Action Alert: Two Upcoming FDA Emergency Use Authorization Meetings

Questions regarding the upcoming C0VID vaccine, how it will be developed, rolled out, and if it will be mandated are at the forefront of our work here at TFVC. While details are emerging, we have a unique opportunity to make our voices heard.

Who is this committee?
The FDA uses committees and panels to obtain independent expert advice on scientific, technical, and policy matters. https://www.fda.gov/advisory-committees

What is this committee’s job?
This FDA Advisory Committee will meet in two open sessions to discuss Emergency Use Authorization (EUA) of both COVID-19 vaccine candidates. In this instance, an EUA would allow use of unapproved vaccines to prevent Covid-19. At this meeting, vaccine manufacturers will present the findings of their fast tracked trials in hopes that the committee will issue an EUA, allowing nationwide vaccine distribution.

What is an EUA:
Under an Emergency Use Authorization, the FDA permits the use of unapproved medical products during health emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives.

The EUA process is different from the usual FDA approval or licensing process because the EUA permits authorization based on significantly less data than what is normally required for approval or licensure. This enables the FDA to authorize the emergency use of medical products that meet the criteria within weeks rather than months to years.

It should be noted that the FDA has never granted an EUA to a previously unapproved vaccine. Vaccines approved under an EUA will likely have questionable informed consent procedures and their manufacturers will have no liability for vaccine injuries.

What Can You Do?

Provide public comment and attend online! Details below:

December 10, 2020: Pfizer (for use in individuals 16 years and older)
Submit Public Comment:
https://www.regulations.gov/document?D=FDA-2020-N-1898-0036

Attend Online: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement

December 17, 2020: Moderna (for use in individuals 18 years and older)
Submit Public Comment:
https://www.regulations.gov/document?D=FDA-2020-N-2242-0001

Attend online: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcement

Concerns to discuss in your public comment:
– How will manufacturers be held liable for their product?
– What is the plan for reporting vaccine reactions or injury?
– Who will compensate for damages?
– Will there be protections for those opting out?
– Will this vaccine be mandated for certain populations?
– What is the process for ensuring informed consent?

This is what they say:

“We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.”

Stephen M. Hahn, M.D., FDA Commissioner, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

How are they going to ensure the public’s trust during the EUA process?

17 thoughts on “Action Alert: Two Upcoming FDA Emergency Use Authorization Meetings”

  1. I am deeply concerned the rush for this vaccine will leave individuals vulnerable to unforeseen long term side effects, perhaps in some cases even death. To have no responsibility or recompense for the injections by the Pharmaceutical company or even by the government gives rise to distrust and outright fear from their lack of liability. What Big Pharma and Government is not taking into account is it’s my body, my life.. I would have to live everyday with what could go wrong with the vaccine or die.. My body is my body, not theirs. It is my Constitutional Right that cannot be overridden!! The Covid-19 virus is not as deadly as the media hype has tried to present it as.. 200+ thousand Covid deaths among 330 million people is not even a drop in the bucket to try and create a mandatory vaccination.. And 99.5 % of the most at risk survive… I took the Swine flu vaccine back in the 1980’s. It had terrible side effects for me. As though I had the influenza itself. The vaccine was pushed by a fear mongering media without consequences. Again, it is my body, my right, and there should be no forced mandatory vaccination nor should there be any penalization for those of us who are more cautious and want to wait to see.. If the vaccine performs as Pharma says it will, then those who willing take it should have no problem with those who don’t. It’s their bodies, and they should be protected. They would have nothing to fear from those who love their body’s, too , but don’t want to subject them and their lives to something that’s unproven, and no consequences for liabilities., This is still America.. We still have Constitutional Rights that cannot be overturned or overruled under any circumstances.. Because we are a Tepublic!!

  2. It is, frankly, unfathomable how reasonable, responsible regulators would approve such an experimental, rushed vaccine(s) for Americans for a virus that has an overall (according to CDC) recovery rate of 99%, much less for vaccines for which data has not been peer reviewed, nor apparently has any claim been made or proven about a positive effect in terms of transmission of the virus. Will manufacturers be held liable, as they are not now for most every single vaccine, and if emergency use is approved, then presumably they will not be accountable at all, nor will entities that seek to mandate them?!?!? Will there be any avenue for adequate compensation for damages, injuries and death? What is FDA’s position on true informed consent???
    It appears the vaccines will be prioritized for the most vulnerable elderly and also health care workers first – will there be mandates for these or other groups within our population? And most importantly, how will those people who refuse be protected from any sort of punishment for non compliance? This is a critical time for humanity.

