axelvento
2 days ago
Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine, Spikevax, in Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 Disease
July 10, 2025
Spikevax is now approved for all adults aged 65 years and older, and individuals aged 6 months through 64 years at increased risk for COVID-19 disease
CAMBRIDGE, MA / ACCESS Newswire / July 10, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax®, the Company's COVID-19 vaccine, in children 6 months through 11 years of age who are at increased risk for COVID-19 disease. The Company's COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under Emergency Use Authorization (EUA).
"COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization," said Stéphane Bancel, Chief Executive Officer of Moderna. "We appreciate the FDA's diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease."
Moderna expects to have its updated Spikevax vaccine available for eligible populations in the U.S. for the 2025-2026 respiratory virus season.
About Moderna
Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.
Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
Spikevax® is a registered trademark of Moderna.
INDICATION
SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine to protect you against COVID-19. SPIKEVAX is for people who are:
65 years of age and older, or
6 months through 64 years of age at high risk for severe COVID-19.
Vaccination with SPIKEVAX may not protect all people who receive the vaccine.
IMPORTANT SAFETY INFORMATION
You or your child should not get SPIKEVAX if you had a severe allergic reaction after a previous dose of SPIKEVAX or any Moderna COVID-19 vaccine or to any ingredient in these vaccines.
What are the risks of SPIKEVAX?
There is a very small chance that SPIKEVAX could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of SPIKEVAX. For this reason, the healthcare provider may ask you or your child to stay for a short time at the place where you or your child received your vaccine. Signs of a severe allergic reaction can include:
Trouble breathing
Swelling of your face and throat
A fast heartbeat
A rash all over your body
Dizziness and weakness
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines. Myocarditis and pericarditis following mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age. You should seek medical attention right away if you or your child has any of the following symptoms after receiving Spikevax, particularly during the 2 weeks after receiving a dose of the vaccine: chest pain, shortness of breath, feelings of having a fast-beating, fluttering, or pounding heart. Additional symptoms in children may include fainting, irritability, poor feeding, lack of energy, vomiting, pain in the abdomen, or cool, pale skin.
Other side effects that have been reported include:
Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection or in the groin, swelling (hardness), and redness
General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, fever, rash, irritability/crying, sleepiness, and loss of appetite.
Fainting and febrile seizures (convulsions during a fever) were also reported
Tell the healthcare provider about all of your or your child's medical conditions, including if you or your child:
have any allergies
had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or on a medicine that affects your immune system
are pregnant or plan to become pregnant
are breastfeeding
have received any other COVID-19 vaccine
have ever fainted in association with an injection
These may not be all the possible side effects of SPIKEVAX. Ask your healthcare provider about any side effects that concern you. You may report side effects to Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov.
https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-Full-U-S--FDA-Approval-for-COVID-19-Vaccine-Spikevax-in-Children-Aged-6-Months-Through-11-Years-at-Increased-Risk-for-COVID-19-Disease/default.aspx
axelvento
2 weeks ago
NHS rolls out 5-minute ‘super-jab’ for 15 cancers
Thousands of patients will benefit from a new cancer jab for more than a dozen types of the disease, with the NHS the first in Europe to offer the new injection.
The health service is rolling out an injectable form of immunotherapy, nivolumab, which means patients can receive their fortnightly or monthly treatment in 5 minutes instead of up to an hour via an IV drip.
The roll-out will save over a year’s worth of treatment time for patients and NHS teams annually – enabling patients to spend less time in hospital while freeing up staff capacity to deliver more appointments and treatments.
The new jab can be used to treat 15 cancer types, including skin cancer, bladder, and oesophagus, and it is estimated around 1,200 patients in England per month could benefit.
This follows approval from the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) today.
In clinical trials, patients were highly satisfied with the under-the-skin injection, which takes 3-5 minutes to administer, and preferred it to the IV form of the drug which takes 30 to 60 minutes every 2 weeks or four weeks, depending on the cancer type.
Around 2 in 5 patients who currently receive IV nivolumab, which is one of the most widely used cancer treatments, should be eligible for the new jab.
