Merck wins Gardasil litigation over cancer vaccine risks

On Tuesday, Merck & Co (NYSE:MRK) Inc. emerged victorious in a significant legal dispute concerning its Gardasil vaccine, which is designed to prevent cervical and other serious cancers. U.S. District Judge Kenneth Bell, presiding in Charlotte, North Carolina, dismissed more than 200 cases that were part of a consolidated multidistrict litigation.

The plaintiffs in the litigation had accused Merck (NSE:PROR) of failing to warn about potential side effects of Gardasil, specifically an increase in heart rate and ovarian issues. They contended that these warnings should have been included on the vaccine’s labels. However, Judge Bell determined that under federal law, Merck did not have the power to independently add warnings about such risks without more substantial evidence.

In his decision, Bell emphasized the importance of not deterring the use of vaccines that save lives with warnings that are not well-supported by evidence. He stated that federal law demands more than "speculative inferences" before imposing severe warnings on vaccines, which could potentially dissuade people from using them.

Merck responded to the ruling with approval, stating that they were "extremely pleased" with the outcome. The decision effectively resolves a large group of claims that had been brought against the pharmaceutical company regarding its Gardasil vaccine.

This ruling supports the position that vaccine manufacturers are not responsible for independently updating warnings on their products without the explicit direction of the Food and Drug Administration or a solid foundation of scientific proof. The dismissal of the cases underscores the legal protections in place for vaccine makers, especially when the allegations are not substantiated by robust scientific data.

Moderna at Barclays Conference: Strategic Focus on Oncology and Vaccines

On Tuesday, 11 March 2025, Moderna Inc. (NASDAQ: MRNA) presented at the Barclays 27th Annual Global Healthcare Conference

https://www.investing.com/news/transcripts/moderna-at-barclays-conference-strategic-focus-on-oncology-and-vaccines-93CH-3921808

Can anyone on this board help to understand

Why vaccines are necessary

In one's own words

Profit aspect excluded

Would be helpful

Netherlands starts bird flu vaccination program at hen farm

The Netherlands, one of the world's largest egg exporters, has launched a pilot program on a laying-hen farm to vaccinate poultry against bird flu with the aim of achieving large-scale vaccination, the government said on Monday.

"I am pleased that the poultry sector wants to take this step with me. Vaccination offers a huge opportunity to better control bird flu," said Agriculture Minister Femke Wiersma.

https://www.reuters.com/business/healthcare-pharmaceuticals/netherlands-starts-bird-flu-vaccination-program-hen-farm-2025-03-10/

U.S. Bird Flu Cases Continue in Poultry. Here’s Where HPAI Is Spreading in March 2025

https://www.agriculture.com/u-s-bird-flu-cases-continue-in-early-2025-here-s-where-hpai-is-spreading-in-march-11690063

Why not more on virology

How does one know

There are unicorns

Dr. Tom Cowan

Is there more to this

RFK Jr's flipflop

The world should prepare now for a potential H5N1 flu pandemic, experts warn

https://cepi.net/world-should-prepare-now-potential-h5n1-flu-pandemic-experts-warn

Moderna at TD Cowen Conference: Strategic Diversification Focus $$$$$$$$$$

On Wednesday, 05 March 2025, Moderna Inc. (NASDAQ: MRNA) participated in the TD Cowen 45th Annual Healthcare Conference. The discussion, led by Tyler Van Buren from TD Cowen and Steven Hoege, President of Moderna, highlighted the company’s strategic initiatives, including product diversification and cost reduction. While Moderna remains committed to its ambitious growth plans, it also acknowledged potential challenges, such as lower COVID vaccination rates and market uncertainties.

