• Home
  • Articles
  • COVID-19
  • News
    • Biotech News – Featured
    • Biotech News
    • BioGadgets
  • Interviews
    • Interviews – Academia
    • Interviews – Industry
  • Issues
  • Subscribe
  • Board
  • Advertise
Facebook Twitter Instagram
Trending
  • BioAsia 2023 to be held in February 24-26 in Telangana, India
  • Praj Industries and ESIIC partner to further bioeconomy in Egypt
  • Who is The Real Anthony Fauci? A true Doctor, liar, pharma profiteer or a totalitarian?
  • Guestorial: MALNUTRITION ACCELERATES THE METABOLIC AGE
  • Event: Australia’s biggest week in biotech kicks off in Perth
  • $3 trillion growth reported for biotech sector in USA
  • Event : FABA’s Whale Tank Event – “Venture Capital – Biotech Start-up Connect”
  • Vaccination, Rising Deaths, And The False Narrative
Biotech Express Magazine
  • Home
  • Articles
  • COVID-19
  • News
    • Biotech News – Featured
    • Biotech News
    • BioGadgets
  • Interviews
    1. Interviews – Academia
    2. Interviews – Industry
    Featured
    January 16, 20211

    Interview – Prof Rajeev K Varshney “The Youngest Indian Scientist (47)” who achieved an h-index of 100 recently

    Recent
    July 26, 2022

    We are making best hygiene solutions through Biotech applications: Dr Rachna Dave, founder MicroGO

    March 30, 2022

    Interview- Bioenergy: India’s Ministry of New and Renewable Energy started almost four decades ago…but did not catch up…, Professor Ashok Pandey

    January 24, 2022

    Interview: Prof Kailash Chander Bansal, Secretary, National Academy of Agricultural Sciences (NAAS), India

  • Issues
  • Subscribe
  • Board
  • Advertise
Biotech Express Magazine
You are at:Home»Biotech News - Featured»India’s speedy approvals of COVID-19 vaccines come under fire

India’s speedy approvals of COVID-19 vaccines come under fire

0
By Biotech Express on April 27, 2022 Biotech News - Featured, SARS- CoV2 & COVID-19 Updates

A COVID-19 vaccine named Corbevax looked like a triumph for India’s burgeoning drug industry. Because its U.S. developers hadn’t claimed a patent on it, an Indian manufacturer named Biological E was able to sell the two-dose protein-based vaccine to the government at the extraordinarily low price of 145 rupees ($1.90) per dose. In March, the country began to give the shots to 12- to 14-year-olds, a group for which India did not yet have a licensed COVID-19 vaccine.

But the celebration was quickly drowned out by questions over whether India’s drug regulator, the Central Drugs Standard Control Organization (CDSCO), had properly vetted the vaccine.
In February, CDSCO had authorized the use of Corbevax for adolescents ages 12 to 18. But within weeks, the Indian media outlet The Wire Science revealed that the National Technical Advisory Group on Immunisation (NTAGI), an expert group that advises the health ministry on which vaccines to add to the national immunization program, had questioned whether Biological E had shown the vaccine is effective. In adolescents, who are at a lower risk of severe COVID-19, the benefits of a vaccine should be beyond any doubt, NTAGI member Jayaprakash Muliyil tells Science: “Anytime you vaccinate children, you have to be extremely careful.”

Other CDSCO approvals of COVID-19 vaccines have raised questions as well, both from NTAGI and independent experts. The agency has used “suboptimal” standards on several occasions, says Vineeta Bal, an immunologist at India’s National Institute of Immunology. That has led some scientists to ask whether the agency has the capabilities—and is independent enough—to oversee the quality of medicines for India’s 1.4 billion people.

The implications go beyond India, because the country is a major global medicine supplier. The World Health Organization has “prequalified” 54 vaccines produced in India for use elsewhere, and WHO relies on CDSCO to oversee the manufacturers.

CDSCO didn’t respond to questions from Science about the criticism. In May 2020, India’s health ministry appointed a committee to advise it on how to restructure India’s drug regulatory system in line with global best practices, but that committee’s recommendations haven’t been published. It’s unclear whether they will address vaccine regulation.

