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

Tier-2 and Tier-3 Cities: India's Next Big Healthcare Growth StorySeptember 18, 2026
Why Regional Hospital Chains Are Becoming More Important in IndiaSeptember 18, 2026
The Future of Indian MedTech Exports: Can India Compete With Global Leaders?September 17, 2026
Robotic-Assisted Procedures Beyond Surgery: Where Is Automation Going Next in Healthcare?September 17, 2026
58 Students from SRM Medical College Selected for Union Government Research Programmes and Grants September 16, 2026
Handpickd Questions the Role of Science in Food with ‘Science-Less’ Newspaper CampaignSeptember 16, 2026
As Women’s Cancer Burden Rises, Integrated Care Emerges as The Next Frontier in Cancer TreatmentSeptember 16, 2026
Odia Superstar Babushaan Mohanty Inaugurates Manoj Das Library at Utkal Gaurav International SchoolSeptember 16, 2026
Yashoda Hospitals, Somajiguda Successfully Treats 10-Month-Old with Complex Heart Condition Through Staged ApproachSeptember 16, 2026
Tracky launches 16D, India's first 16-day continuous glucose monitoring system (CGM)September 16, 2026
Why Local Medical Device Manufacturing Matters for Indian HealthcareSeptember 16, 2026
Next-Generation Surgical Robots Entering the Indian Market: What It Means for Patients and ProvidersSeptember 16, 2026
ShardaCare - Healthcity Marks World Sepsis Day with Training for Over 50 NursesSeptember 15, 2026
From Empowerment to Ownership: Upasana Kamineni Konidela Calls for a BRICS Women’s Economic CorridorSeptember 15, 2026
WORLD HEART DAY 2026: Don't Miss a Beat: The Heart Attacks That Never Had to HappenSeptember 15, 2026
BL Agro Announces Investment of ₹1,500 Crore In Its Biotech-Arm Leads Genetics To Build An Integrated Dairy and Genetics EcosystemSeptember 15, 2026
Can You Have PMOS With Regular Periods? What Women Often Get WrongSeptember 15, 2026
Hospital Data Breaches in India: What Every Patient Needs to Know Right NowSeptember 15, 2026
Cybersecurity of ICUs: Protecting Connected Critical-Care Systems in Indian HospitalsSeptember 15, 2026
Fortis Hospital, Shalimar Bagh Becomes Delhi NCR’s First Multi-speciality Hospital to Launch Rezūm™ Water Vapor Therapy for Enlarged ProstateSeptember 14, 2026