Key Takeaways
Moderna aims for 2025 vaccine sales between $1.5 billion and $2.5 billion.
The company targets cash breakeven by 2028 through diversification and cost management.
Moderna’s product pipeline includes vaccines for RSV, flu COVID combo, norovirus, and CMV.
The individualized neoantigen therapy (INT) program is a key focus in oncology.
Moderna is prepared to advance its bird flu vaccine program as needed.
Financial Results
Moderna reiterated its 2025 sales guidance of $1.5 billion to $2.5 billion, acknowledging potential headwinds.
The company aims to achieve cash breakeven by 2028 through product launches and cost reductions.
Cash investment is projected to decrease from $6.4 billion in 2024 to $5 billion in 2026.
Operational Updates
RSV Vaccine: Contracting discussions are ongoing, with label expansion under review for high-risk 18-59 year olds.
Flu COVID Combo Vaccine: No revenue expected in 2025, with a 2026 opportunity pending efficacy data.
Norovirus Vaccine: Data expected in 2026, with trials paused due to a Guillain Barre syndrome case.
INT Program: Phase 3 melanoma trial fully enrolled, with potential approval in 2027.
Bird Flu Vaccine: Phase 3 study in the U.S. under agreement, with a proactive approach to pandemic preparedness.


Future Outlook
Product Launches: Aiming to launch 10 products in three years, with three files under FDA review.
Cost Discipline: Continued cost reductions to balance investment and revenue by 2028.
Q&A Highlights
RSV Competition: Moderna aims to offer the broadest label and strong efficacy for its RSV vaccine.
Flu Season: Challenges include declining vaccine coverage and evolving influenza viruses.
Flu COVID Combo vs. Monotherapy: Two-thirds of the population prefer the combination vaccine, though monovalent products will remain significant.



Full transcript - TD Cowen 45th Annual Healthcare Conference:

https://www.investing.com/news/transcripts/moderna-at-td-cowen-conference-strategic-diversification-focus-93CH-3913103

Moderna anticipates 2027 release for cancer vaccine in collaboration with Merck

https://www.investing.com/news/stock-market-news/moderna-anticipates-2027-release-for-cancer-vaccine-in-collaboration-with-merck-93CH-3909817

BioNTech and Pfizer must pay damages to Moderna for the use of one of its patents in Germany. This was the ruling handed down today by Düsseldorf Regional Court in the dispute over mRNA vaccines. It is the second win for Moderna after a favourable ruling in London last year.

https://www.juve-patent.com/cases/moderna-and-freshfields-triumph-in-dusseldorf-against-biontech-and-pfizer/

Before the measles vaccine

We had the Brady Bunch

Telling it like it is


Natural immunity from measles is lifelong

While vaccines push endless boosters

Trust your immune system

Not the pharma-driven panic

~ Dr Sherri Tenpenny ~


Fear mongering = vaccine push

Must keep those dollars rolling

From the uneducated

Must feel good

About that

MRNA $32s bottom feeder $$$$

insider buy$ https://www.secform4.com/filings/1682852/0001127602-25-007904.htm

Moderna CEO Stephane Bancel purchases $5 million in company stock


Bancel acquired a total of 160,314 shares of Moderna’s common stock, with purchase prices ranging from $31.04 to $31.53 per share.

https://www.investing.com/news/insider-trading-news/moderna-ceo-stephane-bancel-purchases-5-million-in-company-stock-93CH-3907204

-clown- RFK Jr urges Americans to get vaccinated amid measles outbreak: ‘A call to action’

https://www.hindustantimes.com/world-news/us-news/rfk-jr-urges-americans-to-get-vaccinated-amid-measles-outbreak-a-call-to-action-101740995866989.html

Recent advances and perspectives on the development of circular RNA cancer vaccines


https://www.nature.com/articles/s41541-025-01097-x

Moderna Receives Medicines and Healthcare Products Regulatory Agency Marketing Authorization in the UK for RSV Vaccine

https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-Medicines-and-Healthcare-Products-Regulatory-Agency-Marketing-Authorization-in-the-UK-for-RSV-Vaccine/default.aspx

Killer T cells could hold key to future 'bird flu' vaccines, study suggests

https://medicalxpress.com/news/2025-02-killer-cells-key-future-bird.html

Moderna to Present at Upcoming Conferences in March 2025

https://investors.modernatx.com/news/news-details/2025/Moderna-to-Present-at-Upcoming-Conferences-in-March-2025/default.aspx

From Tumor Biology to Breakthrough Therapies: The Rise of Personalized Cancer Vaccines

