Vaccines Video Recap—December 12, 2025

This biweekly Vaccines video recap highlights covers regulatory/policy decisions, real-world evidence findings, and clinical pipeline progress—from early-stage readouts to late-stage trial milestones—plus a public-health supply update.

🎯 Watch Our Video Summary Capturing Vaccines News from the Last Two Weeks

Dive deeper

🗓️ Explore weekly details and sources

Week 28 November–4 December 2025
Week 5–11 December 2025

📚 See the full Vaccines archive on our research hub page.

Transcript

Welcome to the latest edition of Vaccines Research Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

Datar Cancer Genetics challenged the CDSCO denial of Phase 1 for Per-C-Vax; the Bombay High Court directed a CDSCO appointed nine member expert panel, expanded with two nominees, to review the company’s submissions and report within three months, which could influence pricing and formulary access.

WHO’s SAGE Position Paper lists the MAV/06 varicella strain alongside Oka and endorses interchangeability in two dose schedules; GC Biopharma’s BARYCELA Inj. is already supplied via PAHO, supporting broader procurement and access.

Observational analyses in Wales and Australia linked shingles vaccination with a lower incidence of new mild cognitive impairment and reduced dementia mortality over follow up up to nine years; these are not randomized trials, so causality and vaccine product specificity cannot be confirmed.
The BPZE1 intranasal live attenuated pertussis vaccine generated robust mucosal and systemic immune responses in early testing led by the NIHR Southampton team, aiming to reduce carriage and transmission beyond infant protection with current acellular vaccines.

Vaxcyte dosed the first participants in OPUS, an approximately 4,000 participant FDA aligned Phase 3 noninferiority study of VAX-31 versus Capvaxive, PCV21, and versus Prevnar 20, PCV20; primary endpoints use opsonophagocytic activity geometric mean ratio noninferiority on shared serotypes and superiority on VAX-31 unique serotypes, with safety and tolerability, and topline data targeted for Q4 2026.

GC Biopharma shipped initial doses of BARYTHRAX inj., the first recombinant anthrax vaccine using purified protective antigen, to the KDCA national stockpile; facility capacity is up to 10 million doses per year for a four dose regimen.

Peptinov’s PPV-06, an IL-6 vaccine for knee osteoarthritis, reported Phase 1 double blind results in 24 participants testing 10 micrograms and 50 micrograms versus placebo; the vaccine was well tolerated, all treated participants developed anti IL-6 responses, and functional improvement was observed at week 42 in fully dosed patients, with Phase 2 planned for 2026.

Osivax fully enrolled 2,850 adults across Belgium, France, Finland, and Germany in the Asuniva OVX836-005 Phase 2b; a single 480 microgram intramuscular dose is being evaluated, with efficacy readout expected mid 2026, contingent on seasonal influenza A circulation.

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Why It Matters

Regulators are weighing novel trial justifications for complex cancer immunotherapies.
WHO recognition of MAV/06 supports resilient varicella supply and interchangeability.
Real-world shingles vaccine data raise testable hypotheses for neuroprotection.
Intranasal pertussis strategies target transmission, not just severe disease.
Adult pneumococcal field is moving to head-to-head immunogenicity standards.
Broad influenza A and cytokine-targeting vaccines diversify respiratory and musculoskeletal pipelines.

🗓️ Explore weekly details and sources

Week 28 November–4 December 2025
Week 5–11 December 2025

📚 See the full Vaccines archive on our research hub page.

FAQ

What is Per-C-Vax and what did the Bombay HC direct?

Per-C-Vax is a cancer immunotherapy from Datar Cancer Genetics. The court asked a CDSCO expert panel, expanded with two nominees, to review the Phase 1 denial and report within three months from 01 Dec 2025 [1].

What does WHO’s MAV/06 inclusion change for varicella programs?

WHO lists MAV/06 alongside Oka and endorses interchangeability in two-dose schedules, enabling BARYCELA Inj. to integrate with existing programs and procurement channels like PAHO [2].

Does the shingles vaccine prevent dementia?

Analyses in Wales and Australia suggest lower MCI incidence and dementia mortality after vaccination, but these are observational and not definitive for causality or specific vaccine products [3].

How is BPZE1 different from current pertussis vaccines?

It is an intranasal candidate intended to induce mucosal immunity and reduce carriage, aiming to curb transmission beyond infant protection seen with current acellular vaccines [4].

What comparators are in Vaxcyte’s OPUS trial and what is measured?

VAX-31 is compared with Capvaxive (PCV21) and Prevnar 20 (PCV20). Primary endpoints use OPA GMR noninferiority on shared serotypes and superiority on VAX-31-unique serotypes, plus safety and tolerability [5].

Entities / Keywords

Datar Cancer Genetics; Per-C-Vax; CDSCO; NDCT Rules; GC Biopharma; MAV/06; BARYCELA; WHO SAGE Position Paper; shingles vaccine; mild cognitive impairment; dementia; BPZE1; NIHR Southampton; pertussis; Vaxcyte; VAX-31; OPUS; PCV21 Capvaxive; PCV20 Prevnar 20; BARYTHRAX inj.; KDCA; IL-6 vaccine; PPV-06; Peptinov; osteoarthritis; Osivax; OVX836; Asuniva; influenza A.