ACIP Guidelines Show
ACIP: Guidance for Vaccine Recommendations in Pregnant and Breastfeeding Women Risk to a developing fetus from vaccination of the mother during pregnancy is theoretical. No evidence exists of risk to the fetus from vaccinating pregnant women with inactivated virus or bacterial vaccines or toxoids. Live vaccines administered to a pregnant woman pose a theoretical risk to the fetus; therefore, live, attenuated virus and live bacterial vaccines generally are contraindicated during pregnancy. “Benefits of vaccinating pregnant women usually outweigh potential risks when the likelihood of disease exposure is high, when infection would pose a risk to the mother or fetus, and when the vaccine is unlikely to cause harm.”
Routine Vaccines:COVID-19
Hepatitis A
Hepatitis B
Human Papillomavirus (HPV)
Influenza (Inactivated or Recombinant)
Influenza (LAIV)
Top of Page Measles, Mumps, Rubella (MMR)
Meningococcal (MenACWY or MPSV4)
Meningococcal (MenB)
Pneumococcal Conjugate (PCV15 and PCV20)
Pneumococcal Polysaccharide (PPSV23)
Top of Page Polio (IPV)
Tetanus, Diphtheria, and Pertussis (Tdap); & Tetanus and Diphtheria (Td)
Top of Page Varicella
Zoster
Top of Page Travel & Other VaccinesPrenatal Screening for Vaccine-Preventable DiseasesAnthrax
BCG
Japanese Encephalitis (JE)
Top of Page Rabies
Typhoid
Top of Page Vaccinia (Smallpox)
Top of Page Yellow Fever
Top of Page Prenatal Screening“Pregnant women should be evaluated for immunity to rubella and varicella and be tested for the presence of HBsAg during every pregnancy. Women susceptible to rubella and varicella should be vaccinated immediately after delivery. A woman found to be HBsAg positive should be monitored carefully to ensure that the infant receives HBIG and begins the hepatitis B vaccine series no later than 12 hours after birth and that the infant completes the recommended hepatitis B vaccine series on schedule.” 7 Passive Immunization during Pregnancy“No known risk exists for the fetus from passive immunization of pregnant women with immune globulin preparations.” 7 Breastfeeding and Vaccination“Neither inactivated nor live-virus vaccines administered to a lactating woman affect the safety of breastfeeding for women or their infants. Although live viruses in vaccines can replicate in vaccine recipients (i.e., the mother), the majority of live viruses in vaccines have been demonstrated not to be excreted in human milk. Varicella vaccine virus has not been found in human milk. Although rubella vaccine virus might be excreted in human milk, the virus usually does not infect the infant. If infection does occur, it is well tolerated because the virus is attenuated. Inactivated, recombinant, subunit, polysaccharide, and conjugate vaccines, as well as toxoids, pose no risk for mothers who are breastfeeding or for their infants.” 7 “Breastfeeding is a contraindication for smallpox vaccination of the mother because of the theoretical risk for contact transmission from mother to infant. Yellow fever vaccine should be avoided in breastfeeding women. However, when nursing mothers cannot avoid or postpone travel to areas endemic for yellow fever in which risk for acquisition is high, these women should be vaccinated.” 7 Top of Page Principles for Developing Pregnancy RecommendationsFormulating policy to guide vaccination of women during pregnancy and breastfeeding is challenging because the evidence-base to guide decisions is extremely limited. In 2008, CDC published Guiding Principles for Developing ACIP Recommendations for Vaccination During Pregnancy and Breastfeeding to “provide guidance to help standardize both the process of policy formulation and the format and language of recommendations for pregnant and breastfeeding women” to CDC workgroups or subject matter experts developing vaccine statements subsequent to that date. Top of Page References
Top of Page FDA Pregnancy CategoriesRegulation traditionally required that each product be classified under one of five pregnancy categories (A, B, C, D, or X, as described below), on the basis of risk of reproductive and developmental adverse effects or, for certain categories, on the basis of such risk weighted against potential benefits. These FDA pregnancy letter categories are: Pregnancy Category A. Adequate and well controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of a risk in later trimester), and the possibility of fetal harm appears remote. Pregnancy Category B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus during the first trimester (and there is no evidence of risk in later trimesters). Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks OR Animal reproduction studies have not been conducted and there are no adequate and well-controlled studies in humans. Pregnancy Category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Pregnancy Category X. Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in the use of the drug in pregnant women clearly outweigh potential benefits. Recently, FDA determined that these letter categories were often confusing and did not accurately or consistently communicate differences in degrees of fetal risk. Because risk-benefit decisions regarding use of a drug during pregnancy are more complex than the category designations suggest, reliance on the categories by health care providers may often be misplaced and could result in poorly informed clinical decision making. In December of 2014, the FDA published the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR or final rule). The PLLR removes pregnancy letter categories – A, B, C, D and X. Instead, under the final rule, narrative summaries of the risks of a drug during pregnancy and discussions of the data supporting those summaries are required in labeling to provide more meaningful information for clinicians. These labeling changes went into effect on June 30, 2015. Prescription drugs and biologic products submitted after June 30, 2015, will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually. As of August 2016, most vaccines have not yet converted from the FDA letter categories, and are rated in manufacturers’ package inserts as follows:
Vaccines that have converted from the letter categories as of August 2016 are: Pneumococcal (Prevnar13) – “Available data on Prevnar 13 administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.” Polio – “Animal reproduction studies have not been conducted with IPOL vaccine. It is also not known whether IPOL vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. IPOL vaccine should be given to a pregnant woman only if clearly needed.” Varicella: Contraindication. Varivax should not be administered to pregnant females since wild-type varicella can sometimes cause congenital varicella infection. Pregnancy should be avoided for three months following vaccination with Varivax. Yellow Fever: “It is also not known whether YF-195 VAX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 196 YF-VAX should be given to a pregnant woman only if clearly needed.” Zoster: There is currently no ACIP recommendation for RZV use in pregnancy. Consider delaying RZV until after pregnancy. Centers for Disease
Control and Prevention (CDC) Top of Page Why are live vaccines contraindicated in pregnancy?Live vaccines during pregnancy
Theoretically the live attenuated virus in a vaccine could cross the placenta and result in viral infection of the fetus. Owing to this concern, most live attenuated vaccines, including the measles-mumps-rubella (MMR) and varicella vaccines, are contraindicated during pregnancy.
What vaccines are contraindicated in the pregnant patient?Some vaccines are not recommended during pregnancy, such as:. Human papillomavirus (HPV) vaccine.. Measles, mumps, and rubella (MMR) vaccine.. Live influenza vaccine (nasal flu vaccine). Varicella (chicken pox) vaccine.. Certain travel vaccines: yellow fever, typhoid fever, and Japanese encephalitis.. What happens if you get pregnant after varicella vaccine?No complications of pregnancy have been reported in studies of pregnant people who have received the varicella vaccine.
Is BCG vaccine contraindicated in pregnancy?Pregnancy. BCG vaccination should not be given during pregnancy. Even though no harmful effects of BCG vaccination on the fetus have been observed, further studies are needed to prove its safety.
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