Flu Shot Safety for Moms-to-Be
The Centers for Disease Control and Prevention (CDC) recommend that pregnant women receive the influenza vaccine. However, the influenza vaccine is considered a category C drug by the FDA. The FDA uses a letter to categorize drugs based on what is known about the drug when used in pregnant women and animals. The categories are as follows:
- Drugs in category A: Adequate and well-controlled studies have not found any risk to the fetus in the first trimester and no risk in later trimesters.
- Drugs in category B: animal reproduction studies do not demonstrate any risk to the fetus. In pregnant women, there are no adequate or well-controlled studies.
- Drugs in category C: animal reproduction studies have showed averse affects on the animal fetus and there are no adequate and well-controlled studies in humans. However, the benefits may outweigh the risks.
- Drugs in category D: there is evidence of human fetus risk based on studies or from investigational or marketing experiences. However, benefits may outweigh the risks.
- Drugs in category X: there are studies in animals and/or humans that have demonstrated fetal abnormalities. The risk in using these drugs outweigh the benefits, do not take these medications during pregnancy.
The Fluzone vaccine, states in the insert “Pregnancy Category C: Animal reproduction studies have not been conducted with Fluzone. It is also not known whether Fluzone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone should be given to a pregnant woman only if clearly needed”
Flu Vaccine: Only If Clearly Needed
So what is a pregnant woman to do? Do your homework, do your research, look at the facts and the studies, and talk with someone that you trust to give you sound medical advice to determine whether or not you should receive the flu shot. The flu shot can and does save lives, and it can reduce the severity of the flu, or prevent you from getting it altogether. We just don’t have any sound studies on its safety in pregnant women. As the authors of a 2012 study that specifically addressed the issue of tracking the flu and the flu vaccine in pregnant women state, “there are remarkably little data available on the fetal and maternal safety of influenza vaccines when given to pregnant women.”
“Should I get a flu shot when I’m pregnant?” Without clinical data, this is a hard question for all moms.
Atladóttir HÓ, Henriksen TB, Schendel DE, Parner ET. Autism after infection, febrile episodes, and antibiotic use during pregnancy: an exploratory study. (2012). Pediatrics. 2012. Accessed October 20, 2013.
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Centers for Disease Control and Prevention. Summary* Recommendations: Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—(ACIP)—United States, 2013-14. (2013). Accessed October 20, 2013.
Hansley, NA., Hyman, SL., Conference writing panel. “Measles-mumps-rubella vaccine and autistic spectrum disorder: report from the New Challenges in Childhood Immunizations Conference convened in Oak Brook, Illinois, June 12-13, 2000″. (2001). Pediatrics. Accessed October 20, 2013.
Food and Drug Administration. FDA Pregnancy Categories. Accessed October 20, 2013.
Mayo Clinic. Flu Shots During Pregnancy Reduce Autism Risk Transcript. (2013). Accessed October 20, 2013.
Parboosing R, Bao Y, Shen L, Schaefer CA, Brown AS. “Gestational Influenza and bipolar Disorder in Adult Offspring“ (2013). JAMA Psychiatry. Accessed October 20, 2013.
Sanofi Pasteur. Highlights of prescribing information. (2013). Accessed October 20, 2013.
Carol Louik, Christina Chambers, Dawn Jacobs, Fiona Rice, Diana Johnson, Allen A. Mitchell. Influenza vaccine safety in pregnancy: can we identify exposures? (2012). Pharmacoepidemiology and Drug Safety Volume 22, Issue 1. Accessed October 20, 2013.© Copyright 2013 Janelle Vaesa, MPH: Health, All rights Reserved. Written For: Decoded Pregnancy
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