FDA Submission Expected This Summer - Invest Before It Happens

This company is making heart disease easier to detect with AI. Their tech has officially been designated a "Breakthrough" by the FDA. You now have an opportunity to get in at a potential inflection point.

FDA requires updated warning about rare heart risk with COVID shots

MATTHEW PERRONE
June 25, 2025

WASHINGTON (AP) -- The Food and Drug Administration said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about a rare heart side effect mainly seen in young men.

Myocarditis, a type of heart inflammation that is usually mild, emerged as a complication after the first shots became widely available in 2021. Prescribing information from both Pfizer and Moderna already advises doctors about the issue.

In April, the FDA sent letters to both drugmakers asking them to update and expand the warnings to add more detail about the problem and to cover a larger group of patients. While the FDA can mandate label changes, the process is often more of a negotiation with companies.

Specifically, the new warning lists the risk of myocarditis as 8 cases per 1 million people who got the 2023-2024 COVID shots between the ages of 6 months and 64 years old. The label also notes that the problem has been most common among males ages 12 to 24. The previous label said the problem mostly occurs in 12- to 17-year-olds.

The FDA's labeling change appears to conflict with some prior findings of scientists elsewhere in the U.S. government.

The Centers for Disease Control and Prevention previously concluded there was no increased risk of myocarditis detected in government vaccine injury databases for COVID-19 shots dating back to 2022. Officials also noted that cases tend to resolve quickly and are less severe than those associated with COVID-19 infection itself, which can also cause myocarditis.

The FDA announcement came as new vaccine advisers appointed by Health Secretary Robert F. Kennedy Jr. met to debate the continuing use of COVID-19 vaccines for key groups, including pregnant women. It's the first meeting of the CDC advisory panel since Kennedy abruptly dismissed all 17 members of the group, naming a new panel that includes several members with a history of anti-vaccine statements.

The FDA's label update is the latest step by officials working under Kennedy to restrict or undercut use of vaccines. FDA Commissioner Marty Makary and a top deputy recently restricted annual COVID-19 shots to seniors and other Americans at higher risk from the virus. They've also suggested seasonal tweaks to match the latest circulating virus strains are new products that require extra testing.

Outside experts said the new warning is the wrong approach.

"They are right to suggest that we need to consider myocarditis risks associated with the vaccine, but what they propose is exactly the wrong solution," said Dr. Robert Morris, a public health specialist at the University of Washington. "We should be investigating who is prone to myocarditis to see if we can predict and mitigate that risk."

Makary and several other FDA officials gained prominence during the pandemic by suggesting the federal government exaggerated the benefits of COVID-19 boosters and downplayed serious side effects, including myocarditis.

Before joining the government, Makary and two of his current FDA deputies wrote a 2022 paper that said mandating booster shots in young people would cause more vaccine-related injuries than prevented hospitalizations from COVID-19 infections. The conclusion contradicted that of many leading vaccine and public health experts at the time, including at the CDC.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

Continue Reading...

Popular

Trump's 'Big, Beautiful Bill' Offers Seniors A $6,000 'Bonus' Tax Deduction: Here's How You Qualify For The Benefit

Trump's Big, Beautiful Bill offers a $6,000 senior bonus deduction from 2025-28. Couples can save $12,000. Retirees with incomes up to $75,000 benefit most.

Trump keeps saying the GOP mega bill will eliminate taxes on Social Security. It does not

WASHINGTON (AP) — President keeps saying that Republicans' mega legislation will eliminate taxes on federal benefits.

Elon's Greatest Invention... Hidden in South Memphis? - Ad

In South Memphis, I uncovered what could be Elon Musk's biggest invention yet. It's so secretive, rivals are flying drones to spy on it. If you're serious about investing in AI, now's the time to see what's really going on inside those walls.

Bitcoin's 4-Year Cycle Is Dead, Researcher Says: Here's Why It Matters For XRP

The crypto market has changed, and experts say relying on the traditional 4-year halving cycle could leave investors poorly positioned in

Is Elon's Empire Crumbling? - Ad

Jeff Brown - the legend who called Tesla and Nvidia early - says Elon is about to launch a $25T AI revolution. This isn't another chatbot. It's real-world AI that could 14X the impact of ChatGPT. But after July 23rd, it may be too late.

