<p><strong>Pregnancy</strong>: All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15- 20%, respectively. Available human data from clinical trials of Pneumococcal Vaccine in pregnancy have not established the presence or absence of a vaccine-associated risk. Developmental toxicity studies have not been conducted with Pneumococcal Vaccine in animals.<br />
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<strong>Lactation</strong>: It is not known whether Pneumococcal Vaccine is excreted in human milk. Data are not available to assess the effects of Pneumococcal Vaccine on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother&rsquo;s clinical need for Pneumococcal Vaccine and any potential adverse effects on the breastfed child from Pneumococcal Vaccine&nbsp;or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to the disease prevented by the vaccine.</p>