Bharat Biotech, MoHFW deny rush, political pressure in regulatory approval for Covaxin
Hyderabad: Vaccine maker Bharat Biotech has dismissed media reports that claimed regulatory approval for Covaxin was rushed due to political pressure as false. The Government of India too said the reports were misleading and fallacious.
The company in a statement issued on Thursday said the narrative against Covaxin was put forth by a select few individuals and groups who had no expertise in vaccines or vaccinology. The company said there was no external pressure to accelerate the development of Covaxin. The pressure was all internal to develop a safe, and effective vaccine for the Covid-19 pandemic, to save lives and livelihoods in India and globally, the Hyderabad-based company said.
“We condemn the targeted narrative against Covaxin put forth by a select few individuals and groups who have no expertise in vaccines or vaccinology. It is well known that they helped perpetuate misinformation and fake news throughout the pandemic. They are unable to comprehend global product development and licensure processes,” the company said.
The media reports suggested that the company skipped certain processes because of “political pressure” to develop an indigenous vaccine, that their modifications to the trial process were “vetted” by the regulator and that the vaccine’s clinical trials were dictated by “speed”.
Covaxin is one of the most highly studied Covid-19 vaccines worldwide. It was evaluated in 20 pre-clinical studies, including 3 challenge trials and 9 human clinical studies, more than any other Indian Covid-19 vaccine. These trials have demonstrated safety and efficacy of Covaxin. With several hundred million doses administered worldwide, Covaxin has demonstrated an excellent safety record with minimal adverse events and no vaccine associated cases detected for myocarditis or thrombocytopenia.
The phase I study for Covaxin was one of the largest in the world. The decision to proceed to phase III trials was taken based on data from phase I studies and results from successful animal challenge trials. The phase II studies were designed to determine if the lower dose of 3 mcg would be effective, instead of the 6 mcg dose, which would have doubled our manufacturing capacity. In the interest of public health, it was decided to proceed with the 6 mcg dose for phase III clinical trials.
“Vaccines against ebola and monkey pox were approved by stringent regulatory agencies in developed countries based on phase I and II clinical data only and without phase III data. If such an approval was given by regulators in India, there would be an uproar, but the same people and organisations remain silent, demonstrating their hypocrisy,” the company statement said.
More than 1,000 personnel at Bharat Biotech across India were busy developing, testing, manufacturing and distributing Covaxin. “Our diligent efforts have resulted in an universal Covid-19 vaccine for adults and children alike, which can be administered repeatedly as booster doses. The Bharat Biotech team is extremely proud of its efforts to develop a novel Covid-19 vaccine for India and the world. These efforts to discredit our work will not deter us,” it said.
The Ministry of Health and Family Welfare clarified that the Government of India and the national regulator. CDSCO has followed a scientific approach and prescribed norms in approving Covid-19 vaccines for emergency use authorisation. The Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO) met on January 1 and 2 in 2021 and after due deliberations made recommendations in respect of the proposal for Restricted Emergency Approval of Covid -19 virus vaccine of Bharat Biotech.
