Source: Kyle Becker
Update: See further legal analysis from an attorney at the bottom of the story.
The Food and Drug Administration’s “full authorization” for the Pfizer-BioNTech vaccine for Covid-19 was announced with a fair amount of hooplah and fanfare. The President of the United States announced the monumental development and touted it as rationale for the vaccine mandates to commence in the private sector, throughout the government, and in the U.S. military.
President Joe Biden was on the spot Monday morning with a quick reaction to the FDA’s “full authorization” of the Covid-19 vaccines.
“The FDA has officially approved the Pfizer COVID-19 vaccine,” Biden said. “While all three COVID vaccines have met FDA’s strict standards for emergency use, this FDA approval should give added confidence that this vaccine is safe and effective. If you’re not vaccinated yet, now is the time.”
Biden’s announcement followed upon the widespread media coverage that the Pfizer-BioNTech had “full” approval for the use of the vaccine in the United States.
“The Food and Drug Administration granted Pfizer and BioNTech full U.S. approval of their Covid-19 vaccine – becoming the first in the U.S. to win the coveted designation and giving even more businesses, schools and universities greater confidence to adopt vaccine mandates,” CNBC reported.
“Up until now, the mRNA vaccine was on the U.S. market under an Emergency Use Authorization, which was granted by the FDA in December. Since then, more than 204 million of the Pfizer shots have been administered, according to data compiled by the Centers for Disease Control and Prevention,” the report added.
The Pentagon on Wednesday finally issued its order that U.S. troops get the vaccine — or else.
“To defend this Nation, we need a healthy and ready force,” the Defense Department memo said. “After careful consultation with military experts and military leadership, and with the support of the President, I have determined that mandatory vaccination against coronavirus disease 2019 (COVID-19) is ncessary to protect the force and defend the American people.”
But a closer examination of the “full authorization” documents has some Americans feeling deceived. There is the matter that Pfizer-BioNTech still appears to be afforded the legal protections that accompany Emergency Use Authorization, all while it purportedly has “full” FDA approval. How did the pharmaceutical company manage such a commercial ‘coup’?
Upon a more critical look at the documents, it now very much seems to be the case that the company, along with the indispensable aid of a complicit media and the Biden administration, has engaged in a classic bait-and-switch.
Before proceeding, examine the technical language used in the awkwardly phrased release. The new label for the ‘fully authorized’ vaccine is called ‘Comirnarty.’
“On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19 for individuals 16 years of age and older pursuant to Section 564 of the Act,” the FDA stated in a letter to the Global Senior Director of Pfizer Ms. Elaine Harkins. “FDA reissued the letter of authorization on: December 23, 2020, February 25, 2021, May 10, 2021, June 25, 2021, and August 12, 2021.”
“On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.”
PhD. biochemistry and molecular biology student Kathleen Lee picked up on the change in language and decided to press further.
“I called the Pfizer BioNtech number 1-800-666-7248,” she said. “The recording clearly states that it has not been approved by the FDA. Pfizer BNT162B2 is still under EUA. This clears up that messy FDA authorization between Comirnaty and Pfizer BioNtech.”
Overlooking the odd choice for an area code, I decided to call and confirmed this is still the case. But it could just be an old recording. Lee continued to express her analysis of the apparent discrepancy.
“It’s deceitful,” Lee claimed. “If the vial says Comirnaty- It’s FDA approved. It the vial says Pfizer BioNtech- it’s under EUA and they’re not subject to liability. There’s millions of doses to get rid of first.”
Yet if the next batch of vaccines being dispensed were being produced under the Cominarty label, then that would appear to reconcile the issue.
Except that isn’t the case. Buried deep within the footnotes of the Pfizer-BioNTech documents is one footnote that puts into rather jolting perspective that the currently labeled vaccines are still under Emergency Use Authorization (EUA).
The profound implications of this admission was mentioned by notable vaccine critic Alex Berenson, formerly of the New York Times and a best-selling author on the subject.
