Vaccines
Vaccines Pipeline
Vaccine Late-Stage Hits and Misses, 2024 to 2026
CMV and norovirus misses, mFLUSIVA approval, Capvaxive launch, and intismeran still the oncology option.
| Window | Asset | Company | Result | Note |
|---|---|---|---|---|
| Oct 2025 | mRNA-1647 CMV | Moderna | Phase 3 miss | 6% to 23% efficacy. Congenital program discontinued. |
| 2026 | mRNA-1403 norovirus | Moderna | Phase 3 miss (interim) | Did not meet early-success criteria. Additional cohort planned. |
| 5 Aug 2026 | mFLUSIVA (mRNA-1010) | Moderna | FDA approved, adults 50+ | First US mRNA flu shot. ACIP and contracting still pending for 2026-27 volume. |
| 2026 | Intismeran autogene + Keytruda | Moderna / Merck | Phase 3 melanoma readout expected | Phase 2b five-year: 49% cut in recurrence or death vs Keytruda alone. Confirm CSR and filing path from the joint release. |
| 2024-2025 | Capvaxive | Merck | Launch hit | $759M in first full year. Adult pneumococcal share taker versus Prevnar. |
| Jun 2025 | Enflonsia (clesrovimab) | Merck | FDA approved | Infant RSV mAb. Sales not yet a disclosed franchise line. |
Named Shots After Congenital CMV
Lyme VALOR (statistical miss, Pfizer still filing), Qdenga commercial, CMV transplant Phase 2 still on, HEPLISAV-B nine-month sales. Not respiratory, not intismeran.
| Asset | Company | Status | Printed mark |
|---|---|---|---|
| LB6V (formerly VLA15) Lyme | Pfizer / Valneva | Phase 3 VALOR. Pfizer planning regulatory submissions (23 Mar 2026 PR) | 73.2% reduction in confirmed Lyme vs placebo from 28 days post-dose 4 (95% CI 15.8, 93.5). The pre-set criterion (CI lower bound above 20) was not met in the first pre-specified analysis because fewer cases accrued than planned. Second analysis lower bound was above 20. |
| Qdenga dengue | Takeda | Commercial. WHO prequalified. Available in more than 30 countries per the FY2025 presentation | JPY 40.8B sales in FY2025 (year ended 31 Mar 2026), +10.7% CER. Plan to manufacture 21 million doses in FY2026. |
| mRNA-1647 congenital CMV | Moderna | Discontinued October 2025 | Phase 3 (NCT05085366) did not meet the primary endpoint. Vaccine efficacy 6% to 23% depending on case definition. Not a remaining commercial bet. |
| mRNA-1647 CMV in HCT | Moderna | Phase 2 ongoing | NCT05683457. ClinicalTrials.gov: active, not recruiting. Actual enrollment 84. No efficacy print. Do not treat congenital discontinuation as a transplant readout. |
| HEPLISAV-B adult HepB | Dynavax / Sanofi | Commercial. Sanofi agreed to buy Dynavax on 24 Dec 2025 | 9M 2025 net product revenue $246.8M (Dynavax Q3 2025). FY 2025 is not taken from a 10-K here. Not a peak-sales model. |
| Z-1018 shingles | Sanofi / Dynavax | Pipeline challenger inside the Dynavax deal | No 2026 US commercial competitor to Shingrix. Long-dated. No Phase 3 efficacy number printed for a 2026 launch. |
Personalized Cancer Vaccine Trials
Intismeran autogene with Merck versus BioNTech iNeST. Option-value, not 2026 product revenue.
| Program | Company | Setting | Evidence | 2026 commercial |
|---|---|---|---|---|
| Intismeran autogene (mRNA-4157 / V940) + Keytruda | Moderna / Merck | Adjuvant melanoma; other tumors in INTerpath | Phase 2b five-year: 49% reduction in recurrence or death vs Keytruda alone | No 2026 product revenue. Phase 3 melanoma is the filing gate. |
| iNeST individualized neoantigen | BioNTech / Genentech | Solid tumors | Individualized mRNA; part of a broader oncology stack | BioNTech guided no oncology product revenue in 2026. Vaccines are the cash residual. |
| Pumitamig (PD-L1/VEGF-A) + BMS | BioNTech / BMS | Not a vaccine | €613M collaboration revenue recognized in Q3 2025 | Shown so readers do not confuse BMS collab cash with Comirnaty. |
Vaccine CBER and EMA Decision Calendar
Dates that can move MRNA, GSK, SNY, PFE, and BNTX. ACIP still sits after FDA for coverage.
