EU Signals Major Shift on 2035 Combustion Engine Ban Amid Auto Industry Pressure 
Federal Judge Blocks Trump Administration’s Pause on New Wind-Energy Permits 
Woolworths Faces Fresh Class Action Over Alleged Underpayments, Shares Slide 
Nomura Expands Alternative Assets Strategy With Focus on Private Debt Acquisitions 
U.S. Backs Bayer in Supreme Court Battle Over Roundup Cancer Lawsuits 
FAA Unveils Flight Plan 2026 to Strengthen Aviation Safety and Workforce Development 
Trump and Merck KGaA Partner to Slash IVF Drug Costs and Expand Fertility Coverage 
Trump Set to Begin Final Interviews for Next Federal Reserve Chair 
U.S. Reveals 2026 Medicare Star Ratings: Aetna, UnitedHealth Lead in Quality Scores 
United Airlines Tokyo-Bound Flight Returns to Dulles After Engine Failure 
Ireland Limits Planned Trade Ban on Israeli Settlements to Goods Only 
U.S. Military Bill Seeks to End Dependence on China for Display Technology by 2030 
Australia’s Under-16 Social Media Ban Sparks Global Debate and Early Challenges 
Pfizer Sues Novo Nordisk Over Alleged Tactics to Block Obesity Drug Competition 
Ford Takes $19.5 Billion Charge as EV Strategy Shifts Toward Hybrids 
U.S. Experts to Reassess Newborn Hepatitis B Vaccination Guidelines Amid Growing Debate 
Trump’s Approval of AI Chip Sales to China Triggers Bipartisan National Security Concerns 
The U.S. Food and Drug Administration (FDA) has no plans to place a “black box” warning—the most serious safety label—on COVID-19 vaccines, according to a recent Bloomberg News report citing FDA Commissioner Marty Makary. The clarification comes amid conflicting media reports and ongoing public debate over vaccine safety and regulatory oversight.
In an interview with Bloomberg, Makary said that while some FDA officials had recommended adding a boxed warning to COVID-19 vaccines, senior agency leadership ultimately decided it was not necessary. This group included Vinay Prasad, the FDA’s chief medical and scientific officer and top vaccine regulator. The Department of Health and Human Services (HHS), which oversees the FDA, did not immediately respond to requests for comment on the issue.
The statement follows a CNN report from last week claiming that the FDA was preparing to add a black box warning to COVID-19 vaccines and that the move was being driven by Prasad. Makary disputed that characterization, emphasizing that the agency’s final position does not support the addition of the warning at this time.
Makary also noted that administering two COVID-19 vaccine doses just three months apart had been linked to higher rates of side effects, including myocarditis, particularly among younger individuals. However, he added that these risks may not apply in the same way to annual COVID-19 booster dosing, which is now the more common approach.
Last month, Prasad stated in an internal memo that COVID-19 vaccines may have contributed to the deaths of at least 10 children who died from heart inflammation, intensifying scrutiny of vaccine safety data. The FDA confirmed it is continuing to investigate deaths potentially associated with COVID-19 vaccines across multiple age groups as part of an ongoing safety review.
Meanwhile, Health and Human Services Secretary Robert F. Kennedy Jr., known for his skepticism toward vaccines, has significantly shifted U.S. COVID-19 vaccine policy. Access has been limited primarily to adults aged 65 and older and individuals with underlying health conditions.
Pharmaceutical companies continue to defend their products. Moderna reiterated that it has found no new or undisclosed safety concerns related to its mRNA vaccine, Spikevax, including in children and pregnant women. Pfizer and its partner BioNTech also reaffirmed the safety and effectiveness of their COVID-19 vaccine, underscoring confidence in the benefits of vaccination despite renewed controversy.