In January 2021, for example, the agency greenlit Covaxin, an inactivated-virus vaccine produced by Bharat Biotech, without data from large-scale efficacy trials—only phase 2 data about the immune response generated by the vaccine. By the time the company published data showing 78% efficacy against symptomatic COVID-19, 6 months later, millions of Indians had already received the shot.

NTAGI also differed with CDSCO’s assessment when the regulator approved a COVID-19 vaccine named ZyCoV-D for use in both adults and adolescents in August 2021. Produced by Zydus Cadila in Gujarat state, ZyCoV-D is the first DNA vaccine approved by any country for use in humans. CDSCO based its decision on results of a trial in about 28,000 participants over 12 years of age, which found the vaccine 67% efficacious at preventing symptomatic COVID-19.

NTAGI, which does not typically make its advice public, opposed the use in adolescents, Muliyil says; it felt a completely new vaccine platform should only be used in adults at first. Moreover, the phase 3 trial had a single efficacy estimate for all ages, says another NTAGI member who asked not to be identified, even though efficacy can differ by age group.

In March, CDSCO’s reputation took another hit when a WHO inspection of the Covaxin manufacturing facility in Hyderabad found quality control deficiencies, whose nature WHO has not disclosed. WHO recommended that member countries stop using the vaccine, and Bharat voluntarily halted exports. But the company has downplayed the problems and says it will keep selling Covaxin in India.

CDSCO did not respond to questions from Science about the problems or why it failed to spot them. “It concerns me that CDSCO, the custodian of public health as India’s national drug regulator, haven’t issued any statements yet on this issue,” says Jayanthi Vuppala, an independent expert on good manufacturing practice based in Hyderabad.

Last month’s approval of Corbevax—which by now has been given to 30 million adolescents—raised more questions. CDSCO authorized the vaccine for 12- to 18-year-olds based on interim data from a 312-participant study that showed the vaccine triggered a rise in neutralizing antibodies. But NTAGI wasn’t convinced the vaccine was entirely responsible for the rise, Muliyil says. Data from the unvaccinated placebo group could have shed light on whether CO VID-19 infections were also contributing, but as a preprint posted on 26 April shows, the trial did not assess antibodies in the placebo group. Biological E did not respond to a question about the data.

In March, CDSCO’s reputation took another hit when a WHO inspection of the Covaxin manufacturing facility in Hyderabad found quality control deficiencies, whose nature WHO has not disclosed. WHO recommended that member countries stop using the vaccine, and Bharat voluntarily halted exports. But the company has downplayed the problems and says it will keep selling Covaxin in India.

Original article by Priyanka Pulla, first appeared in Science.

 

Share. Facebook Twitter Pinterest LinkedIn Tumblr Email
Biotech Express
  • Website
  • Facebook
  • Twitter
  • LinkedIn

ISSN: 2454-6968 | Biotech Express Magazine publishes articles in the field of biotechnology and allied sciences in a way that have never been presented earlier. It publishes Editorials, Guest Articles, Reports, Interviews, Current News of Govt. Academics and Business, Research Highlights and Notifications of Events, Jobs, Research Proposals in the field of Biotechnology, Biological Sciences, Life Sciences, Microbiology, Biochemistry, Neurosciences, Genetics, Medical Sciences, BioPharma etc.

Related Posts

Who is The Real Anthony Fauci? A true Doctor, liar, pharma profiteer or a totalitarian?

Maker of Dolo-650, pandemic’s ‘magic pill’, faces income tax searches and PIL petitions

Anthony Fauci, Controversial US Top-doc FINALLY, To Retire By Year-end

Leave A Reply Cancel Reply

Current Issue – October 2022
Upcoming Event

                   VIEW SUBSCRIPTION PLANS

JOBS/NOTIFICATIONS

   

