Vaccine Safety for Ob-Gyns
Every Child By Two (ECBT)
Vaccine Education Center (Children's Hospital of Philadelphia)
NEW! Please click below for two recent studies in press in the journal Vaccine regarding the safety of the H1N1 vaccination in pregnant women. The Chambers article found for the 2009-2012 influenza seasons combined, no meaningful evidence of increased relative risks or hazard ratios for major birth defects, spontaneous abortion, or small for gestational age infants. The Louik article finds there was decreased preterm birth risk during the 2010-2011 influenza season, however, risk was increased in the 2009-2010 season by <2 days. No meaningful risk was found for any of 41 specific defect categories, and the study adds to reassuring literature about pH1N1 vaccine in pregnancy.
Journal of Pediatrics Study: "Increasing exposure to antibody-stimulating proteins and polysaccharides in vaccines is not associated with risk of autism", evaluating the impact of early childhood vaccines, and researchers have found that there is no connection with autism. Please click here to read more.
Updated! Seasonal flu vaccine safety and pregnant women, from the CDC.
Immunization against seasonal influenza (flu) and other vaccine-preventable diseases is an essential component of women’s prenatal, primary and preventive health care. A key barrier to vaccine acceptance is a lack of knowledge about the benefits and safety of vaccination. For pregnant, adolescent, and adult women, advice and information from a trusted health care provider plays an important role in the decision to get vaccinated. As the primary health care providers for most women, ob-gyns are in a unique position to educate their patients about the benefits of immunization against seasonal flu and other vaccine-preventable diseases and to provide them with (or refer them for) all their recommended vaccinations.
Research with pregnant women finds that the safety of the baby is a key factor in pregnant women’s motivation to adopt recommendations. Pregnant women are taught to be selective about taking medications. Vaccination messages should acknowledge this belief and provide a clear rational for why vaccine is recommended. Postpartum women have concerns about taking medications while breastfeeding. Health care providers are a key trusted source of information. Ob-gyns should encourage and/or administer seasonal influenza (flu) vaccine to pregnant women. Acknowledge that pregnant women are, and should be, careful about medications they take. Explain that influenza causes risk to mom and baby and stress the safety of the vaccine during pregnancy and while breastfeeding. First time mom’s-to-be are high information seekers. Provide vaccination materials and websites for pregnant women and new moms. See CDC’s Overview and Key Facts on Seasonal Influenza Vaccine Safety: A Summary for Clinicians.
No study to date has shown an adverse consequence of inactivated influenza vaccine in pregnant women or their offspring. The influenza vaccine is made the same way each year, with the only difference being the use of a new strain. There have been no reports of any adverse outcomes in pregnant women or their infants.
Thimerosal, a mercury-containing preservative used in multidose vials, has not been shown to cause any adverse effects, such as autism, except for occasional local skin reactions. There is no scientific evidence that thimerosal (mercury)-containing vaccines cause adverse effects in children born to women who received vaccines with thimerosal.
Vaccines are developed with the highest standards of safety. However, as with any medical procedure, vaccination has some risks. Individuals react differently to vaccines, and there is no way to predict how individuals will react to a particular vaccine. Anyone who gives or receives a licensed vaccine in the U.S. is encouraged to report any significant health problem or unexpected event (even if uncertain that the vaccine caused the event) for any vaccine. The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration. VAERS is a national passive reporting system that accepts reports from the public on adverse events associated with vaccines licensed in the United States. Providers and patients should fill out a VAERS report to document adverse reactions. VAERS also provides a vehicle for disseminating vaccine safety-related information to parents and health care providers, among others.
Black S, Eskola J, Siegrist CA, et al. Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines. Lancet 2009;374(9707):2115–22.
Heinonen OP, Shapiro S, Monson RR, Hartz SC, Rosenberg L, Slone D. Immunization during pregnancy against poliomyelitis and influenza in relation to childhood malignancy. Int J Epidemiol 1973;2:229–35.
Last Updated: 10/18/2013
Vaccine Safety for Patients
Parents: Interested in how a vaccine is developed, approved, and manufactured? Scroll down for a CDC infographic!
Read Seasonal Flu Vaccine Safety and Pregnant Women, from the Centers for Disease Control and Prevention (CDC).
An important part of health care is getting vaccines against seasonal influenza (flu) and other diseases. Some people avoid getting vaccines because they don’t know enough about them. Others have concerns about the benefits and safety of vaccines. Ask your health care provider about your concerns and what vaccines are recommended for you.
If you are pregnant or breastfeeding, you may have special concerns about taking medicine, including vaccines. You should know that flu poses higher risks to you and your baby. You should also know that the flu vaccine is safe for you and your baby. Studies have shown that is safe and can be given during any trimester. If you are pregnant or breastfeeding, you should get the inactivated flu vaccine. No studies have shown any adverse effects in pregnant women or their babies from the inactivated flu vaccine.
Some influenza vaccines are made with thimerosal, which is a mercury-based preservative. Vaccines were once mistakenly reported to cause adverse effects in children, such as autism. No study has shown adverse effects in children born to women who received vaccines with thimerosal.
Vaccines are developed with the highest standards of safety. Before a vaccine can be made available to the public, it is tested for many years. But, as with any medical procedure, vaccination has some risks. Individuals react differently to vaccines, and there is no way to predict how individuals will react to a particular vaccine.
Once a vaccine is licensed for use, it is still watched carefully for problems, called adverse events. Anyone who gives or receives a licensed vaccine in the United States should report any adverse events even if unsure that the vaccine caused the problem. The Vaccine Adverse Event Reporting System (VAERS) is a vaccine safety program sponsored by the CDC and the U.S. Food and Drug Administration. Patients can use VAERS to report any problems they have had with vaccines. VAERS also provides information on vaccine safety.
For more information, visit CDC's section on vaccine safety as well as materials on vaccine safety for parents.
FOR PARENTS: The Jounrey of Your Child's Vaccine, via CDC.
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Last Updated: 9/25/2013