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The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday.The news is the latest sign of the FDA’s heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr., particularly those using mRNA technology, which he has criticized before and after becoming the nation’s top health official.Moderna received what’s called a “refusal-to-file” letter from the FDA that objected to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today. That trial concluded the new vaccine was somewhat more effective in adults 50 and older than that standard shot.The letter from FDA vaccine director Dr. Vinay Prasad said the agency doesn’t consider the application to contain an “adequate and well-controlled trial” because it didn’t compare the new shot to “the best-available standard of care in the United States at the time of the study.” Prasad’s letter pointed to some advice FDA officials gave Moderna in 2024, under the Biden administration, which Moderna didn’t follow.According to Moderna, that feedback said it was acceptable to use the standard-dose flu shot the company had chosenbut that another brand specifically recommended for seniors would be preferred for anyone 65 and older in the study. Still, Moderna said, the FDA did agree to let the study proceed as originally planned.The company said it also had shared with FDA additional data from a separate trial comparing the new vaccine against a licensed high-dose shot used for seniors.The FDA “did not identify any safety or efficacy concerns with our product” and “does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” Moderna CEO Stephane Bancel said in a statement.It’s rare that FDA refuses to file an application, particularly for a new vaccine, which requires companies and FDA staff to engage in months or years of discussions.Moderna has requested an urgent meeting with FDA, and noted that it has applied for the vaccine’s approval in Europe, Canada, and Australia.In the last year, FDA officials working under Kennedy have rolled back recommendations around COVID-19 shots, added extra warnings to the two leading COVID vaccineswhich are made with mRNA technologyand removed critics of the administration’s approach from an FDA advisory panel.Kennedy announced last year that his department would cancel more than $500 million in contracts and funding for the development of vaccines using mRNA.The FDA for decades has allowed vaccine makers to quickly update their annual flu shots to target the latest strains by showing that they trigger an immune response in patients. That’s a far more efficient approach than running long-term studies tracking whether patients get the flu and how they fare. In an internal memo last year, Prasad wrote that the streamlined method would no longer be permittedleading more than a dozen former FDA commissioners to pen an editorial condemning the statements.-The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content. Lauran Neergaard and Matthew Perrone, Associated Press
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E-Commerce
This year, the number of mothers with young children exiting the U.S. labor market saw the sharpest January-to-June decline in more than four decades. That isnt a coincidenceand it isnt a lack of ambition. Across industries, women are reassessing howand whetherwork fits into their lives. Not because they want to step back, but because too many workplaces are still designed around outdated assumptions about who provides care and how work gets done. As leaders debate return-to-office mandates, women are quietly doing the mathand deciding whether staying is worth the cost. This isnt a womens issue. Its a design failure. And its one leaders can choose to fix. THE PERPETUAL STRUGGLE OF THE DOUBLE SHIFT The pandemic exposed and intensified a long-standing dilemma: how working women can balance their careers with family demands. Even years later, in dual-income households, women continue to shoulder the majority of caregiving responsibilities, often juggling work, childcare, elder care, and the invisible but relentless mental load that comes with it. Even now, many women are still working two full-time jobs: one at work and another at home. In a recent workplace study conducted by my company, 65% of working mothers reported carrying more household and childcare responsibilities than their partners, and nearly half said they shoulder most of the mental and emotional burden at home. When workplaces remain rigid and unsupportive, that strain compounds, pushing women toward burnout or out of the workforce entirely. Now, rigid return-to-office (RTO) mandates threaten to add more fuel to the fire. For the first time since COVID, most Fortune 100 companies have reinstated full-time, in-office policies, and women are among the groups disproportionately affected. In our study, three out of four working women said RTO mandates make it harder for them to stay in the workforce long term. THE HIGH COST OF LOSING SENIOR FEMALE TALENT Supporting and retaining female talent isn’t only about equity; its about competitive advantage. While losing top-performing talent of either gender can hurt, when senior female leaders leave, there are broader financial and cultural ripple effects. The business case is well established: when women hold 30% or more executive roles within an organization, the company outperforms its peers. In a competitive labor market, the ability to attract and retain top talentincluding highly educated, experienced womencan make or break a company’s growth trajectory. THE REDESIGN: FLEXIBILITY, SUPPORT, AND TRUST The solution isnt another round of workplace perks. Its redesigning work. Im a strong believer in the value of coming together in person. Offices create connections and strengthen culture in ways that are hard to replicate remotely. They provide an environment for collaboration and