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…
Category: FDA
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…
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…
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…
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…
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…
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…
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.
