“Recent media reports around the approvals for Covaxin are incorrect and erroneous. These few individuals and organizations were mostly involved in fake news and false information during the pandemic. They fail to understand product development and licensure pathways worldwide,” Bharat Biotech said while denying any external pressure to accelerate Covaxin development.
“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,” it added.
Terming the reports as “completely misleading, fallacious and ill-informed”, the Centre said the national regulator CDSCO (Central Drugs Standard Control Organisation) followed a scientific approach and prescribed norms in approving Covid-19 vaccines for emergency use authorization (EUA).
It also pointed out that CDSCO’s Subject Expert Committee (SEC), which consists of domain knowledge experts, granted restricted emergency approval to Covaxin only after due deliberations in meetings on January 1 & 2, 2021.
“Before Covaxin was approved for restricted emergency use in January 2021, the SEC reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains,” the government said.
“The SEC’s approval for commencement of Phase-3 clinical trial of proposed dose of Covaxin was based on scientific data presented by Bharat Biotech and established practices in this regard. Moreover, the purported ‘unscientific changes’ in clinical trials of Covaxin, as claimed in the news reports, were made after submission made by Bharat Biotech in compliance of due process in CDSCO and with approval from the DGCI,” the Centre said.
It also pointed out that based on further submission made by Bharat Biotech and assessment of interim efficacy and safety data by the SEC, the condition of administration of Covaxin in ‘clinical trial mode’ was removed on March 11, 2021.
Reiterating that the entire product development and clinical studies of Covaxin were executed as per global guidelines, Bharat Biotech said that Covaxin was one of the most highly studied Covid-19 vaccines worldwide and was evaluated in around 20 pre-clinical studies, including 3 challenge trials and 9 human clinical studies that clearly demonstrated its safety and efficacy.
“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 company asserted.
On the Phase-1 study, BBIL said it was one of the largest in the world, resulting in both the 3 and 6 mcg doses demonstrating safety and comparable immunogenicity.
“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,” Bharat Biotech explained.
Here, BBIL pointed out that 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 organizations remain silent, demonstrating their hypocrisy,” Bharat Biotech said.
“While these people and organizations were busy with false information and fake news during the pandemic, more than 1000 personnel at Bharat Biotech across India were busy developing, testing, manufacturing and distributing Covaxin. Our diligent efforts have resulted in a universal Covid-19 vaccine for adults and children alike, which can be administered repeatedly as booster doses without safety concerns,” it said.
“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 added.