The U.S. Food and Drug Administration (FDA) has been sued for withholding the results of key COVID-19 vaccine safety analyses.
The FDA’s actions violate federal law, the new lawsuit, filed on Jan. 26 in federal court in Washington by the nonprofit Children’s Health Defense (CHD), alleges.
The suit is seeking the raw results from the FDA’s analyses of reports to the Vaccine Adverse Event Reporting System (VAERS).
The system, which the FDA runs with the U.S. Centers for Disease Control and Prevention, accepts reports of post-vaccination adverse events.
As part of its vaccine safety monitoring, the FDA pledged to run a type of analyses called Empirical Bayesian (EB) data mining on the reports to see if any safety signals were triggered. Signals give agencies an idea of which problems may be caused by vaccines. Agencies are supposed to research signals to verify them or rule them unrelated to vaccination.
“A report to VAERS does not mean that a vaccine caused an adverse event. But VAERS can give CDC and FDA important information. If it looks as though a vaccine might be causing a problem, FDA and CDC will investigate further and take action if needed,” the CDC says on its website.
The FDA denied CHD’s request for the results of the data mining, claiming the records are “intra-agency memoranda consisting of opinions, recommendations, and policy discussions within the deliberative process of FDA, from which factual information is not reasonably segregable.”
The FDA also claimed the sought-after information “contains a discussion of legal and policy matters and fall within the attorney work product and attorney-client privileges as enunciated by the Supreme Court.”
The FDA also refused to provide the results of the EB data mining to The Epoch Times, using the same rationale.
In a set of operating procedures, the federal government said the FDA would carry out Empirical Bayesian data mining and the CDC would conduct a separate type of analyses using a method called Proportional Rate Ratio, or another way to analyze the VAERS data.
After lying about when it started the proportional data mining and stonewalling inquiries, the CDC recently released the results of the analyses to The Epoch Times, revealing the agency identified hundreds of adverse events potentially connected to the Pfizer and Moderna COVID-19 vaccines.
Kim Witczak, co-founder of Woodymatters, a nonprofit that advocates for a stronger FDA and drug safety system, said at the time that the agency’s refusal to provide the analyses was not acceptable.
“The secrecy is unacceptable for an agency that said it is transparent with the public about vaccine safety,” Witczak said.
Lawmakers, including Rep. Ronny Jackson (R-Texas), have also questioned (pdf) why the records were not released.
The FDA and CDC only publicly acknowledge a small number of adverse events as being definitely caused by or potentially caused by the messenger RNA shots, including myocarditis, or heart inflammation.
The CDC claimed that the results of its analyses “were generally consistent with EB data mining.”
CHD says the refusal by the FDA to release the EB mining results violates the Freedom of Information Act, which enables people and organizations to request information from federal agencies.
While exemptions exist, the FDA improperly withheld the requested data, the new lawsuit charges. It notes that the FDA did not provide any evidence to support its claims that it could not release the records.
While the CHD appealed to the government for a fresh look at the request, the FDA said it would not have a response to the appeal until “around” the summer of 2023.
The Freedom of Information Act requires an agency to make requested records “promptly available” to a requester and imposes other time restrictions, which have not been adhered to, the suit says.
CHD is asking the court to find the FDA’s failures to meet the time requirements unlawful and order the FDA to produce all non-exempt records within 20 days. CHD is also asking the court to award attorneys’ fees and other litigation costs. The FDA did not respond to a request for comment.
“It is long overdue for the FDA to release the data on the Empirical Bayesian data mining that it promised even before the COVID shot rollout” Mary Holland, president and general counsel of CHD, said in a statement. “It is reprehensible for this agency, established to protect the American people, to conceal critical data. I trust that the courts will command the FDA to do its job.”
Article cross-posted from our premium news partners at The Epoch Times. Image by Felton Davis via Flickr, CC BY 2.0.
Bypass Big Tech Censors
Two Storms, One Harvest
Every food crisis in living memory has been a one-shock event. The 2008 price spike was a commodity bubble. The 2020 shortages were a logistics failure. The 2022 grain scare was a war on one exporter’s ports. Each time, the system bent, adjusted, and recovered, and each time the experts assured us afterward that global markets are simply too big and too diversified to fail.
What nobody in Washington seems eager to discuss is that 2026 is shaping up to be something the modern food system has never actually faced. Two independent shocks, one climatic and one geopolitical, are converging on the same harvest cycle at the same time. Not sequentially. Simultaneously.
Start with the weather. The Pacific Ocean is currently building toward what forecasters now openly call a record event. NOAA’s Climate Prediction Center puts the odds of at least a strong El Niño near 88 percent, with roughly two in three odds it reaches “very strong” status, the tier reserved for perhaps three or four events in the entire satellite era. Every major global model now projects a median peak in Super El Niño territory, and most of them project it exceeding the 2015-16 event, which until now held the modern record. Sea surface anomalies were already brushing the super threshold in mid-July, months before these events normally peak. The atmosphere has already shifted into El Niño mode, and the event is forecast to crest in late fall and early winter.
This is not about “climate change.” It’s about the standard cycles of weather, and the cycle we’re currently in is one that has likely devastated societies in the past. We’re better prepared as a society today, but not all Americans are equally prepared.
