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.
Starting the Day With a Scripture-Inspired Roast Helps Center Your Thoughts on Eternal Truths Amid Temporal Pressures
The world can seem chaotic, especially right after we wake up. Many believers start their mornings reaching for something familiar — a hot cup of coffee — yet end up settling for mediocre brews that do little more than deliver a caffeine jolt. The daily grind of life, with its endless distractions, news cycles, and responsibilities, can leave even the most faithful feeling spiritually parched alongside their physical fatigue. What if your morning ritual could do more than wake you up? What if it could ground you in truth, nourish your body with exceptional quality, and quietly advance a kingdom purpose at the same time?
That’s the promise — and the reality — behind Promised Grounds Coffee. This Christian-founded company doesn’t just roast beans; it approaches every step as an act of worship and discipleship. By selecting only the top 10% of specialty-grade beans, ethically sourced from dedicated farmers in Central and South America, and small-batch roasting them with reverence in Austin, Texas, Promised Grounds delivers what many describe as the best coffee available — never burnt, never bland, but rich with origin stories and layered flavors that honor God’s creation.
From the vibrant Psalm 27 Roast (a light, bright medium option) to the bold yet peaceful 2 Timothy 1:7 Decaf, each bag carries a Scripture verse that turns your daily pour into a gentle reminder of faith. And through their Ounce Per Ounce Promise, every ounce of coffee you enjoy provides an equal ounce of clean water to families in need via partnership with Filter of Hope — literally brewing hope for body and soul, one cup at a time.
The challenge for today’s Christians runs deeper than finding a decent cup. In an age of convenience-driven consumerism, it’s easy to support companies that dilute values or remain silent on matters of faith. Many believers want their everyday choices — from what they drink to how they spend — to reflect discipleship rather than just convenience. Promised Grounds solves this by weaving Christian excellence into the entire process: beans nurtured with prayerful stewardship by farming families, roasted as an offering rather than a commodity, and packaged with Bible verses to encourage a mindset of gratitude and purpose from the first sip. Reviewers consistently praise the smooth, rich profiles — whether enjoyed black in a drip maker, iced on a warm day, or shared in fellowship — noting how the quality stands toe-to-toe with premium secular brands while delivering something far more meaningful.
This integration of faith and flavor addresses a real need in Christian households and ministries. Busy parents, church leaders, and remote workers alike report that starting the day with a Scripture-inspired roast helps center their thoughts on eternal truths amid temporal pressures. The coffee’s exceptional character — bright citrus notes in lighter roasts or deep chocolate undertones in bolder ones — comes from meticulous selection and careful roasting that respects the bean’s natural gifts rather than masking them. It’s the kind of coffee that elevates a simple quiet time, fuels productive workdays, or sparks meaningful conversations when shared at Bible studies or outreach events. And because it’s ethically sourced with integrity, every purchase supports sustainable livelihoods for farmers who treat their crops like family harvests.
For those leading churches or small groups, the impact multiplies. Promised Grounds offers bundles and options perfect for hospitality ministries, turning ordinary coffee service into an opportunity to point people toward the living water of Christ. Imagine greeting visitors with a warm cup whose very bag carries God’s Word — a subtle yet powerful witness that aligns with the Great Commission. The company’s Texas roots and commitment to “brewing hope” resonate especially with believers who value American enterprise paired with global compassion.
Of course, quality alone isn’t enough if the experience feels out of reach. Promised Grounds keeps it accessible with practical perks like free shipping on orders over $40, sample sets for discovering favorites, and thoughtful add-ons such as faith-themed mugs. Whether you prefer whole beans for fresh grinding, grounds for convenience, or even bulk options for larger households and ministries, the result is consistently superior coffee that makes discipleship feel integrated rather than added on.
As you consider how to align even the smallest habits with your walk with God, Promised Grounds Coffee stands out as a refreshing solution. It tackles the dual problems of subpar daily sustenance and disconnected consumption by offering a product that genuinely excels in taste while advancing a mission of clean water, farmer dignity, and scriptural encouragement. Believers who make the switch often describe it as more than a beverage upgrade — it becomes part of their rhythm of gratitude, a daily invitation to remember that every good gift comes from above.
If you’re ready to transform your mornings (and perhaps your church gatherings) with coffee that honors both exceptional craftsmanship and Christian values, I encourage you to explore what Promised Grounds has to offer. One sip at a time, you’ll be nourishing your body, refreshing your spirit, and participating in something far greater — all while enjoying what truly is among the best coffee available.
