The Robotics Underdog Ready to Run

An AI robotics company cutting crime by 46% and scaling fast-yet its valuation lags behind peers.

FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff

MATTHEW PERRONE
July 02, 2025

WASHINGTON (AP) -- The government's top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval of two COVID-19 vaccines, disregarding recommendations from government scientists, according to federal documents released Wednesday.

The new memos from the Food and Drug Administration show how the agency's vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID shots from vaccine makers Novavax and Moderna.

Both vaccines were approved by the FDA in May after months of analysis by rank-and-file FDA reviewers.

But internal correspondence show Prasad disagreed with staffers who planned to approve the shots for everyone 12 and older, similar to previous COVID vaccines. The scientists had concluded the benefit from the vaccines and the risk of COVID-19 outweighed the risk of possible side effects, which are rare.

Instead Prasad decided the shots should be limited to those who face special risks from the virus-- seniors or children and adults with underlying medical issues.

Prasad explained that the COVID vaccine benefits must be reconsidered in light of falling rates of death and hospitalization and the possibility for vaccine side effects. It's the latest in a series of vaccine restrictions imposed by officials working under Kennedy, who has long questioned the benefits of vaccines.

"Even rare vaccination related harms both known and unknown now have higher chance of outweighing potential benefits" Prasad wrote in a five-page memo explaining his decision.

COVID-19 remains a public health threat, resulting in 32,000 to 51,000 U.S. deaths and more than 250,000 hospitalizations since last fall, according to the Centers for Disease Control and Prevention. Most at risk for hospitalization are seniors and children under 2 -- especially infants under 6 months.

Top FDA leaders are typically not involved in the review of individual products. Officials like Prasad can overrule staffers, but such cases are rare and often controversial.

News of the FDA documents was first reported by the New York Times.

Prasad was hired to lead the FDA's vaccine center in May, after the previous director, Dr. Peter Marks, was forced to resign over disagreements with Kennedy. An academic researcher specializing in cancer therapies, Prasad came to prominence during the pandemic for criticizing public health measures, including the FDA's approval of COVID boosters for healthy adults and children.

Since arriving at the agency he has worked with FDA Commissioner Mark Makary on new guidelines that will limit approvals of future COVID boosters to higher-risk Americans, mainly seniors and those with medical conditions like asthma and obesity.

Those limits match the terms FDA recently approved for Novavax's shot, Nuvaxovid and Moderna's mNexspike. Novavax's vaccine is the only protein-based coronavirus vaccine available in the U.S. Moderna's vaccine is an updated, lower-dose version of its existing mRNA-based vaccine.

The review team for the Novavax vaccine pointed to data from a study in 30,000 adults, concluding that "the risk-benefit assessment for this vaccine technology remains favorable."

FDA staff reached a similar conclusion for the Moderna vaccine, deeming it similar in safety and effectiveness to the company's original shot.

Last week, the FDA finalized new warning labeling about the risk of myocarditis, a rare form of heart inflammation, on shots from Moderna and Pfizer, the other maker of an mRNA-based shot for COVID.

In his "override memo," reversing FDA staff's decision on the Moderna shot, Prasad pointed to the ongoing risk of myocarditis and questions about its frequency. The agency ordered Moderna to conduct further studies of the risk as a condition for the approving its updated shot.

A spokesman for the administration said Prasad "has raised serious concerns" about the issue.

"We will not ignore these risks and will ensure that the gold standard of science is used for any decisions," said Andrew Nixon, in an emailed statement.

Outside researchers have noted that cases of the heart condition tend to resolve quickly and are less severe than those associated with COVID infection itself, which can also cause myocarditis.

___

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.

Continue Reading...

Popular

1.4M of the nation's poorest renters risk losing their homes with Trump's proposed HUD time limit

WOODINVILLE, Wash. (AP) — Havalah Hopkins rarely says no to the chain restaurant catering gigs that send her out to Seattle-area events — from church potlucks to office lunches and graduation parties.

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.

The Pentagon Is Stockpiling and This Company Is Poised With a "Tier 1 Priority" Resource - Ad

America is racing to rebuild its domestic supply of strategic materials. One company with projects across key allied nations is in the right place at the right time.

Cantor Equity Partners I (CEPO) Soars On Potential Bitcoin Deal With Satoshi Nakamoto-Linked Adam Back

Shares of special purpose acquisition company Cantor Equity Partners I Inc (NASDAQ:CEPO) surged into the close on Tuesday following a report that the company is nearing a deal to invest billions in Bitcoin (CRYPTO:

Drone attacks on oil fields in Iraq's Kurdish region shut down another facility

BAGHDAD (AP) — Drones targeted Wednesday, the latest in a series of attacks in recent days that have put several oil facilities out of commission.

Robotics Valuation Gap: Who Will Win? - Ad

Two companies. Same sector. Vastly different valuations. One brings in millions in revenue, the other, barely a fraction. The market hasn't caught on yet.

Robinhood Just Made Crypto Simpler — And Way More Powerful

Robinhood Markets (NASDAQ:HOOD) has made a significant push into crypto, unveiling a suite of inno

Do as I say, not as I do: On my failings as an investor

If a knowledgeable observer trained his or her sights on my choices, what are the trouble spots they would identify? Here are some of the biggies.

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.

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.

Elon Musk Changed His Number, Became Unreachable After Trump Feud, Reveals Speaker Mike Johnson: 'I Sent Him A Long Text Message, And Then...'

Tesla Inc. (NASDAQ: TSLA) CEO Elon Musk has reportedly changed his phone number following a fued with President Donald Trump and disagreement with Speaker Mike Johnson over the Republican's tax-and-spending bill.

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.

