Laura E. Riley, MD

Protecting pregnant women and their newborns by offering timely and effective vaccinations is a critical component of disease prevention, particularly given the rise of vaccine-preventable disease in the United States and around the globe. Studies show that when clinicians are knowledgeable about the benefits of vaccines and offer them to their patients, uptake of vaccination rises.

This is particularly true during pregnancy, when patients are concerned about vaccine safety and efficacy.

In this review, we provide an
	evidence-based summary of the vaccines that are recommended for women preconception, during pregnancy, and postpartum and provide counseling tips to help providers achieve the highest vaccine uptake rates possible.

The preconception period offers a unique opportunity to optimize a woman’s health for pregnancy and beyond. 


	Influenza infection during pregnancy has been associated with severe maternal illness, pregnancy loss, and preterm birth.

 Immunity confers significant benefits to both pregnant women and their offspring.

 Generally available for administration from late August through March of each year to correspond with the influenza season (timing may vary by region), the trivalent or quadrivalent, inactivated influenza vaccine should be given to all individuals older than age 6 months, including women considering pregnancy. Do not administer live vaccine (LAIV, Flumist) to women who may be pregnant but there is no contraindication to their family members receiving the live vaccine.


	Given the global measles outbreak, the Centers for Disease Control and Prevention (CDC) and American College of Obstetricians and Gynecologists (ACOG) recommend assessing measles immunity in addition to rubella immunity.

 The CDC recommends an evaluation of either a patient’s vaccine record or confirmatory measles serology to prove immunity (Table 1).

 While a single prior MMR dose may be adequate for some women, patients at high risk for exposure to measles should demonstrate proof of two doses. Many providers ask if the demonstration of rubella immunity from a prior pregnancy is adequate to confirm measles immunity. While rubella immunity is generally correlated with receipt of at least one MMR vaccine, that is not a valid surrogate for measles immunity. If the appropriate number of MMR doses has not been documented or the vaccine record is not available, measles serology can be obtained, and an MMR vaccine booster administered to patients with a negative Measles IgG antibody result. After receiving the MMR vaccine-a live, attenuated vaccine-women should wait 4 weeks prior to attempting pregnancy, given theoretical risks to the fetus with live vaccines.

 However, if pregnancy occurs inadvertently within the 4-week window, patients should be reassured that there have been no reports of fetal harm due to this exposure. 

Assessing rubella immunity has been a longstanding part of prenatal testing given the preventability of congenital rubella syndrome for those who have been adequately vaccinated with MMR. Therefore, women who are either measles non-immune or rubella non-immune should be vaccinated in the preconception period.  


	Given the significant risk of maternal and fetal harm with primary VZV infection during pregnancy, assessing a woman’s VZV immunity preconception will allow you to provide her with varicella vaccine if she is not immune. A history of chicken pox infection, evidence of VZV vaccination, or positive VZV serologies are all acceptable means to assess immunity.  For a woman without proof of immunity, a preconception VZV vaccine can protect her from life-threatening pneumonia and her fetus from congenital varicella syndrome. Because the vaccine for VZV is live attenuated, vaccination should be performed, at least 4 weeks prior to attempted conception given the theoretical concern for causing birth defects.

Other vaccines may be indicated, particularly in women who have medical illnesses that put them at high risk for
	vaccine-preventable illnesses. Obtaining a thorough preconception immunization history as part of routine care also may uncover adult women who have missed prior vaccination opportunities. 

Hepatitis B (HPV) and hepatitis A (HAV) 


	HAB and HAV immunity is particularly important for women planning pregnancy who are at high risk for these infections (Table 2). HBV vaccine is administered in a three-dose series (0, 1, and 4 months apart). The vaccine for HAV is inactivated and can be given pre-exposure as a two-dose series (6 to 18 months apart), or as post-exposure prophylaxis. These vaccines are recombinant and have not been associated with adverse fetal outcomes. Therefore, no waiting period is required after administration in the preconception period and they can be administered during pregnancy if needed or if the three-dose series has not been completed.


	The pneumococcal vaccine is indicated for adult women who are at high risk for serious complications from pneumococcus, such as individuals who smoke or who have asthma or diabetes.  Additional indications are summarized in Table 2.

