August 26, 2021
Janet Woodcock, MD.
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.
#RonJohnson #FDA #Vaccination