All articles tagged with #mrna vaccine
The Washington Post profiles Mark Orwig and other melanoma patients in a Moderna/M Merck trial testing an mRNA-based cancer vaccine. Early results suggest the vaccine could prevent cancer recurrence after surgery, a finding experts say could transform cancer care and accelerate FDA approval, despite participants experiencing side effects and a tough recovery.
The FDA approved Moderna’s mFLUSIVA (mRNA-1010), the first mRNA-based seasonal flu vaccine, for adults 50 and older, based on phase 3 data showing superior protection against flu-like illness versus standard vaccines; accelerated approval for 65+, with post‑approval confirmatory data required. The vaccine can be produced more quickly to better match evolving influenza strains, potentially adding an important option without replacing existing vaccines; common vaccine side effects apply, and availability is anticipated for the 2026–2027 season.
Moderna and Merck reported Phase 3 results for intismeran autogene (a personalized mRNA cancer vaccine) combined with Keytruda in high-risk melanoma patients after surgery, showing longer recurrence-free and metastasis-free survival versus Keytruda alone; safety was consistent with prior data. If confirmed, the vaccine could reshape cancer prevention and treatment and bolster mRNA vaccine credibility, but overall survival results and external validation are still pending.
Moderna and Merck report that adding the patient-specific mRNA cancer vaccine intismeran (mRNA-4157) to Merck’s Keytruda significantly extended recurrence-free and distant metastasis-free survival versus Keytruda alone in a Phase 3 trial of 1,137 melanoma patients. Interim results suggest meaningful benefit, with mature overall-survival data still pending; five-year Phase 2 data had previously shown substantial risk reductions. Full details will be presented at an upcoming conference.
Moderna and Merck report interim Phase 3 results suggesting their personalized mRNA cancer vaccine Intismeran, used with Keytruda after melanoma surgery, may delay cancer recurrence in high-risk patients; data have not yet been peer‑reviewed and will be presented at a medical meeting and shared with regulators as the trial continues to assess overall survival.
FDA approves Moderna’s mRNA-based flu vaccine, mFlusiva, for adults 50 and older (standard approval for ages 50–64 and accelerated approval for 65+), leveraging faster manufacturing to allow strain updates closer to the season. In a large trial, it was about 27% more effective than standard flu shots in people over 50 but had more mild to moderate side effects; serious events were similar to other vaccines. A post-marketing study is required, and availability may be limited this fall while a CDC recommendation is pending due to a delay in the ACIP meeting. Insurance coverage remains uncertain until guidelines are issued. The vaccine could be a valuable option for an older population at higher risk of severe flu outcomes.
FDA approves Moderna’s mFlusiva, the first mRNA-based flu vaccine, for adults 50+, with standard approval for 50–64 and accelerated approval for 65+, enabling faster production and closer strain matching; in a 40,000+ participant trial it was about 27% more effective than standard vaccines for ages 50+, though with more transient side effects; a post-marketing study is required, rollout may be limited this fall, and insurance coverage remains unclear until ACIP weighs in (scheduled for October).
The FDA approved Moderna’s mRNA flu vaccine, mFLUSIVA, for adults 50–64 and gave accelerated approval for adults 65+, with the potential to rapidly reformulate to match circulating influenza strains. In trials, it showed a 26.6% relative reduction in lab-confirmed flu versus standard vaccines and was generally well tolerated, though side effects were more common. Regulators in the EU, Canada, and Australia are reviewing similar uses, and a Phase IV trial is planned to assess efficacy against an enhanced 65+ vaccine. Separately, Europe has approved a combined influenza and COVID-19 mRNA vaccine (mCombriax). Experts say the technology could improve responsiveness to evolving flu strains and ease manufacturing bottlenecks, but real-world effectiveness will determine its ultimate impact.
Regulators approved Moderna’s mFlusiva, a new mRNA flu vaccine, for adults 50 to 64 (fully) and 65+ (accelerated) after trials showed about 27% greater effectiveness than standard flu shots; the vaccine, available this fall, uses mRNA technology to allow faster production and potential yearly updates to match circulating strains, though side effects may be stronger than traditional vaccines; if you’re eligible, get whichever flu shot is available to start protection early in the season.
FDA approval grants Moderna’s mRNA influenza shot, mFLUSIVA (mRNA-1010), for adults 50 and up, marking the first mRNA flu vaccine and following a unanimous June advisory panel vote citing strong efficacy and safety in about 44,000 people. The path to approval was politically tense due to anti-vaccine motivations within the Kennedy administration, and questions remain about ACIP recommendations, coverage, and near-term sales expectations, with Moderna aiming for the 2026–27 season.
A phase 1 trial by Oxford and Moderna is testing an mRNA vaccine (INTERCEPT – Lynch) designed to help the immune system identify and eliminate very early cancer changes in people with Lynch syndrome, potentially shifting care from treatment to prevention; the first participant, Sarah Ewart, marks a step toward validating safety and immune response with a plan to move to phase 2 across UK centres if successful.
CEPI pledged over $60 million to accelerate Bundibugyo ebolavirus vaccine development, including up to $50 million to Moderna for preclinical work and early-stage trials of an mRNA BDBV vaccine and to ramp up manufacturing for larger Phase 2/3 testing; other funds go to IAVI and the Oxford/Serum Institute effort. No licensed vaccines exist for Bundibugyo yet, and the current DRC outbreak has about 1,041 cases and 241 deaths as reported by the WHO.
Researchers describe a trio of advances against pancreatic cancer: a drug targeting a key cancer-driving gene, a personalized mRNA vaccine, and an AI imaging tool that can flag cancer years earlier than typical diagnoses. A Mayo Clinic study suggests the AI system could detect pancreatic cancer up to three years before diagnosis, with about 85% overall accuracy and sensitivity higher than radiologists in earlier scans. While promising, experts caution that such tools must be applied to high‑risk populations to avoid false positives and that more work is needed before broad clinical adoption.
At the AACR meeting, researchers report a phase 1 trial of a patient-specific mRNA vaccine for pancreatic cancer, made from each patient's tumor material after surgery and used with immunotherapy and chemotherapy. Eight patients showed immune responses, and seven of these responders were alive up to six years post-surgery, with about 90% of responders remaining alive at follow-up. While promising, the findings come from a small early trial, and a global phase 2 study is now underway to assess broader efficacy.
A small Phase 1 trial of personalized mRNA vaccines given after surgical removal of operable pancreatic cancer and standard chemo shows that after nine doses, several patients mounted a durable T-cell–driven immune response. Six years of follow-up indicate that some responders remain alive and cancer-free, suggesting potential long-term benefit, though the results are early and come from a limited group as researchers move to a larger Phase 2 study.