Global and National Initiatives to Facilitate Studies of Vaccines in Pregnant Women

Vaccination of pregnant women can protect women and newborn infants against certain infectious diseases, as evidenced by the success of maternal tetanus vaccination programs [1, 2]. There has been recent renewed interest and focus on maternal immunization, defined in this article as vaccination of pregnant women, as a means to protect the mother and young infants from additional vaccine-preventable diseases. For example, because of increased morbidity associated with influenza during pregnancy, inactivated influenza vaccines are now recommended for use in women during all stages of pregnancy in numerous countries [3, 4]. In addition, tetanus, diphtheria, and acellular pertussis vaccines have been recommended recently for pregnant women in an effort to reduce the burden of pertussis in infants [5, 6]. Other maternal immunization strategies to protect the fetus, the newborn, and the infant from infectious diseases not preventable by current vaccination strategies are in development and include vaccines against cytomegalovirus, respiratory syncytial virus, and group B Streptococcus (GBS) [7–9]. Implementation of maternal vaccination programs has been poor or modest in many countries [10–12]. This is due to several reasons including lack of safety and effectiveness data obtained in pregnant women for specific vaccines, theoretical concerns about fetal risk from vaccination of pregnant women, manufacturers’ liability concerns, and practical barriers such as a lack of infrastructure for storing vaccines in antenatal clinics. For maternal immunization programs to be successfully implemented, overcoming these perceived and real obstacles is important. A number of global and national initiatives to promote and facilitate maternal immunization are under way and are summarized in this article. Although the majority of these initiatives focus on maternal immunization with inactivated influenza vaccines, the concepts are applicable to other vaccines that are either currently in development or recommended by public health bodies for use in pregnant women. In recent years, growing interest in maternal immunization has been evident in the activities of both public and private entities concerned with international public health. In 2012, the World Health Organization (WHO) recommended that pregnant women have the highest priority for seasonal influenza vaccination in countries considering the initiation or expansion of influenza immunization programs [4]. The recommendation was based on a review of burden of influenza disease, influenza vaccine safety, and influenza vaccine effectiveness by the WHO Strategic Advisory Group of Experts on Immunization (SAGE) [13]. In 2012, the WHO Global Advisory Committee on Vaccine Safety evaluated data from interventional and noninterventional studies and spontaneous reporting systems derived from vaccination of pregnant women with a number of viral, bacterial, toxoid, and live attenuated vaccines. The Committee concluded that there is no evidence of adverse pregnancy outcomes from vaccinating pregnant women with inactivated viral, bacterial, or toxoid vaccine [14].Based on a meeting in 2013, convened to devise methods to promote maternal immunization and Correspondence: Marion F. Gruber, PhD, US Department of Health and Human Services, 10903 New Hampshire Ave, Bldg 71, Rm 3230, Silver Spring, MD 20993 (marion.gruber@fda.hhs.gov). Clinical Infectious Diseases 2014;59(S7):S395–9 Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US. DOI: 10.1093/cid/ciu707