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


Deprecated: strlen(): Passing null to parameter #1 ($string) of type string is deprecated in /home/medicircle/public_html/script_newsdetails.php on line 75
▴ 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

Why Modern Lifestyle Causes Chronic InflammationAugust 05, 2026
Endometriosis Awareness: Understanding the Silent Condition Affecting Millions of Indian WomenAugust 05, 2026
A Complete Guide to Pregnancy Health Tips for Indian Women: Nutrition, Wellness, and What Every Expectant Mother Should KnowAugust 05, 2026
Why Preventive Healthcare for Children Is One of the Most Important Investments India Can MakeAugust 04, 2026
The Role of Pathology in Healthcare: From Diagnosis to Disease PreventionAugust 04, 2026
Pathophysiology of Psoriatic Arthritis: Clinical Presentation, Joint Damage Mitigation, and BiologicsAugust 04, 2026
Comprehensive Evaluation of Syncope: Cardiac vs. Neurological Origin WorkupsAugust 04, 2026
Common Medical Terms Explained: A Plain-Language Guide for Indian Patients and Healthcare SeekersAugust 03, 2026
Why Radiology Is the Backbone of Modern Medical Diagnosis and TreatmentAugust 03, 2026
Managing Urban Stress: Science-Backed Strategies for Mental Resilience in 2026 August 01, 2026
Managing Chronic Inflammation: The Role of Anti-Inflammatory Indian SuperfoodsAugust 01, 2026
Pathophysiology of Psoriatic Arthritis: Clinical Presentation, Joint Damage Mitigation, and BiologicsAugust 01, 2026
Early Markers of Glaucoma: Structural vs. Functional Ophthalmic Diagnostic ProtocolsAugust 01, 2026
Managing Complex Diabetic Foot Ulcers: Multidisciplinary Wound Care, Offloading, and RevascularizationAugust 01, 2026
The Future of Preventive Medicine: How India Is Moving From Cure to PreventionAugust 01, 2026
Why Young Indians Are Facing Heart Problems: Causes, Symptoms, and PreventionAugust 01, 2026
The Future of Preventive Screening: AI-Driven Early Cancer Detection in IndiaJuly 31, 2026
The Impact of Climate Change on Allergic Respiratory Diseases in Indian Cities July 31, 2026
Electronic Medical Records: What They Are, Why They Matter, and How India Is Embracing ThemJuly 31, 2026
Heatwave Health Risks in India: Symptoms, Treatment, and Prevention StrategiesJuly 31, 2026