Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Acellular Pertussis Vaccine Is Safe & Effective

JAMA Pediatr; 2018 Nov; Wood, Nolan, et al

Administration of the acellular pertussis (aP) vaccine at birth can reduce severe morbidity from Bordetella pertussis infection in the first 3 months of life, especially for infants of mothers who have not received a pertussis vaccine (Tdap) during pregnancy. This according to a recent randomized clinical trial that compared IgG antibody responses to vaccine antigens at 6, 10, 24, and 32 weeks of age between newborn infants receiving the aP vaccine and hepatitis B vaccine (HBV) or HBV alone. The primary outcome was detectable IgG to both pertussis toxin (PT) and pertactin at 10 weeks. Among the details:

  • 440 infants (207 girls and 233 boys; median gestation, 39.2 weeks) were randomized to receive the aP vaccine plus HBV (n=221) or HBV only (control group; n=219).
  • At 10 weeks, 192 of 206 infants (93.2%) had detectable antibodies to both PT and pertactin vs 98 of 193 infants (50.8%) in the control group.
  • At 32 weeks, all infants who received the aP vaccine at birth had detectable PT IgG and significantly lower IgG geometric mean concentrations for Haemophilus influenzae type b (Hib), hepatitis B, diphtheria, and tetanus antibodies.
  • Local and systemic adverse events were similar between groups at all time points.


Wood N, Nolan T, Marshall H, et al. Immunogenicity and safety of monovalent acellular pertussis vaccine at birth. A randomized clinical trial. JAMA Pediatr. 2018;172(11):1045–1052. doi:10.1001/jamapediatrics.2018.2349.


This is a very exciting study. Despite our best efforts of vaccinating expectant mothers, we have not been able to eliminate the risk of pertussis in children in the first few months of life. By being able to give a pertussis vaccine at birth, this study shows that we are able to produce immunity in these children without any local or systemic consequences. This vaccine would be a leap forward in protecting newborn babies. A subsequent question would be if this is a vaccine that could be given to pregnant mothers during pregnancies instead of a Tdap if their tetanus vaccination is up-to-date. —John Russell, MD