Search This Blog

Thursday, June 12, 2025

RFK Jr. Announces New Members Of Vaccine Advisory Panel

 by Zachary Stieber via The Epoch Times (emphasis ours),

Health Secretary Robert F. Kennedy Jr. has chosen eight new members for the panel that advises the Centers for Disease Control and Prevention on vaccines.

Health Secretary Robert F. Kennedy Jr. testifies before the Senate Health, Education, Labor, and Pensions Committee on Capitol Hill in Washington on May 14, 2025. Madalina Vasiliu/The Epoch Times

The new members of the Advisory Committee for Immunization Practices (ACIP) include Dr. Joseph Hibbeln, a psychiatrist and neuroscientist who is acting chief of the Section on Nutritional Neurosciences at the National Institute on Alcohol Abuse and Alcoholism; Dr. Robert Malone, who helped invent messenger ribonucleic acid technology; and Dr. Cody Meissner, a pediatrics professor at Dartmouth College and former ACIP member, Kennedy announced on June 11.

“All of these individuals are committed to evidence-based medicine, gold-standard science, and common sense. They have each committed to demanding definitive safety and efficacy data before making any new vaccine recommendations,” he said in a statement.

Malone said on social media platform X that he was honored to be named to the committee. “I will do my best to serve with unbiased objectivity and rigor,” he wrote.

The other new members are:

  • Dr. Martin Kulldorff, an epidemiologist and biostatistician who helped found Hillsdale College’s Academy for Science and Freedom.
  • Retsef Levi, a professor of operations management at the Massachusetts Institute of Technology’s Sloan School of Management who holds a PhD in operations research.
  • Dr. James Pagano, an emergency medicine doctor.
  • Vicky Pebsworth, who holds a PhD in public health and nursing, and is a regional director of the National Association of Catholic Nurses.
  • Dr. Michael Ross, a clinical professor of obstetrics and gynecology at George Washington University and Virginia Commonwealth University.

Levi told The Epoch Times that while he believes the outgoing ACIP panelists “applied their best judgment and did it with the very best of intentions and based on very deep expertise,” the secretary’s reforms are based on “a broader sentiment that the process by which we evaluate the safety and benefits of drugs, and specifically vaccines, can be improved and can be more transparent and also more trustworthy by the public.”

He added that he views the role of ACIP members as “giving advice based on their best judgment.”

“The advice might not be uniform, the advice might be nuanced and might be diverse. And then there are decision-makers and policy-makers that take the responsibility, and they will have to make their best judgment based on the opinions that they hear and the data that they see—they will have to make decisions,” he said.

I think that scientists should stay in the role of analyzing the science and reflecting what the science suggests. And the same scientists should not be the decision-makers.

Having worked with academics, clinicians, and patients in the health care system across his career, Levi said he hopes to bring his experience with data-driven frameworks for balancing “different types of risks and different types of benefits.”

He said that modern advances should now allow for “the aspect of personalization” in medicine.

“We want to think about those risks and benefits in the personalized context of individual patients or groups of patients that may have different characteristics, different desires, different wishes, different cultures,” Levi said. “And we really want to think about it in a way that will allow them to make the best choices for their own health, together with their physicians.”

Kennedy heads the Department of Health and Human Services, the CDC’s parent agency. The department on June 9 notified the 17 previous members of their dismissals.

“The Committee will no longer function as a rubber stamp for industry profit-taking agendas,” Kennedy said in a statement at the time.

The ACIP is a panel convened by the CDC to offer advice about vaccines, including childhood and adult immunization schedules.

Members “are knowledgeable in the fields of immunization practices and public health, have expertise in the use of vaccines and other immunobiologic agents in clinical practice or preventive medicine, have expertise with clinical or laboratory vaccine research, or have expertise in assessment of vaccine efficacy and safety,” according to the committee’s charter.

Kennedy told reporters in Washington this week that the new members would be credentialed scientists and doctors “who are going to do evidence-based medicine, who are going to be objective, and who are going to follow the science and make critical public health determinations for our children based upon the best science.”

Some Ex-Members Paid by Pharma Companies

Eight of the members whom Kennedy fired had been paid by pharmaceutical companies in the past, according to an Epoch Times review of disclosures and payment information.