Democratic Congressman Tom Suozzi's Stock Sale Used A Disclosure Loophole: Report

Rep. Suozzi under scrutiny for $50,000 stock sale without disclosure. Congress now addressing loophole in law.

The Tesla Shock Nobody Sees Coming - Ad

While headlines scream "Tesla is doomed"...Jeff Brown has uncovered a revolutionary AI breakthrough buried inside Tesla's labs. One that is helping AI escape from our computer screens and manifest itself here in the real world all while creating a 25,000% growth market explosion starting as early as July 23rd.

Tesla Cybertruck Bet Not Paying Off? Ford, GM Outsell EV Giant

Elon Musk's dream of having a top-selling electric pickup may be a thing of the past as the Cybertruck continues to see declining demand.

Back This Medical AI Tech - Ad

You don't often find healthcare tech company valued at $4M. HeartSciences is an exception. With $75M invested, including R&D, clinical trials, and product development, their patented AI software is approaching FDA submission, a potential major inflection point.

What's Fueling ON Semiconductor's Recent Stock Surge?

ON Semiconductor has recently seen a significant surge, gaining over 47% in the last three months and outperforming the index's 34% rise, and it currently trades above its 50-day moving average of $47.56.

Del Monte, the 139-year-old canned fruits and vegetables company, seeks bankruptcy protection

Del Monte Foods, the 139-year-old company best known for its canned fruits and vegetables, is filing for bankruptcy protection as U.S. consumers increasingly bypass its products for healthier or cheaper options.

Trump Issued Direct Warning: "Don't Touch This American Stock" - Ad

What happens when Trump helps push a $1 trillion deal between U.S. tech and Saudi oil? Energy stocks go vertical. One tiny U.S. company could be the biggest winner-with $3B in income, an A.I. partnership, and Trump's backing. This could be Karim Rahemtulla's next unicorn.

Jim Cramer Made 'FAANG' Popular, Now He Says There's A New Acronym To Describe These Retail Favorite Stocks — 'PARC'

Renowned TV host Jim Cramer is stirring chatter on X with another buzzworthy "meme stock" acronym, aimed at a new group of retail-favorite stocks that are defying gravity.

Cathie Wood Doubles Down On Tesla Amid Elon Musk's Feud With Trump, Sells $3 Million Worth Of Coinbase Stock

On Tuesday, Cathie Wood-led Ark Invest made significant trades involving Tesla Inc. and Coinbase Global Inc. . These trades reflect Ark’s strategic positioning amid ongoing market developments.

Elon's New Device Could Launch Biggest IPO of the Decade - Ad

Elon Musk's new device is being called a "game-changer"-and even the White House is using this tech. Jeff Brown says it could launch Musk's next trillion-dollar company and make early investors rich. You can claim a stake now for as little as $500.

ProKidney Stock Shoots Up Over 8% After Hours After Staggering 515% Rally On Wednesday

ProKidney (NASDAQ: PROK) experienced a surge of 515% during Tuesday's trading session and gained additional 8.58% after-hours to $4.05 on positive Phase 2 trial results, with trading volume seeing a jump to 39.8 million shares from an average of 1.12 million.

Putting Your Name on This List Could Hand You $1,270 on Friday - Ad

URGENT: On Tuesday, a simple set of instructions will be sent out to an elite group of investors. The folks in this group will have the opportunity to place a 10-minute trade that could double their money by Friday. Consider this your invitation to join them. The next trade is just days away.

Trump's 'Happy Crypto Week' Gets Off To Rocky Start As House Suspends Votes On Key Bills

The House of Representatives called off Tuesday’s votes on pivotal cryptocurrency bills, citing a procedural failure.

Seven & i Crashes 9% After Couche-Tard Yanks $47 Billion Takeover Bid, Slams 'Lack of Good Faith' Talks — Tokyo Retail Giant Calls Move 'Unilateral'

Seven & i Holdings shares tumbled 9% on Thursday on the Tokyo exchange to a low of 2,000 Japanese Yen ($13.50) after Canada's Alimentation Couche-Tard withdrew its $47 billion takeover bid, citing "persistent lack of good faith engagement." Trading resumed at 10:16 a.m. local time following a halt.

Have You Seen this Strange Elon Musk Device? - Ad

Tech legend Jeff Brown predicts this "space technology" will be Elon Musk's next trillion-dollar business, and it will make a lot of people rich. This could be the biggest internet innovation since the first web browser Netscape kicked off the internet boom in the late 1990s.

