'Targeted narrative': Govt, Bharat Biotech deny political pressure led to Covaxin's early approval

NEW DELHI: The Centre on Thursday refuted reports claiming regulatory approval for the manufacture of Covaxin, India’s first indigenously developed anti-Covid vaccine manufactured by Hyderabad-based Bharat Biotech, was rushed due to “political pressure” as "misleading," "fallacious" and “ill-informed.” 

The Union Health Ministry said the government and the national regulator - Central Drugs Standard Control Organisation (CDSCO) - have followed a scientific approach and prescribed norms in approving Covid-19 vaccines for emergency use authorisation.

In a statement, the health ministry said that there had been media reports claiming that Bharat Biotech “had to skip certain processes” and “speed” up clinical trials due to political pressure. 

“The reports further claim that there were several irregularities in the three phases of the clinical trials conducted for the vaccine. These media reports are completely misleading, fallacious and ill-informed,” the statement said.

Bharat Biotech also issued a statement condemning the “targeted narrative" against Covaxin, whose supply to UN agencies was suspended by the World Health Organisation (WHO) in April, citing deficiencies in good manufacturing practices.

Giving details about how the pharma company got the approval, the ministry said the Subject Expert Committee (SEC) of CDSCO met on January 1-2, 2021. After due deliberations, it made recommendations regarding the proposal 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 an emergency in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains,” the statement further said.

The ministry said that the SEC’s approval for the commencement of the phase 3 clinical trial of the proposed dose of Covaxin was based on scientific data presented by Bharat Biotech and established practices in this regard.

Moreover, the purported ‘unscientific changes’ in clinical trials of Covaxin, as claimed in the news reports, were made after submission made by Bharat Biotech in CDSCO, compliance of due process in CDSCO and with approval from the DGCI, the ministry added.

Additionally, later on, based on the further submission made by the company and assessment of interim efficacy and safety data by SEC of CDSCO, the condition of administration of the Covid-19 vaccine in ‘clinical trial mode’ was removed on March 11, 2021. 

The ministry clarification came after a report claimed to have accessed the ‘internal documents’ related to Covaxin’s approval, noting that the Covid-19 vaccine was approved despite discrepancies in the number of clinical trial participants.

Covaxin was developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).

The pharma company, in its statement, said, “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. There was no external pressure to accelerate the development of COVAXIN,” the company said.

“The pressure was all internal to develop a safe and effective vaccine for the Covid-19 pandemic, to save lives and livelihoods in India and globally. COVAXIN is one of the most highly studied covid-19 vaccines worldwide.”

The company further said that 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 health ministry also said that authorisation for Covid-19 vaccines, including Covaxin, for restricted use in emergencies with various conditions and restrictions, was granted by the national regulator only on the recommendations of the SEC. 

The SEC consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc., the ministry added.

NEW DELHI: The Centre on Thursday refuted reports claiming regulatory approval for the manufacture of Covaxin, India’s first indigenously developed anti-Covid vaccine manufactured by Hyderabad-based Bharat Biotech, was rushed due to “political pressure” as "misleading," "fallacious" and “ill-informed.”  The Union Health Ministry said the government and the national regulator - Central Drugs Standard Control Organisation (CDSCO) - have followed a scientific approach and prescribed norms in approving Covid-19 vaccines for emergency use authorisation. In a statement, the health ministry said that there had been media reports claiming that Bharat Biotech “had to skip certain processes” and “speed” up clinical trials due to political pressure.  “The reports further claim that there were several irregularities in the three phases of the clinical trials conducted for the vaccine. These media reports are completely misleading, fallacious and ill-informed,” the statement said. Bharat Biotech also issued a statement condemning the “targeted narrative" against Covaxin, whose supply to UN agencies was suspended by the World Health Organisation (WHO) in April, citing deficiencies in good manufacturing practices. Giving details about how the pharma company got the approval, the ministry said the Subject Expert Committee (SEC) of CDSCO met on January 1-2, 2021. After due deliberations, it made recommendations regarding the proposal for restricted emergency approval of the Covid-19 vaccine developed by Bharat Biotech.  ALSO READ | 50 million doses of Covaxin set to expire in early 2023 due to poor demand “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 an emergency in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains,” the statement further said. The ministry said that the SEC’s approval for the commencement of the phase 3 clinical trial of the proposed dose of Covaxin was based on scientific data presented by Bharat Biotech and established practices in this regard. Moreover, the purported ‘unscientific changes’ in clinical trials of Covaxin, as claimed in the news reports, were made after submission made by Bharat Biotech in CDSCO, compliance of due process in CDSCO and with approval from the DGCI, the ministry added. Additionally, later on, based on the further submission made by the company and assessment of interim efficacy and safety data by SEC of CDSCO, the condition of administration of the Covid-19 vaccine in ‘clinical trial mode’ was removed on March 11, 2021.  The ministry clarification came after a report claimed to have accessed the ‘internal documents’ related to Covaxin’s approval, noting that the Covid-19 vaccine was approved despite discrepancies in the number of clinical trial participants. Covaxin was developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). ALSO READ | Global roll-out of 12 billion COVID-19 vaccine doses largest-ever but access an issue: WHO The pharma company, in its statement, said, “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. There was no external pressure to accelerate the development of COVAXIN,” the company said. “The pressure was all internal to develop a safe and effective vaccine for the Covid-19 pandemic, to save lives and livelihoods in India and globally. COVAXIN is one of the most highly studied covid-19 vaccines worldwide.” The company further said that 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 health ministry also said that authorisation for Covid-19 vaccines, including Covaxin, for restricted use in emergencies with various conditions and restrictions, was granted by the national regulator only on the recommendations of the SEC.  The SEC consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc., the ministry added.