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RFK Jr. Team Divided on Pharma & Vaccines at PhRMA Forum

by Dr. Priya Deshmukh - Senior Editor, Health
written by Dr. Priya Deshmukh - Senior Editor, Health

Washington D.C. – A recent forum hosted by the Pharmaceutical Research and Manufacturers of America (PhRMA) revealed a notable divergence in perspectives among key figures within the Biden administration, particularly concerning the future of pharmaceutical regulation and vaccine policy. The event, held Tuesday, showcased contrasting viewpoints from Centers for Medicare & Medicaid Services Administrator Mehmet Oz and Food and Drug Administration (FDA) Commissioner Marty Makary, both of whom serve as top lieutenants to Health and Human Services Secretary Robert F. Kennedy Jr.

The dynamic highlighted the complexities facing the pharmaceutical industry as it navigates a new political landscape under Kennedy Jr., who has previously expressed skepticism towards established medical institutions and vaccine protocols. The forum underscored the potential for both collaboration and friction between the industry and the administration, as differing approaches to regulation and policy were openly discussed.

Oz Signals Collaboration, Raises Revolving Door Concerns

Dr. Mehmet Oz, known for his television appearances and medical advocacy, engaged in a cordial conversation with Pfizer CEO and PhRMA board chair Albert Bourla. According to reports, Oz expressed support for the benefits of vaccines and indicated openness to closed-door meetings between industry executives and policymakers to develop new policy initiatives. Notably, Oz even suggested that industry leaders consider taking on roles within the government, a statement that appears to contradict Kennedy Jr.’s past criticisms of the “revolving door” phenomenon – the movement of personnel between government and the private sector. Fierce Pharma reported on PhRMA’s preparations for meetings with Trump, suggesting a proactive approach to engagement with the current administration.

Makary Faces Scrutiny Over FDA’s Vaccine Approach

In contrast to Oz’s conciliatory tone, FDA Commissioner Marty Makary faced pointed questioning from former CNBC reporter Bertha Coombs. The discussion centered on the FDA’s increasingly cautious approach to vaccine regulation, specifically referencing a recent decision by a top agency official, Vinay Prasad, to decline review of Moderna’s application for a new flu shot. This decision has sparked debate within the scientific community and raised questions about the agency’s commitment to accelerating the approval of new vaccines. The Independent reported on the dinner between Kennedy Jr. And Pfizer CEO Albert Bourla, highlighting the administration’s willingness to engage with industry leaders despite differing viewpoints.

The differing stances of Oz and Makary at the PhRMA forum underscore the internal tensions within the Kennedy Jr. Administration regarding pharmaceutical regulation and public health policy. While Oz appears to favor collaboration and a more traditional approach, Makary’s actions suggest a willingness to challenge established norms and prioritize a more skeptical evaluation of vaccine safety and efficacy.

Kennedy Jr.’s Industry Engagement

The forum took place against a backdrop of increased engagement between Kennedy Jr. And pharmaceutical industry leaders. Just weeks prior, Pfizer CEO Albert Bourla revealed he had dined with Kennedy Jr. Following an introduction by former President Donald Trump. During the dinner, Bourla stated that the conversation focused on areas of agreement, such as chronic diseases, cardiovascular health, and cancer research, rather than contentious topics like vaccine safety. The Daily Mail detailed this meeting, noting that vaccine discussions were deliberately avoided.

Bourla expressed cautious optimism about the new administration, suggesting that the opportunities presented by the Trump administration may outweigh the risks associated with significant policy changes. PhRMA’s announcement of Bourla’s chairmanship further solidifies the industry’s engagement with the administration.

The situation is further complicated by Kennedy Jr.’s past criticisms of the pharmaceutical industry and his advocacy for alternative health approaches. His appointment of individuals with differing viewpoints, such as Oz and Makary, suggests a deliberate attempt to foster internal debate and challenge conventional wisdom. However, it also raises concerns about potential conflicts of interest and the direction of future health policy.

Looking ahead, the pharmaceutical industry will be closely watching the Kennedy Jr. Administration’s actions regarding drug pricing, regulatory approvals, and vaccine mandates. The outcome of these policy decisions will have significant implications for the industry’s profitability and its ability to innovate and develop new treatments. The contrasting perspectives showcased at the PhRMA forum suggest that the path forward will be complex and potentially contentious.

What impact will these internal divisions have on the administration’s long-term health policy goals? Share your thoughts in the comments below.

Disclaimer: This article provides informational content only and is not intended to be a substitute for professional medical advice.

