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--- covid-19_vaccines:government_approval [2022/01/21 13:46]
mathew added Wiseman on ACIP from August
+++ covid-19_vaccines:government_approval [2022/10/04 18:07] (current)
dennis [United States]
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 ===== United States =====
-The world's eyes are on the [[:United States]], which led the breakneck pace of vaccine development via [[:Operation Warp Speed]].
+The world's eyes are on the [[:United States of America|United States]], which led the breakneck pace of vaccine development via [[:Operation Warp Speed]].
+An important concept to understand for Vaccine authorization, as well as other Covid treatments such as Paxlovid is the concept of Emergency User Authorization.  To quote YaleMedicine, 'Put simply, an emergency use authorization (EUA) is a tool the Food and Drug Administration (FDA) can use to expedite the availability of medical products, including drugs and vaccines, during a public health emergency. An EUA can only be granted when no adequate, approved, available alternatives exist, and when the known and potential benefits outweigh the potential risks. An EUA also only lasts as long as the public health emergency for which it was declared.'  --https://www.yalemedicine.org/news/what-does-eua-mean
+Some have speculated if the demanding criteria of the Emergency Use Authorization in regards to 'no adequate, approved, available alternatives exist' impacted the development of treatment protocols using pre-existing generic medications.
 ==== Public Discussion and Recommendations ====
 During the Advisory Committee on Immunization Practices (ACIP), the committee unanimously voted to approve a recommendation for the Pfizer-BioNTech COVID-19 vaccine for people age 16 and older despite discussion of six studies showing waning vaccine efficacy being presented only after the vote took place.((September 10, 2021 | [[:David Wiseman]] | [[:TrialSite News]] | [[https://trialsitenews.com/the-smoking-syringe-was-evidence-withheld-from-acip-when-they-recommended-the-pfizer-vaccine/|The Smoking Syringe: Was evidence withheld from ACIP when they recommended the Pfizer-Vaccine?]]))
-====CDC October 2020 Vaccine Forecast====
+Late in 2021, the [[:Food and Drug Administration|FDA]] and [[:Centers for Disease Control and Prevention|CDC]] stopped holding advisory committee meetings altogether.((December 16, 2021 | [[NewsTarget]] | [[https://newstarget.com/2021-12-16-fda-cdc-skipping-advisory-committees-authorize-shots.html|FDA and CDC now just SKIPPING their own advisory committees and rubber-stamping authorization for covid shots]]))
+==== Confusing or Misapplied Standards ====
+Official contraindications for the [[:Janssen]] [[:quasi-vaccine]] warning about adverse events (AEs) such as [[:thrombosis]] and [[:myocarditis]] have not been similarly applied to other vaccines despite similar AE profiles.((December, 2021 | [[:David Wiseman]] et al | preprint | [[https://www.researchgate.net/publication/357300150_Why_limit_contraindication_to_Janssen_Using_same_criteria_revisit_EUABLA_for_all_C19_quasi-vaccines_Transparency_Emergency_ACIP_Meeting_Dec_16_2021_A_second_open_letter_to_Dr_Grace_Lee_ACIP_Chair?channel=doi&linkId=61c55733da5d105e55f237a7&showFulltext=true|Why limit contraindication to Janssen? Using same criteria revisit EUA/BLA for all C19 quasi-vaccines. Transparency: Emergency ACIP Meeting Dec 16 2021: A second open letter to Dr. Grace Lee, ACIP Chair]]))
+===CDC October 2020 Vaccine Forecast===
-In the United States, there is currently no authorized or approved vaccine to prevent **coronavirus disease** 2019 (COVID-19). [[Operation Warp Speed]] external icon has been working since the pandemic started to make a COVID-19 vaccine(s) available as soon as possible. CDC is focused on vaccine planning, working closely with health departments and partners to get ready for when a vaccine is available. CDC does not have a role in developing COVID-19 vaccines.
+In the United States, there is currently no authorized or approved vaccine to prevent **coronavirus disease** 2019 (COVID-19). Operation Warp Speed external icon has been working since the pandemic started to make a COVID-19 vaccine(s) available as soon as possible. CDC is focused on vaccine planning, working closely with health departments and partners to get ready for when a vaccine is available. CDC does not have a role in developing COVID-19 vaccines.
 With the possibility of one or more COVID-19 vaccines becoming available before the end of the year, here are 8 things you need to know about where those plans currently stand.