 There are two pneumococcal vaccines. For adults with risk factors, the CDC recommends administering one dose of PCV13 followed by the PPSV23 dose at least 8 weeks later without a delay in conception.


	Vaccination against HPV is recommended to prevent new HPV infections and HPV-associated diseases, including cervical cancer. While this vaccine remains targeted to young adolescents, the Advisory Committee on Immunization Practices (ACIP) now endorses catch-up HPV vaccination for all individuals through age 26 years. Adults who have previously been infected with one or more HPV types can still benefit from protection for other types available in the vaccine. For adults aged 27 through 45 years, and at risk for new HPV infection, decisions around vaccination should be made using a shared clinical decision-making model

 HPV vaccination for patients older than age 15 should follow a three-dose regimen (0, 1 to 2 and 6 months). Counseling and guidance about the benefits of HPV vaccination are ideal for preconception women who plan for pregnancy in greater than 6 months. While the HPV vaccine is not recommended during pregnancy, inadvertent HPV vaccination during pregnancy is not associated with adverse events for a woman or her fetus.


	Incorporating vaccine administration as a routine part of prenatal care is key to protecting pregnant women and their offspring from vaccine-preventable diseases. Evidence-based strategies to build a robust vaccination program embedded within an obstetrical practice include: staff education for all individuals who encounter the patient (front desk, medical assistants, lab techs, nurses, midwives, and physicians), patient education in multiple languages, and standing-order sets.

When vaccines are not available within your office or clinic, encouraging women to receive needed vaccines at the pharmacy or through their employer is also important, but a less effective strategy. 

Vaccines that should be given to every pregnant woman during every pregnancy include influenza during flu season and Tdap.

 As noted previously, other vaccines may be given if women have high-risk comorbidities or are midway through a vaccine series. HAV, HAB, and the pneumococcal vaccine should be considered for administration during pregnancy based on a patient’s medical history and additional risk factors (Table 3). Obstetrical providers  who are knowledgeable about vaccine safety and efficacy and prepared to debunk myths about vaccines in pregnancy will have the highest rates of vaccine uptake (Table 4).


	Attention to vaccination continues as we care for women in the postpartum period. All women who are found to be rubella, measles, or VZV non-immune during pregnancy should receive these live-attenuated virus vaccines postpartum without concerns about lactation. Postpartum and lactating women who are age 26 or younger and who have not previously received HPV vaccination should have this series initiated. The vaccine may also be considered for women older than age 26 who are at risk for HPV exposure.

 Finally, postpartum and lactating women with risk factors (Table 2) who have not previously been vaccinated should receive HAV, HBV, and pneumococcal vaccines according to ACOG and CDC recommendations. 

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Grohskopf LA, Alyanak E, Broder, KR et al . Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2019–20 Influenza Season. 

Measles & the MMR Vaccine: Recommendations Around Pregnancy, Including the Periconception and Postpartum Periods - UW Medicine Provider Resource. 

http://providerresource.uwmedicine.org/flexpaper/measles-and-the-mmr-vaccine-recommendations-around-pregnancy-including-the-periconception-and-postpartum-periods

Centers for Disease Control and Prevention. Measles: Evidence of Immunity. 

https://www.cdc.gov/measles/hcp/index.html#immunity

McLean HQ, Fiebelkorn AP, Temte JL, et al. Centers for Disease Control and Prevention. Prevention of measles, rubella, congenital rubella syndrome, and mumps, 2013: summary recommendations of the Advisory Committee on Immunization Practices (ACIP). 

Marin M, GÃ¼ris D, Chaves SS, S et al.  Centers for Disease Control and Prevention (CDC). Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP). 

American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 86: Viral hepatitis in pregnancy. 

Mast EE, Weinbaum CM, Fiore AE, et al. A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP) Part II: immunization of adults. 

Fiore AE, Wasley A, Bell BP. Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). 

Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). 

Centers for Disease Control and Prevention (CDC), Advisory Committee on Immunization Practices. Updated recommendations for prevention of invasive pneumococcal disease among adults using the 23-valent pneumococcal polysaccharide vaccine (PPSV23). 

Pneumococcal Vaccination Summary | Who and When to Vaccinate | For Providers | CDC. 

https://www.cdc.gov/vaccines/vpd/pneumo/hcp/who-when-to-vaccinate.html

. Published June 20, 2019. Accessed September 25, 2019.