“So now that Come-Here-Naughty is approved (ish), the [Moderna] and [Johnson & Johnson] lose their Emergency Use Authorizations, right?” Berenson asked. “Because there’s an approved alternative and you can’t have an EUA when there are ‘adequate, approved, and available alternatives’.”
“Or is this another reason [the FDA] is going out of its way to say Comirnaty is not available?” Berenson continued. “[A]lthough COMIRNATY (COVID-19 Vaccine, mRNA) is approved… there is not sufficient approved vaccine available for distribution to this population.”
Attorney Robert Barnes got to the heart of the matter in a post on Wednesday night:
“There is no *available* FDA approved licensed vaccine,” Barnes said. “Here’s what is happening. If FDA approved & licensed COVID19 vaccine, it would have to revoke the EUA vaccines & subject the vaccine maker to more liability risk. So it only approved a future vaccine that isn’t ‘available’.”
When a user questioned his analysis with the extremely persuasive point “full stop,” Barnes countered with an indisputable point.
So, the little trick that they’ve done here is they have issued two separate letters… The Pfizer vaccine, which is what is currently available… is still under Emergency Use Authorization,” Dr. Malone said. “Once again, the mainstream media has lied to you.”
The entire vaccine rollout has broken the public trust — from the lies about “15 days to stop the spread” to the lie that the COVID vaccine prevents transmission and thereby protects “the public” — the pharmaceutical companies, as well as the Biden administration and its bureaucratic arms, no longer get the benefit of the doubt.
If the Pfizer-BioNTech vaccine is being treated as a ‘fully authorized’ vaccine, then it should no longer be afforded the protections offered by EUA.
There is one way the American people can find out for sure: Let the lawsuits begin.
============================= On The Flip Side =====================
The mainstream media, some public health authorities, and the pharmaceutical industry have engaged in a massive disinformation campaign. This campaign has focused on using fear to get everyone to take an experimental vaccine as the only way to get out of the pandemic. On Sunday, Biden urged America’s employers to make vaccination a condition of employment and expressed a hope that all Americans would be vaccinated.
Why? What is the agenda if vaccinating everyone is not medically necessary? (It is not!)
1) The COVID-19 death count has been artificially elevated to maximize fear. California’s fifth-most populous county revised its COVID-19 death count down by 22% after reviewing the cases for the last 18 months. Washington and Minnesota previously also lowered their counts. It is likely that overcounting happened across our country.
2) The PCR test for COVID-19 is flawed in many ways and led to overcounting cases. Two weeks ago, the CDC and FDA quietly said they would abandon the PCR test for COVID-19 in December 2021, acknowledging it did not work.
They also alluded to the fact that the PCR test could not distinguish between COVID and the flu. Did the flu go away last year? No, many cases were counted as COVID-19.
The CDC and FDA also now admit that they did not have any physical samples of the COVID-19 virus so they used common cold Coronaviruses and human cells to make a less accurate test. Covid-19 testing has been inaccurate and ramped up cases for fear.
3) The new mRNA vaccines are far from safe. While the VAERS reporting system now has over 10,000 deaths (EU 20,000 deaths) after the vaccine, a whistleblower with the CDC says the actual count is closer to 50,000 and not being reported. Adverse reactions, including anaphylaxis, blood clots, neurologic injury, and spontaneous abortion have approached 650,000 patients in the USA. After only eight months of vaccination, longer-term side effects remain unknown. Instead of a push to vaccinate everyone, the vaccination program should be stopped.
4) The mRNA vaccine is not safe in pregnant women. An article in the New England Medical Journal showed a rate of spontaneous abortion of 12% which is close to what is normally expected and the conclusion was the vaccine was safe to give. However, the study was skewed to include mostly women in the third trimester (84%). The remaining women in the 1st and 2nd trimesters had a 75% spontaneous abortion rate (96 out of 127). (See the footnotes to Table 4 in the article). The CDC also tried to hide this. Pregnant women should not take the experimental vaccine.
