All articles tagged with #mrna
The FDA has agreed to review Moderna’s experimental mRNA flu vaccine after previously declining to file, with a decision due by August 5; Moderna seeks full approval for adults 50–64 and accelerated approval for 65+, contingent on a post‑marketing study, amid broader regulatory shifts and debate over vaccine oversight.
The FDA will review Moderna’s newly developed mRNA seasonal flu vaccine after a prior rejection over trial design, with no safety or efficacy concerns cited. Moderna says it has met with the FDA and proposed a revised regulatory pathway, seeking full approval for adults 50–64 and accelerated approval for 65+, potentially making the vaccine available for those 50+ in the 2026–2027 flu season if approved.
The FDA reversed its earlier decision and will review Moderna’s new mRNA flu vaccine for adults 50 and older, using a standard pathway for ages 50–64 and accelerated approval for those 65+, with a required post‑marketing study and a target review date of August 5.
Moderna’s mRNA influenza vaccine was not even considered by the FDA after a “refuse to file” ruling, despite earlier signals that its trial design was acceptable. The decision is described as coming from Vinay Prasad, an FDA appointee aligned with RFK Jr., who overruled career staff, signaling a broader shift under Kennedy’s leadership away from standard scientific processes. The piece warns this regulatory pivot could deter vaccine investment, undermine pandemic preparedness, and slow the development of future mRNA vaccines.
The FDA declined to review Moderna’s experimental mRNA flu vaccine, citing an allegedly inadequate trial design for adults 65 and older that used a standard-dose control instead of a high-dose option, prompting critics to allege an anti-vaccine agenda and a chilling effect on vaccine development; Moderna and its supporters argue the design was approved and that higher-dose controls should have informed the analysis.
MIT/Harvard researchers reprogrammed cellular vaults to bind and preserve mRNA, turning them into a living time capsule that records a cell’s gene-expression changes during stress and treatment, enabling retrospective insights without destroying the cell.
MIT researchers demonstrated in aging mice that delivering mRNA encoding key immune-signaling pathways causes the liver to transiently manufacture factors that boost thymus-driven T-cell production. This rejuvenation improved immune responses to vaccines and cancer immunotherapy with minimal side effects, and slowed tumor progression in treated mice. The therapy has not been tested in humans and would require ongoing injections to maintain benefits, but it represents a potential approach to counteract age-related immune decline and possibly broader aging processes.
Moderna and Merck report promising results for a patient-tailored mRNA cancer vaccine paired with Keytruda in high-risk melanoma. The vaccine, designed from a patient’s tumor mutations (neoantigens), reduced recurrence or death by 49% versus immunotherapy alone and demonstrated durable immune memory over five years, signaling a potential breakthrough for personalized cancer vaccines and future skin-cancer prevention.
Moderna shares rose about 10% after Phase 2 data showed its cancer vaccine, when combined with Keytruda, reduced relapse or death risk in melanoma, signaling potential for its oncology pipeline as Covid-era vaccine sales fade and cash stockpiles dwindle. Evercore ISI called the asset a key value driver, while the stock remains rated a Hold by analysts with notable downside risk baked into targets.
In a Phase 2 trial of 157 high‑risk stage 3/4 melanoma patients, Moderna and Merck’s personalized mRNA vaccine (mRNA-4157) plus Keytruda reduced recurrence or death at five years by about 49% versus Keytruda alone. Earlier two- and three-year data showed similar risk reductions (44% and 49%). Safety was similar between groups, with fatigue, injection-site pain, and chills most common. Full data aren’t yet published; a Phase 3 trial is underway and more data from this program are expected.
An experimental, tumor-genome–targeted mRNA therapy developed by Moderna and Merck, when combined with Keytruda, reduced the risk of melanoma recurrence or death in an ongoing clinical trial, signaling a potential new precision approach for aggressive skin cancer.
A mouse study demonstrates that an experimental mRNA treatment can rejuvenate immune cells, specifically T cells, potentially improving immune response in aging, but further research is needed to assess its applicability in humans.
A Stanford study highlights a rare risk of myocarditis, or heart inflammation, associated with mRNA Covid-19 vaccines, especially in young men and children, with an estimated occurrence of 1 in 140,000 after the first dose and 1 in 32,000 after the second. While most recover quickly, the study emphasizes that Covid itself is more likely to cause myocarditis than the vaccine, and advises seeking medical help if chest pains occur post-vaccination.
MIT researchers have identified potential new targets for a tuberculosis vaccine by screening bacterial proteins and testing immune responses, aiming to develop a more effective vaccine than the current BCG, with promising results from mRNA vaccine experiments in human cells.
The article discusses the revolutionary potential of mRNA technology for treating cancer, genetic diseases, and autoimmune conditions, highlighting how US federal policies are currently hindering its development and application, risking a setback in biomedical innovation and international competitiveness.