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Moderna Not Approved for Flu Shot

The Food and Drug Administration rattled the biotech industry last week when it said it wouldn't even look at Moderna's application to market the first mRNA flu shot. But on Wednesday, the agency reversed course and told Moderna it would review the application with some changes.

Health

What the FDA's rejection of Moderna's flu shot means for the future of vaccines
FDA Commissioner Marty Makary hinted during a Pharmaceutical Research and Manufacturers of America event on Tuesday that the agency's refuse-to-file letter to Moderna wasn't the end for the company's shot.

"That letter, in my mind, is part of the conversation where you'll see a dialogue between the company and the agency, and they can always, after that letter, ask for the more detailed review," he said during the PhRMA Forum in Washington, D.C. "But that's part of the process. That's a conversation."

The FDA's reversal, however, didn't reassure health economist Rena Conti at Boston University, who says the Moderna decisions appear to be part of a pattern with the current FDA. "This type of chaotic decision-making is the opposite of what the regulator should be doing to regulate medicines in the U.S.," she said.

Moderna used its mRNA technology to swiftly create and manufacture its COVID-19 shot during the pandemic. The company is hoping to use that technology to make flu shots, too. Moderna says the total investment in the shot is over a billion dollars, including up to $750 million from Blackstone, an asset management firm.

Initially, the FDA said it wouldn't review the new shot because the company didn't compare it to a high-dose flu vaccine for older people as part of its main clinical trials.

Moderna said the FDA had agreed to its study design 18 months ago. "The industry depends on clear, transparent rules that are applied consistently in order to make the long-term investments that benefit Americans," Moderna spokesman Chris Ridley wrote in an email to NPR last week.

According to a company statement, Moderna included data from a separate trial comparing its mRNA shot to a high-dose flu vaccine when it submitted the application. "At no time in the pre-submission written feedback or meeting did [the FDA's Center for Biologics Evaluation and Research] indicate that it would refuse to review the file."

Health and Human Services Department spokesman Andrew Nixon said in an emailed statement to NPR last week that "the FDA rejected Moderna's application for filing because the company refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy."

On Wednesday, Nixon said in an email to NPR that the FDA had a meeting with Moderna, leading the company to amend its application for the experimental shot, which the FDA accepted. "FDA will maintain its high standards during review and potential licensure stages as it does with all products," he said.

Moderna says it agreed to add a confirmatory study in older adults that will use a high-dose flu shot after the mRNA vaccine is on the market, the company confirmed to NPR.

The company says the new vaccine will be ready for the next flu season, pending FDA approval.

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Life is the One Day - Yesterday is Dead - Tomorrow is a Not Born

The Eternal Now: Living Wholly in the Only Day

The clock ticks forward, marking the moments that slide from the now into the past. Yet, for all our planning and remembering, the profound truth remains: Today is the one day we only live in the one day. Tomorrow is not yet born, and yesterday is dead. This realization is not merely a statement of time, but a powerful philosophy—a guide to a life lived fully, consciously, and without the paralyzing burdens of what was or the anxiety of what might be.

The Tyranny of Time

Humanity is uniquely capable of mental time travel. 

• Ruminating on Yesterday: Rehashing past mistakes, successes, regrets, and glories. This dead weight can anchor us, preventing forward movement.

• Anxious about Tomorrow: Projecting fears, hopes, and endless to-do lists onto a future that exists only as a possibility in our minds.

This mental tug-of-war robs us of our most precious and only true possession: the present moment.

Yesterday is Dead: Releasing the Anchor ⚓

The philosophy insists that "yesterday is dead." This doesn't mean we ignore history or fail to learn from experience. It means recognizing that the power of yesterday to shape your current actions is an illusion.

• Lesson, Not Load: View past events as lessons recorded in a closed book. You've learned from them, but you don't have to carry the physical weight of the book itself every second.

• Forgiveness and Acceptance: This philosophy fosters self-compassion. The person who made yesterday's errors no longer exists; only the one who can act rightly now remains. Release the regret, accept the circumstance, and step into the new moment unburdened.

Tomorrow is Not Born: Dispelling the Illusion 🎈

Similarly, "tomorrow is not born." Tomorrow is a concept, a plan, a hope, but it has no reality in the current moment. When tomorrow finally arrives, it will, without fail, be called Today.

• Action, Not Worry: While we must plan, focusing on future worries is unproductive. The most effective way to prepare for an un-born tomorrow is to take the most focused, productive, and meaningful action today.

• Presence in the Process: By focusing solely on the task at hand—the preparation, the learning, the conversation—we maximize our efficiency and joy. The future will take care of itself based on the quality of our current input.

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The Philosophy of the Eternal Now

This philosophy is found in various forms across cultures and centuries, from Stoicism (living according to nature/the present) to Eastern principles of mindfulness. It centers on three core principles for practical living:

1. Radical Focus and Effectiveness

When you commit to living only in this one day, your focus sharpens. Distractions (past grudges, future fears) melt away. You can pour your full mental and emotional energy into the current task, whether it's a critical project, a family meal, or a moment of reflection. Full presence yields maximal effectiveness.

2. Deep Appreciation and Joy

The things we often overlook—the smell of coffee, a warm conversation, the sun on our skin—are the complete reality of this day. By honoring the only day we have, we train ourselves to notice and appreciate these mundane miracles. Joy resides in the awareness of the present moment.

3. Unflinching Responsibility

If today is the only day, then every action and inaction is instantly significant. There is no "I'll start tomorrow." The commitment must be made now. This philosophy demands that we stop postponing our lives, our dreams, and our authentic selves until some mythical future date.

"Do not wait for tomorrow to do what you can do today."

— A timeless wisdom applied with renewed intensity.

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Embracing the One Day

To embrace this philosophy is to find a profound sense of peace and power.

• How to Practice:

  • The Morning Reset: As you wake, mentally declare: "This is a brand new day. Yesterday is gone. The future is an unwritten slate. I will commit my full self to the hours between now and rest."

  • The 5-Minute Rule: When anxiety about tomorrow or regret from yesterday creeps in, allow yourself 5 minutes to acknowledge it, then consciously re-anchor your attention to one sensory detail of the present (your breathing, the feel of the chair, the sound of the clock).

Today is the only life you truly possess. It is a gift of action, experience, and beauty. By fully inhabiting this single, solitary day, you will find that you are not just preparing for life, but genuinely living it.

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Vaccines/Pfizer/Terrorists/Babies get HepB

Did you know babies get HepB?

Are you aware that EVERY baby born in a hospital is given HEP B? Ya know why? Because the drug was created for people who got HEP B from sexual activity and/or drug use but the drug was not selling because drug users have only the next fix on their mind not getting a Hep B shot. So, because it was not selling they decided to give it to every baby in every hospital. And mothers are not asked their permission to have this shot given to their new baby.

Vitamin K is also given without the mother’s knowledge or consent. This practice only makes sense if you care more about making money than you do about damaging the future health of a new human life. If you know anyone that is going to have a baby let them know about this and tell them to demand no HEP B or Vitamin K for their newborn baby. If this presentation by Del Bigtree doesn’t open people’s eyes about vaccines then nothing will.