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Clinical Reviews

Women’s Health: A realistic vaccination program for all patients, including gravidas

‘Delegate’ is the key to success for this simple screening and vaccination protocol, which uses free forms available online. A detailed chart covers vaccination during pregnancy.

December 2003 · Vol. 15, No. 12


  • Adults, not children, incur a greater risk of death due to vaccine-preventable diseases.
  • During flu season, almost half of the hospitalizations and deaths for cardiopulmonary conditios in healthy pregnant women are due to influenza.
  • Screening all gravidas for hepatitis B surface antigen would prevent chronic hepatitis B viral infection in 6,000 neonates every year.
  • Only 54% of community-dwelling elderly persons are immunized against Streptococcus pneumoniae, which has a 55% to 60% mortality rate in persons aged 70 or older.
  • Influenza is more likely to cause death in middle-aged persons with multiple medical conditions than in healthy elderly persons.

Because of our unique access to women at all stages of life—who often consult no other physician—Ob/Gyns are well positioned to proclaim and bestow the benefits of vaccination.

For women who are pregnant or planning to conceive, benefits extend to the neonate through the first 4 to 6 months of life. For all women, especially those with coexisting chronic diseases, immunization stands to reduce mortality and serious morbidity.

This article details a simple 6-step plan for an immunization program in a typical practice. A key success factor is to minimize disruption by delegating authority for the program to a specific person or persons.

‘Success’ leaves adults at greater risk than children

Few doctors in any specialty pay regular attention to immunization. Over the past 20 years in particular, the United States has lacked a comprehensive adult vaccination program. As a result, many gynecologic patients today are underimmunized.

The tremendous success of childhood immunization has rendered diseases such as polio and measles “invisible” and fostered the perception that vaccination beyond childhood is no longer necessary. As a result, adults, not children, are now at greater risk of death due to vaccine-preventable disease (TABLE 1).

Another reason behind underimmunization is disproportionate media attention to adverse reactions, which discourages people from getting vaccinated.

Ob/Gyns and other clinicians face these challenges:

  • Establishing an office routine for screening all patients and giving vaccinations.
  • Informing ourselves and our patients of the benefits of vaccination in specific groups.
  • Providing reliable information about possible adverse effects.

TABLE 2 details targeted populations, dos-ing, and safety in pregnancy for vaccines recommended for adults.


Estimated preventable deaths with complete vaccination of targeted adult populations






Pneumococcal infection










Hepatitis B





Hepatitis A





Measles, mumps, rubella















*Indicates efficacy in immunocompetent adults. Among elderly and immunocompromised patients, efficacy is estimated to be lower.

† The percentage of targeted groups who have been immunized according to current recommendations. Rates vary among different targeted groups.

‡ Highly variable (range, 1% to 60%) among different targeted groups.

§ Estimate based on seroprevalence data.

|| Among children 19 to 35 months of age.

Adapted from the Centers for Disease Control and Prevention10,17and from Gardner P, Schaffer W18with permission of the Massachusetts Medical Society (copyright 1993, Massachusetts Medical Society. All rights reserved)

The sobering facts: Morbidity and mortality rates of vaccine-preventable iseases

Streptococcus pneumoniae causes roughly 3,000 to 6,000 cases of meningitis, 50,000 cases of bacteremia, and 500,000 cases of pneumonia each year in the United States.1 In people over age 70, the mortality rate is 55% to 60%.2 Compounding the risk is the increase in penicillin-resistant pneumococci. Still, only 54% of elderly patients get immunized against pneumonia—well below the goal of 90% set by Healthy People 20103 for noninstitutionalized elderly.

Influenza causes approximately 20,000 deaths each year, but that figure can reach 40,000 or more in some epidemics.4 The death rate begins to rise in midlife and is greatest in persons with chronic medical conditions such as cardiovascular disease, chronic obstructive lung disease, asthma, and diabetes. In fact, influenza has a higher fatality rate in middle-aged persons with multiple medical conditions than in healthy persons 65 years of age or older.