Notably, in the KEYNOTE-942 trial (NCT03897881) led by Jeffrey S Weber, investigators observed improved relapse-free survival (RFS) with a combination of neoantigen vaccines and pembrolizumab (Keytruda; Merck & Co), marking a significant step forward in clinical translation.1,2 This phase 2b study evaluated the efficacy and safety of mRNA-4157 (V940; Moderna and Merck), an mRNA-based individualized neoantigen therapy, combined with pembrolizumab vs pembrolizumab monotherapy in patients with resected high-risk melanoma (stage IIIB-IV). The trial enrolled 157 patients across the US and Australia, randomized 2:1 to receive either the combination therapy or monotherapy.2

At a median follow-up of 24 months, the combination therapy improved RFS (HR 0.561, P=0.053), with 18-month RFS rates of 79% vs 62% in the monotherapy group. The combination therapy was associated with more grade 3 or higher treatment-related adverse events (AEs, 25% vs 18%), though no grade 4 to 5 events were attributed to mRNA-4157. Immune-mediated AE rates were similar between groups.2

Overall, the findings suggest that mRNA-4157 plus pembrolizumab enhances RFS with a manageable safety profile, supporting the potential role of mRNA-based neoantigen therapy in the adjuvant treatment of high-risk melanoma.2

With promising results such as those observed in the KEYNOTE-942 trial, Wu explained that pharmaceutical industry has begun to provide funding for larger studies investigating neoantigen vaccines in the adjuvant and neoadjuvant settings. For example, one study (NCT05933577) investigating melanoma (nearly finished) received funding from Merck and Moderna and enrolled 1089 patients. Another study (NCT06295809) investigating cutaneous squamous cell carcinoma in the adjuvant and neoadjuvant setting (will be commencing soon) also received funding from industry and has enrolled 1000 patients. Other studies include investigations into renal cell carcinoma (RCC, NCT06307431), bladder (NCT06305767), non-small cell lung cancer (NCT06077760), and resected pancreatic ductal adenocarcinoma (NCT05968326), all in the adjuvant setting with between 200 and approximately 900 patients enrolled.1

“Now we're getting—with support from industry—not 10 or 15 patient studies, but rather on the order of 200 and even more than 1000 patients,” Wu said. “I think in the time to come, we'll be able to really, truly look at the clinical impact of such vaccines.”

https://www.pharmacytimes.com/view/from-tumor-biology-to-breakthrough-therapies-the-rise-of-personalized-cancer-vaccines

What if cancer

Is a parasite

Yale doctor's use of ‘cancer vaccine' makes waves after early trials show promising results

The patients remained cancer-free for nearly three years, up until the study ended, Braun said. “We’re able to generate a long-lasting, anti-cancer immune response with the vaccine,” he said.

The next stage is a larger trial, in partnership with pharmaceutical companies Merck and Moderna, that will test the vaccine in combination with other treatments in 270 patients around the world. The first patient who enrolled in the new trial is being treated at Yale Cancer Center, Braun said.


https://www.nature.com/articles/s41586-024-08507-5

https://www.ctinsider.com/business/article/yale-cancer-vaccine-kidney-tumor-dna-research-20173018.php

RNA neoantigen vaccines prime long-lived CD8+ T cells in pancreatic cancer

https://www.nature.com/articles/s41586-024-08508-4

-history repeats itself - New coronavirus with potential to cause pandemic discovered in China

The new virus is even closer related to MERS, a deadlier type of coronavirus that kills up to a third of people it infects.

HKU5-CoV-2 is strikingly similar to the pandemic virus, sparking fears that history could repeat itself just two years after the worst was declared over.



https://www.dailymail.co.uk/health/article-14421599/coronavirus-potential-cause-pandemic-discovered-china.html

Reading between the lines

Now up for reassessment

$BNTX Experimental vaccine for common cancer shows potential in clinical trial
Some pancreatic cancer patients showed immune response to mRNA vaccine

Vinod Balachandran, MD, principal investigator of the trial and senior study author at MSK, stated his optimism about the efficacy of this treatment.

"We find that with RNA vaccine technology, we can teach the immune system to recognize pancreatic cancer, and this immune response could potentially last for many years," he said.

"The ability to trigger a robust, long-lasting immune response is a requisite feature for any cancer vaccine."

https://www.foxnews.com/health/experimental-vaccine-common-cancer-shows-potential-clinical-trial

Kennedy has downplayed concerns about his anti-vaccine sentiments, saying in a Senate hearing that “all of my kids are vaccinated, and I believe vaccines have a critical role in healthcare.”

