(The Epoch Times)—The Food and Drug Administration is not adding “black box” warnings to COVID-19 vaccines, even though an agency center recommended it, FDA commissioner Dr. Marty Makary said on Dec. 15
“When it comes to the ‘black box’ warning, we have no plans to put that on the COVID vaccine,” Makary said during an appearance on Bloomberg Television.
Black box warnings are the highest safety-related warnings that FDA officials can place on products. Scenarios warranting their usage include when there is an adverse reaction so serious that it is “essential that it be considered in assessing the risks and benefits of using the drug” or when there is a serious adverse reaction that can be prevented or reduced by appropriate use of the drug, according to FDA documents.
The announcement comes several weeks after FDA officials reported deaths of children following COVID-19 vaccination and concluded that at least 10 deaths were related to the vaccines, according to a November memorandum obtained by The Epoch Times. The review, which included looking at autopsies, has been broadened to other age groups.
The announcement also came several months after regulators updated language on the vaccine labels for a form of heart inflammation called myocarditis. The inflammation was discovered after the FDA first authorized COVID-19 vaccines in December 2020. The updated labels state that the highest observed risk of myocarditis was among young males aged 12 to 24 after receipt of vaccines from Pfizer-BioNTech and Moderna.
Makary said Monday that an FDA safety and epidemiology center did recommend adding a black box warning to the COVID-19 vaccines, and indicated the recommendation stemmed from the risk of myocarditis.
But, he said, Dr. Vinay Prasad, the agency’s top vaccine official, and other FDA leaders opted against accepting the recommendation because the dosage people are receiving has changed from the original two doses within weeks or months of each other.
“When you have those two doses three months apart, that’s when you see the side effects go way up, like myocarditis in young people,” Makary said on Bloomberg. “Now that it’s annual, you may not see that same prevalence. So we don’t want to extrapolate findings to today if it’s not transferable.”
COVID-19 vaccines had been cleared and recommended for virtually all Americans until Trump administration officials took a series of steps to narrow the clearance and recommendations. They are now only advised on an annual basis after consulting with a health care professional and taking into account various factors, including whether people have characteristics such as obesity that could put them at higher risk of severe problems if they contract COVID-19.
Moderna and Pfizer have said their vaccines protect people and have favorable safety profiles, a position also held by some groups such as the American Academy of Pediatrics. The academy counts Pfizer and Moderna among its partners.
Other experts and advocates have called for the removal of COVID-19 vaccines.
Dr. Robert Redfield, former director of the Centers for Disease Control and Prevention, recently told The Epoch Times that clearance for them should be withdrawn because the spike protein they deliver is immunotoxic, and that he would not be surprised if, after the FDA finished its investigation, regulators placed a black box on the shots.
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.