Only a fraction of persons aged 50 to 65 with a high-risk condition are immunized against influenza.

Influenza and pneumonia together are the seventh leading cause of death nationally and the fifth leading cause in older adults.5 A study of working adults aged 18 to 64 showed that flu vaccination decreased episodes of upper-respiratory illness by 25% and reduced doctor visits for such illness by 44%.6

Ample quantities of flu vaccine are available this flu season. The past 3 seasons, shortages compelled the Centers for Disease Control and Prevention (CDC) to recommend a graduated vaccination schedule to ensure that the neediest individuals were immunized first, while supplies were adequate.

Each year the CDC, the US Food and Drug Administration (FDA), and vaccine manufacturers review the vaccine supply and notify physicians of projected shortages.

Hepatitis B virus (HBV) infects between 128,000 and 320,000 people each year in the United States. Approximately 1.25 million Americans have chronic infection. The lifetime risk of acquiring the disease is estimated at 5%.7 More than 5,000 people die of HBV-related liver disease annually, and HBV infection is the second leading cause of cancer worldwide.

Measles, mumps, and rubella (MMR) cases declined greatly in the 20th century, thanks to widespread vaccination. By 2001, the number of cases reported annually had declined to 116 for measles (from an all-time high of more than 500,000), to 266 for mumps, and to 23 for rubella.8,9 Although the vaccines for these 3 viruses are extremely effective, occasional outbreaks of all 3 illnesses are still reported in the United States. Measles outbreaks occur because the disease is highly contagious, with an attack rate of 90% or higher among unvaccinated household contacts.

Varicella. Before vaccination became available, roughly 4 million cases of varicella zoster virus infection occurred each year in the United States. Although the virus usually causes relatively benign chickenpox, death is a possibility. From 1990 to 1994, for example, before the varicella vaccination program, 11,000 hospitalizations and 100 deaths were attributed to varicella disease each year.10 Most of those who died were previously healthy.

During 2002, 9 fatal cases of varicella in adults and children were reported.10 That figure likely represents only a partial accounting of varicella-related deaths. According to National Center for Health Statistics data for 2000, varicella was listed as the primary cause of death on 44 death certificates in 23 states and the District of Columbia, although only 9 (20%) varicella-related deaths were reported to the CDC.10

FluMist intranasal vaccine approved for ages 5 to 49—but not for gravidas

Although it is roughly 7 times more expensive than a flu shot (at approximately $46 per dose), the new intranasal vaccine, FluMist, has appealing qualities—especially for people who spurn vaccination to avoid the needle. FluMist (MedImmune Inc, Gaithersburg, Md) is a cold-adapted, live, trivalent vaccine approved June 17, 2003, by the US Food and Drug Administration for ages 5 to 49 years. It is available for the 2003–2004 influenza season.

Easy to administer. Each prefilled sprayer contains a 0.5-mL dose, which clinicians administer by placing the Teflon tip into the patient’s nose and depressing the plunger. (A dose separator ensures that 0.25 mL is delivered into each nostril.) Because of its simplicity, the vaccine ultimately could be available in nonclinical settings such as shopping malls, boosting the number of persons who get immunized each year.

FluMist induces intranasal immunoglobulin A that is specific for each of the 3 influenza strains targeted this season by the US Public Health Service. This is important because influenza virus enters the body through the nose. (The shots do not induce intranasal immunoglobulin.)

How effective is FluMist? The estimated efficacy of live-attenuated vaccine in healthy adults exposed to wild-type influenza A and B viruses was 85% in 1 study, but ranged as high as 100% in a meta-analysis.19,20

When FluMist was tested in a randomized, double-blind, placebo-controlled trial, recipients were as likely as controls to experience 1 or more febrile illnesses during peak outbreak periods. However, they had significantly fewer severe febrile illnesses and febrile upper respiratory tract illnesses. They also missed fewer work days and required fewer visits to a healthcare provider.21

Contraindications include pregnancy. Because its effects during pregnancy are unknown, FluMist should not be given to gravidas.