HPV Vaccine Recommendations | Human Papillomavirus | CDC. 

https://www.cdc.gov/vaccines/vpd/hpv/hcp/recommendations.html

. Published June 27, 2019. Accessed September 25, 2019.

Committee Opinion No. 704 Summary: Human Papillomavirus Vaccination. 

Use of Standing Orders Programs to Increase Adult Vaccination Rates:  Recommendations of the Advisory Committee on Immunization Practices. 

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Committee on Obstetric Practice, Immunization and Emerging Infections Expert Work Group. Committee Opinion No. 718: Update on Immunization and Pregnancy: Tetanus, Diphtheria, and Pertussis Vaccination. 

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When clinicians are knowledgeable about the benefits of vaccinations, vaccination rates among patients increase.

Perinatal vaccination: A practical guide for obstetric providers

HIV and mother-to-child transmission of the disease remain global problems.

 As of 2015, 36.7 million people worldwide were living with HIV.

 Worldwide, 6% to 20% of all maternal deaths are related to HIV, with the predominant association being infectious disease complications related to HIV.

 The estimated worldwide rate of mother-to-child transmission is 14%

 but is less than 1% in the United States due to the success of antiretroviral therapy (ART). In the United States, there is a perception that HIV has become less of a public health issue. The goal of elimination of mother-to-child transmission remains elusive, yet it has been attained in countries with fewer economic resources.

There are several barriers to elimination of mother-to-child transmission such as lack of access to healthcare, family planning, HIV testing and preconception counseling.

 Significant racial and ethnic disparities are apparent. Infants born to African-American women with HIV are 50 times more likely than infants born to white women and 8 times more likely than Hispanic infants to be perinatally infected with HIV. These trends in the United States have not changed over the past decade.

The complex cascade of interventions required to further reduce mother-to-child transmission relies heavily on the ob/gyn. The “Recommendations for Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States” (HIV Perinatal Guidelines) are updated regularly as new data emerge and provide the most comprehensive recommendations for care of women and babies.

 The goal of this article is to summarize the recommendations for care of pregnant women with HIV, highlighting recent changes in the guidance, which could bring us closer to our goal to eliminate mother-to-child transmission of HIV in the United States.

Preconception counseling: effective and safe conception

Many men and women with HIV desire children, but data suggest their providers fail to discuss family planning goals.

 A study of 181 women with HIV found that only 31% reported a personalized discussion with their provider about childbearing plans, and those conversations were typically initiated by the patient rather than the provider.

Discussion about pregnancy desires should occur during routine appointments, including primary care, well-woman exams, and infectious disease visits. Based on these discussions, women can receive counseling either regarding safe methods of conception or appropriate contraceptive options.

A World Health Organization expert group reviewed evidence regarding drug-drug interactions and hormonal contraception and recommended that women with HIV can continue to use all existing methods without restriction.

 However, some forms of ART can interact with hormonal contraceptives, decreasing the efficacy of the contraceptives. This should be discussed and options reviewed with patients. 

 in the HIV Perinatal Guidelines lists these drug interactions based on the specific ART.

Below are key components to reduce transmission in HIV-discordant couples (i.e., one partner is HIV-positive and the other
HIV-negative) that desire pregnancy:

Couples should be tested and treated for other sexually transmitted infections before attempting conception.

HIV-positive women contemplating pregnancy should be on an antiretroviral (ARV) regimen with a low risk of teratogenicity.

HIV-positive partners should have a suppressed (undetectable) viral load prior to conception.

Pre-exposure prophylaxis (PrEP) should be offered for 30 days prior to and 30 days after attempting conception, or for as long as the risk of HIV acquisition persists, such as remaining sexually active without barrier protection with condoms.

 This is particularly important when the HIV-positive partner has not achieved viral suppression or the viral status is unknown.

For HIV-positive women in a discordant couple, options include:

assisted insemination at home or in a provider’s office with a partner’s semen during the peri-ovulatory period.

adding PrEP for the male partner as outlined above PLUS timed intercourse, which may further decrease the risk of HIV for her partner.

artificial insemination with donor sperm from an HIV-uninfected man or with washed sperm coupled with PrEP for the female partner.

