First mRNA‑based flu vaccine wins US approval, Moderna’s Ebola candidate reaches the clinic, and early‑phase cancer vaccine trials broaden across personalized and off‑the‑shelf platforms

Moderna's mRNA Ebola candidate entered its first human trial [1]

The vaccine candidate, mRNA-1469, applies the same lipid nanoparticle-delivered messenger RNA platform used in Moderna's COVID-19 and RSV vaccines to Bundibugyo ebolavirus (BDBV), the strain driving the outbreak in the Democratic Republic of the Congo. Following Health Canada's authorization, the first participants have been vaccinated in a first-in-human study conducted at three Canadian sites, which is expected to enroll approximately 80 healthy adults to assess safety, tolerability, and immunogenicity. No licensed vaccine exists against BDBV, although vaccines are approved against Zaire ebolavirus. The program is supported by the Coalition for Epidemic Preparedness Innovations, which has committed up to $50 million toward preclinical work, the trial, and expanded manufacturing of clinical doses.

A new site database aims to accelerate African-led Ebola vaccine trials [2]

Forty-five clinical trial units across 17 African countries were profiled in a new resource published jointly by Africa CDC and the Coalition for Epidemic Preparedness Innovations, intended to help vaccine developers identify experienced sites for future Bundibugyo ebolavirus studies. The announcement coincided with the initiation of Moderna's Phase 1 trial and reflects continued efforts to build regional clinical research capacity following prior Ebola outbreaks. The initiative is intended to shorten site-selection timelines as candidate vaccines, including programs from Moderna and the University of Oxford, progress toward larger trials in affected regions.

A colorized transmission electron micrograph of an Ebola virus virion; Pandemic & Global Health. Credit: CDC Museum.

Declining coverage left the Americas vulnerable to a resurgent measles threat [3]

As of mid-July 2026, countries across the Americas had reported 47,459 confirmed measles cases, the highest total in 22 years and more than three times the 15,011 cases recorded for all of 2025. Guatemala, Mexico, the United States, and Peru account for 95% of this year's cases, with 44 deaths reported across three countries. The Pan American Health Organization classified the associated public health risk as very high, citing ongoing outbreaks, suboptimal vaccination coverage, and population mobility linked to international travel and mass gatherings. The region lost its measles elimination status in 2025, and PAHO called on member states to raise two-dose vaccine coverage to at least 95% and strengthen surveillance to help restore it.

A UK antenatal RSV vaccine drove a sharp fall in infant intensive care admissions [4]

The vaccine, offered to pregnant women from 28 weeks of gestation, transfers protective antibodies to the fetus ahead of birth, reducing severe respiratory syncytial virus (RSV) disease in infants during the early months of life. In its first annual report on the program, the UK Health Security Agency found that infants under six months admitted to intensive or high-dependency care with confirmed RSV infection fell from 131 during the 2024-25 winter season to 63 during 2025-26, a 50% reduction, across the 20 NHS trusts included in its sentinel surveillance system. Between March 2025 and February 2026, 61.7% of women giving birth in England had received the vaccine.

A new financing deal aims to establish Africa's first fully domestic cholera vaccine supply chain [5]

Africa currently imports more than 99% of the vaccines it uses, a gap the African Development Bank Group is helping to address with a loan of up to $15 million to Biovac, South Africa's national vaccine manufacturer. The financing will support a new multi-vaccine facility in Cape Town, expected to triple Biovac's annual production capacity to 500 million doses by 2028 and to become the continent's first end-to-end producer of oral cholera vaccine, before adding polio, pneumococcal, and meningococcal vaccines to its output. The Bank joins a wider syndicate of development finance institutions led by the International Finance Corporation backing the project.