Serious households have started doing the quiet math on their own. Grocery bills tell part of the story, and the forecast maps tell the rest, which is why long-term food storage has moved from fringe hobby to mainstream line item in the family budget, with established suppliers like Heaven’s Harvest seeing demand from people who five years ago would have rolled their eyes at the idea. That instinct is not paranoia. It is pattern recognition, and the pattern is worth walking through carefully.
Editor’s Note: Heaven’s Harvest IS a sponsor, but the warnings of this article are real and would be written even if we didn’t have a survival food sponsor. With that said, those who take advantage of what they offer can use promo code “Patriot” for 15% off.
The Fertilizer Clock Is Already Running
While the Pacific warms, the second shock has been unfolding in the Strait of Hormuz. The conflict with Iran turned the world’s most important energy chokepoint into a contested waterway, and the consequences reach far beyond the gas pump. Roughly a third of global fertilizer trade moves through Hormuz, and the disruption sent urea prices up 86 percent year over year by March, with a 53 percent jump in a single month.
The World Bank projects energy prices rising about 24 percent in 2026 and fertilizer about 31 percent. By its own accounting, fertilizer prices ran 35 percent higher in the first five months of this year than the same period last year.
Here is the mechanism the nightly news will not explain. Fertilizer is not a grocery item. It is a time-delayed input. The nitrogen a farmer in Iowa or Punjab could not afford to apply this spring does not show up as a problem this spring. It shows up as a thinner harvest six to twelve months later.
The World Bank’s own food security brief concedes that the effects of reduced applications earlier this season “are likely to become visible only later in harvest outcomes.” Translate that from institutional language into plain English and it means this. The damage is already done, it is already in the ground, and we are simply waiting for it to arrive on the shelf.
Now check the calendar. Six to twelve months from the spring planting season lands us squarely in late 2026 and early 2027. Which is precisely when the strongest El Niño in the instrumental record is forecast to peak, bringing its signature droughts to Southeast Asia, Australia, southern Africa, northern Brazil, and South Asia, the very regions that grow the world’s rice, sugar, and oilseeds.
The World Bank warns openly that a strong El Niño “could disrupt multiple crop belts simultaneously” on top of the conflict-driven input costs. Their baseline projection assumes the Middle East disruptions ease by autumn. What in the last two years of Middle East history suggests that assumption is safe?
The System Has No Slack Left
The comfortable answer is that global markets always adjust. But adjustment requires slack, and the slack is gone. Global cereal production is expected to decline from last year’s records even before El Niño does its work. The UN World Food Programme, hardly a den of right-wing preppers, is calling this the most significant disruption to its supply chains since Covid and the invasion of Ukraine, and its supply chain director put the stakes bluntly.
Today’s supply chain challenges are tomorrow’s hunger crisis.
There is also a political dimension that markets cannot price. When food gets scarce, governments do not behave like economists. They behave like politicians. Export bans, hoarding mandates, and panic buying at the national level turned the modest rice shortfall of 2008 into a global crisis, and analysts are already warning that import-dependent nations are the first dominoes.
The 2015-16 Super El Niño, a far weaker event than what is now forecast, threw tens of millions into food stress across Africa and Asia. This one is projected to be stronger, and it arrives with fertilizer already rationed by price and shipping lanes already contested by missiles.
What Joseph Knew
Scripture does not treat preparation for lean years as faithlessness. It treats it as wisdom delivered in advance to those willing to act on it.
Behold, there come seven years of great plenty throughout all the land of Egypt: And there shall arise after them seven years of famine; and all the plenty shall be forgotten in the land of Egypt.
Joseph did not respond to that warning with a hashtag or a committee. He stored grain during the years of abundance, and when the famine came, Egypt stood while its neighbors begged. The lesson is not that famine is certain. It is that the time to prepare is precisely when preparation still looks optional.
Nobody who filled a pantry in a year of plenty has ever regretted it, and nobody standing in an empty aisle has ever been glad he waited for certainty.
None of this calls for panic, and panic is the enemy of sound judgment anyway. It calls for the same unglamorous prudence our grandparents considered ordinary. Keep some cash margin, know your local growers, and put real food in deep storage while it is cheap and available, because the entire arc of this story is that cheap and available is a closing window.
Families looking for a straightforward place to start can visit Heaven’s Harvest and use promo code Patriot for 15 percent off long-term storable food. The forecasts may yet soften, the strait may yet reopen, and we should pray they do. But hope is a fine thing to hold and a foolish thing to eat.
The Courts Will Command the FDA to Do Its Job?????
That would be a good idea.
But not right away. The courts usually get it right, but not in the time it matters to the litigants.
Not much you can do to force the FDA to do their job – they are a law unto themselves and will do what they dam well please.
Fire about half of them or more is the real remedy. And if that doesn’t work, fire another half. Rinse and repeat until they can do no harm.
Courts in a banana republic don’t consider the law or constitution in making their rulings. There is no arguing that the USA is 100% banana republic (since 2008.)
The FDA and CDC both violated the law by changing the definition of “vaccine” as stated in USC 26 §4132 (a)(2). THEY DO NOT HAVE THE AUTHORITY TO CHANGE THE DEFINITION ONLY THE LEGISLATURE DOES. USC 26 states that a vaccine is defined as a “substance that prevents one or more diseases”.
NONE of the paperwork for ANY OF THE Candidate shots meets that level in their description. They only say “may reduce the symptoms”. FDA and CDC are guilty of FRAUD and “Crimes against Humanity” and should be held accountable.