 It should be noted that recommendations about the need for semen preparation techniques may change as additional data about the efficacy of PrEP for serodiscordant couples emerge.

Although PrEP can decrease HIV acquisition, is approved by the US Food and Drug Administration and has been recommended by the Centers for Disease Control and Prevention (CDC) for these high-risk individuals since 2012, it is under-utilized, particularly in women.

 PrEP is once-daily tenofovir/emtricitabine (Truvada). Importantly, breastfeeding and pregnancy are not contraindications to PrEP. In fact, studies have shown low if not undetectable levels of the medication in breast milk.

Recommended evaluation and follow-up for those on PrEP include:

baseline testing for HIV, renal function, pregnancy, and hepatitis B surface antigen and surface antibody

HIV testing and pregnancy testing every 3 months

vaccination against hepatitis B if not immune

There have been two main changes to the CDC’s recommended algorithm for HIV testing (Figure 1). The first-line testing is a fourth-generation HIV test, which includes HIV IgM and IgG, as well as, the p24 antigen. The fourth-generation HIV test increases recognition of acute HIV by several days to weeks before the previous first- to third-generation tests. The second significant change is elimination of the western blot as the “confirmatory test.” The latter is replaced by an HIV differentiation immunoassay which decreases the time to final result from days to hours. In addition, the immuno-assay allows recognition of HIV-2 which accounts for disease mainly seen in West Africa and parts of India.

Any pregnant woman who has HIV should be tested for the following in addition to routine prenatal laboratory studies: 

HIV genotype resistance, if possible (which requires a viral load (VL) > 500 -1000 copies/mL)

The mainstay of therapy for HIV-positive pregnant women is combination ART to control disease progression for the mother and to prevent maternal fetal transmission of HIV. Several care models exist for pregnant women with HIV, including models where patients are treated by obstetric providers experienced in managing HIV in pregnancy or models where collaboration between obstetric and infectious disease providers exist. The recommendations specific to pregnancy are updated frequently. Therefore, it is advised that anyone initiating ART be experienced in caring for pregnant women with HIV.



When determining the ideal combination of ARV drugs, one should consider the following:

impact on obstetric outcomes such as preterm birth (PTB), low birth weight (LBW) and stillbirth

assessment of resistance testing, if available

minimizing pill burden to optimize compliance

Women who are on ART prior to pregnancy and have an undetectable viral load should continue their regimens. The Antiretroviral Pregnancy Registry, a prospective collection of cases of ARV drug exposure, demonstrates that prevalence of birth defects amongst all ARV first-trimester exposures is 2.9/100 live births (221/7738 exposures; 95% CI, 2.5-3.3) and following second- or third-trimester exposure is at 2.8/100 live births.

 Therefore, risk of birth defects associated with ART is no greater than the background rate of birth defects and discontinuation may allow an increase in viral load, which is more detrimental to the fetus.

Certain ARV medications have raised concern. For example, there were reports of neural tube defects (NTDs) observed in non-human primates exposed to efavirenz in utero. However, a large meta-analysis that included 26 studies of 2,026 first-trimester human pregnancies showed no increased risk of NTDs following first-trimester exposures (RR 0.78; 95% CI 0.56-1.08).

 Given these data and reassuring data from a French Perinatal cohort of more than 5000 babies, the most recent HIV Perinatal Guidelines recommend continuing efavirenz-containing regimens during the first trimester if the woman is virally suppressed.

In addition to teratogenicity, there are a number of studies which suggest an increased risk of PTB for babies exposed to ART, as outlined in 

However, the mechanism of action remains unknown and many studies do not control for presence of well-known PTB risk factors. A few studies suggest that some ART regimens are associated with LBW, small for gestational age and stillbirth.

 Despite these concerns, the preponderance of evidence suggests that these risks are low and that the benefits of ART to both mother and baby warrant their use.

In pregnant women with a new HIV diagnosis, combination therapy is a must. Consultation with an infectious disease specialist is helpful given the number of new ARV medications and the complexities of some regimens. The HIV Perinatal Guidelines evaluate and recommend ARV regimens as “preferred” or “alternative” as new efficacy and safety data emerges.

