Tweet
Vaccine. 2019 Oct 5. pii: S0264-410X(19)31291-5. doi: 10.1016/j.vaccine.2019.09.063. [Epub ahead of print] Developing product label information to support evidence-informed use of vaccines in pregnancy.
Manca TA1, Graham JE2, Dub? ?3, Kervin M4, Castillo E5, Crowcroft NS6, Fell DB7, Hadskis M8, Mannerfeldt JM9, Greyson D10, MacDonald NE11, Top KA12; Canadian Vaccine Product Monograph Working Group.
Author information
1 Canadian Center for Vaccinology, IWK Health Centre 5850/5980 University Ave, B3K 6R8 Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: tmanca@ualberta.ca. 2 Canadian Center for Vaccinology, IWK Health Centre 5850/5980 University Ave, B3K 6R8 Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: janice.graham@dal.ca. 3 Department of Anthropology, Laval University Pavillon Charles-De Koninck, 1030, avenue des Sciences humaines, Bureau 3431, Universit? Laval, G1V 0A6 Qu?bec, Qu?bec, Canada. Electronic address: eve.dube@inspq.qc.ca. 4 Canadian Center for Vaccinology, IWK Health Centre 5850/5980 University Ave, B3K 6R8 Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: Melissa.Kervin@iwk.nshealth.ca. 5 Department of Medicine, University of Calgary, 2500 University Drive NW T2N 1N4, Calgary, Alberta, Canada; Department of Obstetrics and Gynecology, University of Calgary, 2500 University Drive NW T2N 1N4, Calgary, Alberta, Canada. Electronic address: castillo@ucalgary.ca. 6 Public Health Ontario, 480 University Avenue, Suite 300, M5G 1V2 Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences G1 06, 2075 Bayview Avenue, M4N 3M5 Toronto, Ontario, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street 6F, M5T 3M7 Toronto, Ontario, Canada. Electronic address: natasha.crowcroft@oahpp.ca. 7 School of Epidemiology and Public Health, University of Ottawa, Alta Vista Campus, Room 101, 600 Peter Morand Crescent, K1G 5Z3 Ottawa, Ontario, Canada; Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Rd, K1H 5B2 Ottawa, Ontario, Canada. Electronic address: dfell@cheo.on.ca. 8 School of Health Administration and Schulich School of Law, Dalhousie University, Weldon Law Building, 6061 University Avenue, PO Box 15000, B3H 4R2 Halifax, Nova Scotia, Canada. Electronic address: Michael.Hadskis@dal.ca. 9 Department of Obstetrics and Gynecology, University of Calgary, 2500 University Drive NW T2N 1N4, Calgary, Alberta, Canada; Department of Family Medicine, University of Calgary, 2500 University Drive NW T2N 1N4, Calgary, Alberta, Canada. 10 Department of Communication, N308 Integrative Learning Center, 650 N. Pleasant St, University of Massachusetts Amherst, 01003-1100 Amherst, MA, United States. Electronic address: dgreyson@umass.edu. 11 Canadian Center for Vaccinology, IWK Health Centre 5850/5980 University Ave, B3K 6R8 Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: Noni.MacDonald@dal.ca. 12 Canadian Center for Vaccinology, IWK Health Centre 5850/5980 University Ave, B3K 6R8 Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: karina.top@dal.ca.
Abstract
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.
Copyright ? 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.
KEYWORDS:
Consensus methods; Immunization; Influenza; Pertussis; Pregnancy; Vaccination
PMID: 31594709 DOI: 10.1016/j.vaccine.2019.09.063