Dr. Yvonne Maldonado, for instance, whose term started in 2024, received $4.6 million in research funding from Pfizer and $39,547 in payments from Pfizer and Merck in recent years. Her conflict of interest disclosures stated that she worked on clinical trials for Pfizer’s meningococcal, COVID-19, and RSV vaccines and that she abstained from related votes.

Other previous members received thousands of dollars from Sanofi, GlaxoSmithKline, Pfizer, Valneva, Merck, Janssen Pharmaceuticals, and Boehringer Ingelheim.

Most of the funding, but not all, came before the members joined the panel. Dr. Helen Keipp Talbot’s term started in 2018, and she reported receiving $7,500 in research funding and $4,662 in payments from Sanofi in 2019.

An email to Talbot returned an automated message directing requests for comment to a spokesman for Vanderbilt University Medical Center, her employer. The spokesman did not return an inquiry.

Kennedy has criticized members over their ties to pharmaceutical companies.

The committee has been plagued with persistent conflicts of interest and has become little more than a rubber stamp for any vaccine. It has never recommended against a vaccine—even those later withdrawn for safety reasons,” he wrote in an op-ed.

The Department of Health also noted that all 17 members were appointed or had their terms renewed during the Biden administration, and that many were set to serve until 2027 or 2028. Keeping them in place would have meant that the Trump administration could appoint only a minority of members until then, limiting its ability “to take the proper actions to restore public trust in vaccines,” the department said in a statement.

Of the new members, Pagano reported receiving about $4,600 from pharmaceutical companies in recent years; Hibbeln reported receiving $338, including from AbbVie; and Meissner received less than $150 from Sanofi and another firm.

Criticism and Praise

Some doctors and health groups voiced opposition to the terminations.

The move, along with the recent narrowing of COVID-19 vaccine recommendations, “interferes with the practice of evidence-based medicine and destabilizes a trusted source and its evidence-based process for helping guide decision-making for vaccines to protect the public health in our country,” Dr. Jason Goldman, president of the American College of Physicians and the college’s liaison to the advisory committee, said in a statement.

“The decision to suddenly remove all 17 members of the CDC independent advisory committee in one sweeping move is deeply damaging to confidence in vaccines that have proven to be safe for decades and in the healthcare providers who counsel patients and their families about immunization decisions every day,” Jason Prevelige, president and chair of the board of directors of the American Academy of Physician Associates, stated.

Sen. Bill Cassidy (R-La.), chairman of the Senate Health Committee, and Sen. Bernie Sanders (I-Vt.), the top minority member of the panel, also expressed concern about the move.

Others praised the dismissals, including Mary Holland, CEO of Children’s Health Defense, a group that Kennedy chaired before he became health secretary.

“The committee has been riddled with financial conflicts of interest, through research grants, stock portfolios, and patent stakes,” Holland said in a statement. “This change is critical if this committee is to have any future role in advising on vaccines without bias.”

Jan Jekielek contributed to this report.

https://www.zerohedge.com/political/rfk-jr-announces-new-members-vaccine-advisory-panel

Simulations Plus Q3 revenue forecast misses expectations

 Simulations Plus (SLP) shares dropped more than 12% in premarket trading on Friday after the company's forecast for the third quarter missed views.

https://seekingalpha.com/news/4457506-simulations-plus-shares-drop-over-12-premarket-as-q3-revenue-forecast-misses-expectations

Reshpe in Distribution Agreement with Recon Supply to Access the VA and DoD

 Recon Supply Named Exclusive U.S. Distributor of ReShape’s STIMEL-03, Lap-Band® 2.0 FLEX, and Full Product Portfolio to Reach U.S. Veterans and Active-Duty Service Members

ReShape Lifesciences® (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health solutions company, today announced the signing of an exclusive U.S. distribution agreement with Recon Supply. Through this new strategic partnership, Recon Supply will distribute ReShape’s cutting-edge portfolio, including the STIMEL-03 neuromuscular rehabilitation device, the next-generation Lap-Band® 2.0 FLEX, and the full range of ReShape products, across the Veterans Administration (VA) and Department of Defense (DoD) healthcare systems. This collaboration will expand access to proven, life-changing treatments for more than 18 million U.S. veterans and active military personnel.

https://finviz.com/news/79212/reshape-lifesciences-signs-exclusive-distribution-agreement-with-recon-supply-to-access-the-va-and-dod-markets

BioNTech buys German mRNA vaccine peer CureVac in $1.2B all-stock deal

 BioNTech is buying fellow German mRNA vaccine developer CureVac in an all-stock transaction that values the acquired biotech at $1.25 billion.

