The January 2018 recommendations are available at www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.PDF.
Yes; people who are identified as being at risk for HBV infection during pregnancy should be vaccinated. They also should be counseled concerning other methods to prevent HBV infection. Providers should administer an age-appropriate 3-dose series of Twinrix, Engerix-B or Recombivax HB.
Until safety data are available for Heplisav-B or PreHevbrio administration during pregnancy, ACIP does not recommend the use of either of these products to vaccinate during pregnancy. Pregnancy testing prior to administration of these products is not recommended.
There are insufficient data available to inform assessment of Heplisav-B or PreHevbrio vaccine-associated risks during pregnancy.
Dynavax has established a Heplisav-B Vaccination in Pregnancy Registry in order to understand the effect (if any) of Heplisav-B vaccination during pregnancy. Individuals who receive Heplisav-B within 28 days before pregnancy or at any time during pregnancy are encouraged to participate in the registry by calling 1-844-443-7734 (toll-free).
VBI has established a registry that monitors pregnancy outcomes in mothers exposed to PreHevbrio during pregnancy. Individuals who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).
Decreased seroconversion rates might occur among preterm infants with birth weights less than 2,000 grams after administration of HepB at birth. However, by the chronological age of 1 month, all preterm infants, regardless of initial birth weight, are likely to respond as adequately as larger infants. Infants who weigh less than 2,000 grams born to HBsAg-positive mothers and mothers with unknown HBsAg status (if the mother’s HBsAg status cannot be determined within 12 hours of birth) must receive immunoprophylaxis with HepB and hepatitis B immune globulin (HBIG) within 12 hours of birth. The initial vaccine dose should not be counted toward completion of the hepatitis B series, and 3 additional doses of HepB should be administered, beginning when the infant is age 1 month. Infants weighing less than 2,000 grams born to HBsAg-negative mothers should receive the first dose of the HepB series at hospital discharge or at chronological age 1 month (even if weight is still less than 2,000 grams), whichever comes first.
Screening should be done with the hepatitis B surface antigen (HBsAg) test only. This blood test will tell whether a mother has current HBV infection that can be transmitted to the infant. Ordering a total antibody to hepatitis B core antigen (total anti-HBc) and/or anti-HBs are not useful when screening to prevent perinatal HBV infections and should not be included in screening during pregnancy for risk of perinatal HBV infection. Total anti-HBc will be positive in all HBsAg-positive people and anti-HBs is rarely positive in an HBsAg-positive person. Pregnant people who are found to be positive should be tested for HBV DNA to guide the use of maternal antiviral therapy during pregnancy for the prevention of perinatal HPV transmission (see MMWR 2018;67 [RR-1]:13).
An infant born to a mother for whom HBsAg screening test results during pregnancy are not available but other evidence suggesting maternal HBV infection exists (e.g., presence of HBV DNA, HBeAg-positive, or mother known to be chronically infected with HBV) should be managed as if born to an HBsAg-positive mother. The infant should receive both HepB and HBIG within 12 hours of birth. The mother should also be referred to their jurisdiction’s Perinatal Hepatitis B Prevention Program for case management to ensure that the infant receives timely prophylaxis and follow-up.
Yes. Mothers who have received HepB should still be screened for HBsAg early in each pregnancy. Just because a pregnant person has been vaccinated does not mean they are HBsAg negative. Since postvaccination testing is not performed for most vaccinated people, the mother could have been vaccinated when already actively infected.
The earlier the evaluation is done, the better. Consultation with or referral to a liver disease specialist (such as a hepatologist, gastroenterologist, or infectious disease specialist) should be done. The consulting/referral physician should be aware of the patient’s obstetrical status. In addition, the patient’s sex partner and children or other household contacts should be tested for HBV infection (total anti-HBc and HBsAg) as soon as possible. If any are susceptible to HBV infection (total anti-HBc and HBsAg negative), they should be vaccinated. If any are HBsAg positive, they should be referred to or have consultation with a liver disease specialist.
Preterm infants weighing less than 2,000 grams (4.4 pounds) at birth have a decreased response to HepB administered before age 1 month. By age 1 month, medically stable preterm infants, regardless of initial birth weight or gestational age, have an immunologic response to HepB vaccination that is comparable to that of full-term infants. For preterm infants weighing less than 2,000 grams at birth:
For preterm infants weighing 2,000 grams or more at birth, follow the recommendations for full-term infants including a HepB dose within 24 hours of birth.
In 2015, CDC revised the recommendation for the timing of hepatitis B serologic testing for infants born to an HBsAg-positive woman. Postvaccination testing (HBsAg and hepatitis B surface antibody [anti-HBs]) is now recommended 1 to 2 months after completion of at least three doses of the HepB vaccine series, but not before 9 months of age. For a child vaccinated on schedule, testing should be done at age 9 to 12 months. Testing should not be performed before age 9 months because hepatitis B immune globulin (HBIG) might still be present at age 6 to 8 months, nor should testing be performed within 1 month of the most recent HepB dose because a transient false positive HBsAg might occur. Antibody to hepatitis B core (anti-HBc) testing of infants or children is not recommended because passively acquired maternal anti-HBc might be detected up to age 24 months in children of HBV-infected mothers. Children who are HBsAg positive should receive medical evaluation and ongoing follow-up. For additional information, see www.cdc.gov/mmwr/pdf/wk/mm6439.pdf, pages 1118–20.