NHS staff administering the jab could save around 1,000 hours of treatment time for patients and clinicians every month – the equivalent of more than 1 full year of time annually.
Most eligible new patients are also expected to begin on the injectable form of nivolumab.
NHS cancer services will now be preparing to treat the first patients with the new treatment next month when supplies of the product are received in the UK, helping to free up valuable resources in nursing and pharmacy teams, as well as helping with capacity demands in cancer day units, where the drug is currently administered.
This is the latest in a series of NHS cancer treatment innovations introduced to save patients time and improve access, including the rollout of new injections for breast cancer, multiple sclerosis, and blood disorders.
Professor Peter Johnson, NHS England National Clinical Director for Cancer said: “Immunotherapy has already been a huge step forward for many NHS patients with cancer, and being able to offer it as an injection in minutes means we can make the process far more convenient.
“This treatment is used for 15 different types of the disease, so it will free up thousands of valuable clinicians’ time every year, allowing teams to treat even more patients and helping hospital capacity.
“And this is just the latest development in the NHS’s ongoing commitment to provide patients with the latest cancer therapies and treatment options that truly transform lives”.
Minister for Public Health and Prevention Ashley Dalton said: “Britain is a hotbed of innovation, masterminding the newest tech and medical inventions to help people navigating illness. A new jab that fastens up cancer treatment is a prime example of this, so it’s fantastic to see cancer patients in England will be among the first in Europe to benefit.
“With cancer medicines getting better all the time, this government will ensure that NHS patients are among the first to access the latest treatments and technology.
“Our National Cancer Plan will transform the way we approach this disease, improving care and bringing this country’s cancer survival rates back up to the standards of the best in the world”.
The faster treatment comes at no extra cost to the NHS thanks to an agreement negotiated by NHS England with the manufacturer Bristol Myers Squibb.
James Richardson, Clinical Pharmacist and National Specialty Adviser for Cancer Drugs said: “I am delighted that NHS patients across England will soon be able to benefit from this quicker-to-administer, effective treatment, that can be used to treat a range of cancer types, including skin cancer and solid tumours originating in the kidneys. This is a significant advancement in cancer treatment, with the potential to improve the lives of thousands of patients each month”.
Elizabeth O’Mahony, NHS England Chief Financial Officer said: “This is fantastic news for patients – reducing treatment times from an hour to just minutes is a huge boost for people going through cancer care, helping them to spend less time in hospital.
“It’s also a major win for the NHS, saving the equivalent of a year’s worth of treatment time which can be used to deliver other care, building on the great strides made in the past 6 months, and thanks to a deal struck by NHS England this quick treatment will be available without any additional cost”.
The rollout forms part of NHS England’s 3-pillar approach to delivering the best value from medicines – combining cutting-edge innovations such as a potential cure for sickle cell and life-changing cystic fibrosis drugs; smarter use of biosimilars and generics delivering hundreds of millions in annual savings; and new treatments like this that free up clinical capacity and improve patient experience.
Date published: 30 April, 2025
Date last updated: 30 April, 2025
https://www.england.nhs.uk/2025/04/nhs-rolls-out-5-minute-super-jab-for-15-cancers/
axelvento
2 weeks ago
Moderna Announces Positive Phase 3 Results for Seasonal Influenza Vaccine
mRNA-1010 demonstrated superior relative vaccine efficacy that was 26.6% (95% CI; 16.7%, 35.4%) higher than a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older
today announced positive results from a Phase 3 efficacy study (P304) evaluating the relative vaccine efficacy (rVE) against influenza illness of mRNA-1010, the Company's seasonal influenza (flu) vaccine candidate, compared to a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older. mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol, with an rVE of 26.6% (95% CI; 16.7%, 35.4%) in the overall study population. Additionally, strong rVE was observed for each influenza strain contained in the vaccine, including A/H1N1 (rVE=29.6%), A/H3N2 (rVE=22.2%), and the B/Victoria lineages (rVE=29.1%). Subgroup analyses confirmed a consistently strong rVE point estimate across age groups, risk factors and previous influenza vaccination status. In participants aged 65 years and older, mRNA-1010 demonstrated an rVE of 27.4%.
