Hyderabad, Nov 17 (IANS): Vaccine-maker Bharat Biotech has denied that there was any external pressure to accelerate development of Covaxin, its vaccine for Covid-19.
"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 Hyderabad-based company said in a statement on Thursday.
"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," it added.
The company claimed that Covaxin is one of the most highly studied covid-19 vaccines worldwide.
Covaxin was evaluated in about 20 preclinical studies, including three challenge trials and nine human clinical studies, more than any other Indian Covid-19 vaccine. These trials have clearly demonstrated safety and efficacy of Covaxin, Bharat Biotech said.
The vaccine-maker further claimed that 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 entire product development and clinical studies were executed as per global guidelines and submitted worldwide. Data from Covaxin has resulted in more than 20 publications, documenting every aspect of its development."
It termed as "incorrect and erroneous' the recent media reports around the approvals for Covaxin.
"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," reads the statement.
It pointed out that the phase 1 study for Covaxin 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.
According to Bharat Biotech, 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.
"While these people and organizations were busy with false information and fake news during the pandemic, 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 without safety concerns. 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.