Further, persons with a history of Guillain-Barré syndrome or hypersensitivity to eggs or egg products should not receive the vaccine. Nor should FluMist be given to those with known or suspected immune deficiency diseases or immuno-suppression, or whose immune status may be depressed due to therapies such as systemic corticosteroids, antimetabolites, alkylating drugs, and radiation.22

Precautions. Vaccinated persons may shed live virus and should avoid close contact with immunocompromised people for 21 days or more.

The effects of administering FluMist at the same time as other vaccines have not been studied. For this reason, it is best given alone.

Adverse reactions include cough, runny nose, sore throat, chills, tiredness or weakness, nasal congestion, rhinitis, and sinusitis.

Vaccination during pregnancy: Benefits versus risks

As the American College of Obstetricians and Gynecologists (ACOG) notes in a committee opinion,11 preconception vaccination “to prevent disease in the offspring, when practical, is preferred to vaccination of pregnant women.” However, in pregnancy, the benefits of immunization usually outweigh the risk of adverse events when:

  • the likelihood of exposure to disease is high,
  • infection would pose a risk to the mother or fetus, and
  • the vaccine is unlikely to cause illness or injury.12

Rubella vaccine is of particular concern for pregnant women. Thus, it is reasonable to ask any premenopausal patient if she is pregnant. If she is pregnant and has no antibodies to rubella, she should receive the MMR vaccine postpartum at the time of hospital discharge.

If she is not pregnant, she should be vaccinated and advised to postpone pregnancy for 4 weeks. In addition, when indicated, the patient’s children and other household contacts should be immunized against MMR and varicella.

Influenza is a significant concern for the pregnant patient. A retrospective cohort study found that, during flu season, almost half of the hospitalizations and deaths for cardiopulmonary conditions in healthy pregnant women are attributable to influenza.13 Thus, inactivated influenza vaccine is recommended for gravidas who are in the second or third trimester of pregnancy during flu season.

Hepatitis B. According to ACOG, the Advisory Committee on Immunization Practices, and other organizations, all pregnant women should be screened for hepatitis B surface antigen (HBsAg), preferably at an early prenatal visit.

Screening all pregnant women in the United States would detect about 22,000 HBsAg-positive women and prevent chronic HBV infection in 6,000 neonates each year.14 Gravidas whose initial test is negative but who are at high risk for infection should be tested again late in pregnancy.

TABLE 2 gives specifics on immunization in pregnancy.

STEP 1Assign an advocate in charge of vaccination

Any office-based vaccination program requires an enthusiastic advocate—a nurse, physician, or, better yet, several health professionals who understand that an immunization program is key to improved medical care. The advocate’s job is to promote the benefits of vaccination among both staff and patients.

In a pediatric setting, physicians and nurses cite lack of time as the main reason they do not communicate with patients about the importance of immunization15—and that time shortage is likely a barrier when adult vaccination is at issue, as well. For example, 57% of medical patients interviewed gave the same reason for their failure to get immunized against pneumonia: No one told them it was recommended for their age group.16 By assigning this responsibility to one individual or several persons as a team, it becomes more likely that the issue will be addressed.

Each office visit presents an opportunity. Women with chronic illnesses are most likely to benefit from pneumonia and influenza vaccines, and women who are planning to conceive should be up to date on MMR, tetanusdiphtheria, and varicella (TABLE 2)

STEP 2Use free questionnaires for history-taking, records

Both new and established patients should have their immunization history reviewed. Unfortunately, an accurate history may be difficult to obtain, since patients receive their vaccinations from different providers and often do not keep adequate records. The most reliable sources of information are the patient, her previous physician and, sometimes, her parents.

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