ACIP approach to mAbs

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▪Passive immunization
–Transfer of preformed antibody produced externally to provide protection to the 
recipient
–Provides temporary protection that wanes with time
–Transfer of maternal antibody across the placenta that provides protection in early 
infancy is an example of passive immunization
▪Active immunization
–Administration of specific components of an infectious agent that elicit an immune 
response in the recipient
–Immunology memory provides prolonged protection that may be lifelong
–Traditional vaccines provide active immunizationPassive and Active Immunization
▪With development of long -acting monoclonal 
antibodies ( mAbs ), there is an opportunity to 
provide protection beyond what can be 
provided by traditional vaccines
▪Especially valuable when
–Full protection is needed without delay
–A traditional vaccine is not available 
▪For some indications, a long -acting mAb
might provide “long enough” protection
–For a respiratory disease season
–For a critical part of a pregnancy
–For prevention of travel -related infectionMonoclonal antibodies for 
prevention of infectious diseases
who -monoclonal -antibodies.jpg (2480 ×3508)

CDC will prioritize for ACIP consideration those long -acting monoclonal 
antibodies for prevention of infectious diseases that are:
▪Expected to address conditions that result in a significant burden of 
disease to the public’s health; 
▪Not expected to present significant implementation issues –at least 
from the perspective of mode of administration, storage and handling, 
and frequency of administration --for immunization providers; and
▪Expected to be priced at a level allowing for incorporation into 
immunization programs. CDC’s Approach to Prioritizing Long -Acting Monoclonal 
Antibodies for Prevention of Infectious Diseases