The announcement makes no specific mention of onboarding any of CureVac’s wholly-owned candidates, which are led by a phase 1-stage therapeutic mRNA vaccine for resected glioblastoma. Instead, BioNTech singled out CureVac’s “state-of-the-art” research and manufacturing site in Tübingen, Germany as a major prize.

The deal, which is expected to be finalized later this year, will see each CureVac share exchanged for around $5.46 worth of BioNTech American depository shares (ADSs)—above the $4 that CureVac’s stock closed at on Wednesday. This equates to an equity value of around $1.25 billion for CureVac. After the transaction, CureVac’s shareholders will own somewhere between 4% and 6% of BioNTech, according to a June 12 release.

BioNTech rose to prominence and financial success thanks to its partnership with Pfizer for the blockbuster COVID-19 vaccine Comirnaty. More recently, the company’s strategy to become a “fully integrated immunotherapy powerhouse” is seeing it gear up for a potential approval filing later this year for a next-gen HER2-targeted antibody-drug conjugate licensed from China’s DaulityBio.

The company is also working on two priority oncology programs in the form of the PD-L1xVEGF bispecific antibody BNT327 and its mRNA cancer immunotherapy platform.

BioNTech set today’s acquisition in the context of these cancer ambitions, claiming the deal “will strengthen the research, development, manufacturing and commercialization of mRNA-based cancer immunotherapy candidates, marking BioNTech’s next key milestone in the execution of its oncology strategy.”

“This transaction is another building block in BioNTech’s oncology strategy and an investment in the future of cancer medicine,” CEO Ugur Sahin, M.D., said in the Thursday release. “We intend to bring together complementary capabilities and leverage technologies with the goal of advancing the development of innovative and transformative cancer treatments and establishing new standards of care for various types of cancer in the coming years.”

CureVac has also attempted to pivot to oncology—laying off 30% of its staff in the process—after GSK handed over $430 million in upfront cash a year ago for the rights to CureVac’s vaccines against influenza and COVID-19.

CureVac CEO Alexander Zehnder, M.D., used this morning’s announcement to highlight the biotech’s similarity to its new owner.

“For more than two decades, both companies have operated with related ambitions, often tackling challenges from different angles,” Zehnder said. “This transaction aims at combining complementary scientific capabilities, proprietary technologies, and manufacturing expertise in the mRNA field under one roof.”

Assuming the acquisition is signed off by both companies’ shareholders, BioNTech will launch a corporate reorganization of CureVac, resulting in CureVac becoming a subsidiary of BioNTech.

https://www.fiercebiotech.com/biotech/biontech-buys-german-mrna-vaccine-peer-curevac-12b-all-stock-deal

Goldman Small Cap Research Issues New Research Update on OKYO

Goldman Small Cap Research has issued an updated research report on OKYO Pharma Limited (NASDAQ:OKYO), raising its price target from $5.00 to $8.00. OKYO, a clinical-stage biopharma company focused on treatments for neuropathic corneal pain (NCP) and dry eye disease (DED), has seen its stock price double since January 2025. The company's lead drug candidate urcosimod received Fast Track designation and completed two Phase 2 trials - a 240-patient trial for DED and a 17-patient trial for NCP, with the latter concluding earlier than expected. Top-line results are now anticipated in Q3 2025, ahead of schedule. The early trial completion and accelerated data release timeline are viewed positively by analysts, who note the company's potential in the multi-billion-dollar ocular market and possibility for M&A activity in the space.

Russia Won't End Ukraine War Until NATO Pulls Forces Out Of Eastern Flank

A top Kremlin official was quoted in Newsweek this week warning that Russia won’t end the Ukraine war until NATO pulls its troops out of the Baltic and 'eastern flank' states.

Russia's Deputy Foreign Minister Sergei Ryabkov demanded that NATO must withdraw its troops from the Baltic region. Russia has long seen the Baltics as very near, and its sphere of influence, also given its territory of of Kaliningrad. 

"The American side requires practical steps aimed at eliminating the root causes of the fundamental contradictions between us in the area of security," he had said, originally in state TASS.

