Using maternal and neonatal data collection systems for coronavirus disease 2019 (COVID-19) vaccines active safety surveillance in low- and middle-income countries: an international modified Delphi study.
Gates Open Res
; 5: 99, 2021.
Article
em En
| MEDLINE
| ID: mdl-39049963
ABSTRACT
Background:
Given that pregnant women are now included among those for receipt coronavirus disease 2019 (COVID-19) vaccines, it is important to ensure that information systems can be used (or available) for active safety surveillance, especially in low- and middle-income countries (LMICs). The aim of this study was to build consensus about the use of existing maternal and neonatal data collection systems in LMICs for COVID-19 vaccines active safety surveillance, a basic set of variables, and the suitability and feasibility of including pregnant women and LMIC research networks in COVID-19 vaccines pre-licensure activities.Methods:
A three-stage modified Delphi study was conducted over three months in 2020. An international multidisciplinary panel of 16 experts participated. Ratings distributions and consensus were assessed, and ratings' rationale was analyzed.Results:
The panel recommended using maternal and neonatal data collection systems for active safety surveillance in LMICs (median 9; disagreement index [DI] -0.92), but there was no consensus (median 6; DI 1.79) on the feasibility of adapting these systems. A basic set of 14 maternal, neonatal, and vaccination-related variables. Out of 16 experts, 11 supported a basic set of 14 maternal, neonatal, and vaccination-related variables for active safety surveillance. Seven experts agreed on a broader set of 26 variables. The inclusion of pregnant women for COVID-19 vaccines research (median 8; DI -0.61) was found appropriate, although there was uncertainty on its feasibility in terms of decision-makers' acceptability (median 7; DI 10.00) and regulatory requirements (median 6; DI 0.51). There was no consensus (median 6; DI 2.35) on the feasibility of including research networks in LMICs for conducting clinical trials amongst pregnant women.Conclusions:
Although there was some uncertainty regarding feasibility, experts recommended using maternal and neonatal data collection systems and agreed on a common set of variables for COVID-19 vaccines active safety surveillance in LMICs.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Idioma:
En
Revista:
Gates Open Res
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Argentina