Clinical Data on Pertussis Vaccination During Pregnancy
from: product manufacturer. See: http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm142764.pdf
from: product manufacturer. See: http://www.fda.gov/downloads/biologicsbloodvaccines/ucm152842.pdf
- Click here to read ACIP summary recommendation.
- Click here to read data presented to ACIP to “guide” this decision (starts on page 30)*
- Click here to read study published in Am J Obstet Gynecol. 2012 titled, Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women
* from Advisory Committee on Immunization Practices (ACIP) Summary Report February 23-24, 2011 minutes (p. 34-35)
“From January 1, 2005 through June 30, 2010, of 10,350 reports after Tdap vaccines, 129 involved pregnant women who submitted a report to VAERS. Although there were reports of 20 spontaneous abortions, 2 stillbirths, and 2 congenital anomalies, VAERS is not designed to assess whether a vaccine caused an adverse event. A review of VAERS reports in pregnant women who received Tdap vaccines revealed no elevated frequency or unusual patterns. Both GSK and sanofi pasteur maintain vaccination pregnancy registries to collect data on pregnancy outcomes and newborn health status outcomes following vaccination. Both were kind enough to allow Dr. Liang to present on their behalf. The work group reviewed their data in detail, and she provided the summary points. Boostrix® was licensed in 2005 for 10 through 18 year olds, and in 2008 for adults. GSK maintains a registry to collect data on pregnancy outcomes and newborn health status outcomes following vaccination. From its U.S. market launch in 2005 through August 2, 2010, 33 pregnancies were prospectively registered. Of these pregnancies, 18 were lost to follow-up. Outcomes were reported for seven pregnancies, and consisted of six live infants born without birth defects and one spontaneous abortion at seven weeks gestation. The remaining eight pregnancies were on-going at the time of last contact. In addition to the prospective reports of pregnancy received to the pregnancy registry from the U.S., GSK has received 13 reports from other countries. Just over half of these reported normal outcomes. The rest are on-going or were lost to follow-up. There have been no birth defects after Boostrix® vaccination reported to GSK.”
Ingredients (from CDC)
- Tdap (Adacel) – click here for package insert
aluminum phosphate, formaldehyde, glutaraldehyde, 2-phenoxyethanol, ammonium sulfate, Mueller’s growth medium, Mueller-Miller casamino acid medium (without beef heart infusion)
- Tdap (Boostrix) – click here for package insert
formaldehyde, glutaraldehyde, aluminum hydroxide, polysorbate 80 (Tween 80), Latham medium derived from bovine casein, Fenton medium containing a bovine extract, Stainer-Scholte liquid medium
Inform Yourself. There are no “pertussis only” shots – so you will be giving consent to be injected with the “Tdap” vaccine – Tetanus, diptheria and acellular Pertussis vaccine. You may also be asked to enroll in the vaccine maker’s registry for any vaccine you accept while pregnant – because they are still collecting data to assess safety.