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Category: FDA

Posted on January 15, 2021January 15, 2021

Indian scientists divided over restricted use approval for Covaxin

In a tweet on January 14, the Health Ministry said both Covishield and Covaxin approved for restricted use by the Indian regulator are safe. The Health Ministry released a statement…

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Posted on January 15, 2021January 15, 2021

Vaccine dilemma: To take or not to take Covaxin

True, in the U.S., vaccines from both Pfizer and Moderna are available and recipients, who are health-care workers and nursing home residents, have no option to choose the vaccine. In…

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Posted on January 5, 2021January 5, 2021

With hasty approval, India squanders an opportunity to build trust in COVID-19 vaccine

Transparency in the approval process is vital for gaining the trust of people so that they don’t hesitate to take the vaccine. If there is already some degree of anxiety…

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Posted on December 12, 2020

Can COVID-19 vaccines with EUA be used at the population level?

Meanwhile, the Indian government has spelt out four high-risk groups — healthcare workers, frontline workers, those over 50 years of age and those aged below 50 years but with co-morbidities…

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Posted on December 11, 2020

By putting the vaccine approval on hold for want of data, DCGI has underscored its priorities

The greatly reassuring decision to seek additional safety and immunogenicity data from the Pune-based Serum Institute of India and Hyderabad’s Bharat Biotech underlines the regulator’s priorities even for emergency use…

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Posted on December 8, 2020December 8, 2020

Transparency in COVID-19 vaccine trials vital to gain public trust

Unlike Pfizer, AstraZeneca, which is carrying out the phase-3 trials of the Oxford vaccine in four countries, is yet to secure a nod from any of the regulatory agencies despite…

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Posted on December 1, 2020

Moderna’s mRNA vaccine has 94.1% efficacy in final analysis, has applied for EUA

According to the release, the Phase-3 trial has exceeded two months of median follow-up post vaccination as required by the U.S. FDA for the purpose of Emergency Use Authorization (EUA). While the…

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Posted on November 22, 2020

Ethics of denying COVID-19 vaccine to placebo group participants once EUA is granted

Offering the vaccine right away to those in the placebo group will first require unblinding the study. Unblinding the study and offering the vaccine to the placebo group will make it almost impossible to gather further information on vaccine efficacy, thus making full licensure challenging.

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Recent Posts

  • Indian scientists divided over restricted use approval for Covaxin January 15, 2021
  • Vaccine dilemma: To take or not to take Covaxin January 15, 2021
  • Serious violations in Covaxin trial in Bhopal show nothing has changed since the egregious HPV vaccine trial January 13, 2021
  • New challenges in conducting COVID-19 vaccine trials in India January 9, 2021
  • I would not take Covaxin without efficacy data: Gagandeep Kang January 8, 2021

Most Read Posts

  • Vaccine dilemma: To take or not to take Covaxin
  • Indian scientists divided over restricted use approval for Covaxin
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  • 'Serum’s pneumococcal vaccine will be available by June 2020'
  • Sadhguru Jaggi Vasudev, stop spreading vaccine misinformation
  • India's TB control programme renamed to reflect its intent on ending TB
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