Equity in coronavirus disease 2019 vaccine development and deployment.

Published on Jan 15, 2021in American Journal of Obstetrics and Gynecology6.502
· DOI :10.1016/J.AJOG.2021.01.006
Neena Modi60
Estimated H-index: 60
(Imperial College London),
Diogo Ayres-de-Campos29
Estimated H-index: 29
+ 12 AuthorsLiliana S. Voto10
Estimated H-index: 10
(UBA: University of Buenos Aires)
The COVID-19 pandemic exposed weaknesses in multiple domains and widened gender-based inequalities across the world. It also stimulated extraordinary scientific achievement, bringing vaccines to the public in under a year. In this article, we discuss the implications of current vaccination guidance for pregnant and lactating women, whether their exclusion from the first wave of vaccine trials was justified, and if a change in the current vaccine development pathway is necessary. Pregnant and lactating women were not included in initial SARS-CoV-2 vaccine trials. Perhaps unsurprisingly therefore, the first vaccine regulatory approvals have been accompanied by inconsistent advice from public health, governmental, and professional authorities around the world. Denying vaccination to women who though pregnant or breastfeeding are fully capable of autonomous decision-making is a throwback to a paternalistic era. Conversely, lack of evidence upon which to make an informed decision generated in a timely manner, shifts responsibility from research sponsors and regulators, and places the burden of decision-making upon a woman and her healthcare advisor. The World Health Organization (WHO), the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), and others have highlighted the long-standing disadvantage experienced by women in relation to the development of vaccines and medicines. It is uncertain whether there was sufficient justification for excluding pregnant and lactating women from initial SARS-CoV-2 vaccine trials. In future, we recommend regulators mandate plans that describe the development pathway for new vaccines and medicines that address the needs of women who are pregnant or lactating. These should incorporate at the outset, careful consideration of the balance of risks of exclusion or inclusion from initial studies, patient and public perspectives, details of “Developmental and Reproductive Toxicity” studies, and approaches to collect data systematically from participants who are unknowingly pregnant at the time of exposure. This requires careful consideration of any prior knowledge of the mode of action of the vaccine and the likelihood of toxicity or teratogenicity. We also support the view that the default position should be a “presumption of inclusion”, with exclusion of women who are pregnant or lactating only if justified on specific, not generic, grounds. Finally, we recommend closer coordination across countries with the aim of issuing consistent public health advice.
📖 Papers frequently viewed together
5 Authors (Tina Proveaux, ..., Neal A. Halsey)
11 Citations
37 Citations
4 Citations
#1Raigam J Martinez-Portilla (University of Barcelona)H-Index: 9
#2Alexandros Sotiriadis (A.U.Th.: Aristotle University of Thessaloniki)H-Index: 29
Last. Liona C. Poon (CUHK: The Chinese University of Hong Kong)H-Index: 42
view all 11 authors...
OBJECTIVE: There are limited, unmatched data reporting low complication rates in pregnant women with coronavirus disease 2019 (COVID-19). The aim of this study was to compare COVID-19-related outcomes between pregnant and non-pregnant women after adjusting for potential risk factors for severe outcomes. METHODS: Data were obtained from the COVID-19 National Data Registry of Mexico, which is an ongoing prospective cohort of people of any age with clinically suspected severe acute respiratory synd...
20 CitationsSource
#1Carleigh B. Krubiner (Johns Hopkins University)H-Index: 11
#2Ruth R. Faden (Johns Hopkins University)H-Index: 65
Last. Paulina TindanaH-Index: 21
view all 17 authors...
Abstract Zika virus, influenza, and Ebola have called attention to the ways in which infectious disease outbreaks can severely – and at times uniquely – affect the health interests of pregnant women and their offspring. These examples also highlight the critical need to proactively consider pregnant women and their offspring in vaccine research and response efforts to combat emerging and re-emerging infectious diseases. Historically, pregnant women and their offspring have been largely excluded ...
39 CitationsSource
#1Alexander Kotlyar (Yale University)H-Index: 5
#2Olga Grechukhina (Yale University)H-Index: 6
Last. Reshef Tal (Yale University)H-Index: 24
view all 8 authors...
