(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.

Three Reasons a Coffee Gift Set From This Christian Company Is Perfect for Christmas

When you’re searching for a Christmas gift that’s meaningful, useful, and rooted in faith, you don’t want to settle for anything generic. This season is filled with noise — mass-produced products, last-minute picks, and trends that fade as quickly as they appear. But one gift stands apart because it blends genuine quality with a message that matters: a coffee gift set from Promised Grounds Coffee.

This small Christian-owned company has become a favorite among believers who want to support faith-driven businesses while giving friends and family something they’ll actually enjoy. Here are three reasons a Promised Grounds Coffee gift set may be the most thoughtful and impactful present you give this year.

1. It’s Truly Delicious Coffee

Too many “gift-worthy” coffees look beautiful in the package but disappoint when the cup is poured. Promised Grounds takes the opposite approach — exceptional taste first, thoughtful presentation second.

Their beans are sourced with care, roasted in small batches, and crafted to bring out a rich, smooth flavor profile that appeals to both casual drinkers and true coffee lovers. Whether someone enjoys bold, dark roasts or lighter, more delicate blends, every sip reflects quality that stands shoulder-to-shoulder with the biggest specialty brands.

Simply put: this coffee is good. Really good. Some say it’s absolutely fantastic. If you want a gift that won’t be re-gifted, ignored, or shoved in a cabinet, this is it.

2. It Spreads the Word While Serving a Real Purpose

There are many Christian gifts that are meaningful… but not exactly practical. There are also useful gifts that have nothing to do with faith. Promised Grounds Coffee bridges both worlds beautifully.

Each gift set delivers an encouraging, faith-centered message through its packaging and presentation — a simple but powerful reminder of God’s goodness during the Christmas season. The cups are especially popular and serve as a daily reminder of the blessings from our Lord. At the same time, the product itself is something people will actually use and appreciate every single day.

It’s a gift that uplifts the spirit and fills the mug. A gift that points loved ones toward Scripture while still being part of the normal rhythm of life. And in a culture that increasingly pushes faith to the margins, giving a gift that quietly but confidently honors Christ can make a deeper impact than you might expect.

3. It’s Affordable, Valuable, and Elegantly Presented

Many people want to give something meaningful without breaking their Christmas budget. Promised Grounds Coffee strikes that perfect balance — the sets look and feel premium, but the price remains accessible.

The packaging is classy, clean, and gift-ready, making it ideal for:

Family members of all ages

Co-workers or employees

Church friends or small-group leaders

Hosts, neighbors, and last-minute gift needs

It’s the kind of gift that feels more expensive than it is — and more thoughtful than most of what you’ll find on store shelves.

The Perfect Blend of Faith, Flavor, and Christmas Cheer

A coffee gift set from Promised Grounds Coffee checks every box: a gift that tastes amazing, conveys your faith, supports a Christian business, and brings daily enjoyment to the person who receives it. In a season when so many gifts are forgotten, this one stands out for all the right reasons.

If you want a Christmas present that reflects your values and delivers genuine joy, Promised Grounds Coffee is the perfect place to start.