This week’s Vaccines and Infectious Disease update highlights clinical trial progress, regulatory milestones, manufacturing partnerships, financing activity, and geographic expansion across multiple vaccine programs.
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🧪 SK bioscience, IDT Biologika, MSD expand Ebola vaccine manufacturing tie-up [1] [23 Mar 2026]
https://www.businesskorea.co.kr/news/articleView.html?idxno=265838
Context: SK bioscience and IDT Biologika will support an updated manufacturing process for MSD’s Zaire Ebola vaccine, following CEPI’s earlier $30 million funding announcement.
Key point: SK bioscience will make drug substance, while IDT Biologika will handle drug product development and manufacturing.
Implication: Signals pipeline investment and modality expansion.
🦠 Pfizer, Valneva press on with VLA15 filing plans after Phase 3 miss [2] [23 Mar 2026]
https://pharmaphorum.com/news/pfizer-valneva-shrug-phase-3-lyme-disease-vaccine-miss
Context: In the Phase 3 VALOR trial, VLA15 (PF-07307405) showed efficacy, but did not meet the trial’s prespecified statistical criterion because case counts were lower than expected.
Key point: Pfizer and Valneva said they still intend to file for approval of the Lyme disease vaccine candidate.
Implication: May influence prescriber choice and payer reviews pending full data.
💉 Vaxcyte completes Phase 3 enrollment for VAX-31 adult pneumococcal studies [3] [23 Mar 2026]
https://www.investing.com/news/company-news/vaxcyte-completes-enrollment-in-two-phase-3-trials-for-vax31-93CH-4575259
Context: OPUS-1 enrolled about 4,000 adults and OPUS-2 about 1,300 adults; both studies are designed to support a planned U.S. BLA.
Key point: Vaxcyte completed enrollment in two Phase 3 trials for VAX-31, its 31-valent pneumococcal conjugate vaccine candidate for adults.
Implication: May influence prescriber choice and payer reviews pending full data.
🌎 GC Biopharma wins Guatemala approval for Barycela varicella vaccine [4] [26 Mar 2026]
https://www.koreabiomed.com/news/articleViewAmp.html?idxno=31073
Context: Barycela uses GC Biopharma’s MAV/06 strain and, according to the company, is an antibiotic-free live varicella vaccine.
Key point: Guatemala granted marketing authorization, marking Barycela’s first named approval in a Latin American country.
Implication: Introduces competition that may affect pricing and formulary access.
👵 Clover reports added U.S. Phase 1 RSV revaccination data for SCB-1019 [5] [US • 25 Mar 2026]
https://www.cloverbiopharma.com/media/191.html
Context: The study enrolled older adults previously vaccinated with GSK’s AREXVY at least two seasons earlier and assessed safety, reactogenicity, and immunogenicity.
Key point: Clover said additional Phase 1 data continued to support SCB-1019 as a heterologous RSV revaccination option versus AREXVY in older adults.
Implication: May influence prescriber choice and payer reviews pending full data.
🧫 GeoVax moves GEO-MVA toward pivotal mpox and smallpox study [6] [25 Mar 2026]
https://www.geovax.com/investors/press-releases/geovax-provides-update-on-geo-mva-program
Context: GeoVax said release testing for GEO-MVA clinical supplies is complete, with final release for clinical use scheduled for early April.
Key point: The company said this supports initiation of a planned immune-bridging study under an EMA-aligned pathway.
Implication: May influence prescriber choice and payer reviews pending full data.
💰 Centivax raises follow-on funding for universal flu vaccine program [7] [25 Mar 2026]
https://www.axios.com/pro/biotech-deals/2026/03/25/centivax-37m-universal-flu-vaccine
Context: Axios reported Centivax raised $37 million; the company said its flu vaccine is in Phase 1, with results expected by the end of 2026.
Key point: The financing is intended to support advancement toward a Phase 2 flu vaccine trial in early 2027.
Implication: Signals pipeline investment and modality expansion.