Abstract Objective We sought to conduct a systematic review of the current literature to determine estimates of vertical transmission of COVID-19 based upon early RNA detection of SARS-CoV-2 after birth from various neonatal/fetal sources and neonatal serology. Data sources Eligible studies published up to May 28, 2020 were retrieved from Pubmed, EMbase, MedRXiv, BioRXiv collection databases. Study eligibility criteria This systematic review included cohort studies, case series and case reports ...
118 CitationsSource
Studies suggest that pregnant women might be at increased risk for severe illness associated with coronavirus disease 2019 (COVID-19) (1,2). This report provides updated information about symptomatic women of reproductive age (15-44 years) with laboratory-confirmed infection with SARS-CoV-2, the virus that causes COVID-19. During January 22-October 3, CDC received reports through national COVID-19 case surveillance or through the National Notifiable Diseases Surveillance System (NNDSS) of 1,300,...
204 CitationsSource
106 CitationsSource
#1Roger Pique-Regi (WSU: Wayne State University)H-Index: 27
#1Roger Pique-Regi (WSU: Wayne State University)H-Index: 3
Last. Nardhy Gomez-Lopez (WSU: Wayne State University)H-Index: 38
view all 9 authors...
The pandemic of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected more than 10 million people, including pregnant women. To date, no consistent evidence for the vertical transmission of SARS-CoV-2 exists. The novel coronavirus canonically utilizes the angiotensin-converting enzyme 2 (ACE2) receptor and the serine protease TMPRSS2 for cell entry. Herein, building upon our previous single-cell study (Pique-Regi et al., 2019)...
88 CitationsSource
Last. Daniele De Luca (French Institute of Health and Medical Research)H-Index: 34
view all 8 authors...
SARS-CoV-2 outbreak is the first pandemic of the century. SARS-CoV-2 infection is transmitted through droplets; other transmission routes are hypothesized but not confirmed. So far, it is unclear whether and how SARS-CoV-2 can be transmitted from the mother to the fetus. We demonstrate the transplacental transmission of SARS-CoV-2 in a neonate born to a mother infected in the last trimester and presenting with neurological compromise. The transmission is confirmed by comprehensive virological an...
347 CitationsSource
#1Ann M. Arvin (Stanford University)H-Index: 97
#2Katja FinkH-Index: 30
Last. Herbert W. Virgin (WashU: Washington University in St. Louis)H-Index: 121
view all 9 authors...
The possibility of antibody-dependent enhancement (ADE) of disease is a general concern for the development of vaccines and antibody therapies because the mechanisms that underlie antibody protection have the theoretical potential to amplify viral infections or trigger immunopathology. Observations relevant to the risks of ADE of disease require careful review at this critical point in the SARS-CoV-2 pandemic. At present, no clinical findings, immunologic assays or biomarkers are known to differ...
220 CitationsSource
#1Tomer Zohar (MIT: Massachusetts Institute of Technology)H-Index: 4
#2Galit Alter (Ragon Institute of MGH, MIT and Harvard)H-Index: 84
Understanding the properties and mechanisms by which antibodies provide protection is essential to defining immunity. Although neutralizing antibodies have been proposed as a potential key mechanism of protection against many viral pathogens, antibodies mediate additional immune functions that may have both protective and pathological consequences. Dissecting these properties against SARS-CoV-2 is likely necessary for defining metrics of immunity that will inform the design of vaccines and thera...
104 CitationsSource
#1A. Lamouroux (University of Montpellier)H-Index: 2
#2Tania Attié-Bitach (Necker-Enfants Malades Hospital)H-Index: 67
Last. Yves Ville (Necker-Enfants Malades Hospital)H-Index: 83
view all 5 authors...
Abstract COVID-19 can severely affect pregnant women and the issue of vertical transmission of sars-cov-2 has also emerged. Sars-cov-2 could be recovered by real-time (RT) PCR from nasal and throat swabs, sputum and feces of symptomatic patients including neonates but not from vaginal swabs, amniotic fluid, placenta, cord blood, neonatal blood or breast milk. Viremia was present in 1% of symptomatic adults. We identified 12 articles published between February 10th and April 4th 2020 reporting on...
83 CitationsSource
Cited By9
#1Ishan Garg (Mayo Clinic)H-Index: 6
Last. Suman Pal (UNM: University of New Mexico)H-Index: 3
view all 2 authors...
