On Thursday (November 17), Press Information Bureau (PIB) issued a press release refuting claims made by media reports alleging that regulatory approval for Bharat Biotech-manufactured Covaxin was rushed due to political pressure.
According to the claims made by some media reports, Bharat Biotech, the manufacturer of the indigenous COVID-19 vaccine – Covaxin – was forced to skip certain processes and accelerate clinical trials of the Covid-19 vaccine due to political pressure. According to the Union Health Ministry, these media reports are completely false, fallacious, and ill-informed.
The Central government clarified that it has along with the Central Drugs Standard Control Organisation (CDSCO) “have followed a scientific approach and prescribed norms in approving COVID-19 vaccines for emergency use authorization.”
Myths Vs Facts
— PIB India (@PIB_India) November 17, 2022
❌Media Reports claiming regulatory approval for Covaxin was rushed due to Political Pressure are Misleading & Fallacious
✅Scientific approach & prescribed norms adhered to in approving Covid-19 vaccines for Emergency Use Authorization
🔗https://t.co/BAJnAdxS2K
The CDSCO subject expert committee (SEC) met on January 1 and 2, 2021, and made recommendations on the proposal for restricted emergency approval of the COVID-19 virus vaccine developed by Bharat Biotech.
“The SEC of the CDSCO met on January 1st and 2nd, 2021, and made recommendations on M/s Bharat Biotech’s proposal for Restricted Emergency Approval of the COVID-19 virus vaccine. Before Covaxin was approved for restricted emergency use in January 2021, the SEC reviewed the vaccine’s data on safety and immunogenicity and recommended that permission be granted for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, particularly in the case of infection by mutant strains,” the press release read.
It was only after Bharat Biotech presented scientific data, that the SEC granted approval for the commencement of the phase 3 clinical trial of the proposed dose of Covaxin.
Furthermore, the purported ‘unscientific changes’ in Covaxin clinical trials, as claimed in news reports, were made following M/s Bharat Biotech’s submission to CDSCO, compliance with due process in CDSCO, and approval from the DGCI.
Moreover, on March 11, 2021, the condition of administering the COVID-19 vaccine in ‘clinical trial mode’ was removed based on additional submissions made by M/s Bharat Biotech and an assessment of interim efficacy and safety data by SEC of CDSCO.
Notably, a STAT report published on November 15 titled, ‘A very worrying scenario’: Internal documents on India Covid-19 vaccine raise troubling questions about the approval process,” claimed that Covaxin, despite discrepancies in clinical trials was approved by the regulators. The report also claimed that trial protocols were ‘changed’ to ‘expedite’ the approval process.
The report further claimed that several executives at Bharat Biotech ‘argued’ that they faced ‘political pressure’ to get the vaccine developed quickly, however, denied taking any shortcuts for the same.
Interestingly, the ‘misleading and fallacious’ STAT report was quoted by left-wing propaganda portal The Wire in its report which claimed that one of the directors of Bharat Biotech admitted to having ‘skipped’ mandatory steps in process of approval.
It is worth noting that Bharat Biotech has also issued an official statement regarding the matter. In its statement, the Covaxin manufacturer has condemned the targeted narrative peddled by a few individuals and groups with no expertise in vaccines or vaccinology.
“It is well known that they helped perpetuate misinformation and fake news throughout the pandemic,” the company said. Bharat Biotech outrightly rejected the claims that it was under ‘pressure’ to expedite the development of Covaxin.
“There was no external pressure to accelerate the development of COVAXIN. 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,” the statement read.
#Bharatbiotech #announcement #Vaccine #Covaxin #covid19 #vaccinesafety #healthcare #immunisation #vaccineforall pic.twitter.com/nNwmOuSldw
— BharatBiotech (@BharatBiotech) November 17, 2022
This, however, is not the first time that media, especially The Wire has spread misinformation about Covaxin. The Wire, in an article on 29 December 2021 claimed, “The virologist said currently there is currently no data available on the immune response generated by Covaxin.”
Bharat Biotech, back then, stated that the data on the immune response generated by Covaxin has been published in several reputed international peer-reviewed journals through 2020 and 2021. The data on booster doses has been submitted to the authorities.
According to the company, the above-mentioned false statements by media outlets are only a few examples of the many false claims and misinformation shared by many publications against their vaccine and company. They’ve also stated that they’ll keep ‘fact-checking’ the false claims.
Bharat Biotech had then urged media outlets to be responsible in their reporting, noting that news articles on medicine, science, vaccines, and pharmaceuticals, among other topics, must be based on actual scientific facts and data, rather than ideological, political, or financial biases.