5) The most prestigious medical journals have been part of the disinformation. The Lancet, the top medical journal in Europe, had to retract a study saying Hydroxychloroquine was not working on COVID-19 when it was proved that there was no data for the study. This did not happen by accident.
The Lancet also published a statement signed by several scientists saying the COVID-19 virus could not have possibly come from the Wuhan lab. With evidence mounting now that this is exactly what happened the Lancet cannot admit it was wrong. Faith in our medical leaders is waning.
6) Antibody Dependent Enhancement (“ADE”) may be happening. One initial concern about making a Coronavirus vaccine was ADE. Now reports are beginning to come in from countries that are heavily vaccinated, such as Israel, that vaccinated people are getting sick and may have more serious illnesses than those not vaccinated. If the death rate of the vaccinated is higher than the unvaccinated this would be very scary.
7) The mRNA vaccines are not 95% effective as touted. Efficacy is likely closer to 40-70% but more data is needed. Reports coming in from Israel and states like Massachusetts show high numbers of vaccinated people (over 50%) in the hospital with COVID-19. Those that chose vaccination now looking at endless booster injections (the same vaccine that did not work very well the first time?) every six months (see #3 and #6).
All evidence seems to be pointing to the COVID-19 virus being engineered in the Wuhan virology lab and released there. Despite his denials, Dr. Fauci and our government have been involved in gain of function research for Coronaviruses for a long time.
The response of our government, some health authorities, and the media seems aimed more at social change and control than it is aimed at public health and ending the COVID-19 pandemic. It is not about public health and ending the pandemic when:
faulty PCR testing has been used to inflate cases and maximize fear;
some protests/riots (Antifa/BLM) are deemed OK and others are not;
death counts from COVID-19 were inflated to maximize fear;
safe, cheap, and effective medicines to treat COVID-19 are ignored;
our Southern border is open and illegal immigrants are not being tested (20% +) or allowed to enter regardless of their COVID status;
experimental vaccines are pushed 24/7 as the only solution;
prestigious medical journals fabricate data to maximize fear;
Sweden’s success without masks and lockdowns is ignored;
Privileged people get funerals and the rest don’t;
scientific data on the futility of masking and lockdowns are ignored;
there is a push to vaccinate people with extremely low risk of illness (e.g., children);
media and government censor alternate views of pandemic/vaccine information;
serious vaccine side effects are ignored and there is no informed consent to the vaccine;
every 2 months there is a new Greek letter variant with no outcome data to scare us.
The why of the above behavior remains mysterious, at least in part. Money is always a motivator for vaccine production, but this effort goes beyond monetary gain.
Many postulate that the goal is either the Great Reset or Socialism or remaking our society. Vaccine passports could be a gateway to monitoring everyone all the time.
Another postulate due to concerns about climate change is that COVID-19 and the vaccine are meant as a means for depopulation. Does the vaccine affect fertility? That still hasn’t been evaluated.
More deaths have been associated with the vaccine than any other vaccine in our history. Why hasn’t there been any inquiry into vaccine-related deaths? Will ADE come into play in the future winter seasons?
Americans need to resist further attempts at medical tyranny related to the pandemic. We do not need to be afraid of COVID-19. We need to be more afraid of our pandemic managers/government/media response to COVID-19.
I am with Rand Paul (another M.D.) in his call to resist peacefully. No more lockdowns or masking. We need to preserve the freedom to choose our medical treatments and not be persecuted for that choice. The vaccinated and the unvaccinated need to come together to stop the hysteria, fear, and efforts to control us.
Advocate for Ivermectin and Hydroxychloroquine to be used immediately. America’s Frontline Doctors and Front Line Critical Care Alliance have protocols to treat and prevent COVID-19/variants.
Another excellent article to read on medical tyranny is by Brandon Smith. France, England, and Italy have begun to protest against more medical tyranny. Will America see what is happening, wake up, and fight for its freedom?