This week’s Vaccines update highlights combination respiratory vaccine data, late-stage pneumococcal program advancement, TB cohort expansion, EU-backed influenza innovation, safety surveillance findings, and regional rollout and first-in-human momentum across diverse immunization strategies.
In Today’s Newsletter
Dive deeper
🧬 Moderna combo flu–COVID-19 vaccine mRNA-1073 shows Phase 1/2 promise [1] [23 Feb 2026]
Context: Phase 1/2 trial in 550 healthy adults (18–75), follow-up reported through 6 months.
Key point: mRNA-1073 (seasonal influenza + COVID-19 antigens) showed acceptable safety/reactogenicity and antibody responses across matched strains (endpoint specifics beyond immunogenicity not stated).
Implication: May influence prescriber choice and payer reviews pending full data.
🫁 IAVI expands MTBVAC IMAGINE Phase 2b with IGRA-negative cohort [2] [Africa • 23 Feb 2026]
Context: IMAGINE Phase 2b, new cohort plans 1,200 IGRA-negative participants across South Africa, Kenya, Tanzania (plus an IGRA-positive cohort targeting 4,300).
Key point: IAVI said first vaccination occurred in the new IGRA-negative cohort, intended to broaden safety and immunogenicity data for MTBVAC (efficacy not powered in IGRA-negative cohort).
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 EuBiologics EuHZV shingles vaccine posts interim Phase 1 readout [3] [Korea • 25 Feb 2026]
https://www.koreabiomed.com/news/articleViewAmp.html?idxno=30721
Context: Randomized, observer-blinded, active-controlled Phase 1 in 72 Korean adults (50–69), two doses 8 weeks apart.
Key point: EuBiologics reported no serious or grade ≥3 AEs in EuHZV groups through 4 weeks after dose 2, and immunogenicity comparable to an active control (active control product not specified in the excerpt).
Implication: May influence prescriber choice and payer reviews pending full data.
🇪🇺 NOFLU consortium launches EU-backed Phase 1 mucosal pandemic flu concept [4] [EU • 25 Feb 2026]
Context: HaDEA-selected consortium led by NIVI Development, includes partners across Denmark, Germany, the Netherlands, Italy (plus Ethris platform).
Key point: NOFLU plans Phase 1 clinical evaluation of an mRNA-based H5N8 vaccine concept designed to induce mucosal immunity, including intramuscular vs intranasal comparisons (clinical endpoints not specified).
Implication: Signals pipeline investment and modality expansion.
🇧🇷 Brazil starts chikungunya vaccine administration in pilot rollout [5] [Brazil • 24 Feb 2026]
https://boanoticiabrasil.com.br/bem-estar/vacina-contra-chikungunya-brasil-aplicacao/
Context: Article describes a pilot start in Mirassol (São Paulo state), with Anvisa approval noted as April 2025; partners include Butantan Institute and Valneva.
Key point: Vaccine administration began in a pilot city as part of a gradual rollout in municipalities, with safety notes and eligibility constraints (pregnancy and immunosuppression cautions cited).
Implication: May expand screening, initiation, and follow-up at scale.
💉 Vaxcyte moves VAX-31 into Phase 3 adult program (pneumococcal) [6] [US • 25 Feb 2026]
Context: Company update framed for investors, mentions FDA alignment and an expanded Breakthrough Therapy designation for VAX-31 (details not specified).
Key point: Vaxcyte said it launched a Phase 3 adult program for VAX-31, completed enrollment in a Phase 2 infant study, and is preparing to advance a Group A Streptococcus program (timing stated as 2026 for Phase 1).
Implication: Signals pipeline investment and modality expansion.
🩹 SK bioscience–IDT–Vaxxas win EU support for patch-based influenza vaccines [7] [EU • 26 Feb 2026]
https://www.koreabiomed.com/news/articleViewAmp.html?idxno=30740
Context: Consortium uses Vaxxas high-density microarray patch (HD-MAP) delivery, targets seasonal influenza in elderly and pandemic avian influenza for all ages (specific strains not stated).
Key point: SK bioscience, IDT Biologika, and Vaxxas were selected for a HaDEA-managed initiative with Phase 1 funding, and potential expansion tied to milestones (later-phase funding contingent).
Implication: Signals pipeline investment and modality expansion.
🤰 France SNDS surveillance study reports mostly null AESI signals for mRNA vaccines in pregnancy [8] [24 Feb 2026]
Context: Observed-to-expected safety surveillance using SNDS, compares post-vaccination events to background rates from earlier pregnancies (2015–2019), with doses recorded in 2021–2023 (per source).
Key point: Source reports mostly null AESI findings after Pfizer (BNT162b2) and Moderna (mRNA-1273) vaccination during pregnancy, with two rare-event “signals” for Moderna based on very small counts (causality not established in OE surveillance).
Implication: Could inform practice and payer discussions, interpretation depends on study design and confounding control.