FDA Issues Back-to-Back Vaccine Approvals as RFK Jr. Takes HHS Seat

As they say, history repeats itself
https://www.biospace.com/fda/fda-issues-back-to-back-vaccine-approvals-as-rfk-jr-takes-hhs-seat

Cancer Vaccines: https://finance.yahoo.com/news/cancer-vaccines-market-track-major-180000959.html

Leading cancer vaccine companies such as IO Biotech, Merck, Moderna, Candle Therapeutics, ISA Pharmaceuticals, PDS Biotechnology, PDC*line Pharma, LG Chem, AVEO Oncology, Archival Farma, and others are developing novel cancer vaccines that can be available in the cancer vaccines market in the coming years.

Some of the key cancer vaccines in the pipeline include IO102-IO103, mRNA-4157 (V940) + KEYTRUDA, CAN-2409, Nelipepimut-S + Cemiplimab, PDS0101 + Pembrolizumab, PDC*lung01, LB-LR1109, RUTI, and others.

Scientists Crack The Code For Delivering MRNA Medicine To The Brain

https://scienceblog.com/scientists-crack-the-code-for-delivering-mrna-medicine-to-the-brai/

Unpacking the lies

~~~ That we've been fed ~~~
(3:04)

Get the truth instead

NaturalNews

To learn more, visit: https://discover.brighteon.com/unpacking-the-lies-weve-been-fed

RFK Jr.

Moderna Earnings: Maintaining Our $102 Fair Value Estimate as Long-Term Pipeline and Strategy Intact

https://www.morningstar.com/company-reports/1264965-moderna-earnings-maintaining-our-102-fair-value-estimate-as-long-term-pipeline-and-strategy-intact?listing=0P0001F631

Antidepressant, it's no use......it's just harmful...
$MRNA

Not much repeat business

In that model

What is an Antidepressant

Why is it called for

Personalities

Can be damaging

To the hive mind

How is it currently made

Take out all poisons

Starting point

Revenue: $966 million vs. $942.8 million expected

RFK Jr. Is Already Taking Aim at Antidepressants

Conspicuously absent was any explicit mention of childhood vaccines, which Kennedy has long railed against as the head of the anti-vaccine advocacy group Children’s Health Defense.

https://www.motherjones.com/politics/2025/02/kennedy-rfk-antidepressants-ssri-school-shootings/

RFK Jr. Outlines His Health Secretary Priorities in Post-Confirmation Interview With Fox News

‘I’m not going to take away anybody’s vaccine’

https://time.com/7222533/rfk-jr-health-human-services-secretary-confirmation-interview-fox-vaccines/

Recent Progress and Upcoming Late-Stage Pipeline Milestones

The Company remains focused on a prioritized research and development portfolio, delivering up to 10 product approvals through 2027.

What does the confirmation of RFK Jr. mean

~~~ For FDA and Big pharma ~~~
(23:50)

Follow the data

This is historic

Moderna Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Provides Business Updates

Cash Position: Cash, cash equivalents and investments as of December 31, 2024, were $9.5 billion, compared to $9.2 billion as of September 30, 2024. The increase during the quarter was primarily attributable to the timing of accounts receivable collections.

https://investors.modernatx.com/news/news-details/2025/Moderna-Reports-Fourth-Quarter-and-Fiscal-Year-2024-Financial-Results-and-Provides-Business-Updates/default.aspx

Senate confirms RFK Jr. as HHS secretary in 52-48 vote

https://www.foxnews.com/politics/senate-confirms-robert-f-kennedy-jr-serve-trumps-health-secretary

How about you read the paper first before we have a serious discussion?
https://www.iovance.com/uploads/Chesney-JITC-2022-Efficacy-and-safety-of-lifileucel-TIL-cell-therapy-in-pts-w-adv-melanoma-after-pr-2447-publication.pdf

While you read papers on cell therapy, keep one question in your mind: can the treatment trigger massive and sustainable t-cell (CD4 & 8) infiltration into tumor sites after the treatment stops?

