2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine (The Defender)

As of 8/13/2021

Products on the market are classified as gene therapy (page 106), and viral vector.

1,371 adverse reactions have been reported over a period of only 8 months. (Data Source: US DHHS/VAERS database in Medalerts. View full report here.)

COVID-19 VACCINES WERE AUTHORIZED FOR “EMERGENCY USE ONLY” with VERY LIMITED DATA!

(AND they are exempt from liability)

  • On 12/11/2020 the U.S. Food and Drug Administration (FDA) announced[1] they had issued an Emergency Use Authorization (EUA) to permit the emergency use of the “unapproved product”, Pfizer-BioNTech COVID-19 Vaccine.[2]
  • On 12/18/2020 the U.S. Food and Drug Administration (FDA) announced[3] they had issued an Emergency Use Authorization (EUA) to permit the emergency use of the “unapproved product”, Moderna COVID-19 Vaccine.[4]
  • On 2/27/2021, the U.S. Food and Drug Administration (FDA) announced[5] they had issued an Emergency Use Authorization (EUA) to permit the emergency use of the “unapproved product”, Janssen Ad26.COV2.S Vaccine.[6]

Federal law (21 CFR 50) [7] requires recipients to be informed: YOU have the option to accept or refuse the EUA product [8]

REFERENCES

[1] https://www.prnewswire.com/news-releases/fda-takes-key-action-in-fight-against-covid-19-by-issuing-emergency-use-authorization-for-first-covid-19-vaccine-301191524.html

[2] Pfizer-BioNTech Vaccine EUA Fact Sheet for Recipients and Caregivers https://www.fda.gov/media/144413/download

[3] https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

[4] Moderna Vaccine EUA Fact Sheet for Recipients and Caregivers https://fda.gov/media/144637/download

[5] https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine

[6] Janssen Ad26.COV2.S Vaccine EUA Fact Sheet for Recipients and Caregivers https://www.fda.gov/media/146305/download

[7] Quoting from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities: “Although informed consent as generally required under FDA regulations is not required for administration or use of an EUA product, section 564 does provide EUA conditions to ensure that recipients are informed about the MCM they receive under an EUA. For an unapproved product (section 564(e)(1)(A)(ii)) and for an unapproved use of an approved product (section 564(e)(2)(A)), the statute requires that FDA ensure that recipients are informed to the extent practicable given the applicable circumstances: That FDA has authorized emergency use of the product; Of the significant known and potential benefits and risks associated with the emergency use of the product, and of the extent to which such benefits and risks are unknown; That they have the option to accept or refuse the EUA product and of any consequences of refusing administration of the product; and of any available alternatives to the product and of the risks and benefits of available alternatives. Therefore, FDA recommends that a request for an EUA include a “Fact Sheet” for recipients that includes essential information about the product. “ This statement references 21 CFR 50 (accessible at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=50)

[8] Quoting from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities: “Although informed consent as generally required under FDA regulations is not required for administration or use of an EUA product, section 564 does provide EUA conditions to ensure that recipients are informed about the MCM they receive under an EUA. For an unapproved product (section 564(e)(1)(A)(ii)) and for an unapproved use of an approved product (section 564(e)(2)(A)), the statute requires that FDA ensure that recipients are informed to the extent practicable given the applicable circumstances: That FDA has authorized emergency use of the product; Of the significant known and potential benefits and risks associated with the emergency use of the product, and of the extent to which such benefits and risks are unknown; That they have the option to accept or refuse the EUA product and of any consequences of refusing administration of the product; and of any available alternatives to the product and of the risks and benefits of available alternatives. Therefore, FDA recommends that a request for an EUA include a “Fact Sheet” for recipients that includes essential information about the product. “ This statement references 21 CFR 50 (accessible at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=50)

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