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...


Trending Now

Autonomix Medical Inc. Covered in Benzinga Article Highlighting Innovative Nerve Treatment TechnologyApril 17, 2024
Top 5 online learning platform for learnersApril 17, 2024
Broad-Spectrum RNA Vaccine Breakthrough for Enhanced Virus ProtectionApril 17, 2024
The Impact of Excessive Internet Usage on School Absence: Finnish Study Reveals Key FindingsApril 17, 2024
Uncovering Delhi's Illegal Fertility Centre Operations: Insights from Recent Child Trafficking CasesApril 17, 2024
CarDekho's CSR Arm Girnar Foundation Hosts Health Check-up Camps for Underprivileged Children in Jaipur and GurugramApril 16, 2024
Atal Incubation Centre – Centre for Cellular and Molecular Biology (AIC-CCMB) signs agreement for placement of equipment with Thermo Fisher Scientific to help advance innovation in India April 16, 2024
AVEKSHA, four-day care centres, for the kids of industrial workers inauguratedApril 16, 2024
Nearly a third of the constituencies have zero women candidates in Phase 1 and 2 of LS Elections; reveals The Quantum Hub’s Factsheet April 16, 2024
Emergency Healthcare Provider Medulance Secures $3 Million Series A Funding Led by Alkemi Growth CapitalApril 16, 2024
The Healing Power of Natural Diversity: How Nature Boosts Mental HealthApril 16, 2024
Unveiling Cellular Recycling: How Nutrient-Starved Cells Adapt to Stressful ConditionsApril 16, 2024
Advancing Cancer Care: AIIMS Bhopal’s Workshop on Biomarker Interpretation in Breast CancerApril 15, 2024
10 Powerful Benefits to Diversify Healthcare Advertising ChannelsApril 15, 2024
Understanding Hospital Sink Contamination: Challenges in Fighting Multidrug-Resistant BacteriaApril 15, 2024
Rajasthan’s Swine Flu Situation: Health Department Observes DeclineApril 15, 2024
Is Your Doctor’s Prescription Incomplete ? Insights from Recent ICMR Study Suggests So!April 13, 2024
Ministry of Health Dispels Misinformation on Medicine Price Surge from April 1April 13, 2024
India’s First Indigenous CAR T-Cell Therapy Launched By President Droupadi Murmu: A New Hope in Cancer TreatmentApril 12, 2024
Investigation Launched After Cataract Surgery Patients Experience Side-Effects in IndoreApril 12, 2024