India’s Ministry of Health and Family Welfare (MoHFW) has rubbished allegations that Covaxin, the country’s first domestically-developed COVID-19 vaccine, was rushed through clinical trials without following proper processes due to alleged “political pressure”.
The vaccine was jointly conceived by Bharat Biotech and the government-backed Indian Council of Medical Research (ICMR).
Responding to the allegations in American health publication STAT News, Delhi termed the claims as “completely misleading, fallacious and ill-informed,” underlining that the vaccine was approved for use in “public interest” in the first place, owing to prevalence of mutant COVID strains at the time.
The devastating second COVID wave in India, which broke out in April 2021, witnessed an average of 200,000 to 300,000 people succumbing to the virus on a daily basis for several months. Given the circumstance, Covaxin received an Emergency Use Authorization (EUA) for “restricted use” from the Drug Controller General of India (DGCI) in January 2021 after two rounds of clinical trials.
The statement from the ministry said that the authorities and the federal vaccine regulator Central Drugs Standard Control Organisation (CDSCO) followed a “scientific approach” in approving COVAXIN for emergency use last January.
It also noted that the approval from CDSCO was only granted after the subject matter experts (SME) cleared it for restricted use among public.
The vaccine made it to the list of World Health Organization’s (WHO) list of recognized vaccines last November. However, the WHO ordered the suspension of export of Covaxin to UN agencies in April after a review claimed there were “deficiencies in good manufacturing practices (GMP)”.
Foreign media report claims that “several discrepancies” were found in the Bharat Biotech’s reporting of Phase I and II trials of Covaxin in 2020, triggered by the need to expeditiously develop a domestic COVID vaccine.
In particular, it claims the number of people, who participated in Phase I trial, differed from the number specified in the “trial protocol document” and that in Phase II trials, the company dropped the requirement for a ‘placebo arm’ while testing the vaccine efficacy.