problem-solving. But returning to the office can exacerbate the challenges many employeesespecially caregiversare navigating if not done thoughtfully. How work is structured matters just as much as where it happens. Flexibility isnt about eliminating expectations or avoiding the office. Its about trusting employees to manage their time responsibly and deliver results within a clear, well-designed framework. Our research shows that 90% of employees believe return-to-office policieswhether hybrid or full-timeare more successful when companies pair them with real support, including mental health resources, reasonable flexibility, and leaders who model balance and trust. Ive lived this firsthand. For nearly a decade, I built an executive career while caring for my father through repeated ICU and hospital stays and critical illness. I was fortunate to have the support of my husband, friends, and familybut what made it truly possible was the flexibility and trust my managers extended to me during that time. That trust wasnt given lightly; I earned it through commitment and performance. In return, their support during one of the hardest periods of my life made me fiercely loyal to my company and a stronger, more empathetic leader. Practical support matters just as much. Flexible time-off policies, backup care for emergencies, elder care resources, and mental health services arent perkstheyre infrastructure and are foundational to productivity, engagement, and loyalty. Companies invest millions in office space and technology. To truly benefit from those investments, they must also invest in systems that allow people to show up consistently, focused, and ready to do their best work. And this isnt only about women. Forty percent of men now identify as their familys primary caregiver. If organizations dont support them as well, the imbalance many women experience will only grow. I know from my own life that even today, I couldnt manage my work and family responsibilities without my husbands partnership. BLUEPRINT FOR SUCCESS Companies face a clear choice: cling to outdated assumptions about work and risk losing talented women or evolve how they support work. Some organizations will operate in hybrid models; others will return fully to the office. The real differentiator wont be the policy itself; it will be how thoughtfully leaders design and support work within it, especially for caregivers. Redesigning work doesnt mean lowering standards. It means aligning expectations with how life actually works, and giving people the structure, support, and trust they need to perform at a high level. Workplaces built this way dont just retain womenthey build stronger cultures, develop better leaders, and outperform over the long term. Alison Borland is Chief People and Strategy Officer at Modern Health.
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E-Commerce
The Federal Aviation Administration reopened the airspace around El Paso International Airport in Texas on Wednesday morning, just hours after it announced a 10-day closure that would have grounded all flights to and from the airport.The Federal Aviation Administration said in a social media post that it has lifted the temporary closure of the airspace over El Paso, saying there was no threat to commercial aviation and that all flights will resume.Transportation Secretary Sean Duffy said in a post on X that the FAA and the Defense Department “acted swiftly to address a cartel drone incursion. The threat has been neutralized and there is no danger to commercial travel in the region.”He said normal flights are resuming Wednesday morning.He did not say how many drones were involved or what specifically was done to disable them.The shutdown announced just hours earlier “for special security reasons” had been expected to create significant disruptions given the duration and the size of the metropolitan area.El Paso, a border city with a population of nearly 700,000 people and larger when you include the surrounding metro area, is hub of cross-border commerce alongside the neighboring city of Ciudad Juarez in Mexico. The brief closure does not include Mexican airspace.The airport said in an Instagram post after the closure was announced that all flights to and from the airport would be grounded from late Tuesday through late on February 20, including commercial, cargo, and general aviation flights. It suggested travelers contact their airlines to get up-to-date flight information.Rep. Veronica Escobar, a Democrat whose district includes El Paso, had urged the FAA to lift the restrictions in a statement Wednesday morning. There was no advance notice given to her office, the city of El Paso or airport operations, she said.“The highly consequential decision by FAA to shut down the El Paso Airport for 10 days is unprecedented and has resulted in significant concern within the community,” Escobar said. “From what my office and I have been able to gather overnight and early this morning there is no immediate threat to the community or surrounding areas.”The airport describes itself as the gateway to west Texas, southern New Mexico, and northern Mexico. Southwest, United, American, and Delta all operate flights there, among others.A similar temporary flight restriction for special security reasons over the same time period was imposed around Santa Teresa, New Mexico, which is about 15 miles (24 kilometers) northwest of the El Paso airport.Southwest Airlines said in a statement that it has paused all operations to and from El Paso at the direction of the FAA.“We have notified affected customers and will share additional information as it becomes available,” Southwest Airlines said. “Nothing is more important to Southwest than the safety of its customers and employees.” Darlene Superville, Associated Press
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E-Commerce
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