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Health

Trump’s Executive Orders Impact HHS: Health Data, Funding Cuts, and Policy Changes

by Dr. Priya Deshmukh - Senior Editor, Health
written by Dr. Priya Deshmukh - Senior Editor, Health

In the early days of President Trump’s second term, a series of executive orders initiated significant changes in public health policy under the Department of Health and Human Services (HHS). The orders included directives related to “gender ideology,” “diversity, equity, and inclusion (DEI),” and “merit-based opportunities,” leading to the removal of numerous HHS websites and public health data associated with these themes. The implications for public health were immediate and far-reaching, impacting areas such as reproductive health, health disparities, and LGBTQ+ health issues.

Following the issuance of these executive orders, the HHS began to dismantle a substantial number of federal databases and websites that provided health information deemed aligned with the previous administration’s policies. This action sparked a legal challenge aimed at restoring access to this crucial information. By September 2025, the administration agreed to restore the removed health-focused websites and databases to their state as of January 29, 2025, highlighting the ongoing tensions between differing public health philosophies in the federal government.

In tandem with these actions, on February 7, 2025, the National Institutes of Health (NIH) announced a controversial change to its indirect cost rate guidance, proposing a recent 15% rate for all grants. This figure represented a significant reduction from historical rates and could potentially diminish funding for health research institutions across the nation. The policy was immediately challenged in court, resulting in multiple judicial interventions that temporarily halted its implementation.

Leadership Changes and New Initiatives

On February 13, Robert F. Kennedy, Jr. Was confirmed as the Secretary of HHS, with a narrow Senate vote of 52-48. Shortly thereafter, he unveiled the Trump administration’s “Make America Healthy Again” (MAHA) agenda, which aimed to address chronic diseases and childhood health issues. The MAHA Commission was established, tasked with submitting an assessment report on the “childhood chronic disease crisis” within 100 days, along with a strategic plan within 180 days. This initiative underscored a shift in focus towards combatting prevalent health issues such as obesity and diabetes.

As the administration pushed forward with its health agenda, it likewise issued an executive order on February 14 prohibiting federal funds from supporting educational institutions that mandated COVID-19 vaccinations for in-person attendance. By March 2025, all colleges that had implemented such vaccination requirements rescinded them, emphasizing the administration’s influence on public health policy in educational settings.

Policy Revisions and Funding Cuts

Secretary Kennedy outlined several public health priorities during his welcome ceremony at HHS on February 18, including a commitment to investigate the childhood vaccine schedule and tackle perceived corruption within the health sector. However, several sweeping changes followed, including a rule that eliminated public comment requirements for HHS grants and contracts. This modification raised concerns about transparency and public involvement in health policy decisions.

Under Kennedy’s leadership, the CDC announced plans on March 7 to study factors contributing to rising autism rates in the U.S., while no results from this study have been publicly released. These initiatives, alongside the administration’s controversial statements linking childhood vaccinations and autism, reflect a growing political influence over scientific discourse in public health.

funding for critical health programs faced cuts. The NIH announced the termination of several grants for HIV prevention and treatment programs on March 17, which alarmed public health advocates who noted the previous administration’s commitment to combating the HIV epidemic by 2030. The removal of the Surgeon General’s warning on gun violence as a public health crisis further illustrated the administration’s shifting stance on various health issues.

Impact on Health Departments and Research Funding

Amid these policy changes, the HHS sought to retract $11 billion in supplemental COVID-19 funding allocated to state and local health departments. This move prompted legal challenges from multiple states, resulting in a temporary judicial block against the funding cuts. As of August 2025, many states involved in the lawsuit saw a restoration of nearly 80% of the funds initially targeted for cuts, demonstrating the ongoing struggle between state and federal public health priorities.

The reorganization of HHS, announced on March 27, aimed to consolidate several offices to create an “Administration for a Healthy America.” This restructuring included eliminating 20,000 positions across HHS, significantly impacting public health staffing and operational capabilities. Following this announcement, lawsuits emerged challenging the legality of mass firings and the overall restructuring plan.

Changes in Vaccine Recommendations and Approvals

In addition to staffing changes, significant revisions to vaccine recommendations were implemented. On May 27, Secretary Kennedy announced that the CDC would no longer recommend COVID-19 vaccines for healthy pregnant women and children, a departure from established vaccination protocols. This decision prompted a backlash from medical organizations and led to multiple lawsuits against HHS, asserting that the changes did not follow proper federal procedures.

the CDC’s Advisory Committee on Immunization Practices (ACIP) underwent a complete overhaul when Kennedy dismissed all sitting members on June 9, citing a need to restore public trust. New appointees included individuals with previous criticisms of COVID-19 vaccines, signaling a shift in the advisory body’s composition and potentially its recommendations.