"Today's strong Phase 3 efficacy results are a significant milestone in our effort to reduce the burden of influenza in older adults. The severity of this past flu season underscores the need for more effective vaccines," said Stéphane Bancel, Chief Executive Officer of Moderna. "An mRNA-based flu vaccine has the potential advantage to more precisely match circulating strains, support rapid response in a future influenza pandemic, and pave the way for COVID-19 combination vaccines."
In a previous Phase 3 study, mRNA-1010 had already demonstrated superior seroconversion rates and geometric mean titer ratios (GMR) against all strains included in the vaccine compared to both high-dose and standard-dose licensed seasonal influenza vaccine. [1]
According to the CDC, seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024-2025 season. [2] More than 600,000 Americans were hospitalized due to flu-related illness last year, leading to substantial direct and indirect costs, as well as widespread disruption to daily life and work. [3]
P304 ( NCT06602024) is a Phase 3, randomized, observer-blind, active-controlled, case-driven, pivotal efficacy, immunogenicity and safety study. The trial enrolled 40,805 adults aged 50 years and older across 11 countries. Participants were randomly assigned to receive either a single dose of mRNA-1010 or a standard-dose licensed comparator, with a median follow-up of six months.
Safety and tolerability of mRNA-1010 were consistent with reported results from a previous Phase 3 study. [4] The majority of solicited adverse reactions (SARs) were mild. Injection site pain was the most common local SAR, and fatigue, headache and myalgia were the most common systemic SARs reported. There were no significant differences between the groups in the rates of unsolicited adverse events, serious adverse events, or adverse events of special interest.
Moderna plans to present these data at an upcoming medical conference and submit for peer-reviewed publication. The Company will engage with regulators on filing submissions for mRNA-1010.
https://news.modernatx.com/news/news-details/2025/Moderna-Announces-Positive-Phase-3-Results-for-Seasonal-Influenza-Vaccine/default.aspx
dstock07734
1 month ago
See the roundtable participants? Can you find anyone working on mRNA stuff? I can find several of them who are familiar with DC vaccine.
https://www.fda.gov/vaccines-blood-biologics/workshops-meetings-conferences-biologics/cell-and-gene-therapy-roundtable-06052025
FDA Cell and Gene Therapy Roundtable
June 5, 2025
Roundtable Participants
Jeff Allen, PhD
Present and CEO
Friends of Cancer Research
Ron Bartek
Co-founder and President
Friedreich's Ataxia Research Alliance
Allyson Berent, DVM, DACVIM
Chief Scientific Officer
Foundation for Angelman Syndrome Therapeutics
Co-Director
Angelman Syndrome Biomarker and Outcome Measure
Catherine Bollard, MBChB, MD
Senior Vice President and Chief Research Officer
Director, Center for Cancer and Immunology Research
Professor of Pediatrics and Immunology
Children's National and The George Washington University
Thomas Cahill, MD, PhD
Founder and Managing Partner
Newpath Partners
Andrew M. Cameron MD, PhD
Director
Department of Surgery
The Johns Hopkins University School of Medicine
Paula Cannon, PhD
Distinguished Professor of Microbiology and Immunology
Keck School of Medicine
University of Southern California
Terence R. Flotte, MD
Professor, Provost, Dean of UMass Chan Medical School
President, American Society of Gene and Cell Therapy
Charles A. Gersbach, PhD
John W. Strohbehn Distinguished Professor
Department of Biomedical Engineering
Director, Center for Advanced Genomic Technologies
Duke University
Bambi Grilley, RPh, CCRC, CCRP, CIP, RAC
Director, Clinical Research and Early Product Development
Center for Cell and Gene Therapy
Professor, Pediatrics
Baylor College of Medicine
Chief Regulatory Officer
International Society for Cell & Gene Therapy
Timothy Hunt, JD
Chief Executive Officer
Alliance for Regenerative Medicine
Carl H. June, MD
Richard W. Vague Professor in Immunotherapy
Department of Pathology and Laboratory Medicine
Director Center for Cellular Immunotherapies
Director, Parker Institute for Cancer Immunotherapy