A KRAS-targeted vaccine advanced the case for intercepting pancreatic cancer before it develops [6]

Mutant KRAS drives more than 90% of pancreatic ductal adenocarcinoma cases, making it a target for strategies to intercept the disease before it develops. In a Phase 1 trial published in Cancer Discovery, researchers at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins vaccinated 20 individuals with a hereditary predisposition to pancreatic cancer and a pancreatic lesion on imaging, using mKRAS-VAX, an off-the-shelf long-peptide vaccine targeting six common KRAS mutations. The vaccine was safe and generated mutant-KRAS-specific T cell responses in 90% of participants, detectable in blood for up to two years. The researchers have since opened a follow-up study in patients with high-risk pancreatic cysts undergoing surgical resection to examine whether vaccine-induced immune cells reach precancerous tissue.

A researcher examines a sample under a light microscope; Therapeutic Vaccines. Credit: Pexels.

A synthetic DNA manufacturing platform reached the clinic in a lung cancer vaccine trial [7]

Touchlight's doggybone DNA (dbDNA) format is produced through an enzymatic, cell-free process rather than conventional bacterial fermentation, which the company says can produce clinical-grade DNA in weeks rather than months. That platform has now been used to manufacture a personalized vaccine, matched to a patient's individual tumor mutations, for the first UK patient dosed in NEOVACC, a ten-patient trial led by the Clatterbridge Cancer Centre and the University of Liverpool. The vaccine is being added to standard immunotherapy in patients with advanced lung cancer whose disease has only partially responded to treatment, with the study assessing safety and whether the vaccine can generate an antitumor immune response.

An off-the-shelf cancer vaccine was tested for the first time before surgery rather than after [8]

Infinitopes dosed the first patient in VISTA, a randomized, placebo-controlled Phase 1/2a trial testing its off-the-shelf cancer vaccine candidate, ITOP1, in patients with newly diagnosed, surgically resectable esophageal and gastroesophageal junction adenocarcinoma. ITOP1 was developed using the company's Precision Immunomics platform, which identifies tumor antigens naturally presented by cancer cells and delivers them using engineered viral vectors designed to generate durable T cell responses. Unlike earlier therapeutic vaccine approaches that dose patients only after surgery, VISTA administers ITOP1 alongside standard neoadjuvant chemo-immunotherapy while the tumor remains in place, testing whether earlier immune priming can generate a stronger antitumor response than waiting until after the tumor is removed.

Moderna expanded its oncology pipeline with a shared-antigen approach to solid tumors [9]

Unlike the patient-specific neoantigen approach used in Moderna's personalized cancer vaccine programs, mRNA-4200 encodes seven tumor antigens shared across patients, identified using target-discovery and AI platforms developed by Immatics, rather than antigens unique to each individual's tumor. The first participant has now received the candidate in an open-label, multicenter Phase 1 trial, administered alongside checkpoint inhibitor therapy in patients with advanced or metastatic solid tumors. The study will assess safety, tolerability, and preliminary antitumor activity; mRNA-4200 is Moderna's third off-the-shelf cancer antigen therapy candidate developed under its collaboration with Immatics.

A cancer vaccine candidate entered testing in triple-negative breast cancer [10]

Triple-negative breast cancer (TNBC) lacks the hormone receptor and HER2 targets exploited by many other breast cancer therapies. ITI-5000, Immunomic Therapeutics' investigational vaccine candidate for the subtype, combines the company's UNITE platform with self-amplifying RNA (saRNA) technology to target CT83 and HERV-K, two tumor antigens expressed in TNBC. VITALITI, a first-in-human, multicenter, open-label Phase 1 trial evaluating the vaccine's safety, tolerability, and initial immunological activity in patients with stage 2-3 disease, has now dosed its first patient; no significant adverse events had been observed as of the initial post-dose monitoring period.

