Have Made 16 Vaccines, Don’t Accuse us of Inexperience: Bharat Biotech Hits Back at Critics Questioning Covaxin Efficacy
Ella said it was wrong to say Bharat Biotech was not transparent with data and cited the number of publications by the company in comparison with industry peers.
New Delhi: Hitting back at critics for questioning the efficacy of Covaxin, the founder and chairman of Bharat Biotech asserted that India’s first indigenously developed vaccine against coronavirus was safe and the firm has conducted 200% honest clinical trials. “We don’t deserve this backlash”, said Krishna Ella, while addressing a press conference yesterday.
Notably, a controversy has erupted after the Drugs Controller General of India (DCGI) approved Covaxin for emergency use without Phase III trial data. Several experts and Opposition leaders have claimed ‘premature’ clearance could risk lives and fuel vaccine hesitancy in India.
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“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”, stated Bharat Biotech’s chairman, adding that Covaxin Phase-3 efficacy data will be available by March.
He said it was wrong to say Bharat Biotech was not transparent with data and cited the number of publications by the company in comparison with industry peers. Ella suggested that the vaccine was being targeted as it was a product of an Indian company. He said sufficient data has already been revealed and is available online for people to access.
He also raised questions on another Indian pharma giant without naming it. “There is an Indian company which got licence based on international data in phase III clinical trial data. Did anybody question them? AstraZeneca was giving four grams of paracetamol to volunteers to suppress such adverse reactions. We have not given paracetamol to any volunteer”, said Ella.
Meanwhile, All India Institute of Medical Sciences (AIIMS) director Randeep Guleria said Covaxin has been given approval only in emergency situations as a backup and also rejected claims of fast-tracking the whole exercise of coming out with a vaccine.
“If there is a surge in cases, we may need larger doses of vaccine, then we may go with Bharat Biotech’s vaccine. The Bharat Biotech vaccine is more of a backup. None of the clinical trials was fast-tracked in terms of safety and efficacy. Fast-tracking was done in taking regulatory approval which generally takes a long time while going from one phase to the other,” he said.
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