Pregnant persons are at increased risk for severe COVD-19 illness compared to non-pregnant
women of reproductive age, experiencing higher rates of admission to intensive care,
mechanical ventilation and death. In addition to the direct impacts on the health of pregnant
persons, there is growing evidence to suggest COVID-19 adversely impacts fetal and neonatal
health. As of May 2021, three vaccines have been issued Emergency Use Approval in the US.
However, because pregnant persons were excluded from initial Phase 3 clinical trials, data to
confirm the safety and effectiveness of COVID-19 vaccination during pregnancy are lacking.
Driven by this limited data, obstetric and public health governing bodies do not currently directly
recommend vaccination for pregnant persons. The American College of Obstetricians and
Gynecologists and the US Centers for Disease Control and Prevention (CDC) advise that
COVID-19 vaccines should not be withheld from pregnant persons. As a result, the decision to
vaccinate is made at the individual level, and pregnant persons express anxiety around making
this decision. Additional data to inform the safety and effectiveness of COVID-19 vaccines
administered during pregnancy would strengthen current clinical guidelines.
Despite weak guidance, individuals are choosing to be vaccinated during pregnancy. As of 3
May 2021, 106,241 pregnant persons were reported as having received a COVID-19 vaccine
through V-SAFE, the CDC’s active vaccine safety surveillance system. When surveyed, more
than 50% of pregnant persons report an intention to receive a COVID-19 vaccine. Phase 2/3
clinical trial data are currently being gathered to evaluate safety and efficacy. While these
clinical trial data are being collected, we have the opportunity to learn from large observational
studies of pregnant persons who have chosen to be vaccinated.
Leveraging existing national medical claims and electronic medical records for more than
870,000 pregnancies, we plan to conduct large-scale post-implementation cohort studies to
evaluate the uptake, safety and effectiveness of COVID-19 vaccines administered during
pregnancy. Completion of the proposed research will provide important epidemiological
evidence on the safety and effectiveness of COVID-19 vaccination during pregnancy. This
evidence will aid informed decision and policy-making around COVID-19 vaccination for