Perelman School of Medicine
University of Pennsylvania
Smilow Center for Translational Research
Donald B. Kohn, MD
Distinguished Professor:
- Microbiology, Immunology and Molecular Genetics
- Pediatrics, Hematology/Oncology
- Molecular and Medical Pharmacology
University of California, Los Angeles
Brett Kopelan, MA
Executive Director
The Dystrophic Epidermolysis Bullosa Research Association of America
David Liu, PhD
Richard Merkin Professor and Director of the Merkin Institute for Transformative Technologies in Healthcare
Director of the Chemical Biology and Therapeutic Sciences Program
Core Institute Member and Vice-Chair of the Faculty, Broad Institute
Investigator, Howard Hughes Medical Institute
Thomas Dudley Cabot Professor of the Natural Sciences and Professor of Chemistry & Chemical Biology, Harvard University
Jayme Locke MD, MPH
Vice President, Medical Development Xenotransplantation
United Therapeutics
Crystal Mackall, MD
Ernest and Amelia Gallo Family Professor of Pediatrics and Medicine
Founding Director, Stanford Center for Cancer Cell Therapy
Director of the Parker Institute for Cancer Immunotherapy
Stanford University
Rachel McMinn, PhD
Founder and CEO
Neurogene
Sean J. Morrison, PhD
Investigator, Howard Hughes Medical Institute
Director, Children's Research Institute at UT Southwestern
University of Texas Southwestern Medical Center
Dallas, Texas
Chair of Public Policy Committee
International Society for Stem Cell Research
Terry Pirovolakis
CEO & Founder
Elpida Therapeutics
Vinayak Prasad, MD, MPH
Director
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
Michelle Rengarajan, MD, PhD
Physician-Scientist and Attending Endocrinologist
Massachusetts General Hospital
Instructor in Medicine
Harvard Medical School
Shengdar Q. Tsai, PhD
Associate Member, Department of Hematology, St. Jude Children's Research Hospital
Co-chair, Steering Committee of NIH Somatic Cell Genome Editing Consortium
Fyodor Urnov, PhD
Professor of Molecular Therapeutics at University of California, Berkeley
Scientific Director at Innovative Genomics Institute
Nicole Verdun, MD
Super Office Director
Office of Therapeutic Products
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
jondoeuk
1 month ago
Tumors don't have chance to adapt if DCs can present hundreds of tumor-associated antigens to immune system.
Cancer cells can mutate in real time to evade treatment as well [1,2]. In this, 17% innately have HLA LOH [3], but other papers put it (much) higher.
Also, many TAAs are self-antigens. As a result of negative selection, to prevent autoimmunity, any T-cell that is able to target a TAA will express a TCR with a low affinity. But TCRs with high affinity (for TAAs) are required for efficient antitumour immunity [4]. This is why ADAP (and other companies) do what they do.
The current issue is that with massive t-cell infiltration into tumor site comes tumor-associated macropahges which can be depleted by CSF1R inhibitor.
CD163hi macrophages are resistant to CSF-1(R) targeted therapies, and drive both primary and secondary immune resistance. We know that clinical trials testing CSF-1(R) targeted therapies have shown poor results to date, and that CSF-1R+ macrophages can be positively associated with response [5].
The CD163hi macrophage issue is so minor in comparison of massive and sustainable t-cell infiltration triggered by DCVax-L.
High frequency of CD163hi macrophages correlates with higher risk of relapse, predicts poor response to ICI, and poor survival across different (sub)types of cancer.
CD163hi macrophages were also infiltrating two progressing lesions in the patient I talked after she received tens of billions of TCR-T cells (plus an anti-PD-1).
Refs:
1 https://www.nejm.org/doi/full/10.1056/NEJMoa1609279
2 https://aacrjournals.org/cancerimmunolres/article/10/8/932/707173/Adoptive-Cellular-Therapy-with-Autologous-Tumor
3 https://aacrjournals.org/cancerdiscovery/article/11/2/282/2772/Somatic-HLA-Class-I-Loss-Is-a-Widespread-Mechanism
4 https://academic.oup.com/cei/article/180/2/255/6422173
5 https://jitc.bmj.com/content/10/5/e003890
jondoeuk
1 month ago
You should know that CD163 only accounts for small population and they cannot suppress massive number of t-cells.
