'Misleading' and 'fallacious': Govt's response to media reports alleging irregularities in Covaxin approval

In a statement, the Ministry of Health and Family Welfare termed media reports which claimed that regulatory approval for Covaxin was rushed due to political pressure as "misleading" and "fallacious".

"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 authorisation," the ministry stated.

“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 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,” read the health ministry statement.

“The SEC’s approval for commencement of phase 3 clinical trial of proposed dose of Covaxin was based on scientific data presented by M/s 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 M/s Bharat Biotech in CDSCO, compliance of due process in CDSCO and with approval from the DGCI,” the statement added.

Bharat Biotech, the maker of Covaxin, also categorically stated that there was no external pressure to hasten the development of the anti-Covid vaccine.

“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,” Bharat Biotech said in a statement.

Authorisation to Covid-19 vaccines including Covaxin for restricted use in emergency situation with various conditions and restrictions were granted by the national regulator only on the recommendations of the Subject Expert Committee of CDSCO, it added.