How Trump could use a building renovation to oust the Fed chair

WASHINGTON (AP) — President says he has finally found a way to achieve his goal of removing Federal Reserve Chair Jerome Powell, accusing him of mismanaging the U.S. central bank’s $2.5 billion renovation project.

Intel (INTC) Stock Falls On Report Of Major Chip Strategy Shift

Intel shares are trading lower Wednesday afternoon. CEO Lip-Bu Tan is reportedly considering a strategic pivot away from marketing its costly 18A chipmaking process.

Copper's Spiking - And This Junior Has the Grades to Match - Ad

Copper is climbing again - and this time, it looks tariff-proof. A $31M junior just posted nearly 1B lbs of copper equivalent. With insiders and institutions piling in, this could be the next breakout.

Carney Faces Cross-Border Pressure Amid High-Stakes US Trade Talks

Carney faces growing criticism at home as Trump threatens steep tariffs amid tense Canada-U.S. trade negotiations.

Amy Coney Barrett Earns Trump's Credit After Court Ruling: 'I Have Great Respect For Her'

Trump praises Justice Barrett's Supreme Court ruling limiting nationwide injunctions, while blasting NYC's Mamdani and defending his economic agenda.

Gold Just Hit Another Record. This Junior Could Be Next. - Ad

This copper junior was the smallest company invited to a top global mining conference. With nearly 1B pounds CuEq and 50,000m of funded drilling, this story won't stay quiet for long.

Cramer Praises Monster Beverage As 'Smoking Hot,' Warns Investors About This AI Stock

Cramer recommends buying Okta (OKTA) as it reported strong earnings, but not to trust Nebius Group (NBIS), while Sweetgreen (SG) and Monster Beverage (MNST) have mixed views. He also suggests buying McDonald's (MCD) while their partnership with Krispy Kreme (DNUT) will end in 2025.

Trump Hit With Backlash Over Use of Antisemitic Slur at Iowa Rally

President Trump faced criticism from Jewish leaders and lawmakers on Friday after using a term historically associated with antisemitic stereotypes.

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.

Inside The Trump Family's $620 Million Crypto Empire

Since retaking the White House, Donald Trump's reported net worth has remained broadly stable, around $6.5 billion on Election Day to roughly $6.4 billion today.

Robotics Meets Public Safety Innovation - Ad

Advanced security robots, real-world impact, and a valuation gap too big to ignore. This robotics stock is one to watch.

Trump's Fast-Track Plan: These 3 Stocks Are Set to Soar - Ad

AI isn't the only game-changer on Wall Street right now. President Trump is fast-tracking a select group of U.S. companies-quietly accelerating their growth and profit potential. According to legendary investor Louis Navellier, this move could ignite a massive stock surge...And he's identified three companies that stand to benefit most.

Lisa Murkowski Defends Alaska Carveouts As Elizabeth Warren, Bernie Sanders And Rand Paul Condemn Trump's 'Big Beautiful' Bill: 'Not Good Enough For The Rest Of Our Nation'

Senators across party lines are fiercely divided over Donald Trump's $3.3 trillion "Big Beautiful Bill," which narrowly passed the Senate and now heads to the House amid concerns over debt, tax cuts, and social program rollbacks.

Donald Trump's Approval Rating Jumps Among Baby Boomers — Here's What's Driving It

President Trump's approval rating among Baby Boomers has seen a significant surge, potentially solidifying his political base as we approach the 2026 midterm elections.

The Robotics Underdog Ready to Run - Ad

An AI robotics company cutting crime by 46% and scaling fast-yet its valuation lags behind peers.

Scott Bessent On Replacing Powell As Fed Chair: 'I Will Do What The President Wants' — Plays Down Shadow Chair Speculations

U.S. Treasury Secretary Scott Bessent declined to rule out the possibility of replacing Jerome Powell as Federal Reserve Chair and has instead deferred to President Donald Trump's decision on the matter.

Trump Says Israel Ready For 60 Day Ceasefire In Gaza, Hopes Hamas Takes The Deal Because It Won't 'Get Better'

Trump proposed 60-day ceasefire in Gaza, which Israel has agreed to. Qatar and Egypt will deliver the proposal to Hamas. Trump meets Netanyahu next week.

The Pentagon Is Stockpiling and This Company Is Poised With a "Tier 1 Priority" Resource - Ad

America is racing to rebuild its domestic supply of strategic materials. One company with projects across key allied nations is in the right place at the right time.

Trump's 'Big, Beautiful Bill' Hands $5 Billion Win To Big Pharma: Report

Trump's $3.3 trillion domestic agenda bill, passed by the House on Thursday, includes a significant victory for pharmaceutical companies .

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.

Robotics Valuation Gap: Who Will Win? - Ad

Two companies. Same sector. Vastly different valuations. One brings in millions in revenue, the other, barely a fraction. The market hasn't caught on yet.

Nebius Emerges As Neutral AI Cloud Alternative, Deepens Ties With Nvidia, OpenAI, Microsoft: Analyst

Goldman Sachs analyst initiates coverage of Nebius Group with a Buy rating, citing its strong position in the AI Neoclouds market.

Ex-Trump Family Attorney Raises Alarms Over Trump's Actions as President: 'I Have Never Been As Concerned'

Abbe Lowell expressed serious concerns about the potential harm that the current administration could cause to the country's institutions.

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.

OpenAI Says Tokens Are Not Equity, No Partnership With Robinhood: Musk Says AI Company's Equity 'Is Fake'

OpenAI says the "OpenAI tokens" offered by Robinhood are not OpenAI equity and clarified that it has no partnership or involvement with Robinhood.

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 systemtrading.ca
Privacy Policy | Terms of Service