ViVa News — Week 27

India — CDSCO digital submission mandate (effective 1 July) From 1 July 2026, India’s Central Drugs Standard Control Organization (CDSCO) requires that all Post-Approval Change applications for human vaccines and anti-sera be submitted exclusively through the SUGAM online portal (cdscoonline.gov.in), under the PAC/2024 guidance v1.2. Hard-copy and email submissions are no longer accepted from this date, a procedural shift affecting all domestic manufacturers and importers. This is a practical operational change for manufacturers with products licensed in India, not a clinical or policy update. Australia — Capvaxive adult pneumococcal schedule (effective 1 July) Australia’s NIP adult pneumococcal schedule formally changed on 1 July 2026, with Capvaxive (21-valent PCV) replacing Prevenar 13 and Pneumovax 23 for funded adult indications. This is the effective date for the policy announced by Minister Butler in late June — the change is now live in clinics and ordering systems. USA/FDA — Annual influenza vaccine re-approvals (1–2 July) The...