HBsAg-negative infants with anti-HBs levels 10 mIU/mL or higher are protected and need no further medical management. HBsAg-negative infants with anti-HBs less than 10 mIU/mL should be revaccinated with a single dose of hepatitis B vaccine and receive postvaccination serologic testing 1–2 months later. Infants whose anti-HBs remains less than 10 mIU/mL following single dose revaccination should receive 2 additional doses of HepB to complete the second series, followed by postvaccination serologic testing 1–2 months after the final dose.
Based on clinical circumstances or family preference, HBsAg-negative infants with anti-HBs less than 10 mIU/mL may instead be revaccinated with a second, complete 3-dose series, followed by postvaccination serologic testing performed 1–2 months after the final dose of vaccine.
Available data do not suggest a benefit from administering additional HepB vaccine doses to infants who have not attained anti-HBs of mIU/mL or higher following receipt of two complete HepB series. HBsAg-positive infants should be referred for appropriate follow-up with a physician who specializes in evaluating infants with liver disease.
Yes. An HBsAg-positive mother who wishes to breastfeed should be encouraged to do so, including immediately following delivery. However, the infant should receive HBIG and HepB vaccine within 12 hours of birth. Although HBsAg can be detected in breast milk, studies done before HepB was available showed that breastfed infants born to HBsAg-positive mothers did not demonstrate an increased rate of perinatal or early childhood HBV infection. More recent studies have shown that, among infants receiving post-exposure prophylaxis to prevent perinatal HBV infection, there is no increased risk of infection among breastfed infants.
Yes. The use of a 4-dose HepB schedule is acceptable when giving the monovalent HepB vaccine birth dose followed by the use of Pediarix (DTaP-HepB-IPV) or Vaxelis (DTaP-IPV-Hib-HepB). The use of a 4-dose HepB schedule, including schedules with a birth dose, has not increased vaccine reactogenicity and results in higher final antibody titers that should correlate with longer duration of detectable antibody. The federal Vaccines for Children (VFC) program provides up to four doses of HepB for VFC-eligible children. You may still use monovalent HepB in a 3-dose series.
According to subject matter experts at CDC, your electronic health record is correct. The CDC website states that HepB dose #4, if given, must be at 24 weeks of age or later, at least 16 weeks from dose #1, and at least 8 weeks from dose #2. There is no minimum interval requirement between dose #4 and the previous dose. This information is not published in any current ACIP statement but it can be found under “Hepatitis B” at www.cdc.gov/vaccines/programs/cocasa/reports/algorithm-ref.html.
Yes. Poorer immune response rates are seen in infants who complete the vaccination series prior to age 6 months. Do not count dose #3, which you gave at age 4 months. Repeat dose #3 when the infant is at least 6 months of age (no earlier than age 24 weeks).
If an infant received an adult dose of HepB (contains twice the antigen in a dose of the pediatric formulation), the dose can be counted as valid and does not need to be repeated. Hepatitis B vaccines are very safe vaccine and no unusual adverse events would be expected because of this administration error. The next (age appropriate) dose should be given on the usual schedule.
The minimum age for the last dose of HepB is age 24 weeks (the minimum age is the youngest age that is acceptable for giving a vaccine and having it “count” as a valid dose.) This allows healthcare providers more flexibility in administering HepB should a parent bring an infant in for a well-baby check before the infant reaches a full 6 months of age. If the third dose is given prior to age 24 weeks the dose should not be counted. Poorer response rates are seen in infants who complete the vaccination series prior to age 24 weeks. The third dose should be repeated when the infant is at least age 24 weeks.
Yes. Many years of experience with Engerix-B and Recombivax HB brands of HepB vaccines indicate no apparent risk for adverse events to a developing fetus. Current HepB products contain noninfectious hepatitis B surface antigen (HBsAg) and should pose no risk to the fetus. If not vaccinated, a pregnant person may contract an HBV infection during pregnancy, which might result in severe disease for the newborn.
Available human data on Heplisav-B and PreHevbrio administered during pregnancy are insufficient to assess vaccine-associated risks in pregnancy. For this reason, until safety data are available for Heplisav-B or PreHevbrio, providers should continue to vaccinate people needing HepB during pregnancy with either Engerix-B or Recombivax HB. Pregnancy testing prior to vaccination is not recommended.
Mothers who breastfeed their babies and need HepB can be vaccinated. Although data are not available to assess the effects of Heplisav-B and PreHevbrio on breastfed infants or on maternal milk production and excretion, there is no theoretical risk to the infant and vaccination with any HepB product is acceptable.