Bharat Biotech, Ministry of Health garbage says Covaxin was ‘rushed due to political pressure’

A day after some media claimed Covaxin maker Hyderabad-based Bharat Biotech cut corners to make the COVID-19 vaccine, the Union Health Ministry said on Thursday the claims were “completely misleading , misleading and misinformed”.

“The Government of India and the national regulator Central Drugs Standard Control Organization (CDSCO) have followed a science-based approach and prescribed standards to approve Covid-19 vaccines for emergency use authorization,” the ministry said.

According to the government statement, some media outlets had pointed out that Bharat Biotech “had to skip some processes” and “speed up” clinical trials due to “political pressure” to produce the vaccine after the pandemic hit in 2020.

Condemning the reports, Bharat Biotech also strongly criticized the aforementioned media reports and said the narrative targeted against Covaxin is misleading and claimed that there is no outside pressure to speed up the development of its Covid vaccine. The company clarified that the push was entirely internal to develop a safe and effective vaccine against the Covid-19 pandemic.

“It is well known that they have helped perpetuate misinformation and fake news throughout the pandemic. They are unable to understand the global product development and approval processes,” the biotech company said in a statement. a statement.

The company claimed that Covaxin is one of the most studied Covid-19 vaccines in the world and that it has been evaluated in more than 20 preclinical studies, including three challenge trials and nine human clinical studies, and has been tested more than any other Indian Covid. -19 vaccine. “These trials clearly demonstrated the safety and efficacy of Covaxin. With several hundred million doses administered worldwide, Covaxin has demonstrated an excellent safety record with minimal adverse events and no vaccine-associated cases detected for myocarditis or thrombocytopenia,” the company said in its statement.

The Department of Health, for its part, said a CDSCO Subject Matter Expert Committee (SEC) met on January 1 and 2, 2021 and, after seeing all the points, made recommendations. regarding the proposed restricted emergency approval of the vaccine. The SEC’s approval for the start of the Phase 3 clinical trial of the proposed dose of Covaxin was based on scientific data and established practices in this regard.

“Before Covaxin was approved for restricted emergency use in January 2021, the subject matter expert committee reviewed data on the safety and immunogenicity of the vaccine and recommended granting an authorization restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in the event of infection with mutant strains”, he added.

The ministry also categorically denied media claims that had spoken of certain “unscientific changes” in clinical trials of Covaxin. “Furthermore, the alleged unscientific changes” in clinical trials of Covaxin, as reported, were made after Bharat Biotech’s submission to CDSCO, compliance with due process at CDSCO, and with the approval of the DGCI,” the ministry statement said.

Based on another submission made by Bharat Biotech and an evaluation of interim efficacy and safety data by CDSCO’s SEC, the condition for administering the COVID-19 vaccine in “clinical trial mode” was removed on March 11, 2021, the ministry said. .
Of note, the global health body World Health Organization (WHO) suspended the supply of Covaxin to United Nations agencies in April, saying there were gaps in good manufacturing practice. The WHO said Bharat Biotech made some changes to manufacturing processes after receiving an emergency use license for Covaxin.

What were the reports saying?

The STAT news site, which specializes in health care reporting, had claimed in its report that regulators (CDSCO) had approved the vaccine, Covaxin, despite discrepancies in the number of participants in clinical trials.

He claimed questionable changes were made to trial protocols to speed up the approval process.

He noted that the process was rushed because Bharat Biotech’s vaccine was a desirable alternative to mRNA vaccines from Moderna and Pfizer/BioNTech, which required very low storage temperatures. Covaxin’s shot did not require ultra-low temperature storage, which was easier to deploy in low- and middle-income countries.

Maria J. Book