Exclusion of Pregnant and Breastfeeding Individuals from COVID-19 Vaccine and Clinical Trials

Strategic Insights -

The exclusion of pregnant and breastfeeding individuals from COVID-19 vaccine and clinical trials is a significant concern, particularly given the limited availability of data on the safety and efficacy of these trials in this population. Recent research has highlighted the disparities in trial inclusion and exclusion criteria, with a focus on the rates of exclusion for pregnant and lactating individuals, as well as the requirements for contraception use. This study underscores the need for more inclusive clinical trials that consider the perspectives and needs of all individuals, regardless of their reproductive status.

Key Takeaways:

  • The majority of COVID-19 vaccine trials (88%, or 97.8%) excluded pregnant individuals, while 73 (81.1%) excluded lactating individuals and 56 (62.2%) required contraception use.
  • Similarly, the majority of COVID-19 treatment trials (350, or 70.7%) excluded pregnant individuals, while 269 (54.3%) excluded lactating individuals and 91 (18.4%) required contraception use.
  • Pregnant and lactating individuals were explicitly excluded from most COVID-19 vaccine and treatment clinical trials.
  • There was a significant association between clinical trial exclusion and vaccine type, with lactating individuals excluded at a higher rate in vaccine trials (p < .01).
  • The research highlights the need for more inclusive clinical trials that consider the perspectives and needs of all individuals, regardless of their reproductive status.
  • The authors emphasize the importance of people of childbearing potential being considered for and afforded the same opportunity as males to make informed decisions on study participation.

Statistics:

  • 90 COVID-19 vaccine trials excluded pregnant individuals (97.8%).
  • 73 COVID-19 vaccine trials excluded lactating individuals (81.1%).
  • 56 COVID-19 vaccine trials required contraception use (62.2%).
  • 495 COVID-19 treatment trials excluded pregnant individuals (70.7%).
  • 269 COVID-19 treatment trials excluded lactating individuals (54.3%).
  • 91 COVID-19 treatment trials required contraception use (18.4%).

Sources:

  • Exclusion of Reproductive-aged Women In Covid-19 Vaccination and Clinical Trials. Women's Health Issues, 2022;32(6):557-563.
  • Pennsylvania State University (Penn State) College of Medicine and Milton S. Hershey Medical Center.