As part of a broader strategy to address chronic disease, the MAHA Commission published a report on September 9 that outlined over 120 initiatives aimed at combating childhood chronic diseases. This ambitious plan aimed to reshape federal health priorities and included measures to reform dietary guidelines and enhance public awareness about health risks.

By late 2025, the administration’s actions, including changes to vaccine schedules and funding cuts to health programs, had sparked significant debate within the public health community, raising questions about the future direction of health policy in the United States.

As the Trump administration continues to navigate public health policy through 2026, the implications of these actions remain to be fully realized. Stakeholders from various sectors are closely monitoring the situation, as legal challenges and public discourse evolve in response to these changes.

For more insights into public health policies and their implications, readers are encouraged to engage in the conversation by sharing their thoughts and experiences in the comments below.

Disclaimer: This article is for informational purposes only and does not constitute medical advice.

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Health

Moderna Flu Vaccine: FDA Review Delay & President’s Response

by Dr. Priya Deshmukh - Senior Editor, Health
written by Dr. Priya Deshmukh - Senior Editor, Health

FDA’s Rejection of Moderna’s Flu Vaccine Signals a Potential Shift in Vaccine Regulation

Nearly a billion dollars. That’s approximately how much Moderna invested in a Phase 3 clinical trial for its mRNA-based flu vaccine, a trial involving over 40,000 participants. Yet, the Food and Drug Administration (FDA) recently refused to even review the application, a decision that has sent shockwaves through the biopharmaceutical industry and raises critical questions about the future of vaccine development and regulatory pathways.

A Sudden Reversal and a Question of Comparators

The FDA’s decision, spearheaded by vaccine regulator Dr. Vinay Prasad, centers on the comparator vaccine used in Moderna’s trial. While the FDA initially indicated acceptance of Moderna’s choice – a standard-dose flu vaccine like Fluarix – it ultimately determined the trial didn’t adequately compare the new mRNA shot to the “best-available standard of care.” According to Moderna President Stephen Hoge, the agency would have preferred a comparison against a high-dose vaccine, particularly for older adults. The core issue isn’t safety or efficacy, Hoge emphasized, but rather the benchmark against which the new vaccine was measured.

“We were completely surprised and honestly pretty confused,” Hoge stated in an interview with The Post. “They actually just said, ‘We’re not even going to open it.’” This abrupt shift is particularly jarring given that Moderna had proactively sought feedback from the FDA throughout the development process, receiving assurances that the trial design was acceptable. The company had even provided additional analyses requested by the agency, only to be met with a “refusal-to-file” letter.

The Implications for mRNA Vaccine Technology

This situation extends beyond a single vaccine application. The FDA’s stance could have a chilling effect on the development of other mRNA vaccines, a technology that proved remarkably effective during the COVID-19 pandemic. The speed and flexibility of mRNA vaccine development were hailed as a “modern-day miracle” by former President Donald Trump, but this incident suggests a potential tightening of regulatory scrutiny. The question now is whether the FDA will apply this new standard consistently, and whether it will create undue hurdles for innovative vaccine candidates.

A Broader Trend: Increased Regulatory Rigor?

The timing of this decision is noteworthy. Last fall, Dr. Prasad outlined a desire for a more rigorous vaccine approval process, advocating for a re-evaluation of the framework for annual flu shots. This suggests a potential broader trend toward increased regulatory rigor at the FDA, particularly under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr. While a cautious approach to vaccine approval is understandable, the manner in which this decision was communicated – and the lack of prior warning – has raised concerns about transparency and predictability.

The FDA’s decision likewise highlights the complexities of comparing new vaccines to existing ones. Determining the “best-available standard of care” is not always straightforward, and different regulators may have varying interpretations. This ambiguity could lead to further disputes and delays in the future, hindering the development of potentially life-saving vaccines.

What’s Next for Moderna and the Industry?

Moderna is currently seeking clarification from the FDA regarding the specific requirements for resubmission. Hoge acknowledged the potential fallout from this decision, warning that it could discourage investment in vaccine research and development. The company’s experience will undoubtedly be closely watched by other biopharmaceutical firms, who may now be more hesitant to pursue innovative vaccine candidates without a clearer understanding of the FDA’s expectations.