         CLICK HERE FOR RECENT NOTICES

Recent Posts
  • BioAsia 2023 to be held in February 24-26 in Telangana, India January 10, 2023
  • Praj Industries and ESIIC partner to further bioeconomy in Egypt November 10, 2022
  • Who is The Real Anthony Fauci? A true Doctor, liar, pharma profiteer or a totalitarian? November 1, 2022
  • Guestorial: MALNUTRITION ACCELERATES THE METABOLIC AGE October 31, 2022
  • Event: Australia’s biggest week in biotech kicks off in Perth October 26, 2022
  • $3 trillion growth reported for biotech sector in USA October 25, 2022
  • Event : FABA’s Whale Tank Event – “Venture Capital – Biotech Start-up Connect” September 21, 2022
  • Vaccination, Rising Deaths, And The False Narrative September 20, 2022
  • Guestorial: Genome Mapping Techniques and its Application in Aquaculture September 19, 2022
  • Bombay HC Issues Notice To Bill Gates, Serum Institute, DGCI, Others Over Plea On Alleged ‘Vaccine Death’ September 5, 2022
  • Deaths due Covid-19 vaccines should be compensated by vaccine makers: Expert hope on Kerala HC remark August 21, 2022
  • Maker of Dolo-650, pandemic’s ‘magic pill’, faces income tax searches and PIL petitions August 20, 2022
  • Anthony Fauci, Controversial US Top-doc FINALLY, To Retire By Year-end August 20, 2022
  • SII’s Cervevac: The new DCGI approved vaccine without published clinical trial results August 20, 2022
  • Pitch your Start-up to National/International Venture Capitalists – first ever opportunity provided to Bio-Start-ups by FABA August 19, 2022
  • India’s Clinical Trial Registry might disappear soon and so the history of pharma record August 19, 2022
  • Nearly Half of Pregnant Women in Pfizer Trial Miscarried August 10, 2022
  • Researchers develop Cellulose shoes made by bacteria August 9, 2022
  • Biocon Sdn. Bhd. Enters Malaysia Book of Records as the First & the Largest Integrated Insulin Manufacturing Facility August 5, 2022
  • CBI Arrests of CDSCO officials, a Biocon official & Intermediaries in an alleged bribery case exposed Corruption in Govt and Pharma sector July 27, 2022
  • We are making best hygiene solutions through Biotech applications: Dr Rachna Dave, founder MicroGO July 26, 2022
  • EVENT HIGHLIGHTS: Genome editing as a novel technology for sustainable development July 24, 2022
  • US Military Doctor Testifies under Oath That She Was ORDERED To ‘Cover up’ COVID Vaccine Injuries July 24, 2022
  • Climatic Effect on Marine Biodiversity and their impact on coral reefs July 23, 2022
  • Highlights of India’s first Biotech startup Expo June 13, 2022
  • NTU Singapore scientists develop a ‘fabric’ that turns body movement into electricity June 6, 2022
  • Researchers who jumped into the field from distant disciplines published lower impact work, study finds May 30, 2022
  • Amrita Vishwa Vidyapeetham gets CDSCO nod for clinical trials of first-of-its-kind synthetic jaw-bone graft May 26, 2022
  • AstraZeneca Covid-19 vaccines which uses a chimpanzee adenovirus inked to monkeypox outbreak May 25, 2022
  • Concerns Mount Over COVID-19 ‘Rebounds’ After Treatment With Pfizer’s Paxlovid May 25, 2022
Archives
Categories
  • Articles
  • Articles- Editorials
  • Articles- Guestorials
  • BioControversial
  • BioEvents
  • BioGadgets
  • BioPolicies
  • BioResearch – Academic
  • Biotech News
  • Biotech News – Featured
  • Contents
  • Interviews
  • Interviews – Academia
  • Interviews – Industry
  • SARS- CoV2 & COVID-19 Updates
  • startups
About Us

Biotech Express Magazine publishes articles in the field of biotechnology and allied sciences in a way that have never been presented earlier. It publishes Editorials, Guest Articles, Reports,  Interviews, Current News of Govt. Academics and Business, Research Highlights and Notifications of Events, Jobs, Research Proposals in the field of Biotechnology and allied sciences like Biological Sciences, Life Sciences, Microbiology, Biochemistry, Neurology, Genetics, Medical Sciences, BioPharma etc.

Call us: _91-9311986177

Email – biotechexpressindia@gmail.com

About Us

About Biotech Express

Advisory and Editorial Board

Contact Us

Policy and Guidelines

Submission policies

Peer review policy    

Copyright policy

 

Follow Us
  • Facebook
  • Twitter
We use cookies to help provide and enhance our service and tailor content and ads. By continuing you agree to the use of cookies. Copyright © 2013-2020 Biotech Express except certain content provided by third parties.

Type above and press Enter to search. Press Esc to cancel.