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.

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.

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.

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.

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.

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.