Introduction of new vaccines for immunization in pregnancy – Programmatic, regulatory, safety and ethical considerations

Kochhar, Sonali; Edwards, Kathryn M.; Álvarez, Alba; Moro, Pedro L.; Ortiz, Justin R.

doi:10.1016/j.vaccine.2019.04.075

Cited by 39 publications

(28 citation statements)

References 59 publications

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“…Compared to the general population, pregnant women are often at greater risk for significant morbidity and mortality from epidemic diseases, including Ebola, Lassa fever, and influenza (70). Other epidemics in pregnant women, such as Zika and measles, have also had tragic consequences for their offspring (71,72).…”

Section: The Ethics Of Enrolling Pregnant Women and Children In Reseamentioning

confidence: 99%

SERINC5 as a New Restriction Factor for Human Immunodeficiency Virus and Murine Leukemia Virus

et al. 2018

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SERINC genes encode for homologous multipass transmembrane proteins with unknown cellular function, despite being highly conserved across eukaryotes. Among the five SERINC genes found in humans, SERINC5 was shown to act as a powerful inhibitor of retroviruses. It is efficiently incorporated into virions and blocks the penetration of the viral core into target cells, by impairing the fusion process with a yet unclear mechanism. SERINC5 was also found to promote human immunodeficiency virus 1 (HIV-1) virion neutralization by antibodies, indicating a pleiotropic activity, which remains mostly unexplored. Counteracting factors have emerged independently in at least three retrovirus lineages, underscoring their fundamental importance during retrovirus evolution. Nef and S2 of primate and equine lentiviruses, and glycoGag of gammaretroviruses, act similarly by targeting SERINC5 to endosomes and excluding it from virions. Here, we discuss the features that distinguish SERINC5 from other known restriction factors, delineating a yet unique class of antiviral inhibitors.

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Section: The Ethics Of Enrolling Pregnant Women and Children In Reseamentioning

confidence: 99%

SERINC5 as a New Restriction Factor for Human Immunodeficiency Virus and Murine Leukemia Virus

et al. 2018

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“…Multiple factors complicate the introduction of new vaccines, including epidemiological data on specific disease burden and background on pregnancy outcomes in the target population [21][22][23].…”

Section: Introductionmentioning

confidence: 99%

Adverse pregnancy outcomes among women presenting at antenatal clinics in Ouélessébougou, Mali

Andemel

Gaoussou²,

Issiaka³

et al. 2020

Reprod Health

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Background: In sub-Saharan Africa, malaria continues to scourge the population and is the primary cause of morbidity and mortality in young children and pregnant women. As current preventative measures such as intermittent preventive treatment and use of insecticide-treated nets provide incomplete protection, several malaria vaccines are currently under development, including one to specifically prevent pregnancy malaria. Prior to conducting vaccine trials, it is important to obtain background information on poor pregnancy outcomes in the target population to establish a baseline. Methods: Pregnant women presenting at community health care centers for antenatal care were recruited to the study. Gestational age was determined by ultrasound examination following recruitment. Antenatal care and pregnancy outcome information were collected during a visit 4-8 weeks post-delivery. Results: One thousand eight hundred fifty women completed the study, and analysis included 1814 women after excluding multiple gestations (n = 26) and missing/incomplete data (n = 10). The percentage (95% CI) of adverse pregnancy outcomes is as follows: miscarriage, 0.28% (0.04-0.52); stillbirth, 1.93% (1.30-2.56); early neonatal death, 1.65% (1.03-2.24); late neonatal death, 0.39%, (0.10-0.68); and preterm delivery (PTD), 4.74% (3.76-5.73). The percentages of early and late neonatal deaths and PTD were significantly higher (p < 0.01) in primigravid compared to multigravid women. In primigravidae, 3.1, 1.1 and 7.1% of pregnancies resulted in early neonatal death, late neonatal death and PTD, respectively, while these outcomes in multigravidae were 1.0, 0.1 and 2.7%, respectively. Major malformations were identified in 4 newborns. Conclusions: Low gravidity and young age predict perinatal death and PTD. The information collected here can be used as a baseline for adverse pregnancy outcomes in future vaccine trials in pregnant women.

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“…Although safety was not mentioned by respondents in this study as a barrier to vaccine recommendations in India, previous experience indicates disease burden, vaccine safety and efficacy, and economic evaluations will all be needed to move toward a decision. 63,64 For countries such as India, where decisions have not been made to adopt maternal vaccines beyond Td, sharing experiences about the benefit of maternal immunization programs in other countries, may be useful. Stronger global policies around influenza and pertussis vaccination will likely be needed for countries to adopt them, but the first steps of improving surveillance and developing infrastructure that enables stronger integration with antenatal care will be needed at early stages.…”

Section: Discussionmentioning

confidence: 99%

Determinants of policy and uptake of national vaccine programs for pregnant women: results of mixed method study from Spain, Italy, and India

Privor-Dumm

2020

Human Vaccines & Immunotherapeutics

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An important strategy for addressing maternal and newborn risks of disease is through vaccinating pregnant women. We conducted a mixed-methods study including a narrative literature review of drivers of maternal vaccination and key informant interviews in Spain, Italy, and India to characterize different approaches to national maternal immunization programs. Fifty-nine respondents participated in the study conducted between November 2018 and January 2019. Policies in Spain and Italy both reflect a life-course approach to vaccination, but recommendations and how they ensure uptake differs. Italy was focused on tracking of progress and mandates to ensure compliance in all regions, while Spain, an early adopter, relied more on advocacy and building provider acceptance. India includes Td in their national program, but the political will and advocacy for other vaccines are not seen. Needs for improving rates of maternal vaccination include education of health-care providers and pregnant women, use of central registries to track progress, stronger global guidance for use of vaccines, and engagement of champions, particularly obstetrician-gynecologists (ob-gyns). Health security concerns can also be leveraged to build political priority and needed platforms to detect disease and deliver vaccines in some countries. Understanding what drives a country's maternal immunization program decisions and the success of implementation is useful in designing strategies to share best practices and guide support to strengthen platforms for maternal vaccination.

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Introduction of new vaccines for immunization in pregnancy – Programmatic, regulatory, safety and ethical considerations

Cited by 39 publications

References 59 publications

SERINC5 as a New Restriction Factor for Human Immunodeficiency Virus and Murine Leukemia Virus

SERINC5 as a New Restriction Factor for Human Immunodeficiency Virus and Murine Leukemia Virus

Adverse pregnancy outcomes among women presenting at antenatal clinics in Ouélessébougou, Mali

Determinants of policy and uptake of national vaccine programs for pregnant women: results of mixed method study from Spain, Italy, and India

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