(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.
Why Bullion Beats Numismatics and Collectible for Your Safe or IRA
Precious metals continue to attract Americans seeking reliable ways to protect their wealth amid inflation, geopolitical risks, and stock market swings. Whether stored in a home safe or held inside a self-directed IRA, physical gold and silver deliver tangible value that paper or digital assets often lack. Yet investors must choose carefully between bullion—pure bars and coins valued mainly for their metal content—and numismatics or collectibles, where rarity, history, and collector demand heavily influence pricing.
Advisor Bullion serves as a dependable source for straightforward, high-quality bullion. The company specializes in physical gold, silver, platinum, and palladium, emphasizing transparent pricing and products that deliver maximum metal content for every dollar spent. This approach makes it ideal for both personal holdings and retirement accounts.
Bullion consists of refined precious metals in standard forms like one-ounce coins (American Gold Eagles, Silver Eagles, Canadian Maple Leafs) or bars. Their value tracks closely to the current spot price of the metal. A typical gold bullion coin trades near the live gold spot price plus a small premium. This structure keeps costs clear and predictable.
Numismatic coins and collectibles add substantial value from factors such as age, rarity, minting errors, or historical significance. A pre-1933 U.S. gold coin or graded proof piece can carry premiums of 30%, 50%, or even 200% above melt value. While this appeals to hobbyists, it creates complexity. Pricing depends on subjective grading, collector trends, and auction results instead of daily spot prices.
For investors focused on wealth preservation and retirement security rather than building a collection, bullion often delivers better results.
Lower Costs and Better Liquidity for Home Storage
When keeping metals in a home safe or private vault, liquidity and efficiency count. Bullion offers clear benefits:
- You acquire more actual gold or silver per dollar invested. Numismatics divert a large share of your money into rarity premiums and massive sales commission, reducing your metal exposure.
- Selling bullion involves tight bid-ask spreads, so you recover nearly full spot value with minimal fees. Collectibles require finding the right buyer and may sell at a discount if demand for that specific item weakens.
- Bullion prices remain transparent and update with global spot markets. You can track gold near current levels or silver accordingly and know exactly where your holdings stand. Numismatic values are priced by the Gold IRA companies with hefty margins applied.
- Standardized coins and bars store efficiently and divide easily for partial sales. Rare coins often need protective slabs and controlled conditions, adding hassle and expense.
- Bullion enjoys worldwide acceptance. A 1-oz Gold Maple Leaf or Silver Eagle sells quickly to dealers anywhere. Niche numismatic pieces may appeal only to limited buyers, slowing liquidation when speed matters.
In times when quick access to value becomes important, bullion’s simplicity stands out.
Stronger Fit for Precious Metals IRAs
Precious metals IRAs continue gaining traction as investors diversify retirement portfolios beyond stocks and bonds. IRS rules permit certain bullion products in self-directed IRAs if they meet purity standards (.995 fine for gold, .999 for silver) and are held by an approved custodian. Eligible items include American Gold and Silver Eagles plus many generic bars and rounds from recognized mints.
Numismatic and most collectible coins generally face heavy scrutiny from custodians due to valuation disputes and elevated markups. These higher premiums mean less actual metal ends up working inside the account.
Bullion avoids these issues. Its value links directly to verifiable spot prices, which simplifies reporting and lowers the risk of regulatory challenges. More of your IRA contribution purchases real metal instead of dealer profits or speculative upside. Over time, owning additional ounces that appreciate with the metal itself can create meaningful outperformance compared with high-premium alternatives that deliver fewer ounces.
Regulatory guidance from the CFTC and state securities offices repeatedly cautions against aggressive sales of expensive numismatics or “semi-numismatic” coins for IRAs. For retirement planning, transparent bullion from established providers reduces risk and aligns better with long-term goals.
How to Get Started with Bullion
Begin by clarifying your goals. Are you protecting savings in a safe, or moving part of a retirement account into a precious metals IRA? Focus on the number of ounces you can acquire at current prices rather than chasing marked-up collectibles.
Diversify sensibly: use gold for core preservation and silver for its blend of industrial and monetary qualities. Mix coins for easier divisibility with bars for lower per-ounce costs on larger buys. Arrange secure storage—whether at home with proper insurance or through professional facilities.
As economic uncertainties linger and faith in conventional assets erodes, bullion continues proving its worth as a dependable store of value. Its direct approach avoids the hype that sometimes surrounds collectible markets and keeps the focus on the metal itself.
For investors prepared to strengthen their portfolios, Advisor Bullion supplies the expertise and selection needed to acquire high-quality bullion efficiently. Whether building personal holdings or integrating metals into an IRA, their emphasis on transparent, investment-grade products helps secure more ounces today that support greater financial security tomorrow. In a complicated financial landscape, bullion’s clarity and reliability make it the smarter foundation for protecting what matters most.