria, the chief of Delhi’s AIIMS (All India Institute of Medical Sciences), who 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 had said. Covaxin is India’s first indigenous vaccine against Covid-19. It has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and National Institute of Virology.

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