Subscribe for free to the America First Report newsletter.
The U.S. Food and Drug Administration on Tuesday released a 10,000-page cache of documents pertaining to the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID vaccine.
The documents provide more insights into the FDA’s process for approving the vaccine, and may also shed more light on the safety and efficacy of the vaccines and the number and nature of adverse effects that were observed during the clinical trials and the first months after the EUA was issued.
Important: Our sponsors at Jase are now offering emergency preparedness subscription medications on top of the long-term storage antibiotics they offer. Use promo code “Rucker10” at checkout!
The documents were made public as part of a court-ordered release schedule stemming from an expedited Freedom of Information Act (FOIA) request by Public Health and Medical Professionals for Transparency (PHMPT).
PHMPT, a group of medical and public health professionals and scientists from Harvard, Yale, UCLA and other institutions, submitted the request in August 2021.
The FOIA request asked for the approximately 400,000 pages of documents pertaining to the approval of the Pfizer COVID vaccine to be made public, including safety and effectiveness data, adverse reaction reports and a list of the vaccine’s active and inactive ingredients.
When the FDA ignored the request, PHMPT sued the agency in September 2021, taking the case to the U.S. District Court for the Northern District of Texas. On Feb. 2, federal judge Mark Pittman issued an order requiring the FDA to release redacted versions of the documents in question according to the following disclosure schedule:
- 10,000 pages apiece, due on or before March 1 and April 1, 2022.
- 80,000 pages apiece, to be produced on or before May 2, June 1 and July 1, 2022.
- 70,000 pages to be produced on or before Aug. 1, 2022.
- 55,000 pages per month, on or before the first business day of each month thereafter, until the release of the documents has been completed.
The cache of documents made public on March 1, available on PHMPT’s website, represents the first release of such documents following the issuance of Pittman’s order in February.
However, the FDA released smaller sets of documents in November and December 2021 and January 2022, while the legal case was ongoing.
What do the documents reveal?
The first batch of documents, produced in November 2021 and totaling a mere 500 pages, revealed safety concerns and the fact that more than 1,200 vaccine-related deaths occurred within the first 90 days following the release of the Pfizer-BioNTech COVID vaccine.
The documents also revealed a nine-page list of adverse events observed during that same period. The list recently was circulated widely on social media and wrongly attributed to the set of documents released March 1.
This may be because the March 1 document release garnered widespread attention among those following the issue, likely delivering traffic to PHMPT’s website, which catalogs all of the documents that have been released thus far.
Major media outlets, however, have not covered the latest release of documents and, as of this writing, there has been only limited coverage by smaller media outlets. That may be due, at least in part, to the vast volume of information and data to sort through.
Endpoints News, a publication focusing on the pharmaceutical industry, published a dismissive article regarding the release of the latest cache of documents.
The publication’s editor, Zachary Brennan, reported the documents contain mundane information that is “typical for any drug or vaccine application” and that “will give readers a good overall sense of the required documentation necessary to apply for a drug or vaccine approval at the FDA.”
Such information includes, according to Brennan, “more than 100 pages worth of anonymous safety-related tables of data” and “unidentified participants’ gender, age and BMI.”
Other documentation pertains to “the standard, nearly $2.9 million user fee payment to FDA from Pfizer” and to “the confidential nonclinical overview for the vaccine,” Brennan said.
Brennan noted some documents included in the cache, such as the fast track designation letter and Pfizer’s request for a waiver from adding a suffix to the vaccine’s name, are “not typically released” to the public.
However, aside from this relatively mundane information — whether typically released to the public or not — the latest batch of documents may contain additional revelatory information.
An initial review by The Defender of the information included in this vast set of newly released documents includes:
- Details regarding animal studies that were conducted, and their findings.
- Documents that appear to pertain to specific types of adverse reactions experienced by trial participants, and to COVID-19 infections in trial participants post-vaccination.
- Information about the study protocol, as well as amendments that were made to this protocol.
- Information about Pfizer’s internal review committee for the COVID vaccine.
- The original Pfizer-BioNTech application to market the COVID vaccine, submitted to the U.S. Department of Health and Human Services (HHS).
The sheer volume of information that must be analyzed and processed necessitates careful examination, which will be performed by the editorial staff of The Defender, with further information and any significant revelations to be published in the coming days.
A circuitous legal process and a victory for transparency
The FDA had previously argued it didn’t have enough staff to review, redact and release hundreds of thousands of pages of documents, claiming it could process only 500 pages per month.
This would have meant the cache of documents would not be fully released to the public for approximately 75 years.
Coffee the Christian way: Promised Grounds
In his Jan. 6 order, Pittmann rejected the FDA’s claim and instead required the agency to release 12,000 pages of documents by Jan. 31 and an additional 55,000 pages per month thereafter.