The future of vaccine regulation appears to be at a crossroads. Balancing the necessitate for innovation with the imperative of safety and efficacy is a delicate act. The FDA’s decision regarding Moderna’s flu vaccine serves as a stark reminder of the challenges involved, and underscores the importance of clear communication and consistent application of regulatory standards. What are your predictions for the future of vaccine regulation in light of this decision? Share your thoughts in the comments below!

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Economy

FDA official Vinay Prasad rejects Moderna flu vaccine after overruling scientists

by Daniel Foster - Senior Editor, Economy
written by Daniel Foster - Senior Editor, Economy

FDA Vaccine Review Faces Internal Conflict as Official Blocks Influenza Approval

Table of Contents

Washington D.C. – A high-ranking Official at the Food and Drug Management, Vinay Prasad, has reportedly intervened to prevent the agency from reviewing a novel influenza vaccine developed by Moderna. This decision has ignited internal discord, with career scientists expressing readiness to assess the application, and raises concerns about evolving standards within the regulatory body.

A Disputed Decision on vaccine Review

Sources within the FDA indicate that Prasad bypassed standard protocol and declined to authorize a full evaluation of Moderna’s influenza vaccine submission. David Kaslow,the Director of the Office of Vaccine Research and Review,reportedly authored a complete memorandum advocating for the review’s commencement.Despite this recommendation, Prasad opted against proceeding.

escalating Scrutiny of Vaccines

this instance forms part of a pattern of increased scrutiny towards vaccines under Prasad’s leadership. The development is occurring amidst growing public debate surrounding vaccine policy and the influence of prominent critics within the government. Health and Human Services Secretary Robert F. Kennedy Jr., a well-known figure with reservations about vaccine efficacy and safety, is seen as contributing to a shifting climate at the FDA.

Control of Surveillance and Data

The changes extend beyond application reviews, with reports suggesting a consolidation of control over vaccine surveillance mechanisms.Tracy Beth Høeg, another senior official, is accused of curtailing the involvement of long-term civil servants in thes critical monitoring processes. This move has allegedly fostered an atmosphere of distrust among agency staff.

The Broader Context of Vaccine Regulation

The FDA’s role in ensuring the safety and efficacy of vaccines is paramount to public health. According to data from the Centers for Disease Control and Prevention (CDC), influenza vaccines prevent an estimated 50% to 60% of infections in vaccinated individuals during years when circulating strains closely match the vaccine composition CDC. Though, the process of bringing new vaccines to market is complex and frequently enough fraught with political and scientific challenges.

Area of Concern Details
Official Intervention Vinay Prasad overruled staff recommendations to review Moderna’s flu vaccine application.
Internal dissent FDA scientists expressed readiness to evaluate the vaccine’s safety and effectiveness.
shift in Policy Increased scrutiny of vaccines under current leadership.
Control of Surveillance Tracy Beth Høeg is reported to have consolidated control over vaccine monitoring.

Implications for Future Approvals

The recent actions raise questions about the future trajectory of vaccine approvals within the United States. Experts suggest that a more cautious approach could potentially delay the introduction of innovative vaccines, impacting public health preparedness for emerging infectious diseases. A study published in *The lancet* in 2023 emphasized the importance of swift regulatory responses to pandemic threats The Lancet.

The situation highlights the delicate balance between rigorous scientific evaluation and the urgent need to protect the population. Will this internal conflict impact the speed and objectivity of future vaccine reviews? And how will these changes affect public trust in the regulatory process?

What are your thoughts on the FDA’s current approach to vaccine approvals? Share your opinions in the comments below, and don’t forget to share this article with your network.

What were the main reasons Vinay Prasad rejected Moderna’s flu vaccine despite the FDA advisory panel’s approval?

FDA Official Vinay Prasad Rejects Moderna Flu Vaccine After Overruling Scientists

the recent decision by dr. Vinay Prasad, a prominent FDA official, to reject Moderna’s latest influenza vaccine candidate has sent ripples through the medical community and sparked intense debate regarding vaccine development, data transparency, and the role of scientific consensus within regulatory bodies. This isn’t simply a rejection based on efficacy; it’s a case highlighting a fundamental disagreement over how vaccine trials are conducted and interpreted, particularly concerning surrogate endpoints.

