Lagatar24 Desk
New Delhi, Nov 17: The Union Health Ministry today referred to media reports that suggested that the regulatory approval for the COVID-19 vaccine Covaxin was hurried because of political pressure as “misleading” and “fallacious.”
It claimed that in order to approve COVID-19 vaccines for emergency use authorization, a scientific approach and established norms were followed.
According to media allegations, government pressure forced Bharat Biotech, the company that makes the locally produced COVID-19 vaccine Covaxin, to ‘skip some steps’ and ‘speed’ up clinical studies.
The studies also stated that there were a number of anomalies in the three stages of the vaccination clinical trials that were carried out.
“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.
We condemn 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: BharatBiotech pic.twitter.com/ilnxVBoot0
— ANI (@ANI) November 17, 2022
According to a government release, the Subject Expert Committee (SEC) of CDSCO met on January 1-2 of last year and, after careful consideration, made recommendations regarding the request for restricted emergency approval of the Covid-19 vaccine developed by Bharat Biotech.
“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.
Bharat Biotech, which produces Covaxin and is based in Hyderabad, firmly asserted that no external pressure existed 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.
Only on the advice of the Subject Expert Committee of CDSCO did the national regulator authorise Covid-19 vaccines, including Covaxin, for restricted use in emergency situations with a variety of conditions and restrictions.
