Criticism mounts over India's 'abrupt' approval of COVAXIN

▴ Criticism mounts over India's 'abrupt' approval of COVAXIN
Criticism of India’s approval of a local COVID-19 vaccine without proof of its efficacy grew on Wednesday after news that a regulatory panel approved the shot just one day after asking the vaccine maker for more evidence it would work.

Criticism of India’s approval of a local COVID-19 vaccine without proof of its efficacy grew on Wednesday after news that a regulatory panel approved the shot just one day after asking the vaccine maker for more evidence it would work.

The recommendations of the Indian drugs regulator’s subject expert committee (SEC) released on Tuesday show that the panel asked Bharat Biotech International Ltd to present more efficacy data for its COVID-19 shot before it could consider approving the treatment.

“After detailed deliberation, the committee recommended that the firm ... may perform interim efficacy analysis for further consideration of restricted emergency use approval,” the SEC’s recommendations in a Jan. 1 meeting show.

The very next day, the committee recommended approving Bharat Biotech’s vaccine for “restricted use in an emergency situation in the public interest as an abundant precaution.”

The SEC also separately recommended emergency use authorization for the Oxford University/AstraZeneca COVID-19 vaccine, being produced by India’s Serum Institute.

The greenlighting of Bharat Biotech’s COVAXIN had already faced criticism from opposition lawmakers and health experts for lack of efficacy data, typically obtained from a large, Phase III human trial - which the manufacturer is still conducting.

News of the SEC’s recommendations spurred further criticism.

“Was the Subject Expert Committee (SEC) approval a command performance? This is as serious as it can get,” Manish Tewari, an opposition lawmaker, said on Twitter.

Health experts questioned why the SEC abruptly recommended approval one day after asking Bharat Biotech for more analysis.

“The SEC ... appears to have been pressured overnight into reconsidering its decision and giving approval the next day, albeit hedged in by many conditions,” the All India People’s Science Network, a network of science advocacy groups, said in a statement.

“We are perplexed at the abrupt change in thinking of the SEC from the first two meetings to the third day on which the approval was recommended while apparently discounting the need for efficacy data as the condition of the approval,” the All India Drug Action Network, a nonprofit health watchdog, said.

Both Bharat Biotech and government officials have pointed to regulatory provisions that allow for quick drug approval for serious diseases even without Phase III trial data.

Neither India’s drugs regulator nor Bharat Biotech responded to Reuter's requests for comment on Wednesday.

Regulators also granted approval to Bharat Biotech’s vaccine only “in clinical trial mode”, an unusually cryptic language that left some experts baffled.

“They’ve introduced terminologies that are confusing,” said Giridhar Babu, a professor of epidemiology at the Public Health Foundation of India. “The phrase ‘in clinical trial mode’ is not generally a term you will see in approvals.”

Any confusion around vaccines could harm immunization programs by causing distrust, Babu said. “It takes decades of work to build confidence in vaccines.”

Tags : #IndiasCovidVaccineUpdates #COVID-19vaccine #CriticismofIndiasapproval #BharatBiotechsVaccine #COVAXIN #PhaseIIIhumantrial #SECApproval #Covid-19Vaccination #Covid-19Treatment #ImmunizationProgramme #FightAgainstCovidVirus

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

Scientists in Moscow Develop Fetal Phantom for Obstetric UltrasoundNovember 19, 2024
International Men’s Day: A Celebration of Strength, Vulnerability, and ChangeNovember 19, 2024
The Bloody Truth: Why Menstruation Is Still a Taboo in Indian SchoolsNovember 19, 2024
Toxic Air, Fragile Hearts: The Hidden Cost of Pollution on Heart Failure PatientsNovember 19, 2024
Government of Telangana Hosts the AI in Healthcare Summit – Road to BioAsia 2025November 18, 2024
In yet another groundbreaking medical milestone, Sarvodaya Hospital successfully performs India’s youngest cochlear implant on a 5- month old babyNovember 18, 2024
Sightsavers India in collaboration with AbbVie Therapeutics India Private Limited Hosted the 4th State-Level Consultation on ‘Prevention of Visual Impairment Caused by Glaucoma’November 16, 2024
Is Your Saree Hurting You? How Tight Waist Petticoats Could Trigger Skin CancerNovember 16, 2024
10 New-born Lives Lost: The Jhansi Hospital Fire That Shook India’s ConscienceNovember 16, 2024
Streax introduces revolutionary Shampoo Hair Colour in South India at accessible price point.November 15, 2024
The Silent Killer in Your Genes: Can Splicing Errors Unlock New Cancer Cures?November 15, 2024
Stress on a Schedule: What Your Gut Bacteria Know That You Don’tNovember 15, 2024
A Preventable Catastrophe: Why Are Children Still Dying from Measles?November 15, 2024
The University of Tasmania invites applications for Master of Marine and Antarctic ScienceNovember 14, 2024
ICMR’s Bold Bet: Can India’s Scientists Deliver World-First Health Breakthroughs?November 14, 2024
The Dark Reality Behind India’s Ayushman Bharat: Profits Before Patients?November 14, 2024
Not a Fan of Exercise? Here’s How Few Steps You Actually Need for Better HealthNovember 14, 2024
Shiprocket launches AI Powered Shiprocket Copilot to empower a Self-Reliant Digital Future for over 1,00,000+ Indian MSMEsNovember 13, 2024
AIIMS Darbhanga and More: Can PM Modi’s 12,000 Crore Investment Turn Bihar into India’s Next Growth Engine?November 13, 2024
Self-Made Survivor: How a Virologist Battled Breast Cancer with Her Own Lab-Grown VirusesNovember 13, 2024