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Category: Emergency use authorisation

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 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 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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Posted on November 19, 2020November 23, 2020

Pfizer’s mRNA vaccine 95% efficacious, final analysis shows

On November 18, Pfizer announced that the final efficacy analysis of its candidate mRNA-based vaccine (BNT162b2) in phase-3 trial has been completed and the vaccine shows 95% efficacy to prevent…

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Posted on October 9, 2020October 10, 2020

FDA shows spine, rules out COVID-19 vaccines before Presidential election

With at least two months follow-up data likely to be available earliest only by November or December, the guidance essentially shuts the door on vaccine manufacturers making their vaccines available…

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  • Indian scientists divided over restricted use approval for Covaxin January 15, 2021
  • Vaccine dilemma: To take or not to take Covaxin January 15, 2021

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