FDA grants full approval to Pfizer-BioNTech or Comirnaty.

Pfizer-BioNTech gets full approval from the FDA on 23rd of August, 2021 which means it won’t be under the “emergency use” category anymore. It will now be called “Comirnaty”. This is a big development which will change the course of the COVID-19 pandemic.

There is a difference between emergency use authorization and full approval. Emergency use authorisation means that a vaccine may be used to vaccinate common masses in case of severe, life threatening disease like the COVID-19 pandemic but research on developing the specific vaccine does not stop.

It doesn’t mean that a vaccine will get approved without any clinical testing, what it means is that if vaccine shows signs of resistance against concerned disease after at least one phase of clinical trial which includes several hundred to thousands of people while no other or a significant number of vaccines are not being developed to vaccinate the masses, it gets “emergency use authorisation”.

FDA on 23 August, 2021 notified that it is granting full approval to Pfizer-BioNTech vaccine or “Comirnaty”. It was given emergency use authorization last year in December. The test was conducted on more than 12,000 subjects in the U.S. After getting full approval Pfizer shares went up by 5% while BioNTech shares went up by 9%. The vaccine can be administered to anyone above the age of 16.

7 comments

  1. However, Peter Doshi, the senior editor of the British Medical Journal, said Monday that the FDA should have demanded “controlled studies with long term follow up” before granting the approval.
    Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee said,“It is already concerning that full approval is being based on six months’ worth of data despite the clinical trials designed for two years.” she said. “There is no control group after Pfizer offered the product to placebo participants before the trials were completed.

    https://www.bmj.com/content/374/bmj.n2086

    Liked by 1 person

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