Why it matters
- Pneumococcal competition is intensifying, with Vaxcyte VAX-31 advancing in adults while SK bioscience continues Phase 3 work on PCV21 with Sanofi [1][3].
- RSV revaccination is becoming a clearer development theme, with Clover positioning SCB-1019 against currently approved protein-based RSV vaccines [5].
- Outbreak preparedness remains active across Ebola, mpox, and smallpox, with manufacturing scale-up and supply resilience central to several programs [1][6].
- Latin America remains a meaningful expansion target for established vaccine products, illustrated by GC Biopharma’s Guatemala authorization for Barycela [4].
- Capital is still reaching differentiated vaccine platforms, but the bar for financing and regulatory execution remains high, as shown by Centivax and the Pfizer, Valneva Lyme readout [2][7].
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FAQ
What happened with VLA15 from Pfizer and Valneva?
Pfizer and Valneva said their Lyme disease vaccine candidate showed efficacy in Phase 3, but the study missed its prespecified statistical goal because fewer cases occurred than expected. They still plan to file for approval [2].
Why does Vaxcyte’s VAX-31 enrollment milestone matter?
Vaxcyte completed enrollment in two Phase 3 adult studies designed to support a U.S. BLA for VAX-31, its 31-valent pneumococcal conjugate vaccine candidate. Topline data are expected later, not yet reported [3].
What is notable about GC Biopharma’s Barycela update?
GC Biopharma said Guatemala approved Barycela, making it the company’s first named Latin American authorization for the varicella vaccine. The company also highlighted its antibiotic-free manufacturing claim [4].
What is Clover trying to show with SCB-1019?
Clover is studying SCB-1019 in older adults previously vaccinated with AREXVY, aiming to support revaccination and, longer term, combination RSV plus hMPV with or without PIV3 programs. The latest release reports added Phase 1 data, not pivotal efficacy [5].
Where does GeoVax’s GEO-MVA program stand?
GeoVax said clinical product release testing is complete and final release is due in early April, supporting a planned immune-bridging study for mpox and smallpox under an EMA-guided pathway [6].
What does Centivax’s financing mean for its flu vaccine?
Axios reported the $37 million raise should fund Centivax through Phase 2 planning, with Phase 1 data expected by the end of 2026 and Phase 2 targeted for early 2027 [7].
Entities / Keywords
SK bioscience, SK bioscience Co., IDT Biologika, IDT, MSD, Merck & Co., Inc.
Zaire Ebola vaccine, Ebola vaccine, CEPI, Coalition for Epidemic Preparedness Innovations, Pfizer
Valneva, VLA15, PF-07307405, LBV6
VALOR trial, Lyme disease vaccine Phase 3
Vaxcyte, VAX-31, OPUS-1, OPUS-2, PCV, pneumococcal conjugate vaccine, GC Biopharma, Green Cross, Barycela, varicella vaccine, MAV/06
Clover Biopharma, SCB-1019, RSV PreF vaccine
AREXVY, GSK RSV vaccine
hMPV, human metapneumovirus
PIV3, parainfluenza virus type 3
GeoVax, GEO-MVA
MVA, Modified Vaccinia Ankara
EMA, European Medicines Agency
Centivax, universal flu vaccine
References
- https://www.businesskorea.co.kr/news/articleView.html?idxno=265838
- https://pharmaphorum.com/news/pfizer-valneva-shrug-phase-3-lyme-disease-vaccine-miss
- https://www.investing.com/news/company-news/vaxcyte-completes-enrollment-in-two-phase-3-trials-for-vax31-93CH-4575259
- https://www.koreabiomed.com/news/articleViewAmp.html?idxno=31073
- https://www.cloverbiopharma.com/media/191.html
- https://www.geovax.com/investors/press-releases/geovax-provides-update-on-geo-mva-program
- https://www.axios.com/pro/biotech-deals/2026/03/25/centivax-37m-universal-flu-vaccine