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ACIP recommends Tdap vaccine during each pregnancy

The Advisory Committee on Immunization Practices voted Wednesday, 14-0 with one abstention, to recommend that a tetanus-diphtheria-acellular pertussis booster vaccine be given to pregnant women during each pregnancy, despite concern over the lack of data for the safety of multiple Tdap vaccinations.

Last year, ACIP recommended that pregnant women receive the Tdap vaccine only if they have previously not received one.

In a Vaccine for Children vote, the committee voted unanimously to include a change that recommends that adolescents who are pregnant should receive a dose of Tdap, regardless of their Tdap vaccination history.

 

Carol Baker

“There is absolutely no question that we need more data,” Carol Baker, MD, professor of pediatrics at Baylor College of Medicine, said while representing the IDSA at the meeting. “But we have to consider risk to the mother vs. the benefit, just like this committee always has.”

According to Jennifer Liang, MD, epidemiologist in the CDC’s National Center for Immunization and Respiratory Diseases, antibody response from the Tdap vaccine peaks at 1 month after vaccination and decreases significantly after 1 year. Because of this, women who have received the vaccine during a previous pregnancy may not have the same protection at future pregnancies.

“A single dose of Tdap at one pregnancy is insufficient to provide protection for subsequent pregnancies,” Liang said.

A lack of safety data about multiple Tdap vaccinations caused some hesitancy among the committee, especially when considering women who have short intervals between pregnancies. There are no data available that address this specific issue, but available data suggest that there is no excess risk of adverse events, Liang said, adding that the CDC working group supports the need for a prospective study to determine the adverse event risk in women with multiple pregnancies.

She said data indicate that the average woman has two children, and most have an interval of at least 13 months between pregnancies, meaning that most women would not receive more than two doses of the vaccine.

After recommendations, the ACIP continues to review data about its recommendations and will continue reviewing data on the safety of giving multiple Tdap vaccinations to pregnant women.

Because the recommendation is an off-label use of the Tdap vaccine, there was concern about whether insurance programs, including Medicare and Medicaid, would cover the vaccinations for these women.

“In making an off-label use recommendation, what we need to understand is how the coverage of immunizations under Medicare and Medicaid and individual insurance plans will be affected,” committee member Sara Rosenbaum, JD, said.

A representative from American’s Health Insurance Plans (AHIP) indicated that insurance plans almost always follow ACIP recommendations, even when those recommendations are for off-label use, and there is precedent for it. A representative for the CMS indicated that, for Medicaid, the ACIP recommendations are followed, but for Medicare, ACIP recommendations are not followed under Part D.

Perspective
Sandra Fryhofer

Sandra A. Fryhofer

  • I'm relieved. Recent epidemics suggest that cocooning strategies are not enough to prevent pertussis in infants. It’s time to go to plan B, which is vaccinating mom during every pregnancy. We know that the majority of transmission to the baby is not from the mother. Babies aged 2 months and younger have the most pertussis-related deaths and hospitalizations. These babies are too young to get vaccinated. They need protection and this is a way to do it. Vaccinating mom late in pregnancy means that mom's antibodies will pass to baby, protecting baby during their first 2 months of life when they are most vulnerable.

    That said, this is uncharted territory. Studies need to be done to make sure that mom's antibodies don't significantly blunt baby's immune response when given vaccination. We also don’t know, for sure, if there will be adverse effects for mom when multiple doses of the vaccine are administered. Is there a need for a single antigen vaccine that only provides acellular pertussis component, so that the moms won’t be getting extra doses of tetanus or diphtheria vaccine? The other concern is getting the word out to providers and to women. Influenza vaccine recommendations for pregnant women have helped women get comfortable with idea of vaccination during pregnancy. The recent pertussis epidemic in Washington and the resulting infant deaths is a wake-up call. Women need to make sure they can do everything they can to protect baby from contracting this deadly disease.

    • Sandra A. Fryhofer, MD
    • Internal medicine physician in private practice
      Adjunct associate professor of medicine
      Emory University School of Medicine