Coronavirus 2019 (COVID-19) has created a global pandemic that is devastating human lives, public healthcare systems, and global economies. Multiple effective and safe COVID-19 vaccines have been developed at an unprecedented speed due to the efforts of the scientific community, and collaboration between the federal government and pharmaceutical companies. However, the continued exclusion of pregnant and lactating women from the COVID anti-viral and vaccine trials has created the paradox of a la...
#1Skyler McLaurin-Jiang (TTUHSC: Texas Tech University Health Sciences Center)
#2Christine D Garner (TTUHSC: Texas Tech University Health Sciences Center)
Last. Thomas W. Hale (TTUHSC: Texas Tech University Health Sciences Center)H-Index: 22
view all 4 authors...
Background: The impact of COVID-19 vaccination on breastfeeding is unknown. The primary aim of this study was to determine whether vaccine-related side effects following COVID-19 vaccination were associated with an adverse impact on breastfeeding. Secondarily, we sought to determine perceived symptoms in breastfed children and maternal opinion about COVID-19 vaccination. Materials and Methods: We conducted a cross-sectional survey of breastfeeding mothers who underwent COVID-19 vaccination >2 da...
#1Eleonora Brillo (University of Rome Tor Vergata)H-Index: 2
#2Valentina Tosto (University of Perugia)H-Index: 5
Last. Ersilia Buonomo (University of Rome Tor Vergata)H-Index: 14
view all 4 authors...
Aim To identify whether COVID-19 vaccines should be administered in pregnant and breastfeeding women by reviewing the guidance and other evidence. Methods We reviewed the COVID-19 vaccination guidance for pregnant and breastfeeding women published to date and evidence from preclinical experimental and observational clinical studies, and discuss their implications. Results Pregnant women were excluded from the initial phase 3 clinical trials of COVID-19 vaccines resulting in limited data on their...
#1Eran Hadar (TAU: Tel Aviv University)H-Index: 19
#2Sarah Dollinger (TAU: Tel Aviv University)H-Index: 1
Last. Arnon Wiznitzer (TAU: Tel Aviv University)H-Index: 17
view all 3 authors...
Purpose of the study: To discuss selected aspects of our local and national experience in treating and vaccinating pregnant women with SARS-CoV-2 infection and COVID-19 disease.Materials and methods: A comprehensive, retrospective review of COVID-19 parturients in our center as well as a detailed literature review of several aspects from the groundbreaking research done in Israel to investigate the direct obstetrical impact of COVID-19, indirect effect of the lockdown measures and the vaccinatio...
#1Athimalaipet V Ramanan (University Hospitals Bristol NHS Foundation Trust)H-Index: 42
#2Neena Modi (Imperial College London)H-Index: 60
Last. Saskia N. de Wildt (Boston Children's Hospital)H-Index: 32
view all 3 authors...
The COVID-19 pandemic has had a devastating impact on multiple aspects of healthcare, but has also triggered new ways of working, stimulated novel approaches in clinical research and reinforced the value of previous innovations. Conect4children (c4c, null null null null null null null null null null null null null null null null www.conect4children.org null null null null null null null null null null null null null null null null null null null null null null null null null null null null null ...
#1Meredith L. Snook (University of Pittsburgh)H-Index: 2
#2Richard H. Beigi (University of Pittsburgh)H-Index: 26
Last. Catharine I. Paules (Penn State Milton S. Hershey Medical Center)H-Index: 2
view all 4 authors...
#1Neena Modi (Imperial College London)H-Index: 60
#2Mark A. HansonH-Index: 104
Neena Modi and Mark Hanson argue that new economic policies focusing on the wellbeing of women and children will produce a fairer, stronger, and more resilient society
1 CitationsSource
The COVID-19 pandemic may be of particular concern for pregnant and breastfeeding women. We aimed to explore their beliefs about the coronavirus and COVID-19 vaccine willingness and to assess the impact of the pandemic on perinatal experiences and practices. A multinational, cross-sectional, web-based study was performed in six European countries between April and July 2020. The anonymous survey was promoted via social media. In total, 16,063 women participated (including 6661 pregnant and 9402 ...
7 CitationsSource
#1Yalda Afshar (UCLA: University of California, Los Angeles)H-Index: 14
#2Jacqueline G. Parchem (University of Texas Health Science Center at Houston)H-Index: 1
Last. Jacqueline G. Parchem (University of Texas Health Science Center at Houston)H-Index: 2
view all 2 authors...