The first mRNA-based influenza vaccine won US approval [11]

In the Phase 3 FLUENT trial of 40,805 participants, Moderna's mRNA-1010 showed 26.6% relative vaccine efficacy against laboratory-confirmed influenza-like illness compared with a standard-dose comparator, data that supported full US FDA approval of the vaccine, branded mFLUSIVA, for adults 50-64 years. Adults 65 years and older received accelerated approval based on immunogenicity data, contingent on a confirmatory post-marketing study. The clearance follows a unanimous recommendation from the FDA's Vaccines and Related Biological Products Advisory Committee and an earlier refusal-to-file dispute over the trial's comparator selection, and it marks the first mRNA-based influenza vaccine licensed in the United States.

Vaccine vials and a syringe; Regulation and Policy. Credit: Pexels.

A six-valent Lyme disease vaccine moved a step closer to European approval [12]

In the Phase 3 VALOR trial, PF-07307405, the investigational vaccine co-developed by Pfizer and Valneva, showed more than 70% efficacy against confirmed Lyme disease from 28 days after a fourth dose. The European Medicines Agency has now validated the vaccine's marketing authorization application, confirming the submission is complete enough for formal scientific review to begin. The six-valent protein subunit vaccine targets outer surface protein A across six serotypes of Borrelia burgdorferi. No vaccine is currently approved for Lyme disease, which is diagnosed in an estimated 476,000 people annually in the United States and around 130,000 in Europe.

Europe extended mpox vaccine protection to younger children [13]

Bavarian Nordic's MVA-BN mpox and smallpox vaccine, previously authorized in the European Union only for individuals aged 12 years and older, gained clearance for children as young as 2 following a Phase 2 study of 227 children aged 2-11 and 224 adults, which found a non-inferior, and in some measures higher, immune response in children alongside a safety profile comparable to adults. The extension is intended to support outbreak response in regions where children represent a substantial share of mpox cases and face a higher risk of severe disease. MVA-BN, marketed in the European Union as Imvanex, remains the only mpox vaccine approved for use in the region.

EU regulators cleared a meningococcal vaccine for use shortly after birth [14]

Invasive meningococcal disease caused by serogroups A, C, W, and Y can progress from first symptoms to death within 24 h, posing particular risk to infants in the weeks before other routine vaccinations are completed. The European Commission approved an extension of Sanofi's MenQuadfi, a quadrivalent meningococcal conjugate vaccine previously authorized in the EU only for individuals aged 12 months and older, to infants from six weeks of age. The expanded indication follows a CHMP positive opinion in June 2026 and is supported by the Phase 3 MET58 study, which evaluated the vaccine's immunogenicity, safety, and tolerability in more than 6,000 infants across 11 countries.

A Chinese biotech's mpox vaccine candidate cleared its first US regulatory hurdle [15]

SYS6037, an mRNA-based mpox vaccine candidate that CSPC Pharmaceutical Group co-developed with the Institute of Microbiology at the Chinese Academy of Sciences, uses a single mRNA strand to encode multiple mpox antigens, a design intended to simplify manufacturing and quality control. In preclinical studies, the candidate showed stronger immunogenicity and protective efficacy than a live-attenuated Tiantan-strain vaccine, along with broad cross-reactivity against other orthopoxvirus antigens. The US FDA has now approved a clinical trial application for SYS6037, permitting CSPC to begin early-phase testing in the United States; details of the planned trial design, including dosing and target population, were not disclosed.

China approved a manufacturing shift away from animal-derived serum in rabies vaccine production [16]

SINOVAC's newly approved rabies vaccine, produced using a serum-free, animal-origin-free Vero cell process, became China's first such product approved for both the conventional five-dose regimen and the WHO-recommended four-dose 'abridged' schedule for post-exposure prophylaxis, which can complete the primary vaccination course in as little as 14 days. China's National Medical Products Administration granted marketing approval on August 4, 2026. Removing animal-derived serum from manufacturing can lower the risk of adventitious agent contamination and improve batch-to-batch consistency compared with legacy methods, and the company plans to seek WHO prequalification for the product.

