RFK Jr. Responds To Report He's Considering Removing COVID-19 Vaccines From CDC Schedule

 by Zachary Stieber via The Epoch Times,

Health Secretary Robert F. Kennedy Jr. on April 23 did not deny that he’s considering removing COVID-19 vaccines from the childhood vaccination schedule.

“We need to ask questions and we need to consult with parents, we need to give people informed consent, and we shouldn’t be making recommendations that are not good for the population,” Kennedy said during an appearance on Fox News.

Politico, citing anonymous sources, reported this week that Kennedy is mulling the removal of COVID-19 shots from the Centers for Disease Control and Prevention’s schedule for children.

An official with the Department of Health and Human Services, which Kennedy heads, told The Epoch Times in an email that “no final decision has been made.”

The CDC, which is part of the department, did not return an inquiry.

Kennedy said on Fox that President Donald Trump does not believe that any person should be required to receive a vaccine, and noted that all vaccines carry risks.

“The COVID vaccine, the recommendation for kids was always dubious,” Kennedy said. 

“And it was dubious because kids had almost no risk for COVID-19. Some kids—certain kids that had very profound morbidities—may have a slight risk. Most kids don’t, so why are we giving this to tens of millions of kids? Because the vaccine itself does have profound risks.”

Kennedy noted that established side effects of the COVID-19 vaccine include a form of heart inflammation called myocarditis and a related condition called pericarditis. He also pointed out that 15 vaccinated participants in Pfizer’s clinical trial died, compared with 14 participants who did not receive the company’s vaccine.

Three COVID-19 vaccines are currently available for use in the United States: one from Pfizer, one from Moderna, and one from Novavax.

Advisers to the CDC recommended in 2022 that the agency add COVID-19 vaccines to the schedule, concluding that the benefits of the shots outweighed the risks. The CDC in 2023 added them to the schedule.

According to the schedule, all children who have never received a COVID-19 vaccine should receive at least one dose, depending on their age, while those who have received a vaccine in the past should receive at least one additional dose. Unlike many vaccines on the schedule, the COVID-19 vaccine has not been made compulsory for school attendance in states.

Kennedy said during his confirmation hearings, “I recommend that children follow the CDC schedule, and I will support the CDC schedule when I get in there if I’m fortunate enough to be confirmed.”

Sen. Bill Cassidy (R-La.), a physician, who had been considering voting against Kennedy, said in a speech on the Senate floor that Kennedy committed to maintaining the vaccine schedule without changes. Cassidy later wrote on social media platform X that the commitment “never precluded him from conducting sound scientific research” and that he was “confident any reputable review will further confirm settled science of the safety and efficacy of the childhood vaccine schedule.”

Only 13 percent of children have received one of the COVID-19 vaccines with the 2024–2025 formula, according to CDC data.

Children could still get a COVID-19 vaccine if it is removed from the schedule, but insurance may not pay for it if the removal happens.

Rep. Andy Harris (R-Md.), also a physician, wrote on X, “Secretary Kennedy would be well within his right to reverse the CDC’s Covid-19 vaccine recommendation for children.” 

Harris said he has been concerned that the COVID-19 vaccine recommendations for children “were based on politics rather than science.”

The CDC’s advisers recently discussed telling the agency to narrow its COVID-19 vaccine recommendations. The advisers plan to convene again over the summer to weigh the matter.

Jessica Adams, a former officer with the Food and Drug Administration, said on X that she supports updating the COVID-19 vaccine recommendations but that having the advisers back a change “would be helpful for the full public to embrace this move.”

https://www.zerohedge.com/medical/rfk-jr-responds-report-hes-considering-removing-covid-19-vaccines-cdc-schedule

Relief for Trump in sight — if Supreme Court special session reins in rogue judges

 “What’s the difference between God and a federal judge?” goes the old joke.  Answer: “God knows he’s not a federal judge.”

The district judges issuing scores of “nationwide” injunctions against President Trump appear to take this gag with deadly seriousness. 

Under this dubious practice, a single federal judge claims the ability to block a law or executive order not just in his or her city or state, but throughout the country.

As Supreme Court Justice Neil Gorsuch has wryly observed, they seem to think their power is not just nationwide, but “universal” or even “cosmic.” 

But the Trump administration is looking to counter these judges’ overreach, without taking the politically and constitutionally extreme steps of impeachment or defying a court order.

It’s doing so through a canny Supreme Court filing that contested the nationwide injunctions blocking Trump’s bid to end birthright citizenship.

The government’s plea in that case didn’t center on the problem of “birth tourism” — but instead presented the justices with a “modest” proposal: End nationwide injunctions because they violate the Constitution. 

