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Vaccination for influenza can be administered at any time during pregnancy. maternal vaccination policy set by the Advisory Committee on Immunization Practices (ACIP), a branch of the CDC, recommends that pregnant women receive a variety of vaccinations. This transfer depends on maternal antibody levels and fetal gestational age. Until 6 months of age, infants rely on transferred maternal antibodies, typically IgGs, from the placenta. Currently, vaccination timing for infants six months and older is scheduled around routine checkups. This model could then be further employed to predict infant antibody (Ab) levels at birth. Certara, in collaboration with the Bill and Melinda Gates Foundation and leveraging data from the Maternal Immunization Working Group in the Centers for Disease Control (CDC), developed an M&S model that would better assess the timing and efficacy of maternal vaccinations. These models can provide important information about the cell infection rate, viral production rate, and viral clearance rateĪlthough MIDD is used extensively in anti-infectious drug development, its use to support vaccine development is not widespread. 1 Further, viral kinetic models have been used to describe the changes in viral load with time in an infected patient. for Oseltamivir dosing in babies two weeks of age and older in Europe and the US. Notably, an integrated pharmacology strategy was instrumental in achieving a successful and harmonized approval in Europe and the U.S. MIDD approaches for infectious disease therapeutics have been used in the development of Palivizumab, a monoclonal antibody used for the prevention of Respiratory Syncytial Virus (RSV) in infants at high risk of RSV infection, Rilpivirine and Raltegravir (HIV), Simeprivir (Hepatitis C Virus), Letemovir (Cytomegalovirus), Pretomanid (Tuberculosis), Botulism Toxin Heptavalent (bioterrorism), Tecovirimat (smallpox), and Oseltamivir (influenza virus). Model-Informed Drug Development (MIDD) has become an important quantitative tool in drug development to characterize drug disposition and effects across a broad range of therapeutic areas including infectious diseases.