It was a combative and emotional Krishna Ella, Chairman and Managing Director of Bharat Biotech, who addressed the media in a virtual press conference after several experts raised concern over its COVID-19 vaccine ‘Covaxin’ was granted approval by regulators. Ella began by saying, “My oxygen is science. I live on science. None of my family members are in politics. I am not a media savvy guy. I stay away from the media. Today the vaccine is being politicised.”
The Hyderabad-based vaccine manufacturer was granted approval for its COVID-19 vaccine in a ‘clinical trial mode’ — a term several scientists have been confused by. When asked about the same, Krishna Ella said, “Approval in clinical trial mode means we don't need placebo. It is open label where we keep vaccinating people." An open label trial is one where participants and researchers are aware of the vaccine that is being injected, as opposed to a double-blind trial where both parties are unaware if the shot that is being given is the vaccine candidate or a placebo. However, when pressed again on the matter, he went on to say, “We don't know what does approval in clinical trial mode mean, give us some time to understand this.”
During the press conference, Ella hailed the decision of the Indian drug regulator to approve Covaxin for emergency restricted use and termed it as a giant leap for innovation and novel product development in India. The Bharat Biotech MD also went on to defend the approvals that were granted, stating they were based on Central Drugs Standard Control Organisation (CDSCO)’s 2019 guideline on emergency approval. He said that emergency approval can be given based on phase 2 data. “The CDSCO guidelines issued in 2019 state: If your platform is proven, safe and phase 1 and 2 data is available then you can license the product,” he said.
While the Oxford-AstraZeneca vaccine, manufactured by Serum Institute of India (SII), has 70.42% efficacy, the indigenous vaccine from Bharat Biotech does not have efficacy details because the trials are underway. The Drug Controller General of India (DCGI) had said that the data available to date showed that Bharat Biotech's Covaxin is "safe" for administration.
With phase 3 trial still underway with 24,000 volunteers, Ella said Bharat Biotech has not submitted efficacy data to regulators but added that this would be available by March. “We assume by February first week, the second dose (given to volunteers) will be over. We will then monitor efficacy.”
With Drugs Controller General of India (DCGI) guidelines stating that vaccines will be approved only if they show 50% efficacy, the Bharat Biotech MD said they were confident of over and above that figure.
Meanwhile, he lashed out at cynics who raised concerns over the transparency of approval procedures taken to authorise Covaxin, saying that the firm's Covid vaccine candidate is "no way" inferior to Pfizer in terms of transparency.
“India can innovate. It’s not a copycat country. We don’t deserve a backlash; we do everything systematically and yet we get bashing from the news media. A company has branded our vaccine as water.
It hurts as a scientist and we don’t deserve that. Why is nobody questioning the UK trials? Because, Indian trials are easy to be bashed,” he hit out.
Krishna Ella said that 20 million doses of Covaxin are ready and the manufacturer hopes to produce 150 million doses by July-August. When asked about when the vaccine will be rolled out, he said, "We are ready to roll out the vaccine tomorrow. We would love to launch it as soon as possible." He, however, admitted that rollout of vaccine was not in the company’s hands.
"We have already sent the batch to the Central Research Institute in Kasauali," he said. However, he did not disclose the quantity of vials sent to the government. Ella also did not share information on the order specifying quantity of the doses it received from the government.
The Central Research Institute (CRI), under the Central Drugs Standard Control Organisation (CDSCO), is the nodal agency to test the drugs and facilitate roll out to the northern part of the country.
As far as the price of Covaxin is concerned, Ella said, “In the beginning, it may be a little high. Cost will be controlled by the market when more competitors come in.” He also addressed questions about how efficient Covaxin is against the UK variant, noting that it is a hypothesis and he would be able to submit confirmatory data within a week.
Speaking about Bharat Biotech’s achievements and about how his company is not new to vaccines, he said, “We have developed 16 vaccines. We have tremendous experience in vaccines. We are now touching 123 countries globally. More than 70 articles have been published in top journals in the world. We have filed 433 patents so far. Clinical trials have been carried out not just in India. We have done clinical trials in more than 12 countries, including the UK," he said, adding that he was listing out the achievements in response to those claiming that the company did not have adequate clinical trial experience.
Bharat Biotech has in the past developed vaccines against Zika, H1N1, Rotavirus and Rabies, among others. “Our typhoid vaccine was called a breakthrough vaccine by the WHO (World Health Organisation). So people should not accuse us that we don't know how to do clinical research. We were the first one to file a patent for Zika virus,” he said.
Speaking about the company's efforts to develop the vaccine, Ella said, "We work 24 hours. We scientists don't deserve such bashing." He also went on to mention that a third-party company has been entrusted with the clinical trial and data collection as people will otherwise claim data is being misrepresented.
He also clarified in the conference that he and his family has no involvement with any political party. "Since the politicisation over our vaccine has started, I want to clarify that neither I, nor my other family members are involved and working with any political party," Ella stated.
He concluded the press conference stating, “We will not hurt the public health of people. I want Indian innovation to succeed. I want Indian scientists to get recognition globally."
Covaxin, India's indigenous COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility.
WATCH: Krishna Ella's video conference
(With PTI input)