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BumRushDaShow

(128,860 posts)
9. They are approved via an "Emergency Use Authorization"
Wed May 26, 2021, 03:37 PM
May 2021

This is what it means - https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

What is an Emergency Use Authorization (EUA)?

An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.

Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.


It's not unlike what is done for "IND"s (Investigational New Drugs).

And the above was expedited based on a federal "Public Health Emergency", which was first declared January 31, 2020 and recently extended for another 90 days - https://www.phe.gov/emergency/news/healthactions/phe/Pages/COVID-15April2021.aspx

Renewal of Determination That A Public Health Emergency Exists

As a result of the continued consequences of the Coronavirus Disease 2019 (COVID-19) pandemic, on this date and after consultation with public health officials as necessary, I, Xavier Becerra, Secretary of Health and Human Services, pursuant to the authority vested in me under section 319 of the Public Health Service Act, do hereby renew, effective April 21, 2021, the January 31, 2020, determination by former Secretary Alex M. Azar II, that he previously renewed on April 21, 2020, July 23, 2020, October 2, 2020, and January 7, 2021, that a public health emergency exists and has existed since January 27, 2020, nationwide.


April 15, 2021
_____________________________
Date

/s/
_____________________________
Xavier Becerra

More Emergency and Response Information

Declarations of a Public Health Emergency
Public Health Emergency Determinations to Support an Emergency Use Authorization
Section 1135 Waivers
Emergency Use Authorizations

​​​


The federal health agencies have generally deferred to the states regarding any vaccination mandates, regardless of whether they have "full approval" or not - https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/vaccine-safety-questions-and-answers

What does CDC do when someone wants to exempt out of vaccinations?

Enacting and enforcing immunization laws and regulations are the responsibility of State governments. CDC supports States' decisions to require certain immunizations as recommended on the Childhood Immunization Schedule for children entering school and childcare facilities. Almost all State immunization mandates pertain to entrance into school and childcare facilities. Many States also have college immunization requirements. States' approaches to exemptions for immunization requirements vary. All States allow medical exemptions for immunization. Forty-eight States permit exemptions for religious reasons and 15 States permit parents to claim exemptions on philosophical grounds. Implementation of religious and philosophical exemptions also varies among States. In some States, immunization program staff review written applications for exemption before granting or denying religious or philosophical exemptions. In other States, parents can obtain exemptions by simply signing a form which is accepted without review.

State public health laws and regulations are enacted pursuant to the provisions of individual State constitutions. CDC guidelines are voluntary rather than regulatory. CDC works with States that are ultimately responsible for the development and enforcement of school laws. The issue of philosophical exemptions in State laws was reviewed by the National Vaccine Advisory Committee (NVAC), which is made up of experts in immunization policy. The Committee supports the current policy, which gives States flexibility in developing and enforcing immunization laws. This issue, as well as other immunization issues, are periodically assessed by the NVAC.


Statutory authorities - https://www.cdc.gov/phlp/docs/ph-emergencies.pdf (PDF)

Wouldn't it be nice for Americans to know where the money behind all this is coming from? Midnight Writer May 2021 #1
Hospitals require their employees to get flu shots Freddie May 2021 #2
Post removed Post removed May 2021 #8
They are approved via an "Emergency Use Authorization" BumRushDaShow May 2021 #9
Still doesnt count as "approved". Not many are requiring it yet oldsoftie May 2021 #16
For "public health emergency" purposes it is BumRushDaShow May 2021 #18
How about approvals from the European Union, Israel, the UK, Canada, and Japan? Yavin4 May 2021 #24
Legally, no. Realistically, yes. oldsoftie May 2021 #25
The essential difference between the EUA and the traditional "approval" BumRushDaShow May 2021 #35
Full FDA approval of the Pfizer, Moderna and J&J vaccines will be coming shortly PortTack May 2021 #11
Yup and this part is something to note from your link BumRushDaShow May 2021 #21
It ain't. paleotn May 2021 #30
Each state has its own mandate for children in school..this is so absurd.. asiliveandbreathe May 2021 #3
ZACLY elleng May 2021 #19
I am voluntarily choosing to hope their self-deportation will ultimately be successful bucolic_frolic May 2021 #4
And the pandemic continues among these unvaccinated communities IronLionZion May 2021 #5
As The Jack Kilpatrick Character Said In "Airplane!" COL Mustard May 2021 #6
my senitments exactly gopiscrap May 2021 #7
Second that. nt Tiger8 May 2021 #27
it's not just poor conservative communities NewJeffCT May 2021 #13
My city is like that IronLionZion May 2021 #36
Brutal Fall and Winter. paleotn May 2021 #31
In the southern states the yearly pattern is reversed. GulfCoast66 May 2021 #34
There could be electoral implications IronLionZion May 2021 #37
If only. JudyM May 2021 #39
That makes sense. paleotn May 2021 #38
I wonder if Putin plays any part in this. LastLiberal in PalmSprings May 2021 #10
Yes - a good part of the anti-vax movement NewJeffCT May 2021 #14
Yes! The Russians! Grins May 2021 #23
Stands to reason not fooled May 2021 #15
health insurers shouldnt have to cover costs for any patient who refused a vax rdking647 May 2021 #12
Now THAT would be interesting. oldsoftie May 2021 #17
THIS. roamer65 May 2021 #20
Amen to THAT too! nt oldsoftie May 2021 #26
How did Putin buy all these people... it's mind-bending. n/t TygrBright May 2021 #22
Fuck these people NEOBuckeye May 2021 #28
They're exhausting. maxsolomon May 2021 #29
What do these people have in common... paleotn May 2021 #32
no Vax,,, No Problem,,, Cryptoad May 2021 #33
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