🧠 Brazil greenlights path to first human trials for Calixcoca (anti-crack/cocaine) vaccine [9] [Brazil • 23 Feb 2026]
https://boanoticiabrasil.com.br/bem-estar/vacina-contra-crack-e-cocaina-testes-brasil/
Context: Developed at UFMG, described as having pre-clinical results and patents; regulatory documentation adjustments underway before volunteer studies.
Key point: Brazil’s Ministry of Education statements indicate Calixcoca is approaching authorization for first-in-human trials, aiming to elicit antibodies that bind the drug in the bloodstream (clinical protocol details not stated).
Implication: Signals pipeline investment and modality expansion.
Why it matters
- Combination respiratory vaccines (flu + COVID-19) could simplify adult immunization schedules if durability and effectiveness hold up in later studies. [1]
- TB vaccine development is widening target populations and datasets, which can de-risk safety and immune-marker interpretation, even when efficacy is not powered in every subgroup. [2]
- EU-funded early clinical programs are placing multiple bets on next-gen influenza approaches, including mucosal delivery and patch technologies. [4][7]
- Real-world pregnancy safety surveillance remains a key trust lever, but observed-to-expected methods are signal-detection tools, not causal proof. [8]
- Brazil’s vaccine agenda spans public health rollout (chikungunya) and unconventional immunotherapies (substance-use indications), widening stakeholder scrutiny on evidence thresholds and implementation. [5][9]
🚀 Accelerate your success. Contact us now
📂 Explore our case studies. See examples of our work.
💡 Read our insights. Learn from our latest reports and analysis
🎬 Watch on YouTube. Subscribe and never miss a video.
🧰 See our full range of services. Discover how we can help you.
📚 View the full Vaccines archive on our research hub page.
FAQ
What is mRNA-1073, and what did the Phase 1/2 trial show?
mRNA-1073 is a combined influenza + COVID-19 mRNA vaccine concept described as showing acceptable safety and antibody responses in a Phase 1/2 study in adults, with responses tracked through 6 months (effectiveness endpoints not stated). [1]
What changed in the IMAGINE Phase 2b trial for MTBVAC?
IAVI added an IGRA-negative cohort (1,200 participants) alongside an IGRA-positive cohort, aiming to broaden safety and immunogenicity assessment across exposure statuses (efficacy not powered in IGRA-negative cohort). [2]
How does EuBiologics’ EuHZV compare to existing shingles vaccines?
In interim Phase 1 reporting, EuBiologics said EuHZV showed safety and immune responses comparable to an active control in Korean adults (the source does not specify the control product name in the excerpt). [3]
What is the NOFLU project trying to prove in Phase 1?
NOFLU is testing an H5N8-targeting mRNA vaccine concept intended to induce mucosal immunity, including a comparison of intramuscular vs intranasal administration, under EU-backed early clinical evaluation. [4]
What did the France SNDS analysis conclude about mRNA COVID-19 vaccination in pregnancy?
The source reports mostly null AESI signals in observed-to-expected surveillance, with two rare-event outliers flagged for Moderna based on very small case counts, which limits interpretability. [8]
What is Calixcoca, and what stage is it at?
Calixcoca is a UFMG-developed candidate described as aiming to generate antibodies that bind cocaine/crack in the bloodstream, with Brazil moving toward authorization for first-in-human trials (trial design details not stated). [9]
Entities / Keywords
-
Moderna, mRNA-1073, combination vaccine, influenza, COVID-19, immunogenicity
-
IAVI, MTBVAC, IMAGINE trial, IGRA-negative, IGRA-positive, latent TB, Biofabri (Zendal)
-
EuBiologics, EuHZV, shingles, varicella-zoster virus (VZV), gE antigen, adjuvant
-
HaDEA, EU4Health, NOFLU, NIVI Development, Ethris, mucosal immunity, H5N8, intranasal vaccine
-
Butantan Institute, Valneva, chikungunya, Anvisa, rollout, live-attenuated vaccine
-
Vaxcyte, VAX-31, pneumococcal conjugate vaccine, Phase 3, Group A Streptococcus
-
SK bioscience, IDT Biologika, Vaxxas, HD-MAP, patch vaccine, seasonal influenza, pandemic avian influenza
-
France SNDS, observed-to-expected surveillance, AESI, pregnancy, Pfizer BNT162b2, Moderna mRNA-1273
-
UFMG, Calixcoca, cocaine, crack, addiction immunotherapy, first-in-human
References
-
https://www.koreabiomed.com/news/articleViewAmp.html?idxno=30721
-
https://boanoticiabrasil.com.br/bem-estar/vacina-contra-chikungunya-brasil-aplicacao/
-
https://www.koreabiomed.com/news/articleViewAmp.html?idxno=30740
-
https://boanoticiabrasil.com.br/bem-estar/vacina-contra-crack-e-cocaina-testes-brasil/