Covaxin was rushed because of political pressure; Health Ministry rejects claim!

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 authorization. The Union Health Ministry rejected media reports on Thursday that Covaxin manufacturer Bharat Biotech skipped certain processes and accelerated clinical trials’due to political pressure, calling them ‘completely misleading, fallacious, and ill-informed’.

According to media reports, government pressure forced Bharat Biotech, the company that makes the locally produced Covaxin, to ‘skip some steps’ and ‘speed up’ clinical studies. They also claimed that there were various anomalies in the three stages of the clinical trials. The Subject Expert Committee (SEC) of CDSCO convened on January 1-2, 2021, according to the Ministry, and after appropriate discussion, provided recommendations regarding the request for Restricted Emergency Approval of the vaccine.

Before Covaxin was approved for limited emergency use in January 2021, the Subject Expert Committee reviewed the data on the vaccine’s safety and immunogenicity and recommended that permission be granted for limited use in emergency situations in the public interest as a generous precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The SEC’s clearance for the start of the planned dose of Covaxin’s phase 3 clinical study was based on this information as well as scientific evidence and accepted procedures.

Furthermore, as stated in the news reports, ‘the purported’aunscientific changes’ in the clinical trials of Covaxin were made after submission made by Bharat Biotech in CDSCO, compliance of due process in CDSCO, and with ‘approval from the DGCI.’ The Ministry continued, ‘Based on further submission made by Bharat Biotech and assessment of interim efficacy and safety data by SEC of CDSCO, the condition of administration of the vaccine in ‘clinical trial mode’ was removed on March 31′.

The SEC is made up of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, and internal medicine, according to the statement. ‘Authorization of Covid-19 vaccines, including Covaxin, for restricted use in emergency situations with various conditions and restrictions were granted by the national regulator only on the recommendations of the SEC,’ it said.