Last week, the court appeared to take Trump up on the offer, announcing a highly irregular May 15 oral argument session on the case — at a time when the justices are usually polishing their last opinions for the term and packing their bags for the summer break.

Nationwide injunctions have proven a disaster for the federal judiciary. 

While judges have used them against presidents of both parties — conservatives won them to stop former President Joe Biden’s student loan cancellations, for example — judges have reserved a special place in their courtrooms for Trump. 

By the end of March, just 10 weeks into Trump’s second term, federal judges had issued 17 such injunctions — more than George W. Bush, Barack Obama, or Joe Biden received in their entire terms in office. The anti-Trump tally will almost certainly hit 20, if not two dozen, by the end of April.

That’s given nationwide injunctions an undeniably partisan cast. 

Worse yet, judges must violate the Constitution to issue them. 

Article III of the Constitution limits the federal judicial power only to “cases and controversies” — that is, to the legal claims that appear directly before them in the courtroom. 

Breaching these limits, Justice Antonin Scalia warned long ago, allows the courts “to assume a position of authority over [a] co-equal department and to become virtually continuing monitors of … Executive action,” rather than its legality.

Nationwide injunctions also short-circuit the judiciary’s ability to reach sound decisions. 

Congress has the constitutional authority to create the lower federal courts. The decentralized system it has established includes 94 federal district courts throughout the country, overseen by 13 geographic circuit courts of appeal. 

Cases usually reach the Supreme Court after they have “percolated” up through this system, and multiple judges and courts have weighed in on the issue, often coming to conflicting conclusions. 

But a nationwide injunction thwarts that process. By forbidding the elected president’s policy throughout the nation, no other appeals courts can consider the issue, as if a single umpire called an entire baseball playoff series by himself. 

Instead of percolation and multifaceted consideration, the legal issues receive short shrift. The president has only a single choice: to quickly seek Supreme Court review. 

At least five sitting justices have joined opinions sharing these legal concerns. 

In 2017, Justice Clarence Thomas first identified the lack of legal authority for judges to issue nationwide injunctions, calling them “legally and historically dubious.” 

Gorsuch, joined by Thomas and Justice Amy Coney Barrett, declared in 2023 that these court orders violate the limited powers of the federal courts, which can only “render judgment or decree upon the rights of the litigants,” not upon all theoretical plaintiffs throughout the country. 

In February, Justice Samuel Alito argued that nationwide injunctions violate the “foundational limits” on the jurisdiction of the federal courts to issue remedies — in a dissent joined by Thomas, Gorsuch, and Justice Brett Kavanaugh. 

Even liberal Justice Elena Kagan declared in a 2022 speech, “It just can’t be right that one district judge can stop a nationwide policy in its tracks and leave it stopped for the years that it takes to go through the normal process” of appeal.

Trump may not win the court’s blessing of his birthright citizenship argument. But if the justices put an end to disruptive and unconstitutional nationwide injunctions, they will serve a greater constitutional good. 

For example, the high court might order trial judges to limit their rulings only to the parties who appear in their courtrooms and no others, as the Constitution requires. 

Other plaintiffs who wish to vindicate their rights through the courts, such as children born to illegal aliens in other cities, would have to bring their own lawsuits. 

By repairing the guardrails on rogue trial judges, the justices can begin to restore the limits on the power of the judiciary and the proper constitutional respect for the president’s authority to develop and carry out executive policy.

John Yoo is a distinguished visiting professor at the School of Civic Leadership at the University of Texas at Austin, where he is also a senior research fellow at the Civitas Institute.

https://nypost.com/2025/04/25/opinion/how-supreme-court-special-session-can-halt-anti-trump-judges/

Quit gaslighting us — elite groupthink drove the COVID disaster

 Five years since the COVID-19 pandemic hit our shores and forced us into our homes, we’re in the midst of a strange sort of denialism.

You may remember schools being shuttered, small businesses being destroyed, and small children developing speech impediments because they were unnecessarily forced to wear masks. I certainly do.

But now it turns out no one supported any of that, and none of it was anybody’s fault.

It’s not just Randi Weingarten, president of the American Federation of Teachers, who’s been popping up every few weeks to lie that she super-duper, really and truly wanted schools open in 2020 and 2021, despite actually being the villain who kept the poorest kids out of classrooms for years.

City schools are still trying to readjust years after the COVID-19 pandemic.Daniel McKnight

Atlantic columnist Jonathan Chait and others have attempted it, too.

Now influential economist Tyler Cowen says we’re being too hard on the people who caused us so much needless pain and misery.

