5 ms·

You are incorrect, the FDA only approved extending the emergency use authorization yesterday, but for some reason the media suggested that it was formally appro

You are incorrect, the FDA only approved extending the emergency use authorization yesterday, but for some reason the media suggested that it was formally approved. Read for yourself: https://www.fda.gov/media/150386/download https://www.fda.gov/media/150386/download

m0zg 5y ago
So CNN is fake news then? https://edition.cnn.com/2021/08/23/health/fda-approval-pfizer-covid-vaccine/index.html https://edition.cnn.com/2021/08/23/health/fda-approval-pfize...
- rangoon626 5y ago
  You are countering my primary source with a secondary source. Did you read the letter? Please at least skim the letter and then form your own conclusion about CNN.
  - deleted 5y ago
    [deleted]
  - perl4ever 5y ago
    I looked at the letter, and I believe you have misinterpreted it. They approved the drug fully for ages 16 and over. That appears to be separate and in addition to a renewed EUA. There is a renewed EUA in order to allow the shot to be given to under 16s, and to allow the shot to be given to anyone without a prescription. There might be more to it, I didn't go over every line, but that's the basic outline of where I think you misunderstood.
  - simpleguitar 5y ago
    Pfizer vaccine is approved for 16+. 12+ is still under EUA.
brokensegue 5y ago
It says the biologics license application is approved. It also talks about the extension of the EUA but the drug was approved.
goostavos 5y ago
I don't think there's a conspiracy here. fda.gov has a formal announcement on their home page. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine https://www.fda.gov/news-events/press-announcements/fda-appr... >Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The 12-15 group is still under EUA.
sveiss 5y ago
Quoting the FDA letter you linked: > On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. Approving the biologics license application _is_ the formal approval. The reason the media is reporting that the FDA gave formal approval is because the FDA did in fact do that. The letter goes on to say: > On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA. So as well as granting formal approval, they _also_ extended the EUA. Why did they do both?: The extension of the EUA covers the existing vials of vaccine in the field and the supply chain which don’t have the approved labelling. Drug and biologic products are approved for sale under conditions that include specific labelling (the brand, in this case “Comirnaty” and the prescriber/patient instructions) and for specific indications. The stock in the supply chain doesn’t meet those requirements, but it would be wasteful to recall it. Additionally, the EUA authorises more indications than the full BLA: kids 12-16, for one. The old stock, and now the new Cominarty-labelled stock, are authorised for these populations under the extended EUA.
- Stratoscope 5y ago
  Thank you for the informative and insightful comment. Perhaps surprisingly, I also thank GP (rangoon626). Even if their claim was wrong, it nudged you to write this clarification, in accordance with Cunningham's Law. https://en.wikipedia.org/wiki/Ward_Cunningham https://en.wikipedia.org/wiki/Ward_Cunningham
- perl4ever 5y ago
  Also something I never thought about, the EUA appears to permit the vaccine be given "without an individual prescription for each vaccine recipient".

m0zg 5y ago

So CNN is fake news then? https://edition.cnn.com/2021/08/23/health/fda-approval-pfizer-covid-vaccine/index.html https://edition.cnn.com/2021/08/23/health/fda-approval-pfize...

rangoon626 5y ago
You are countering my primary source with a secondary source. Did you read the letter? Please at least skim the letter and then form your own conclusion about CNN.
- deleted 5y ago
  [deleted]
- perl4ever 5y ago
  I looked at the letter, and I believe you have misinterpreted it. They approved the drug fully for ages 16 and over. That appears to be separate and in addition to a renewed EUA. There is a renewed EUA in order to allow the shot to be given to under 16s, and to allow the shot to be given to anyone without a prescription. There might be more to it, I didn't go over every line, but that's the basic outline of where I think you misunderstood.
- simpleguitar 5y ago
  Pfizer vaccine is approved for 16+. 12+ is still under EUA.

brokensegue 5y ago

It says the biologics license application is approved. It also talks about the extension of the EUA but the drug was approved.

goostavos 5y ago

I don't think there's a conspiracy here. fda.gov has a formal announcement on their home page. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine https://www.fda.gov/news-events/press-announcements/fda-appr... >Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The 12-15 group is still under EUA.

sveiss 5y ago

Quoting the FDA letter you linked: > On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. Approving the biologics license application _is_ the formal approval. The reason the media is reporting that the FDA gave formal approval is because the FDA did in fact do that. The letter goes on to say: > On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA. So as well as granting formal approval, they _also_ extended the EUA. Why did they do both?: The extension of the EUA covers the existing vials of vaccine in the field and the supply chain which don’t have the approved labelling. Drug and biologic products are approved for sale under conditions that include specific labelling (the brand, in this case “Comirnaty” and the prescriber/patient instructions) and for specific indications. The stock in the supply chain doesn’t meet those requirements, but it would be wasteful to recall it. Additionally, the EUA authorises more indications than the full BLA: kids 12-16, for one. The old stock, and now the new Cominarty-labelled stock, are authorised for these populations under the extended EUA.

Stratoscope 5y ago
Thank you for the informative and insightful comment. Perhaps surprisingly, I also thank GP (rangoon626). Even if their claim was wrong, it nudged you to write this clarification, in accordance with Cunningham's Law. https://en.wikipedia.org/wiki/Ward_Cunningham https://en.wikipedia.org/wiki/Ward_Cunningham
perl4ever 5y ago
Also something I never thought about, the EUA appears to permit the vaccine be given "without an individual prescription for each vaccine recipient".