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In reply to the discussion: Resistance to vaccine mandates is building. A powerful network is helping [View all]BumRushDaShow
(128,860 posts)9. They are approved via an "Emergency Use Authorization"
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.
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
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.
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)
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Resistance to vaccine mandates is building. A powerful network is helping [View all]
mahatmakanejeeves
May 2021
OP
Wouldn't it be nice for Americans to know where the money behind all this is coming from?
Midnight Writer
May 2021
#1
Full FDA approval of the Pfizer, Moderna and J&J vaccines will be coming shortly
PortTack
May 2021
#11
Each state has its own mandate for children in school..this is so absurd..
asiliveandbreathe
May 2021
#3
I am voluntarily choosing to hope their self-deportation will ultimately be successful
bucolic_frolic
May 2021
#4
health insurers shouldnt have to cover costs for any patient who refused a vax
rdking647
May 2021
#12