 The current preferred regimen is: a dual-nucleoside reverse transcriptase inhibitor combination (abacavir/lamivudine or tenofovir disoproxil fumarate (TDF)/emtricitabine or lamivudine) and either a ritonavir-boosted protease inhibitor (atazanavir/ritonavir or darunavir/ritonavir) or an integrase inhibitor (raltegravir). ART should be initiated as early in pregnancy as possible without waiting for the first trimester to be completed and regardless of HIV viral load or CD4 count or while waiting for resistance data.

Once ART has been initiated, HIV viral load should be monitored: 

monthly until suppressed or undetectable, and then every 3 months

at 34 to 36 weeks to determine mode of delivery and optimal management of newborn

For women who are coinfected with hepatitis B and HIV, an ART regimen that includes TDF and lamivudine or emtricitabine is preferable to decrease hepatitis B viremia.

Women coinfected with hepatitis C also require liver function monitoring as the potential for severe hepatotoxicity related to ART and/or worsening liver function when immune reconstitution occurs at the initiation of ART.

Obstetric procedures such as chorionic villous sampling and amniocentesis may be performed if needed and ideally when the viral load is undetectable.

 Screening for gestational diabetes may be done at 24 to 28 weeks’ gestation although some experts advocate earlier screening given the association of protease inhibitors with glucose intolerance. Routine vaccinations recommended in pregnancy, including influenza and Tdap, should be given to HIV-positive women. If women are hepatitis A- or B-negative, hepatitis vaccination should be given during pregnancy.

Mode of delivery is dictated by the last viral load prior to delivery, which is often at 34 to 36 weeks’ gestation. 

If the viral load is >1000 copies/mL or unknown around the time of delivery, scheduled cesarean delivery at 38 weeks’ gestation is recommended to minimize perinatal transmission. Intravenous (IV) azidothymidine (AZT) should be given 3 hours prior to scheduled surgery.

If the viral load is < than 1000 copies/mL, the protective benefit of cesarean delivery is not clear and vaginal delivery may be done. In a study of 834 HIV infected women with RNA viral load ≤ 1,000 copies/mL on ART and vaginal delivery, 1% transmitted HIV to their babies.

Management of women whose VL is < 1000 copies/mL who are planning cesarean delivery for obstetric indications may be delivered at 39 weeks.

Mode of delivery must be individualized when rupture of membranes or labor precedes planned cesarean delivery at 38 weeks for those with VL > 1000 copies/mL.

ART should be continued during labor and delivery. IV AZT is no longer required for women with viral loads < 1000 copies/mL as there are no studies showing additional benefit.

 However, there are some providers who advocate use of IV AZT for viral loads between 50 and 999 copies/mL given evidence for slightly higher mother-to-child transmission rate.

 Avoidance of scalp electrodes, operative vaginal delivery, and episiotomy is ideal. An analysis of 2116 term pregnancies showed that for women with viral load < 50 copies/mL, there was no difference in mother-to-child transmission rates between those with rupture of membranes < 4 hours (0.12%) versus ≥ 4 hours (0.14%) prior to delivery, suggesting that amniotomy may be done if indicated.

Women should be reminded to not breast feed nor pre-masticate food for babies. Providers should discuss with parents that infants will undergo virologic testing for newborns at several time points (14-21 days, 1-2 months, 4-6 months). Neonatal prophylaxis should be given as soon as possible postpartum for 4 weeks if the mother has an undetectable viral load and for 6 weeks with combination ART if the mother has a detectable viral load or is not taking ART antenatally.

Current recommendations encourage continuing the ART regimen regardless of maternal CD4 count, since recent studies indicate improved survival with ARV regardless of CD4 counts.

 It may be prudent to simplify the regimen to improve adherence. This should be done in collaboration with an infectious disease specialist or the primary care provider to ensure ongoing coordination of care. Postpartum follow-up is an opportunity to provide depression screening and treatment, social service support, contraception and interval pregnancy planning.

In summary, the goal remains elimination of mother-to-child transmission of HIV. Ob/gyns should follow the latest recommendations for care of the HIV-positive pregnant woman in the United States, which can be found on AIDSInfo.NIH.gov and collaborate with providers with HIV expertise.

The authors report no potential conflicts of interest with regard to this article.

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Mother-to-child transmission of HIV in the United States can be eliminated with the help of obstetricians.

Laura E. Riley, MD

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