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Safety of influenza vaccines in pregnant women

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Prevention of influenza in pregnant women and their newborns through maternal immunization is a safe and effective intervention during seasonal epidemics and a priority during a pandemic. While influenza vaccination of pregnant women has been routine in the United States since the 1950s, coverage rates increased significantly only after the 2009 H1N1 influenza pandemic. Epidemiologic and clinical studies support the safety of inactivated influenza vaccines in pregnant women and their infants. Safety barriers to the use of vaccines during pregnancy can be addressed through research, active surveillance, and education.

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Evaluating the safety of influenza vaccine during pregnancy

Inactivated influenza vaccine has been routinely administered to pregnant women since the 1950s in the United States, and since 1997, pregnancy has been included in the ACIP list of high-risk conditions requiring routine annual influenza vaccination. Therefore, vast experience and clinical data are available for influenza vaccine, the most frequently administered vaccine during pregnancy other than tetanus toxoid. No study conducted to date has shown a harmful consequence of influenza

Seasonal influenza vaccine safety–prospective cohort and randomized controlled clinical trials

A large prospective cohort study and a few randomized controlled clinical trials provide information on the safety of the early formulations of influenza vaccines.

In the Collaborative Perinatal Project conducted from 1959 through 1965 in the United States, >50,000 pregnant women immunized with different vaccines and their children were followed for up to 7 years to evaluate factors associated with central nervous system injury and cerebral palsy.4, 5 Trivalent inactivated vaccine was received

Seasonal influenza vaccine safety–retrospective and database studies

Retrospective studies using established databases to evaluate the occurrence of adverse events that may be associated with influenza vaccination have provided reassuring results in support of the safety of routine administration of influenza vaccine during pregnancy. First, utilizing the California managed care system, France et al15 found no differences in birthweight, gestational age, or length of hospitalization after delivery among 3160 infants born to women who received influenza vaccine

2009 H1N1 influenza pandemic and vaccine safety

The 2009 H1N1 influenza pandemic brought influenza vaccination of pregnant women to the forefront of research and public health implementation efforts. Facing a high rate of complications and mortality, pregnant women were among the first to receive the 2009 H1N1 inactivated monovalent vaccine. Thousands of pregnant women were vaccinated around the world. Clinical trials were performed simultaneously in pregnant and nonpregnant adults, and the clinical experience of maternal immunization has

Continuing safety assessments of influenza vaccines in pregnancy

Efforts to evaluate the safety of influenza vaccines during pregnancy are ongoing. Manufacturers have established pregnancy registries and active postlicensure studies to continuously assess the safety and clinical efficacy of influenza vaccines, particularly novel adjuvanted vaccines. In the United States, established surveillance systems such as VAERS and the Vaccine Safety Datalink, and networks created in response to the H1N1 pandemic, will continue to monitor adverse events that could be

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    The findings and conclusions in this report are those of the author and do not necessarily represent the official position of the National Vaccine Program Office, the Centers for Disease Control and Prevention, or the Food and Drug Administration.

    The author reports no conflict of interest.

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