Vaccine regulation should require and enforce the inclusion of pregnant and breastfeeding women in prelicensure clinical trials

Author:

Manca Terra A.12ORCID,Sadarangani Manish34ORCID,Halperin Scott A.12ORCID,Langley Joanne M.1ORCID,McClymont Elisabeth45ORCID,MacDonald Shannon E.67ORCID,Top Karina A.12ORCID

Affiliation:

1. Canadian Center for Vaccinology, IWK Health, Nova Scotia Health and Dalhousie University, Halifax, Canada

2. Department of Pediatrics, Faculty of Medicine, Dalhousie University, Halifax, Canada

3. Vaccine Evaluation Center, BC Children’s Hospital Research Institute, Vancouver, Canada

4. Department of Pediatrics, University of British Columbia, Vancouver, Canada

5. Department of Obstetrics and Gynecology, University of British Columbia, Vancouver, Canada

6. Faculty of Nursing, University of Alberta, Edmonton, Canada

7. School of Public health, University of Alberta, Edmonton, Canada

Funder

IWK Health Centre

Publisher

Informa UK Limited

Subject

Pharmacology,Immunology,Immunology and Allergy

Reference50 articles.

1. Department for Business, Energy & Industrial Strategy, The Rt Hon Alok Sharma MP. Press release: funding and manufacturing boost for UK vaccine programme. 2020 [accessed 2022 Mar 24]. https://www.gov.uk/government/news/funding-and-manufacturing-boost-for-uk-vaccine-programme.

2. U.S. Department of Health and Human Services. Explaining operation warp speed. 2020 [accessed 2022 Mar 24]. https://www.nihb.org/covid-19/wp-content/uploads/2020/08/Fact-sheet-operation-warp-speed.pdf.

3. The need for inclusion of pregnant women in COVID-19 vaccine trials

4. Pregnant Women in Trials of Covid‐19: A Critical Time to Consider Ethical Frameworks of Inclusion in Clinical Trials

5. Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response

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