A day after some media reports claimed that Covaxin’s maker, the Hyderabad-based Bharat Biotech, had cut corners to make the COVID-19 vaccine, the Union Health ministry on Thursday said the allegations are “completely misleading, fallacious and ill-informed”.
"The Government of India and the national regulator Central Drugs Standard Control Organisation (CDSCO) have followed a scientific approach and prescribed norms in approving the Covid-19 vaccines for emergency use authorisation," the Ministry said.
As per the statement from the government, some media reports had pointed out that Bharat Biotech “had to skip certain processes” and “speed up” clinical trials due to "political pressure" for the production of the vaccine after the pandemic broke out in 2020.
Condemning the reports, Bharat Biotech also in a statement came down heavily on the aforementioned media reports and said that the targeted narrative against Covaxin is misleading and asserted that there was no external pressure to accelerate development of its Covid vaccine. The company clarified that the pressure was all internal to develop a safe, and effective vaccine for the Covid-19 pandemic.
"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 Biotech company said in a statement.
The company claimed that Covaxin is one of the most highly studied Covid-19 vaccines worldwide and that it was evaluated in more than 20 pre-clinical studies, including three challenge trials and nine human clinical studies, and was tested 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 company said in its statement.
The Health Ministry on its part said that a Subject Expert Committee (SEC) of CDSCO met on January 1-2, 2021, and after seeing all points, made the recommendations with respect to the proposal for Restricted Emergency Approval of the vaccine. The SEC's approval for the commencement of the phase 3 clinical trial of the proposed dose of Covaxin was based on scientific data and established practices in this regard.
“Before Covaxin was approved for restricted emergency use in January 2021, the Subject Expert Committee reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains," it added.
The Ministry also categorically denied claims of media reports that had spoken about some 'unscientific changes' in the clinical trials of Covaxin. "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 CDSCO, compliance of due process in CDSCO and with approval from the DGCI," the Ministry's statement read.
Based on a further submission made by Bharat Biotech and an assessment of interim efficacy and safety data by SEC of CDSCO, the condition of administration of the COVID-19 vaccine in 'clinical trial mode' was removed on March 11, 2021, the Ministry said.
It is to be noted that the world health body World Health Organization (WHO) suspended the supply of Covaxin to UN agencies in April stating that there were deficiencies in good manufacturing practices. The WHO said that Bharat Biotech made some changes in the manufacturing processes after receiving an emergency-use license for Covaxin.
What did the news reports say?
The news website STAT, which specialises in reporting on healthcare, had claimed in its report that the regulators (CDSCO) endorsed the vaccine, Covaxin, despite discrepancies in the number of clinical trial participants.
It claimed that questionable changes were made to the trial protocols to expedite the approval process.
It noted that the process was hurried as the Bharat Biotech vaccine was a desirable alternative to mRNA vaccines from Moderna and Pfizer/BioNTech, which required very low temperatures for storage. The Covaxin shot did not require storage at very low temperatures, which was easier to deploy in low- and middle-income countries.
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