A bottleneck-easing approach to virus-like particle manufacturing gained NIH backing [17]

Virus-like particle (VLP) platforms already underpin approved vaccines against hepatitis B, malaria, and HPV, but most are produced in yeast using conventional batch systems in which cell disruption and recovery represent the dominant cost component of commercial manufacturing. Sunflower Therapeutics received a $2 million, two-year Phase 2 Small Business Innovation Research award from the National Institute of Allergy and Infectious Diseases, part of the NIH, to build on earlier Phase 1 work and develop a fully continuous cell disruption platform intended to simplify VLP recovery at commercial scale. The company said the technology is designed to reduce the high costs that have limited global access to VLP-based vaccines, particularly in the Global South.

Ashling Cannon, Commissioning Editor of Vaccine Insights, works with leading scientists and industry experts to develop high-impact, open-access content across vaccine R&D and manufacturing. She holds a BSc (Hons) in Biological Sciences and an MSc in Wild Animal Biology, with experience in biotechnology and clinical research publishing across journals and books.

References

1. Moderna. Moderna announces initiation of Phase 1 clinical trial of mRNA-1469, Moderna's investigational vaccine against Bundibugyo ebolavirus. Aug 4, 2026.

2. Africa Centres for Disease Control and Prevention (Africa CDC); Coalition for Epidemic Preparedness Innovations (CEPI). African institutions' readiness to conduct Phase 1 Bundibugyo vaccine trials. Aug 5, 2026.

3. Pan American Health Organization. PAHO urges countries to strengthen vaccination and surveillance amid rising measles cases in the Americas. Aug 9, 2026.

4. UK Health Security Agency. Surveillance of respiratory syncytial virus: winter 2025 to 2026 annual report. Aug 13, 2026.

5. African Development Bank Group. South Africa: African Development Bank and Biovac sign $15 million agreement to advance Africa's first end-to-end cholera vaccine production. Jul 24, 2026.

6. Haldar SD, Huff AL, Wang HH, et al. First-in-human testing of a mutant KRAS vaccine for pancreatic cancer interception in high-risk cohorts. Cancer Discov. 2026; Epub ahead of print. https://doi.org/10.1158/2159-8290.CD-25-2245.

7. Touchlight. Touchlight's Doggybone DNA (dbDNA) technology enables first UK patient dosing in pioneering personalized lung cancer vaccine trial. Jul 30, 2026.

8. Infinitopes. Infinitopes doses first patient with precision off-the-shelf therapeutic cancer vaccine ITOP1. Jul 23, 2026.

9. Moderna. Moderna announces first participant dosed in Phase 1 clinical trial evaluating investigational tumor-targeted cancer antigen therapy in solid tumors. Jul 16, 2026.

10. Immunomic Therapeutics. Immunomic Therapeutics announces first patient dosed in Phase 1 trial of cancer vaccine candidate ITI-5000. Jul 20, 2026.

11. Moderna. Moderna receives US FDA approval for influenza vaccine mFLUSIVA. Aug 5, 2026.

12. Pfizer; Valneva. Pfizer and Valneva's Lyme disease vaccine candidate marketing authorization application validated by European Medicines Agency. Aug 14, 2026.

13. Bavarian Nordic. Bavarian Nordic receives European Commission approval of mpox/smallpox vaccine for children aged 2 to less than 12 years. Aug 7, 2026.

14. Sanofi. Sanofi's MenQuadfi approved in the EU for use in infants from age six weeks against invasive meningococcal disease. Aug 4, 2026.

15. CSPC Pharmaceutical. CSPC Pharmaceutical Group - SYS6037 injection (mpox mRNA vaccine) obtains clinical trial approval in the US. Aug 10, 2026.

16. SINOVAC. SINOVAC receives NMPA approval for serum-free rabies vaccine for human use. Aug 6, 2026.

17. Sunflower Therapeutics. Sunflower Therapeutics receives Phase 2 NIH SBIR funding to pioneer continuous cell disruption for commercial scale VLP biomanufacturing. Aug 4, 2026.