MMR Unbundling Policy & Supply Impact Workbench

Clinical & Adherence Inputs Cohort: 3.65M/yr

Per-Visit Pediatric Attrition 7.5%

Cumulative missed well-child visits per additional injection appointment

Baseline 1st-Dose MMR Coverage 93.1%

CDC National Immunization Survey kindergarten baseline

Monovalent US Capacity (Doses/yr) 0.0M

Licensed FDA single-antigen measles/mumps/rubella fill lines

FDA Licensure + Retooling Lag 48 Mo

BLA approval, clinical bridging trials & GMP sterile facility re-qualification

Cold-Chain Storage Footprint 2.85x

Clinic ultra-cold & refrigeration cubic volume ratio vs trivalent vial

Structural Constraints

0 Active US Monovalent Licensures: Merck ceased manufacturing Attenuvax (measles), Mumpsvax, and Meruvax II in 2009. No FDA-approved monovalent alternatives exist today.

Injection Burden Surge: An unbundled schedule expands childhood immunization visits from 2 trivalent injections (12-15 mo, 4-6 yr) to 6 distinct injections (3 separate series).

Cold-Chain Saturation: Pediatric clinics require 285% refrigerated vial space, straining VFC (Vaccines for Children) storage assets.

Projected Full Series Coverage

63.1%

-30.0% vs Trivalent

Herd Immunity Status (95% Target)

CRITICAL DEFICIT

1.16M newly vulnerable/yr

National Supply Deficit

21.9M Doses/yr

ETA: 48 mo regulatory lead

Legal Mandate Enforceability

0 / 50 States

State police power vs Fed EO

Pediatric Adherence Decay Curve: Trivalent (2-Dose) vs Unbundled (6-Dose) D3 Adherence Simulator

Estimated timeline for FDA Biologics License Application (BLA), sterile fill-finish retooling, and commercial lot release for 3 distinct monovalent vaccines:

Engineering (12m)

Clinical/BLA (18m)

GMP Audit (10m)

Commercial (8m)

Month 0 (Executive Order Signed) Total Lead Time: 48 Months

Annual US Doses Demanded (6x cohort)

21.90M doses

3.65M infants × 6 single shots

Cold-Chain Clinic Space Required

10.40M L

+185% refrigeration surge

Under Jacobson v. Massachusetts (1905) and 10th Amendment police powers, school vaccination entry requirements are governed exclusively by state statutory codes. A federal executive order cannot compel state school boards or public health departments to alter kindergarten mandates.

Jurisdiction / State	Mandate Statutory Basis	Executive Order Status	Kindergarten MMR Requirement

Clinical Vector	Standard Trivalent (MMR)	Unbundled Monovalent Regimen	Operational Impact
Total Pediatric Injections	2 shots (12-15mo, 4-6yr)	6 separate shots	+200% injection trauma & parent visits
VFC Reimbursement Administrative Overhead	2 billing events	6 billing events	Tripled claims processing & copays
VAERS Adverse Event Surveillance Triaging	1 unified lot trace	3 distinct antigen lots	Complex multi-source causality triage
Missed Opportunity Risk	Single visit protects 3 viruses	Partial antigen gap vulnerability	Rubella/Mumps immunity neglected