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: [version 1;peer review: 1 approved with reservations]
Gates Open Research
; 2021.
Article
in English
| ProQuest Central | ID: covidwho-1835891
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.
Full text:
Available
Collection:
Databases of international organizations
Database:
ProQuest Central
Topics:
Vaccines
Language:
English
Journal:
Gates Open Research
Year:
2021
Document Type:
Article
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