Bharat Biotech today strongly condemned fallacious and misleading information report recently by a foreign media.
The company in a statement 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 Ministry of Health, Government of India also issued a statement and wrote:
Media Reports claiming regulatory approval for Covaxin was rushed due to Political Pressure are Misleading and Fallacious
Scientific approach and prescribed norms adhered to in approving Covid-19 vaccines for Emergency Use Authorization
There have been media reports claiming that Bharat Biotech, manufacturer of the indigenous COVID-19 vaccine – Covaxin, “had to skip certain processes” and “speed” up clinical trials due to political pressure. The reports further claim that there were several irregularities in the three phases of the clinical trials conducted for the vaccine. These media reports are completely misleading, fallacious and ill-informed.
It is clarified that Government of India and the national regulator i.e. CDSCO have followed a scientific approach and prescribed norms in approving COVID-19 vaccines for emergency use authorization. The Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO) met on 1st and 2nd January, 2021 and after due deliberations made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of Bharat Biotech.
There was no external pressure to accelerate development of COVAXIN – Bharat Biotech
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.
COVAXIN is one of the most highly studied covid-19 vaccines worldwide. COVAXIN 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 clearly 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 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 its development.
The 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.
The phase I 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.
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.
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 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.