TY - JOUR
T1 - Developing product label information to support evidence-informed use of vaccines in pregnancy
AU - Manca, Terra A.
AU - Graham, Janice E.
AU - Dubé, Ève
AU - Kervin, Melissa
AU - Castillo, Eliana
AU - Crowcroft, Natasha S.
AU - Fell, Deshayne B.
AU - Hadskis, Michael
AU - Mannerfeldt, Jaelene M.
AU - Greyson, Devon
AU - MacDonald, Noni E.
AU - Top, Karina A.
N1 - Funding Information:
The authors gratefully acknowledge the expert technical assistance of Poh Chua (Dalhousie), Lingyun Ye, Kelly Lefurgey (Canadian Center for Vaccinology), and Kirsten Weagle (Dalhousie). The authors thank the Society of Obstetricians and Gynaecologists of Canada for assistance with study logistics and coordination, especially Dr. Jocelyn Cook and Kyla Kaminsky. This project was funded by the Public Health Agency of Canada, in collaboration with the Society of Obstetricians and Gynaecologists of Canada. KAT has received grants from GSK and consultancy fees from Pfizer outside the submitted work. All other authors report no conflicts of interest. All authors have approved the final version of this article. All authors attest they meet the ICMJE criteria for authorship.
Publisher Copyright:
© 2019 The Author(s)
PY - 2019/11/15
Y1 - 2019/11/15
N2 - Background: Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy. Purpose: To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels. Methods: We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) meeting, followed by a Delphi survey, and then a consensus workshop with a subset of Delphi participants. We developed a methodological tool to analyse data for consensus. Principal results: Stakeholders (N = 14) at the NGT meeting drafted product label statements for evaluation in the Delphi survey. Survey participants (N = 41) provided feedback on statements for five hypothetical vaccines. Workshop participants (N = 27) initiated discussions that demonstrated a lack of awareness that the regulatory purpose of product labels is to provide a scientific summary of product-specific pre-clinical and clinical trial data. Each stage of this project built on earlier stages until we achieved strong consensus on the language, structure, and types of data that stakeholders wanted to include in inactivated influenza vaccine (IIV) and tetanus-diphtheria-acellular pertussis (Tdap) vaccine product labels in Canada. Conclusions: The revised statements for IIV and Tdap aligned with workshop participants’ goals that the product label be evidence-based, with a consistent structure and language that is easily understood by healthcare providers. Emergent methods uncovered stakeholder concerns about the regulatory purpose, content, and evidence used in product labels. Involving healthcare providers in the development and regular updating of product information could prevent interpretations of that information that contribute to vaccine hesitancy.
AB - Background: Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy. Purpose: To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels. Methods: We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) meeting, followed by a Delphi survey, and then a consensus workshop with a subset of Delphi participants. We developed a methodological tool to analyse data for consensus. Principal results: Stakeholders (N = 14) at the NGT meeting drafted product label statements for evaluation in the Delphi survey. Survey participants (N = 41) provided feedback on statements for five hypothetical vaccines. Workshop participants (N = 27) initiated discussions that demonstrated a lack of awareness that the regulatory purpose of product labels is to provide a scientific summary of product-specific pre-clinical and clinical trial data. Each stage of this project built on earlier stages until we achieved strong consensus on the language, structure, and types of data that stakeholders wanted to include in inactivated influenza vaccine (IIV) and tetanus-diphtheria-acellular pertussis (Tdap) vaccine product labels in Canada. Conclusions: The revised statements for IIV and Tdap aligned with workshop participants’ goals that the product label be evidence-based, with a consistent structure and language that is easily understood by healthcare providers. Emergent methods uncovered stakeholder concerns about the regulatory purpose, content, and evidence used in product labels. Involving healthcare providers in the development and regular updating of product information could prevent interpretations of that information that contribute to vaccine hesitancy.
KW - Consensus methods
KW - Immunization
KW - Influenza
KW - Pertussis
KW - Pregnancy
KW - Vaccination
UR - http://www.scopus.com/inward/record.url?scp=85073015782&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2019.09.063
DO - 10.1016/j.vaccine.2019.09.063
M3 - Journal Article
C2 - 31594709
AN - SCOPUS:85073015782
SN - 0264-410X
VL - 37
SP - 7138
EP - 7146
JO - Vaccine
JF - Vaccine
IS - 48
ER -
