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Pregnancy & Vaccines


Pregnancy & Vaccination Resources

Today, pregnant women face a set of difficult questions and choices about keeping themselves and their babies healthy. Among them are whether or not to get vaccinations during pregnancy that public health officials, obstetricians and pediatricians say will protect pregnant women and their newborns from getting sick with influenza and B. pertussis whooping cough.

Ask for the Science - Make an Educated Decision

If you are pregnant and have other children, be aware that the American Academy of Pediatrics is urging pediatricians to vaccinate parents bringing their children in for sick or well baby visits, especially pregnant women. If an obstetrician or pediatrician pressures you to get vaccinated while you are pregnant, ask the doctor to show you the science. If you conclude the vaccine's benefits do not outweigh the risks for you and your baby but are threatened or sanctioned in any way for making an informed choice, you should find another doctor who will treat you with respect and honor your health care choices.

Below are some quick facts to consider when deciding whether or not to accept a vaccine while pregnant.

FACT: Drug companies did not test the safety and effectiveness of giving influenza or Tdap vaccine to pregnant women before the vaccines were licensed in the U.S.1 2 and there is almost no data on inflammatory or other biological responses to these vaccines that could affect pregnancy and birth outcomes.3

 FACT:  The Food and Drug Administration (FDA) lists influenza and Tdap vaccines as either Pregnancy Category B or C biologicals,4 which means that adequate testing has not been done in humans to demonstrate safety for pregnant women and it is not known whether the vaccines can cause fetal harm or affect reproduction capacity. The manufacturers of influenza and Tdap vaccines state that human toxicity and fertility studies are inadequate and warn that the influenza and Tdap vaccines should “be given to a pregnant woman only if clearly needed.” 5 6 7  

FACT: There are ingredients in influenza and pertussis containing Tdap vaccines that have not been fully evaluated for potential genotoxic 8 or other adverse effects on the human fetus developing in the womb that may negatively affect health after birth, including aluminum adjuvants, mercury containing (Thimerosal) preservatives and many more bioactive and potentially toxic ingredients.9 10 11 12 13 14 15 16 17 18

FACT: There are serious problems with outdated testing procedures for determining the potency and toxicity of pertussis vaccines and some scientists are calling for limits to be established for specific toxin content of pertussis-containing vaccines.19

FACT: There are no published biological mechanism studies that assess pre-vaccination health status and measure changes in brain and immune function and chromosomal integrity after vaccination of pregnant women or their babies developing in the womb.20

FACT: Since licensure of influenza and Tdap vaccines in the U.S., there have been no well designed prospective case controlled studies comparing the health outcomes of large groups of women who get influenza and pertussis containing Tdap vaccines during pregnancy either separately or simultaneously compared to those who do not get the vaccines, and no similar health outcome comparisons of their newborns at birth or in the first year of life have been conducted. Safety and effectiveness evaluations that have been conducted are either small,21 retrospective,22 23 compare vaccinated women to vaccinated women24 or have been performed by drug company or government health officials using unpublished data.25

FACT: The FDA has licensed Tdap vaccines to be given once as a single dose pertussis booster shot to individuals over 10 or 11 years old.  The CDC’s recommendation that doctors give every pregnant woman a Tdap vaccination during every pregnancy - regardless of whether a woman has already received one dose of Tdap - is an off-label use of the vaccine.26

FACT: Injuries and deaths from pertussis-containing vaccines are the most compensated claims in the federal Vaccine Injury Compensation Program (VICP) and influenza vaccine injuries and deaths are the second most compensated claim. 27

FACT: A 2013 published study evaluating reports of acute disseminated encephalomyelitis (ADEM) following vaccination in the U. S. Vaccine Adverse Events Reporting System (VAERS) and in a European vaccine reaction reporting system found that seasonal influenza vaccine was the most frequently suspected cause of brain inflammation after 18 years old, representing 32 percent of the total cases reported, and pertussis containing DTaP was among the vaccines most frequently associated with brain inflammation in children between birth and age five.28

FACT: When a pregnant woman is harmed by an influenza or Tdap vaccine, drug companies selling the vaccines in the U.S., doctors and other vaccine providers are shielded from vaccine injury lawsuits29 but it is unclear whether vaccine injuries sustained by an unborn child in the womb will qualify for federal vaccine injury compensation.30

References

1 Gruber MF. Maternal Immunization: US FDA Regulatory Considerations(Abstract). Vaccine 2003; 21(24): 3487-3491.

2 CDC. Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) in Pregnant Women and Persons Who Have or Anticipate Having Close Contact with an Infant Aged Under 12 Months – ACIP, 2011. Safety of Tdap Vaccine In Pregnant Women. MMWR Oct. 21, 2011; 60(41): 1424-1426.

3 Christian LM, Iams JD, Porter K, Glaser R. Inflammatory Responses to Trivalent Influenza Virus Vaccine Among Pregnant Women. Vaccine 2011; 29(48): 8982-8987.

