Bharat Biotech’s founder and chairman Dr Krishna Ella on Monday sought to deny and dismiss criticism against his company and India’s central drug regulator for what has been termed as a hasty emergency approval for their Covaxin vaccine against Covid-19. In a virtual press briefing that lasted well over one hour, a combative Dr Ella underlined that his company sought approval for Covaxin as under the provisions of New Drug and Clinical Trial Rules, 2019, and on the basis of strong safety and immunogenicity data.
Dr Ella said that his company had not done any interim efficacy analysis as they did not want to open or un-blind the trial. About 6,000 people would receive the second dose of Covaxin, the Phase III trial, in the next few days and all participants would have had received the second dose by February, Dr Ella said.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation recommended Covaxin for restricted emergency use on Saturday on the grounds of abundant caution, especially in the context of the UK variant of the novel Coronavirus.
“We are given opportunity under the CDSCO rules to apply for license on the basis of Phase II safety and immunogenicity data. The efficacy data will be ready by March,” Dr Ella said, responding to questions on why the company did not wait for the efficacy data to be generated.
The New Drugs and Clinical Trial Rules provide a relaxation for skipping Phase III clinical trials or allow appraisal of limited data. If the new drug or vaccine shows ‘remarkable efficacy’ with a defined dose in the Phase II clinical trial and if there are ‘unmet medical needs of serious and life threatening diseases in the country’, then the Rules provide a room to recommend an accelerated approval.
Bharat Biotech, Dr Ella said, has a stockpile of 20 million doses of Covaxin and the company was aiming to scale up production to 700 million doses across its four facilities in Hyderabad and Bengaluru. Of the 20 million doses manufactured, a batch of five million has been sent to the government’s lab in Kasauli for testing. When asked about government procurement of Covaxin and its roll out, Dr Ella said, “The government is talking to use right now so I will leave it at that right now. As far as roll out is concerned it is not in our hands, we have sent batches to the Kasauli lab for testing.”
The inactivated virus and proven technology used in the vaccine will make it effective in combating the novel Coronavirus, he said. When asked about the longevity of the vaccine’s potential immunity, Dr Ella said, “Speaking hypothetically, based on my experience, immunology and the T-cell and antibody response, the immunity will last for more than a year. But I want to repeat, this is speaking hypothetically.”
During the briefing, Dr Ella trained guns against the media, competitors and some quarters who criticised the company for not submitting Phase III data.
Without naming Serum Institute of India (SII) directly, Dr Ella trained guns at them and said, “An Indian company has given immunogenicity data of only 100 people and not even 1,200 people efficacy data. Still they (have) received the license. If other company got (the) license based on UK data, then why not for us?”, Dr Ella said.
“News media is bashing us, some Indians are bashing us. Why are they not questioning other vaccines? Do they want a British passport? Please forgive me if I am speaking rashly, but please read up and ask questions but don’t bash us,” he added.”
In his closing remarks, he said, “We have not done anything wrong, we will not hurt anyone. I am contributing to global public health. I am 65 and I don’t have to do this for money. I want Indian innovation to succeed and want Indian scientists to succeed.”