  3. None of our vaccines are safe today. Do not trust Big Pharma or the government. Covid will be no different. Research people what’s in it. So dangerous.

  4. How did manufacture be held liable for their product ?

    What is the plan for reporting vaccine reaction or injury?

    Who will compensate for damage?

    I’m deeply concerned about this vaccine!

  5. I will not get any kind of vaccine. Especially one so hurriedly made public. The whole COVID thing is the biggest scam in world history.

  6. Rebecca O’Gowen

    I hold the rights to what goes into my body. No government mandate or person has the right to tell me I have to have something foreign put into my body with no certainty that there won’t be horrid unforeseen consequences of which I will receive no compensation for. I would have to fix my body myself. As of already having a horrid reaction while
    Pregnant with my third child with the H1N1 and Tdap, I will always fight for others rights over their own bodies. Just like Roe vs. Wade, my body my choice. There are no long term
    Studies and the recovery rate is over 95%! This is the media scaring people
    Into buying a product of pharmaceutical companies who can not by law be held accountable for injuries their products cause.

  7. So many adverse effects that’s all I hear about you and it’s .002 people that have actually died from Covid people need to do research this is ridiculous the people even consider taking it the risk is not worth it! I

  8. Kaye Cherice Pevehouse

    I’m concerned for the fast approval of the Covid-19 vaccine. I’ve heard there have been some bad side effects for those participating in the trials. I’ve also heard that the vaccine that Bill Gates is working on has some very bad ingredients such as the material that fireflies have to make them glow. This will be used to be able to detect if someone has taken the vaccine or not. I also heard that baby parts are also being used in it. And that we have to take the vaccine or we won’t be able to use public transportation or purchase food, etc. I know this sounds extreme but we can’t be to naive and not question what’s being put in these vaccines.

  9. People need to recognize the horrible precedent that is being set. Vaccines are already mandatory in so many situations that this is just another attempt to corner the market and impose medicine on an unwilling public in the name of public health. We have lost so many liberties in the name of public health or national security. Why do people continue to trust the government and pharma when they have a long history of fraud, corruption, death, and malfeasance?

    If people succumb to this Stockholm situation, it will just become the norm, and the world will turn into an open-air prison. The marriage between the industrial intelligence complex and the medical industry be enough to just say no. We have to win this information war because it is the war of our time. Did you really think tyranny would show up with a funny-looking mustache and jackboots? LOL

  10. The question is why arent we having faith in our immune system and why would we continue to weaken it by propping it up everytime anything new arives in our enviornment. This is how we develope an inmune system people ,coming in contact with foreign viruses and our body then recognizes it the next runaround . This will not work because of the virus mutating next year. Why would we take when we havent got the death rate to justify it.
    Everyone best stand up and act like you have a pair.

    ~~”Any man willing to give up his liberties for any amount of safety ,deserves neither liberty nor safety”~~ BENJAMIN FRANKLIN

    I would bet Benjamim Franklin was more intelligent than those telling us we need this today !

  11. The question is why arent we having faith in our immune system and why would we continue to weaken it by propping it up everytime anything new arives in our environment . This is how we develope an inmune system people ,coming in contact with foreign viruses and our body then recognizes it the next runaround . This will not work because of the virus mutating next year. Why would we take when we havent got the death rate to justify it.
    Everyone best stand up and act like you have a pair.

    ~~”Any man willing to give up his liberties for any amount of safety ,deserves neither liberty nor safety”~~ BENJAMIN FRANKLIN

    I would bet Benjamim Franklin was more intelligent than those telling us we need this today !

  12. Pfizer and Moderna have unleashed the disaster of the Century, with no solid safety evaluation. mRNA vaccines produce random and uncontrollable adverse effects that will avalanche downstream functions of the human body. Many human body systems rely upon balanced signaling and precision controls to keep them healthy. mRNA engineered manipulative vaccines will disrupt and create irrevocable harm for generations. Do not be forced into taking this vaccine, it will not protect you or anyone.——We will see very troubling and life threatening reactions with these vaccines in the months and years ahead.

  13. Pfizer and Moderna have unleashed the disaster of the Century, with no solid safety evaluation. mRNA vaccines produce random and uncontrollable adverse effects that will avalanche downstream functions of the human body. Many human body systems rely upon balanced signaling and precision controls to keep them healthy. mRNA engineered manipulative vaccines will disrupt and create irrevocable harm for generations. Do not be forced into taking this vaccine, it will not protect you or anyone.——We will see very troubling and life threatening reactions with these vaccines in the months and years ahead.

Leave a Reply to dru Cancel Reply

Your email address will not be published. Required fields are marked *

Scroll to Top