4 Drugs.com. FDA Pregnancy Categories. Drugs.com October 2013.

5 NVIC.org. Influenza Vaccine Package Inserts (2013-2014): Important Information from Manufacturers. NVIC 2013.

6 Sanofi Pasteur. Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) Full Prescribing Information. Use in Specific Populations: 8.1 Pregnancy Category C. Sanofi Pasteur April 2013.

7 Glaxo-Smith Kline. BOOSTRIX (Tetanus Toxoid, Reducated Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) Full Prescribing Information.  Specific Populations: 8.1 Pregnancy Category B.

8 Schmidt CW.Uncertain Inheritance: Transgenerational Effects of Environmental Exposures. Environmental Health Perspectives October 2013;12(10).

9 CDC. Vaccine Excipients & Media Summary (Vaccine Ingredients).Appendix B.The Pink Book, 12th Edition, Second Printing 2012.  Webpage last updated February 2012.

10 Tomlejenovic L, Shaw CA. Aluminum Vaccine Adjuvants: Are They Safe? Current Medicinal Chemistry 2011; 19(17): 2630-2637.

11 Krewski D, Yokel RA, Nieboer E et al. Human Health Risk Assessment for Aluminum, Aluminum Oxide, Aluminum Hydroxide. J Toxicol Environ Health B Crit Rev 2007; 10(Suppl 1); 1-269.

12 Ayoub D Yazbak FE. Influenza vaccination during pregnancy: A critical Assessment of the Recommendations of the Advisory Committee on Immunization Practices (ACIP). Journal of American Physicians & Surgeons 2006; 11(2): 41-47.

13 Elce D, Celik A. Genotoxicity of thimerosal in cultured human lymphocytes with and without metabolic activation sister chromatid exchange analysis proliferation index and mitotic index. Toxicology in Vitro June 2008; 22(4): 927-934.

14 Speit G, Neuss S, Schutz P et al. The genotoxic potential of gluteraldehyde in mammalian cells in vitro in comparison with formaldehyde. Mutation Research 2008; 649: 146-154.

15 Toxicology Data Network. 2-Phenoxyethanol. National Library of Medicine. Webpage last reviewed Jan. 19, 2012.

16 ScienceLab.com. Material Safety Data Sheet: Polysorbate 80(Tween 80). ScienceLab.com. Webpage last updated May 21, 2013.  

17 Gajdova M, Jakubousky J, Valky J. Delayed effects of neonatal exposure to Tween 80 on female reproductive organs in rats. Abstract. Food Chem Toxicol 1993; 31(3): 183-190.

18 FDA. Summary: Potential for contamination of biological products with the agent of bovine spongiform encephalopathy (BSE). Transmissable Spongiform Encephalopathies Advisory Committee (TSEAC) and Vaccines & Related Biological Products Advisory Committee (VRBPAC). July 27, 2000.

19 Corbel JJ, Xing DKL. Toxicity and potency evaluation of pertussis vaccines. Expert Rev. Vaccines 2004; 3(1): 89-101.

20 Food and Drug Administration (FDA). Guidance for Industry: Consideration for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications (Non-Binding Recommendations). Design of Developmental Toxicity Studies: General Considerations and Recommendations. Centers for Biologics Evaluation Research (CBER) February 2006. (Webpage updated April 19, 2012).  

21 Zeteyeva YA, Moro PL, Tepper HK et al. Adverse event reports after tetanus toxoid, reduced diphtheria toxoid and acelullar pertussis vaccines in pregnant women. Am J Obstet Gynecol 2012 207(1).

22 Mak TK, Mangtani P, Leese J et al. Influenza vaccination during pregnancy: current evidence and selected national policies. The Lancet 2008; 8(1): 44-52.

23 Munoz FM, Greisinger AJ, Wehrmanen DA. Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol 2005; 192(4): 1098-1106.

24 Zaman K, Roy E, Arifeen SE et al. Effectiveness of maternal influenza immunization in mothers and infants. N Engl J Med 2008; 359: 1555-1564.

25 CDC. Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) in Pregnant Women and Persons Who Have or Anticipate Having Close Contact with an Infant Aged Under 12 Months – ACIP, 2011.Safety of Tdap in Pregnant Women. MMWR Oct. 21, 2011; 60(41): 1424-1426.  

26 Infectious Diseases in Children. ACIP recommends Tdap vaccine during each pregnancy. Healio.com November 2012. 

27 Health Resources Services Administration (HRSA). National Vaccine Injury Compensation Program Statistics Report: Claims Filed and Compensated or Dismissed by Vaccine.DHHS: Oct. 17, 2013.

28 Pellegrino P, Carnovate C, Perrone V et al. Acute Disseminated Encephalomelitis Onset: Evaluation Based on Vaccine Adverse Events Reporting Systems. PLOS One October 2013; 8(10).

29 Businesswire. NVIC Cites “Betrayal” of Consumers by U.S. Supreme Court Giving Total Liability Shield to Big Pharma. NVIC Press Release Feb. 23, 2011.

30 Feemster KA. Advisory Commission on Childhood Vaccines Maternal Immunization Working Group Draft Recommendations. ACCV June 7, 2013.

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