“A lot of people do not want to admit it,” he wrote this week in the Free Press, “but when it comes to the COVID-19 pandemic, the elites, by and large, actually got a lot right.”

Cowen weaves many unrelated pandemic measures together into a narrative that neatly absolves the elites of blame.

Yes, Operation Warp Speed produced a vaccine quickly — but no, most of the economic activity our businesses lost was not “going away in any case,” as he asserts.

Sure, he admits, “most states should have ended the lockdowns sooner” — then claims they “mattered less” than we all recall.

Furthermore, he declares, “those restrictions on our liberty proved entirely temporary.”

Gaslighting at its finest.

When our family fled for Florida in January 2022, my children were still forced to mask between bites as they ate their lunches outside on the frozen ground at their New York City public schools.

New York and California have still not recovered from their long forced shutdowns. Their unemployment rates have remained stagnant since the start of the pandemic.

Meanwhile, unemployment in Florida and Texas has declined. Turns out it’s not as easy as it looks to switch an economy off and then on again.

Cowen does admit, “Not reopening the schools was a big mistake and meant a lot of lost learning” — but insists, “plenty of elites protested at the time.”

Did they? When? And where were these elites “protesting,” exactly?

Some of them were in my direct messages on social media, saying they agreed with me on sending kids back to school but obviously couldn’t say so lest they be excommunicated from their liberal tribe.

And that, in fact, was the core problem of that era: Many of the “mistakes” made during COVID were actually just the shoring up of political alliances.

Toward the end of President Trump’s first term, groupthink on the left had become overwhelming, as virtue-signalers policed one another to make sure no one stepped out of line.

The COVID era collided with cancel culture and created a uniquely poisonous herd mentality.

In his new book “Abundance of Caution,” David Zweig lays out how one narrative developed to enforce the liberal line on COVID policies.

On June 29, 2020, the American Academy of Pediatrics released a statement to support reopening schools in the fall. The group “strongly advocate[d] that all policy considerations for the coming school year should start with a goal of having students physically present in school.”

But when conservatives cheered, the AAP realized that opening schools was becoming a Republican-coded ideal — and, to its horror, Trump started citing the AAP statement to push local political officials into following its recommendation.

Just two weeks later, on July 10, the AAP issued a coded about-face: “Public health agencies must make recommendations based on evidence, not politics.”

That statement was joined by three powerful special-interest groups that don’t normally act in concert with the AAP — Weingarten’s AFT, the National Education Association, and the School Superintendents Association.

It was clear the unions had gotten the pediatricians’ collective ear. And of course, the new missive pushed for more federal funding for schools.

Anthony Fauci, too, politicized school openings, flip-flopping on the issue before ultimately, in February 2021, settling on an argument that then-President Joe Biden’s boondoggle spending plan would have to pass Congress before kids could go back to class.

By then, of course, schools had been safely operating for months in red states.

So which elites, exactly, were right in all this?

All of us, of course, were operating in the dark when the pandemic first hit. We didn’t know a lot, and the fear was very real.

But some of us adjusted to new information as it became available — and didn’t put politics first.

No one is waiting for the left to take responsibility for their devastating COVID actions. But the ongoing history rewrite cannot go on unchecked.

Mistakes were made, yes — and the people who made them should get no pass.

Karol Markowicz is the host of the “Karol Markowicz Show” and “Normally” podcasts.

https://nypost.com/2025/04/25/opinion/quit-gaslighting-us-elites-drove-the-covid-disaster/

Samsung Bioepis’ Second Quarter 2025 Biosimilar Market Report: Cancer

  First wave of Stelara (ustekinumab) biosimilars show steep Wholesale Acquisition Cost (WAC) discounts greater than 80% 

• Provides insights to regulatory streamlining in biosimilar development currently under review by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)  

Samsung Bioepis Co., Ltd. today released its Second Quarter 2025 Biosimilar Market Report , which provides the second quarter 2025 Average Sales Price (ASP) and Wholesale Acquisition Cost (WAC) of the commercially available biosimilars in the US, as well as the price and market share trends since each biosimilar’s launch. 

“The first quarter of 2025 has witnessed substantial developments in market competition and regulatory paradigm. Among the most significant milestones was the launch of ustekinumab biosimilars following the loss of exclusivity for Stelara. This expansion has played a pivotal role in fostering market competition and encouraging more dynamic pricing strategies.,” said Thomas Newcomer, Vice President, Head of US Commercial Operations at Samsung Bioepis. “In addition, the FDA and EMA have intensified their efforts to streamline biosimilar development. Notably, the agencies are considering waiving Comparative Clinical Efficacy Studies (CES) and interchangeability switching studies in case of FDA, and these streamlined efforts can significantly reduce both time-to-market and development costs. The agencies’ evolving approach is poised to accelerate biosimilar adoption, creating new opportunities for manufacturers while intensifying competition across the sector.”