This decision was then amended by Pittman’s subsequent Feb. 2 order, truncating the release schedule to a matter of months instead of decades.
The Feb. 2 order also granted the FDA the ability to “bank” excess pages as part of this release schedule — meaning that if the agency exceeds its monthly quota in any given month it can apply those extra pages to a subsequent month.
Previously, Pfizer responded to the Jan. 6 order by filing a memorandum with the court requesting to intervene in the case to assist the FDA with the documents’ release, specifically for the “limited purpose of ensuring that information exempt from disclosure under FOIA is adequately protected as FDA complies with this Court’s order.”
Pfizer claimed to support the disclosure of the documents, but asked to intervene in the case to ensure that information legally exempt from disclosure will not be “disclosed inappropriately.”
Pittman rejected Pfizer’s bid in his Feb. 2 order.
In a related matter, Judge Michael Truncale of the U.S. District Court for the Eastern District of Texas on Feb. 10 unsealed 400 pages of documents pertaining to a lawsuit filed by a whistleblower, Brook Jackson.
Jackson formerly worked for Ventavia, a contractor hired by Pfizer to conduct Phase 3 clinical trials of the Pfizer-BioNTech COVID vaccine.
Take control of your family’s food security with a Harvest Right freeze dryer. There’s a big sale happening right now….
Jackson’s lawsuit alleges multiple improprieties in the clinical trial process during the time that she was employed with Ventavia. The FDA declined to intervene in this case.
Some of the documents pertaining to the approval of the Pfizer-BioNTech COVID vaccine that were released on March 1 appear to directly relate to the clinical trials conducted by Ventavia, and thus may shed light on Jackson’s allegations.
© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
Five Things New “Preppers” Forget When Getting Ready for Bad Times Ahead
The preparedness community is growing faster than it has in decades. Even during peak times such as Y2K, the economic downturn of 2008, and Covid, the vast majority of Americans made sure they had plenty of toilet paper but didn’t really stockpile anything else.
Things have changed. There’s a growing anxiety in this presidential election year that has prompted more Americans to get prepared for crazy events in the future. Some of it is being driven by fearmongers, but there are valid concerns with the economy, food supply, pharmaceuticals, the energy grid, and mass rioting that have pushed average Americans into “prepper” mode.
There are degrees of preparedness. One does not have to be a full-blown “doomsday prepper” living off-grid in a secure Montana bunker in order to be ahead of the curve. In many ways, preparedness isn’t about being able to perfectly handle every conceivable situation. It’s about being less dependent on government for as long as possible. Those who have proper “preps” will not be waiting for FEMA to distribute emergency supplies to the desperate masses.
Below are five things people new to preparedness (and sometimes even those with experience) often forget as they get ready. All five are common sense notions that do not rely on doomsday in order to be useful. It may be nice to own a tank during the apocalypse but there’s not much you can do with it until things get really crazy. The recommendations below can have places in the lives of average Americans whether doomsday comes or not.
Note: The information provided by this publication or any related communications is for informational purposes only and should not be considered as financial advice. We do not provide personalized investment, financial, or legal advice.
Secured Wealth
Whether in the bank or held in a retirement account, most Americans feel that their life’s savings is relatively secure. At least they did until the last couple of years when de-banking, geopolitical turmoil, and the threat of Central Bank Digital Currencies reared their ugly heads.
It behooves Americans to diversify their holdings. If there’s a triggering event or series of events that cripple the financial systems or devalue the U.S. Dollar, wealth can evaporate quickly. To hedge against potential turmoil, many Americans are looking in two directions: Crypto and physical precious metals.
There are huge advantages to cryptocurrencies, but there are also inherent risks because “virtual” money can become challenging to spend. Add in the push by central banks and governments to regulate or even replace cryptocurrencies with their own versions they control and the risks amplify. There’s nothing wrong with cryptocurrencies today but things can change rapidly.
As for physical precious metals, many Americans pay cash to keep plenty on hand in their safe. Rolling over or transferring retirement accounts into self-directed IRAs is also a popular option, but there are caveats. It can often take weeks or even months to get the gold and silver shipped if the owner chooses to close their account. This is why Genesis Gold Group stands out. Their relationship with the depositories allows for rapid closure and shipping, often in less than 10 days from the time the account holder makes their move. This can come in handy if things appear to be heading south.
Lots of Potable Water
One of the biggest shocks that hit new preppers is understanding how much potable water they need in order to survive. Experts claim one gallon of water per person per day is necessary. Even the most conservative estimates put it at over half-a-gallon. That means that for a family of four, they’ll need around 120 gallons of water to survive for a month if the taps turn off and the stores empty out.
