The Ministry of Health and Family Welfare (MoHFW) refuted claims made by some media that Bharat Biotech “had to skip certain processes” and “speed” up clinical trials due to political pressure and that there were several irregularities in the three phases of the clinical trials conducted for the vaccine.

In a statement, the Ministry has called the reports “Misleading and Fallacious”.

MoHFW clarified that the government and Central Drugs Standard Control Organisation (CDSCO) followed a “scientific approach and prescribed norms in approving COVID-19 vaccines for emergency use authorization” and that approval for restricted emergency use of Covaxin was made after “due deliberation”.

The statement also said, “the Subject Expert Committee reviewed the data on safety and immunogenicity of the vaccine” before recommending it for restricted use. The SEC consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.

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, the ministry stated.

It also said that the condition of administration of COVID-19 vaccine in ‘clinical trial mode’ was removed on 11 March 2021 based on further submissions made by M/s Bharat Biotech and assessment of interim efficacy and safety data by SEC of CDSCO.

Further, MoHFW stated that the authorization to COVID-19 vaccines including Covaxin for restricted use in emergency situation were granted by the national regulator only on the recommendations of the Subject Expert Committee of CDSCO.