The Core of the Dispute: Surrogate Endpoints vs. Clinical Benefit

At the heart of the controversy lies the use of “hemagglutinin inhibition” (HAI) assays as a primary endpoint in Moderna’s clinical trials.HAI measures the antibody response to the vaccine, essentially gauging whether the immune system appears to be reacting. Dr. Prasad, along with several overruled scientists, argues that HAI is a surrogate endpoint – a marker believed to predict clinical benefit, but not a direct measure of it.

* Surrogate endpoints can accelerate drug development, but they aren’t foolproof. A strong antibody response doesn’t automatically translate to protection against actual illness.

* Clinical benefit is determined by observing whether vaccinated individuals experience fewer cases of the flu, reduced symptom severity, or lower hospitalization rates.

moderna presented data showing a robust HAI response, leading them to claim the vaccine was effective. However, Dr. Prasad contends that this data doesn’t definitively prove the vaccine will meaningfully reduce flu cases in the real world. He emphasizes the need for trials that directly measure clinical outcomes. This stance aligns with growing concerns within the scientific community about relying too heavily on surrogate endpoints, particularly in the context of respiratory viruses where immune correlates of protection are often complex and poorly understood.

The FDA Panel’s Initial Recommendation & Subsequent Rejection

An FDA advisory panel initially voted in favor of the vaccine, seemingly swayed by the HAI data. However,Dr. Prasad voiced strong objections during the deliberations, citing concerns about the trial design and the lack of compelling evidence demonstrating a clear clinical advantage. He subsequently used his position within the FDA to formally reject the vaccine, effectively overruling the panel’s recommendation. This action is unusual and underscores the seriousness of his concerns.

Examining Moderna’s Trial Data: what Did the Numbers Show?

A closer look at Moderna’s trial data reveals several points of contention. While the vaccine did elicit a strong antibody response (as measured by HAI),the trial didn’t demonstrate a statistically significant reduction in confirmed flu cases compared to a placebo group.

* The trial primarily focused on individuals with prior flu vaccination,possibly masking any true effect of the new vaccine.

* The study population was relatively small, limiting the statistical power to detect a meaningful difference.

* The specific flu strains included in the trial may not accurately reflect the strains circulating in the broader population during the study period.

These factors, according to Dr. Prasad and supporting scientists, raise doubts about the validity of the conclusions drawn from the trial. They argue that the positive HAI results shouldn’t be enough to warrant approval without more robust evidence of clinical efficacy.

implications for Future Vaccine Development

This case has broader implications for the future of vaccine development, particularly for respiratory viruses. It highlights the need for:

  1. More Rigorous Trial Designs: Future trials shoudl prioritize measuring clinical outcomes directly,rather than relying solely on surrogate endpoints.
  2. Larger and More Diverse study Populations: Increasing the size and diversity of trial participants can improve the statistical power and generalizability of the results.
  3. Real-World Evidence Collection: Post-market surveillance and real-world data analysis are crucial for assessing the long-term effectiveness and safety of vaccines.
  4. Transparency in Data Reporting: Open access to raw trial data allows independent researchers to scrutinize the findings and identify potential biases or limitations.

the Role of Independent Scientific Review

Dr. Prasad’s actions have also reignited the debate about the role of independent scientific review within regulatory agencies. His willingness to challenge the initial recommendation of the advisory panel, despite potential professional repercussions, demonstrates the importance of having dissenting voices and a commitment to scientific integrity. This situation underscores the need for a system that encourages open dialog and critical evaluation of data, even when it contradicts prevailing opinions. The incident has prompted calls for greater transparency in FDA decision-making processes and a more robust framework for incorporating independent scientific expertise.

Understanding HAI Assays & Their Limitations

hemagglutinin inhibition (HAI) assays are a common method for measuring the antibody response to influenza viruses. They work by assessing the ability of antibodies in a blood sample to prevent the virus from binding to red blood cells. While HAI assays are relatively easy to perform and have been used for decades, they have several limitations:

* Correlation with Protection is Imperfect: A high HAI titer doesn’t always correlate with protection against influenza infection.

* Strain Specificity: HAI assays are strain-specific, meaning they only measure the antibody response to a particular strain of the virus.

* Assay Variability: HAI assays can be subject to variability depending on the laboratory and the specific protocol used.

These limitations highlight the importance of interpreting HAI data with caution and not relying on it as the sole indicator of vaccine efficacy.

What This Means for Public Health & Flu Season Preparedness

The rejection of Moderna’s flu vaccine doesn’t necessarily mean that flu season will be worse. Existing flu vaccines from other manufacturers remain available and are expected to provide protection against circulating strains. However, it

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