Some of the key insights from the report include:

• As of Mar 2025, the FDA has approved a total of 73 biosimilars across 19 unique biological molecules.  Of the 73 approvals, 48 biosimilars (66%) have launched in the US market. 

• Excluding Cordavis private-label products, adalimumab biosimilars’ market share has modestly increased in 2025 as Humira’s market share continues to slowly erode.

• Beginning of 2025 marked the start of biosimilar competition for ustekinumab upon Stelara's loss of exclusivity, with entrants providing steep WAC discounts of over 80%.

• The ‘Biosimilar Deep Dive’ covers regulatory streamlining for biosimilar development; regulatory agencies are revisiting the requirements for comparative clinical efficacy studies (CES) in biosimilar approvals; for biosimilars whose biosimilarity to the reference product is well-established through analytical and functional data, and whose mechanism of action is well-understood, CES may be deemed unnecessary. ,  The FDA has suggested in its June 2024 guidance that robust analytical, functional, and pharmacokinetic (PK) data may, in some cases, provide sufficient evidence without the need for large-scale switching studies .

• Analyses suggest development streamlining proposals could reduce the US cost of biosimilar development by $50 – $225 million and shorten the development timeline by 1-2 years.

• Currently, 90% of biologics facing patent expiry over the next decade lack biosimilar candidates, limiting potential savings . By shortening development timelines, reducing research and development costs, and expediting regulatory reviews, a more efficient framework could enable developers to pursue biosimilars for biologics previously deemed unfeasible.

Samsung Bioepis has been publishing the Biosimilar Market report quarterly since April 2023 to provide the latest market share and price trends of all biosimilars available in the United States, after the Centers for Medicare & Medicaid Services (CMS) publishes updated quarterly ASP values for each product. In this edition, the methodology for calculating the ASP is described in detail, as well as how ASP based reimbursement impacts the biosimilar marketplace.

 

To access the Second Quarter 2025 Samsung Bioepis Market Report, please visit HERE .

https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=448

ALX Checkpoint Inhibitor for Head and Neck Cancers Did Not Meet Phase 2 Primary Endpoints

ALX Oncology (ALXO) announced that its Phase 2 ASPEN-03 and ASPEN-04 clinical trials for evorpacept in combination with Merck's KEYTRUDA® did not meet primary endpoints for treating head and neck squamous cell carcinoma (HNSCC). The trials evaluated improved objective response rates compared to historical controls.

Despite encouraging trends in ASPEN-03, the company will discontinue pursuing evorpacept with pembrolizumab in HNSCC. However, ALX Oncology will continue multiple clinical trials of evorpacept combined with anti-cancer antibodies, citing positive results in HER2-positive gastric and breast cancer trials.

The company remains focused on evorpacept's primary mechanism of action - blocking the CD47 'don't eat me' signal on cancer cells - and its ongoing evaluation in colorectal cancer, breast cancer, non-Hodgkin lymphoma, and multiple myeloma trials.

https://www.stocktitan.net/news/ALXO/alx-oncology-reports-aspen-03-and-aspen-04-phase-2-trials-evaluating-2jutp2bhxnjq.html

PTC and Jazz Pharmaceuticals among latest firms to win EU backing for drugs

 

• PTC Therapeutics (NASDAQ:PTCT) and Jazz Pharmaceuticals (NASDAQ:JAZZ) announced Friday that an expert panel of the EU drug regulator, the European Medicines Agency (EMA), endorsed their drugs for marketing authorization.
• PTC Therapeutics said that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the marketing authorization application for Sephience to treat phenylketonuria.
• Jazz Pharmaceuticals said that CHMP recommended the marketing authorization for Zanidatamab as a treatment for adults with advanced or spread HER2-positive biliary tract cancer who have already had at least one prior treatment.

https://www.msn.com/en-us/money/markets/ptc-and-jazz-pharmaceuticals-among-latest-firms-to-win-eu-backing-for-drugs/ar-AA1DCTUv

Eli Lilly seeks a review of EU Alzheimer’s drug denial

 Eli Lilly (LLY) seeks EMA reevaluation of a recent decision in which an expert panel of the agency denied EU approval for its Alzheimer's. therapy.

https://seekingalpha.com/news/4435867-eli-lilly-seeks-review-eu-alzheimers-drug-denial