Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy

Roberts, Jeffrey N.; Gruber, Marion F.

doi:10.1016/j.vaccine.2014.12.068

Cited by 41 publications

(36 citation statements)

References 28 publications

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“…Regulatory authorities require that pre-licensure trials evaluate the safety and efficacy of vaccine administration in pregnant women before allowing an indication and usage statement in the prescribing information that specifically addresses use in pregnancy [103]. Until recently, no vaccine has had a specific indication during pregnancy because no licensed vaccine has been studied in pregnant women in pre-licensure trials [103].…”

Section: Regulatory Requirements and Labelling Considerationsmentioning

confidence: 99%

“…Until recently, no vaccine has had a specific indication during pregnancy because no licensed vaccine has been studied in pregnant women in pre-licensure trials [103]. This is beginning to change; many post-licensure studies have been conducted to evaluate vaccine safety and effectiveness in pregnant women.…”

Section: Regulatory Requirements and Labelling Considerationsmentioning

confidence: 99%

“…Based on available post-licensure safety data and after discussions with the European regulatory authorities [104], the posology and the pregnancy sections of the European summary of product characteristics of one of the commercially available Tdap vaccines (Boostrix, GSK) were recently updated to reflect that the use of this vaccine may be considered during the third trimester of pregnancy. However, it should be noted that the absence of a specific statement in the indication section of the vaccine label does not preclude vaccine use in pregnant women [103].…”

Section: Regulatory Requirements and Labelling Considerationsmentioning

confidence: 99%

“…In an attempt to reduce these barriers, regulatory agencies in the US are working with the vaccine industry to delineate the processes to develop and approve vaccines for use during pregnancy [103].…”

Section: Regulatory Requirements and Labelling Considerationsmentioning

confidence: 99%

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Maternal immunization: where are we now and how to move forward?

et al. 2018

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Pregnancy and the postpartum period are associated with elevated risks to both mother and infant from infectious disease. Vaccination of pregnant women, also called maternal immunization, has the potential to protect pregnant women, foetuses and infants from several vaccinepreventable diseases. Maternal immunoglobulin G antibodies are actively transferred through the placenta to provide passive immunity to new-borns during the first months of life, until the time for infant vaccinations or until the period of greatest susceptibility has passed. Currently, inactivated influenza, tetanus, and pertussis vaccines are recommended during pregnancy in many countries, but other vaccines may also be administered to pregnant women when risk factors are present. Several new vaccines with a specific indication for use during pregnancy are under development (e.g. respiratory syncytial virus and group B streptococcus vaccines). Years of experience suggest that maternal immunization against influenza, tetanus or pertussis has an acceptable safety profile, is well tolerated, effective and confers significant benefits to pregnant women and their infants. This review describes the principles of maternal immunization and provides an update of the recent evidence regarding the use and timing of maternal immunization. Finally, the barriers preventing wider vaccination coverage and the current limitations in addressing these are also described (Supplementary Material). KEY MESSAGESMaternal immunization gives pregnant women greater protection against infectious diseases; induces high levels of maternal antibodies that can be transferred to the foetus; and helps protect new-borns during their first months of life, until they are old enough to be vaccinated. Pregnant women and new-borns are more vulnerable to infectious diseases than the overall population; nevertheless, vaccination rates are often low in pregnant women. This review provides an update of the recent evidence regarding the use and timing of maternal immunization and describes the barriers preventing wider vaccination uptake and the current limitations in addressing these. ARTICLE HISTORY

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Section: Regulatory Requirements and Labelling Considerationsmentioning

confidence: 99%

Section: Regulatory Requirements and Labelling Considerationsmentioning

confidence: 99%

Section: Regulatory Requirements and Labelling Considerationsmentioning

confidence: 99%

Section: Regulatory Requirements and Labelling Considerationsmentioning

confidence: 99%

See 2 more Smart Citations

Maternal immunization: where are we now and how to move forward?

et al. 2018

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“…The EMA has outlined specific requirements for evaluating vaccines in pregnant women, including: criteria to select medicinal products, including vaccines, for which active surveillance in pregnancy is necessary, guidance on how to monitor accidental or intended exposure to medicinal products during pregnancy and specific requirements for reporting and presenting data on adverse outcomes of exposure during pregnancy [29]. In the FDA and ICH guidelines, only general guidance was available, but specific requirements are now emerging with the inclusion of available data on maternal immunization in the product labeling [30]. …”

Section: Preamblementioning

confidence: 99%

Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women

Jones

Muñoz

Spiegel

et al. 2016

Vaccine

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Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries.

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Maternal Immunization: Protecting Vulnerable Populations

Englund

2016

The Vaccine Book

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Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy

Cited by 41 publications

References 28 publications

Maternal immunization: where are we now and how to move forward?

Maternal immunization: where are we now and how to move forward?

Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women

Maternal Immunization: Protecting Vulnerable Populations

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