| Date | Asset | Agency | Status | Why it moves the stock |
|---|---|---|---|---|
| 5 Aug 2026 | mFLUSIVA | FDA | Approved, adults 50+ | Unlocks mRNA flu and the combo path. Volume still needs ACIP. |
| 2026-27 season | mFLUSIVA ACIP | CDC ACIP | Recommendation pending at build | Coverage and VFC/Medicare follow the vote, not the FDA letter. |
| 2026 | Intismeran Phase 3 melanoma | FDA path TBD | Readout expected | Largest remaining mRNA option after CMV/norovirus misses. |
| Q2 2026 | mRESVIA EC joint procurement | EC | Up to 24M doses, six countries | Public-sector RSV volume after the US recommendation narrowed. |
| Q1 2026 expected | Sanofi-Dynavax close | Deal / FTC | Announced 24 Dec 2025 at ~$2.2B | HEPLISAV-B plus a shingles challenger. Confirm 8-K that the tender completed. |
Vaccine M&A and Licensing, 2023 to 2026
CureVac, Dynavax, Matrix-M, Icosavax, and the Bavarian-Serum Institute chikungunya transfer.
2023
DealAstraZeneca
AstraZeneca acquires Icosavax
VLP RSV/hMPV platform. AZ already had Beyfortus via Sanofi; this was the vaccine-side option.
Dec 2025
DealBioNTech
BioNTech closes CureVac tender (~86.75%)
mRNA design and LNP manufacturing depth. Compulsory acquisition into 2026.
24 Dec 2025
DealSanofi
Sanofi agrees to buy Dynavax for about $2.2B
HEPLISAV-B (CpG 1018 adjuvant) and a shingles challenger to Shingrix. Close still needs confirmation.
15 Jan 2026
DealNovavax / Pfizer
Novavax licenses Matrix-M to Pfizer
Adjuvant becomes a cash story separate from Nuvaxovid volumes.
Mar 2026
DealBavarian Nordic
Bavarian Nordic and Serum Institute chikungunya tech transfer
LMIC dose volume for Vimkunya moves to the world's largest manufacturer.
Disclosed Pipeline by Pathogen
Issuer programs only, not a Citeline census. After CMV, the map is respiratory plus one oncology option.
| Pathogen | What is left | Lead names | Status |
|---|---|---|---|
| COVID | Seasonal updates plus combos | Pfizer/BioNTech, Moderna, Sanofi/Novavax | Commercial. APA world is over. |
| Flu | mRNA vs egg/cell/recombinant | Sanofi, Seqirus, GSK, Moderna mFLUSIVA | mFLUSIVA approved Aug 2026; ACIP pending. |
| RSV adult | Share fight, not a new TAM | Arexvy, Abrysvo, mRESVIA | Single-dose ACIP. Combos are the next attempt to grow visits. |
| RSV infant | mAb vs maternal vaccine | Beyfortus, Enflonsia, maternal Abrysvo | Beyfortus is the disclosed P&L. |
| CMV | Mostly dead as a congenital mRNA bet | Moderna discontinued | Phase 3 miss Oct 2025. |
| Norovirus | Retry | Moderna mRNA-1403 | Phase 3 interim miss 2026. |
| HPV | No near-term branded US challenger | Gardasil 9; SII Cervavac in LMIC | Country risk, not pipeline risk. |
| Shingles | Long-dated challenger | Shingrix; Sanofi-Dynavax Z-1018 | No 2026 US competitor. |
| Pneumococcal | Valency race | Prevnar 20, Capvaxive, Vaxneuvance | Adult share fight is commercial, not Phase 3. |
| Oncology | Personalized mRNA + checkpoint | Intismeran; BioNTech iNeST | Option-value. No 2026 product revenue guided. |
Adjuvant and Platform Bets
AS01, Matrix-M, CpG 1018, LNP IP, sa-mRNA, and protein/VLP. Who captures the next respiratory or endemic dollar.
| Platform | Owner | Where it shows up | Equity angle |
|---|---|---|---|
| AS01 adjuvant | GSK | Shingrix, Arexvy | Moat on the two biggest GSK vaccines. Not licensed out cheaply. |
| Matrix-M | Novavax; licensed to Pfizer Jan 2026 | Nuvaxovid; future Pfizer programs | Turns NVAX into an adjuvant royalty plus a shrinking COVID P&L. |
| CpG 1018 | Dynavax / Sanofi (pending close) | HEPLISAV-B; shingles candidate Z-1018 | The Dynavax deal is an adjuvant and hepatitis B franchise, and a Shingrix shot across the bow. |
| LNP / Acuitas IP | Acuitas (private) plus sponsors | Comirnaty, Spikevax, mRESVIA, mFLUSIVA | IP and lipid supply, not a public pure-play in this roster. |
| sa-mRNA | Arcturus; CSL Seqirus interest | Kostaive COVID in Japan | Self-amplifying. Small-cap (ARCT), not a US seasonal franchise in 2026. |
| Protein / VLP | Pfizer, GSK, Merck, Novavax, Sanofi | Abrysvo, Arexvy, Gardasil, Nuvaxovid | Still most of the branded dollars. |
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