BTW, you don't happen to think that Merck would construct vaccine manufacturing facilities based on the following results on mRNA trials, do you?

https://clinicaltrials.gov/study/NCT03313778
https://pubmed.ncbi.nlm.nih.gov/39115419/

https://jitc.bmj.com/content/8/Suppl_3/A477.1
https://clinicaltrials.gov/study/NCT03313778

https://clinicaltrials.gov/study/NCT05933577
https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS9616

https://s29.q4cdn.com/435878511/files/doc_presentations/2024/Jun/03/asco-2024-adjuvant-melanoma.pdf
https://clinicaltrials.gov/study/NCT03897881

https://ascopubs.org/doi/10.1200/JCO.2023.41.17_suppl.LBA9503
https://www.clinicaltrials.gov/study/NCT03897881

https://pubmed.ncbi.nlm.nih.gov/33016924/
https://clinicaltrials.gov/study/NCT03480152

Three Years After Experimental Vaccine, These Patients Are Still Cancer-Free

https://gizmodo.com/three-years-after-experimental-vaccine-these-patients-are-still-cancer-free-2000559585

From memory, one of three pivotal trials ongoing. I know they were planing to start a few more PhI/II trials, including one in pancreatic (based on BNTX data*).

* https://www.nature.com/articles/s41586-023-06063-y https://www.globenewswire.com/news-release/2024/04/07/2858841/0/en/Three-year-Phase-1-Follow-Up-Data-for-mRNA-based-Individualized-Immunotherapy-Candidate-Show-Persistence-of-Immune-Response-and-Delayed-Tumor-Recurrence-in-Some-Patients-with-Resec.html

The vaccine targets five antigens VHL, PBRM1, BAP1, KDM5C, PIK3CA. It happens that some of those antigens also exist in three types of brain tumors. DCVax-L in combination with poly-iclc can certainly fix those highly mutated genes. Here I am talking about the version of DCVax-L developed fifteen years ago. Can you imagine the magnitude of efficacy that the latest version of DCVax-L in combination with keytruda can bring after dendritic cells present hundreds of tumor-associated antigens to immune system?

https://www.nature.com/articles/s41586-024-08507-5

CAR-macrophage therapy for HER2-overexpressing advanced solid tumors: a phase 1 trial
Chimeric antigen receptor (CAR) macrophages (CAR-Ms) mediate antitumor immunity via phagocytosis, cytokine release, activation of the tumor microenvironment and antigen presentation. We report results from a non-prespecified interim analysis of a first-in-human, phase 1 clinical trial of CT-0508, an anti-human epidermal growth factor receptor 2 (HER2) CAR-M in patients with advanced HER2-overexpressing tumors. Fourteen patients were treated across two different regimens. Patients with breast cancer and gastroesophageal cancer were primarily enrolled and had to have demonstrated overexpression of HER2 according to the American Society of Clinical Oncology/College of American Pathologists guidelines (HER2 immunohistochemistry 3+ or immunohistochemistry 2+/in situ hybridization-amplified). No lymphodepletion chemotherapy was used before infusion. The primary endpoints were safety and CAR-M manufacturability. Secondary endpoints included cellular kinetics and efficacy using objective response rate, overall survival, progression-free survival and duration of response. No dose-limiting toxicities, severe cytokine release syndrome (≥grade 3) or immune effector cell-associated neurotoxicity syndrome were observed; 44% (n?=?4 of 9, 95% confidence interval?=?14–79%) of HER2 3+ tumors achieved stable disease as best overall response 8 weeks after treatment. No meaningful activity was observed in the HER2 2+ population (n?=?5). Correlative analyses of serial biopsies confirmed that CT-0508 traffics to and remodels the tumor microenvironment, resulting in expansion of CD8+ T cells. These findings demonstrate the preliminary safety, tolerability and manufacturing feasibility of CT-0508 for HER2+ tumors. ClinicalTrials.gov registration: NCT04660929.

https://www.nature.com/articles/s41591-025-03495-z

Carisma and Moderna Expand Collaboration to Develop Two In Vivo CAR-M Therapies for Autoimmune Diseases

https://ir.carismatx.com/news-releases/news-release-details/carisma-and-moderna-expand-collaboration-develop-two-vivo-car-m

data before the market opens on Friday, February 14th. Analysts expect Moderna to post earnings of ($2.86) per share and revenue of $951.09 million for the quarter