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Publications

Journal Article Research Support, Non-U.S. Gov't Ppublish 6 citations

PubMed: 34838689 DOI: 10.1016/j.reprotox.2021.11.006

Lack of effects on female fertility or pre- and postnatal development of offspring in rats after exposure to AS03-adjuvanted recombinant plant-derived virus-like particle vaccine candidate for COVID-19.

Reprod Toxicol 107:69-80

Authors: Charlotte Dubé, Sarah Paris-Robidas, Iryna Primakova, Eric Destexhe, Brian J Ward, Nathalie Landry, Sonia Trépanier

Affiliations

  • Medicago Inc. 1020 route de l'Église office 600, Québec, QC, G1V 3V9, Canada.
  • Charles River Laboratories Montreal ULC, 22022 Transcanadienne, Senneville, QC, H9X 3R3, Canada.
  • GlaxoSmithKline Biologicals, Rue de l'Institut 89, 1330, Rixensart, Belgium.
  • Medicago Inc. 1020 route de l'Église office 600, Québec, QC, G1V 3V9, Canada; Research Institute of the McGill University Health Centre, 1001 Decarie St, Montreal, QC, H4A 3J1, Canada.
  • Medicago Inc. 1020 route de l'Église office 600, Québec, QC, G1V 3V9, Canada.

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection resulting in the coronavirus disease 2019 (COVID-19) has afflicted tens of millions of people in a worldwide pandemic. A recently developed recombinant Plant-Derived Virus-Like Particle Vaccine candidate for COVID-19 (CoVLP) formulated with AS03 has been shown to be well-tolerated and highly immunogenic in healthy adults. Since the target population for the vaccine includes women of childbearing potential, the objective of the study was to evaluate any untoward prenatal and postnatal effects of AS03-adjuvanted CoVLP administered intramuscularly to Sprague-Dawley female rats before cohabitation for mating (22 and 8 days prior) and during gestation (Gestation Days [GD] 6 and 19). The embryo-fetal development (EFD) cohort was subjected to cesarean on GD 21 and the pre/post-natal (PPN) cohort was allowed to naturally deliver. Effects of AS03-adjuvanted CoVLP was evaluated on pregnant rats, embryo-fetal development (EFD), during parturition, lactation and the development of the F1 offspring up to weaning Vaccination with AS03-adjuvanted CoVLP induced an antibody response in F0 females and anti-SARS-CoV-2 spike-specific maternal antibodies were detected in the offspring at the end of the gestation and lactation periods. Overall, there was no evidence of untoward effects of AS03-adjuvanted CoVLP on the fertility or reproductive performance of the vaccinated F0 females. There was no evidence of untoward effects on embryo-fetal development (including teratogenicity), or early (pre-weaning) development of the F1 offspring. These results support the acceptable safety profile of the AS03-adjuvanted CoVLP vaccine for administration to women of childbearing potential.

MeSH

Coronavirus, Pregnancy, Lactation, Sars-Cov-2, Fertility, Vaccines, Vaccines, Virus-Like Particle, Covid-19, Viruses, Toxicology, Fetal Development, Weaning

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