Dr. Walensky should certainly be aware, in issuing Emergency Use Authorizations (EUAs), the FDA has not (under its ridiculously low standards) made a finding that these vaccines are “safe and effective.” Instead, the grant of an EUA means only that the FDA has determined “it is reasonable to believe that [each vaccine] may be effective” and that “it is reasonable to conclude, based on the totality of scientific evidence available, that the known and potential benefits of [each vaccine] outweigh the known and potential risks of the vaccine.”
By claiming – two separate times – that these vaccines are “safe and effective,” Dr. Walensky is misleading the public by suggesting these vaccines have met the legal standard required for licensure.
Worse yet, because her tweet is “descriptive printed matter” that is both advertising and promoting Pfizer’s and Moderna’s vaccines, the tweet itself is in violation of both EUAs issued to these companies because it does not “clearly and conspicuously” contain the required disclaimer that these products have not yet been licensed as safe and effective by the FDA.
https://www.icandecide.org/ican_press/cdc-director-violates-fdas-emergency-use-authorizations-and-posts-misinformation-about-covid-19-vaccines/
By claiming – two separate times – that these vaccines are “safe and effective,” Dr. Walensky is misleading the public by suggesting these vaccines have met the legal standard required for licensure.
Worse yet, because her tweet is “descriptive printed matter” that is both advertising and promoting Pfizer’s and Moderna’s vaccines, the tweet itself is in violation of both EUAs issued to these companies because it does not “clearly and conspicuously” contain the required disclaimer that these products have not yet been licensed as safe and effective by the FDA.
https://www.icandecide.org/ican_press/cdc-director-violates-fdas-emergency-use-authorizations-and-posts-misinformation-about-covid-19-vaccines/
Dr. Walensky should certainly be aware, in issuing Emergency Use Authorizations (EUAs), the FDA has not (under its ridiculously low standards) made a finding that these vaccines are “safe and effective.” Instead, the grant of an EUA means only that the FDA has determined “it is reasonable to believe that [each vaccine] may be effective” and that “it is reasonable to conclude, based on the totality of scientific evidence available, that the known and potential benefits of [each vaccine] outweigh the known and potential risks of the vaccine.”
By claiming – two separate times – that these vaccines are “safe and effective,” Dr. Walensky is misleading the public by suggesting these vaccines have met the legal standard required for licensure.
Worse yet, because her tweet is “descriptive printed matter” that is both advertising and promoting Pfizer’s and Moderna’s vaccines, the tweet itself is in violation of both EUAs issued to these companies because it does not “clearly and conspicuously” contain the required disclaimer that these products have not yet been licensed as safe and effective by the FDA.
https://www.icandecide.org/ican_press/cdc-director-violates-fdas-emergency-use-authorizations-and-posts-misinformation-about-covid-19-vaccines/
0 Comments
0 Shares
1K Views
0 Reviews