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    Added news   to  , Vaccination

    In July, reporter Alex Berenson flagged emerging data from Israel suggesting a rise in cases and, potentially, even hospitalizations and deaths. Israel was perhaps the earliest and most broadly vaccinated nation on earth. Was this a signal of the vaccine’s failure to block transmission and its lack of durability? For asking this question, Twitter suspended Berenson for a week. 

    Unfortunately, Berenson was onto something. Over the next few months, Israeli cases and illnesses surged. Of the 607 Israelis who died of Covid-19 in the month of August, 375 (61.8%) had received either two or three doses of the Pfizer vaccine, while 232 (38.2%) had either zero or one dose. Because a high proportion of Israelis had been fully vaccinated, the rate of illness among the vaccinated was still lower than the unvaccinated. The vaccines reduce the severity of disease – at least for several months. For most high-risk individuals, vaccination probably still makes sense. Yet the rationale for universal vaccination, for coercive measures, and for the vaccination of young people had crashed. 


     

    Added news   to  , Vaccination


    August 26, 2021

    Janet Woodcock, MD.

    Acting Commissioner

    Food and Drag Administration

    10903 New Hampshire Ave

    Silver Spruw 20993

    Dear Acting Commissioner Woodcock:

    On August 23, 2021, the FDA reissued the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COID-19 vaccine. This vaccine is currently available and used in the United States. At the same time, the FDA announced its approval of the biologics license application submitted by BioNTech Manufacturing GmbH for Comirnaty (COVID-19 Vaccine, mRNA) against COVID-19 for individuals 16 years of age and older. According to the FDA, •there IS not sufficient approved vaccine [Comirnaty] available for distribution" in the U.S.

    In the letter that reissued the EUA for the Pfizer-BioNTech COVID-19 vaccine, the FDA stated that Comirnaty and the Pfizer-BioNTech COVID-19 vaccines are "legally distinct with certain differences that do not impact safety or effectiveness" That statement, together with the fact that the FDA issued two distinct letters — one extending the EUA for the vaccine used in the U.S. and the other granting the FDA approval of the Comirnaty vaccine used in Europe and other countries — has caused a great deal of confusion.

    As I stated to you in my letter dated August 22, 2021, "I see no need to rush the FDA approvalprocess for any of the three COVID-19 vaccines. Expediting the process appears to only serve the political purpose of imposing and enforcing vaccine mandates Because the FDA-approved Comirnaty vaccine is not generally available in the U.S., but the Pfizer-BioNTech COWD-19 vaccine will continue to be used in the U.S. under a reissued EUA, the FDA seems to be confirming my suspicion.

    In order to address the confusion created by the FDA's August 23, 2021 letters, I am asking that you expeditiously provide answers to following questions:

    1) Why didn't the FDA grant licensure for the Pfizer-BiaNTech vaccine that is in use and available in the U.S.?

    2) How are the Comirnaty and Pfizer-BioNTecb COVID-19 vaccines "legally distinct" and what are the "certain differences'?

    3) There is no doubt that the FDA's action lead to vaccine mandates and increased pressure on those currently choosing nat to get vaccinated Your letter to Pfizer suggests that if there is not sufficient approved vaccine available for distribution" Is there sufficient supply in the US. of the Comirnaty vaccines to ensure that those being vaccinated under mandates will be receiving the FDA-approved version? is it more likely (or certain) that they be vaccinated using me vaccine administered under the reissued EVA?

    4) If there is insufficient supply of Comirnaty vaccines for those succumbing to the coercion of mandates't the FDA de facto endorsing vaccine mandate's utilizing EUA vaccines?

    5) Will individuals who receive either vaccine be afforded the same legal protections if they are injured by the vaccine? If not, why not?

    I look forward to receiving a response to this limited number of questions no later than August 30.2021. Your answers are crucial to Americans who will be forced intomaking potentially life altering decisions in response to the employer, military and educational mandates that your August 23, 2021 letters hate triggered I also be sending you a more detailed follow-up letter to your inadequate response to my August 22, 2021 letter in the next few days.


    Sincerely,

    Ron Johnson

    VS. Senator



    Added news   to  , Vaccination

    U.S. developing plan to require foreign visitors to be vaccinated - official

    The Biden administration is developing a plan to require nearly all foreign visitors to the United States to be fully vaccinated against COVID-19 as part of eventually lifting travel restrictions that bar much of the world from entering the United States, a White House official...

     

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