Being near a fresh water source, whether it’s a river, lake, or well, is a best practice among experienced preppers. It’s necessary to have a water filter as well, even if the taps are still working. Many refuse to drink tap water even when there is no emergency. Berkey was our previous favorite but they’re under attack from regulators so the Alexapure systems are solid replacements.
For those in the city or away from fresh water sources, storage is the best option. This can be challenging because proper water storage containers take up a lot of room and are difficult to move if the need arises. For “bug in” situations, having a larger container that stores hundreds or even thousands of gallons is better than stacking 1-5 gallon containers. Unfortunately, they won’t be easily transportable and they can cost a lot to install.
Water is critical. If chaos erupts and water infrastructure is compromised, having a large backup supply can be lifesaving.
Pharmaceuticals and Medical Supplies
There are multiple threats specific to the medical supply chain. With Chinese and Indian imports accounting for over 90% of pharmaceutical ingredients in the United States, deteriorating relations could make it impossible to get the medicines and antibiotics many of us need.
Stocking up many prescription medications can be hard. Doctors generally do not like to prescribe large batches of drugs even if they are shelf-stable for extended periods of time. It is a best practice to ask your doctor if they can prescribe a larger amount. Today, some are sympathetic to concerns about pharmacies running out or becoming inaccessible. Tell them your concerns. It’s worth a shot. The worst they can do is say no.
If your doctor is unwilling to help you stock up on medicines, then Jase Medical is a good alternative. Through telehealth, they can prescribe daily meds or antibiotics that are shipped to your door. As proponents of medical freedom, they empathize with those who want to have enough medical supplies on hand in case things go wrong.
Energy Sources
The vast majority of Americans are locked into the grid. This has proven to be a massive liability when the grid goes down. Unfortunately, there are no inexpensive remedies.
Those living off-grid had to either spend a lot of money or effort (or both) to get their alternative energy sources like solar set up. For those who do not want to go so far, it’s still a best practice to have backup power sources. Diesel generators and portable solar panels are the two most popular, and while they’re not inexpensive they are not out of reach of most Americans who are concerned about being without power for extended periods of time.
Natural gas is another necessity for many, but that’s far more challenging to replace. Having alternatives for heating and cooking that can be powered if gas and electric grids go down is important. Have a backup for items that require power such as manual can openers. If you’re stuck eating canned foods for a while and all you have is an electric opener, you’ll have problems.
Don’t Forget the Protein
When most think about “prepping,” they think about their food supply. More Americans are turning to gardening and homesteading as ways to produce their own food. Others are working with local farmers and ranchers to purchase directly from the sources. This is a good idea whether doomsday comes or not, but it’s particularly important if the food supply chain is broken.
Most grocery stores have about one to two weeks worth of food, as do most American households. Grocers rely heavily on truckers to receive their ongoing shipments. In a crisis, the current process can fail. It behooves Americans for multiple reasons to localize their food purchases as much as possible.
Long-term storage is another popular option. Canned foods, MREs, and freeze dried meals are selling out quickly even as prices rise. But one component that is conspicuously absent in shelf-stable food is high-quality protein. Most survival food companies offer low quality “protein buckets” or cans of meat, but they are often barely edible.
Prepper All-Naturals offers premium cuts of steak that have been cooked sous vide and freeze dried to give them a 25-year shelf life. They offer Ribeye, NY Strip, and Tenderloin among others.
Having buckets of beans and rice is a good start, but keeping a solid supply of high-quality protein isn’t just healthier. It can help a family maintain normalcy through crises.
Prepare Without Fear
With all the challenges we face as Americans today, it can be emotionally draining. Citizens are scared and there’s nothing irrational about their concerns. Being prepared and making lifestyle changes to secure necessities can go a long way toward overcoming the fears that plague us. We should hope and pray for the best but prepare for the worst. And if the worst does come, then knowing we did what we could to be ready for it will help us face those challenges with confidence.
See all the latest videos and articles patriots need to watch and read at Discern.tv.
Coffee the Christian way: Promised Grounds
- Concerned about your life’s savings as the multiple challenges decimate retirement accounts? You’re not alone. Find out how Genesis Precious Metals can help you secure your wealth with a proper self-directed IRA backed by physical precious metals.
Sarah getting Paid up to $18953 in the week, working on-line at home. I’m full time Student. I shocked when my sister’s told me about her check that was $97k. It’s very easy to do. everybody will get this job.Go to home media tab qws
for additional details…… http://newpay244.blogspot.com
I essentially make about $6,000-$8,000 every month on the web. It’s sufficient to serenely supplant ID my old employments pay, particularly DS considering I just work around 10-13 hours every week from home. I was stunned how simple it was after I attempted it duplicate underneath web… http://GoCashPro.blogspot.com