"Among these causes, NATO expansion is in the foreground," he emphasized. "Without resolving this fundamental and most acute problem for us, it is simply impossible to resolve the current conflict in the Euro-Atlantic region."

NATO's 'eastern flank' closer to the start of the Ukraine war - forces have since grown...

"Given the nature and genesis of the Ukrainian crisis, provoked by the previous U.S. authorities and the West as a whole, this conflict naturally acts, well, if you like, as a test, a trial, which checks the seriousness of Washington's intentions to straighten out our relations," he said.

Ryabkov said Moscow's position all along has been that the Western military alliance "not deploy strike weapons near Russian border."

"In any case, reducing NATO's Eastern European contingent would likely boost the security of the whole continent," he concluded.

Such a broader ultimatum was actually issued just before the full-scale invasion, but was not heeded. In fact, countries like Estonia, Latvia, and Lithuania have only grown more hawkish and vocal in their anti-Moscow rhetoric, and have even taken legal action against the Russian Orthodox Church in the Baltics.

A very provocative and sensational alert issued by German intelligence...

Newsweek has meanwhile reviewed that "NATO maintains a strong military presence on its eastern flank in Europe, with multinational battle groups and brigades stationed in Bulgaria, Estonia, Hungary, Latvia, Lithuania, Poland, Romania and Slovakia."

* * *

Michael Every of Rabobank has commented the following of this renewed Kremlin demand...

In geopolitics, Russia warned it won’t end the Ukraine war until NATO pulls its troops out of the Baltic states. Whatever asset you look at, take a step back and think about that for a moment. 

Is that a bluff – how can you know? Does it mean the EU surrendering those states back to Russian influence – and where afterwards? That’s the end of the EU as we know it, let alone the version that breezily states it wants to expand to Moldova, next to a Russian client state, and Georgia, next to Russia itself.

Or it implies a permanent state of EU-Russia hostility --the latter not with “an economy the size of Italy”, but a war economy with a purchasing power parity of $7 trillion and a world of physical resources-- with profound implications for both sides socio-politically, economically, and financially. 

https://www.zerohedge.com/geopolitical/russia-wont-end-ukraine-war-until-nato-pull-forces-out-eastern-flank

Hungary Sues European Commission Over €1 Million-A-Day Migrant Fine

 by Thomas Brooke via Remix News,

The Hungarian government has launched a legal challenge against the European Commission’s decision to impose a daily €1 million fine over the country’s refusal to accept illegal migrants. György Bakondi, the chief security advisor to Prime Minister Viktor Orbán, announced on Wednesday that Budapest will file a lawsuit with the European Court of Justice.

Appearing on TV2’s “Mokka” program, Bakondi said Hungary will not comply with the European Union’s new Migration Pact, which he described as “a clear call for illegal immigrants to be allowed in.” He emphasized that Hungary remains committed to its sovereignty and national security, and refuses to be pressured into taking in individuals who entered the bloc unlawfully.

The lawsuit will be led by a team of lawyers with what Bakondi called “a serious reputation,” including two former members of the European Court of Justice.

Hungary’s resistance to EU migration policy is not new. In 2015, the country faced a surge of more than 400,000 illegal border crossings within two months. In response, the government implemented border fences and legal restrictions to halt the flow. Officials credited these measures with preventing the emergence of terrorist threats, no-go zones, and the overburdening of public services.

In a national referendum in 2016, 98 percent of those who voted rejected the proposal to allow the European Union to mandate the obligatory resettlement of non-Hungarian citizens into Hungary without parliamentary approval. The referendum had a 44 percent turnout, under the 50 percent threshold required to be considered valid.

The Orbán administration had already signaled its intent to take legal action against Brussels back in December, setting aside 600 million forints (approximately €1.5 million) to fund the court battle.

Hungary has consistently pushed for a rethinking of the EU’s asylum policy, including relocating asylum processing to centers outside of EU territory. Orbán reiterated this stance on Monday during a speech at a Patriots for Europe rally in France.

“What is happening is not migration,” he said. “It’s an organized exchange of people to replace Europe’s cultural base. For us, €1 million a day is a lot of money, but we’d rather pay than let anyone in illegally. It’s the best investment for the future.”

The European Commission has not yet publicly responded to the lawsuit.

https://www.zerohedge.com/geopolitical/hungary-sues-european-commission-over-eu1-million-day-migrant-fine