Tesla Rival Xiaomi Wants To Sell Cars Internationally Starting 2027, CEO Lei Jun Says

Xiaomi plans to sell its electric vehicles overseas as SU7 and YU7 models gather steam in the Chinese domestic market.

Taiwan's Chip Industry Comes Under Attack By China-Linked Hackers As Trump Administration Tightens Export Controls: Report

Chinese-linked hackers have ramped up cyberattacks on Taiwan's semiconductor industry and financial analysts amid tightening U.S. chip export controls, as part of a broader effort to access critical technology, cybersecurity researchers say.

How to Hack a $1.3T Market - Ad

Forget concrete. The new foundation for real estate success is digital, and Pacaso leads the way. Their tech unlocks a $1.3T real estate market. They've already earned $110M+ in gross profits in their operating history and reserved the Nasdaq ticker PCSO.

Draganfly Stock Is Moving Higher Wednesday: What's Going On?

Dragonfly shares are trading higher Wednesday after the company announced its Cammander3 XL UAV has been selected by the Department of Defense for advanced operation initiatives.

After Diddy's conviction, here's where his business ventures stand

LOS ANGELES (AP) — Sean “Diddy” Combs has been in his federal sex trafficking trial, but that doesn't mean the once-celebrated music mogul will see his business empire restored.

FDA Submission Expected This Summer - Invest Before It Happens - Ad

This company is making heart disease easier to detect with AI. Their tech has officially been designated a "Breakthrough" by the FDA. You now have an opportunity to get in at a potential inflection point.

Nvidia B300 Chips Order Touted By Nayib Bukele's Bitcoin Office — Why Does El Salvador Want These Powerful AI Processors?

El Salvador, under the presidency of Nayib Bukele, placed an order for Nvidia Corp.'s (NASDAQ:NVDA) B300 chips, a powerful artificial intelligence processor that is not yet available to most of the world.

Elon's Greatest Invention... Hidden in South Memphis? - Ad

In South Memphis, I uncovered what could be Elon Musk's biggest invention yet. It's so secretive, rivals are flying drones to spy on it. If you're serious about investing in AI, now's the time to see what's really going on inside those walls.

Anti-Trump Climate Protesters Storm NYC Apple Store, Confront CEO Tim Cook Amid Texas Flood Crisis

Demonstrators gathered inside and outside of New York City's 5th Avenue Apple store on Sunday to denounce big tech companies for backtracking on their previous support of the Paris Climate Agreement and to protest the Trump administration.

Is Elon's Empire Crumbling? - Ad

Jeff Brown - the legend who called Tesla and Nvidia early - says Elon is about to launch a $25T AI revolution. This isn't another chatbot. It's real-world AI that could 14X the impact of ChatGPT. But after July 23rd, it may be too late.

ExxonMobil and partner Qatar Energy find new natural gas deposit off Cyprus

NICOSIA, Cyprus (AP) — A consortium made up of ExxonMobil and partner Qatar Energy International has made a second natural gas discovery beneath the seabed south of , the government said Monday, a find that bolsters the region’s potential as an energy exporter.

The Tesla Shock Nobody Sees Coming - Ad

While headlines scream "Tesla is doomed"...Jeff Brown has uncovered a revolutionary AI breakthrough buried inside Tesla's labs. One that is helping AI escape from our computer screens and manifest itself here in the real world all while creating a 25,000% growth market explosion starting as early as July 23rd.

Feihe Struggles Amid China's Dairy Oversupply And Falling Birth Rates

Declining birth rates and China's slowing economy are taking a toll on the company and its peers as they grapple with oversupply and asset impairments on excess inventory

Trending Now

Information, charts or examples are for illustration and educational purposes only and not for individualized investment management This message contains commercial elements, such as advertising. We only send these offers to those who have opted in to our newsletter. Past performance is not indicative of future results. For these reasons we strongly suggest trading in a DEMO/Simulated account. The information provided by us is for educational and informational purposes only. We make no representations or warranties concerning the products, practices or procedures of any company or entity mentioned or recommended and have not determined if the statements and opinions of the advertiser are accurate, correct or truthful. If you use, act upon or make decisions in reliance on information contained or any external source linked within it, you do so at your own peril and agree to hold us, our officers, directors, shareholders, affiliates and agents without fault.

Copyright 2025 finstrategist.com
Privacy Policy | Terms of Service