Based on the literature CD163hi macrophages are able to suppress T-cells.
In this paper, two HLA-matched patients with metastatic pancreatic ductal adenocarcinoma were treated with a TCR-T cell therapy (the TCRs came from a patient who responded to TIL therapy) [1].
In one patient, who had lung mets only, experienced a durable partial response after receiving 16.2 billion TCR-T cells. Looking into why therapy was more successful, one reason was due to the phenotype of the T-cells (CD45RO+CD103+CD69+CD49a+, so memory and tissue-resident).
However, after about a year, she showed slow progression. Dr. Tran has gone on to give more info at different medical/scientific conferences. She got a second infusion of TCR-T cells (that were more potent) plus an anti-PD-1. Looking at efficacy, at three months she had stable disease (~25% reduction by RECIST) and a six month scan showed stable disease as well. There were regressions of some lesions, but when comparing the scans (three months vs. six months) there was some growth in other lesions. At time they were thinking about the next steps.
Looking at two progressing lesions, the first genetically expressed the HLA and targeted antigen. It contained transduced T-cells as well, with the cells preferentially expressing TIM3, TIGIT, CD25 and IL7RA, suggestive of antigen encounter. It also displayed a high infiltration of non-transduced T-cells and CD163hi macrophages, often intimately co-localised with each other, both with the transduced and non-transduced T-cells.
As for the second progressing lesion (smaller), it contained a neutrophil infiltrate as well as CD163hi macrophages. Based on this, they are trying to further characterise what (neo)antigens might be recognised by the non-transduced T-cells in one of the progressing lesions. In addition, undertaking single-cell transcriptomics of infusion products and peripheral blood samples, and deeper molecular studies on tumour sections.
Merck makes the collaboration with Moderna look so real just like Merck signed the deal with Daiichi on three ADCs.
The first deal was in 2016. Under the terms of the agreement, MRK made an upfront cash payment to MRNA of $200 million. That was expanded in 2017 and amended in 2018, before MRK exercised its option to jointly develop and commercialise MRNA's vaccine in 2022. For the latter, MRK paid MRNA $250 million upfront. Now additional trials are planned.
Targeting for several neoantigens may have efficacy for a certain percentage of hot tumors.
MRNA's vaccine encodes up to 34 patient-specific neoantigens.
But it lacks of efficacy in treating cold tumors.
Autogene cevumeran (which encodes up to 20 patient-specific neoantigens), jointly developed by BNTX and RHHBY's Genentech, continues to show poly-specific T-cell responses and delayed tumour recurrence in patients with resected pancreatic ductal adenocarcinoma [2].
Based on the data, a randomised PhII trial is ongoing. Other randomised PhII trials, including in adjuvant CRC are ongoing as well.
If I am not mistaken, the trials between Merck and Moderna only target hot tumor.
So far, but MRNA's CEO has talked about testing the vaccine in ''cold'' tumours, including resected pancreatic ductal adenocarcinoma.
Refs:
1 https://www.nejm.org/doi/full/10.1056/NEJMoa2119662
2 https://www.nature.com/articles/s41586-024-08508-4
axelvento
1 month ago
On May 14, 2025 - Merck & Co., Inc. filed a 13F-HR form disclosing ownership of 2,308,190 shares of Moderna, Inc. (US:MRNA) valued at $65,437,186 USD as of March 31, 2025. The entity filed a previous 13F-HR on February 14, 2025 disclosing 2,308,190 shares of Moderna, Inc.. This represents a change in shares of 0.00% during the quarter. The current value of the position is $61,305,526 USD.
https://fintel.io/so/us/mrna/merck
it's written on the wall
News
Market Data
Customized watchlists with full streaming quotes from leading exchanges, such as NASDAQ, NYSE, AMEX, OTC Markets Small-Cap, LSE and more.
Vexari
1 week ago
BottomBounce
2 weeks ago
