Pharmacy Phriday #5: COVID-19 Vaccine for Pregnant Women

Contributors: Rachael Duncan, PharmD and Sean McCullough, PharmD

Educational Pearls:

• A 2019 Report by the National Women's Law Center: Most common occupations for pregnant workers are elementary and middle school teachers, registered nurses, and nursing/psychiatric/home health care aides.
• This raises the question: Should pregnant women, specifically front-line workers, get the Covid-19 vaccine?
• According to the FDA, there is currently not enough data to make a conclusion about the safety of the newly approved Pfizer vaccine for populations that include children less than 16, pregnant and lactating women, and those that are immunocompromised.
• Specifically, pregnant women were excluded from the clinical trials testing the Pfizer vaccine.
• According to the CDC, additional data needs to be reviewed from the phase III clinical trials in order to provide recommendations to pregnant and breast-feeding women about taking the Covid-19 vaccine and its safety.
• An Advisory Committee of Immunization Practices (ACIP) meeting will take place on 12/13/2020 and will hopefully provide formal recommendations to pregnant and lactating women.
• The Society for Maternal-Fetal Medicine (SMFM) has consistently advocated for the inclusion of pregnant and lactating women into clinical trials when these criteria are met: 1) pregnancy poses increased susceptibility to or severity of a disease; 2) the best approach to protect the infant is through passive placental antibody transfer, which provides the most efficient and direct protection to the newborn before an infant can be vaccinated, and 3) there is an active outbreak.
• SMFM recommends healthcare workers who are currently being prioritized to receive the vaccine to also receive the vaccine if pregnant.
• Pregnant healthcare workers should take their individual situation into consideration and weigh the risks and benefits for themselves and the risk for detecting disease when considering if or when to take the Covid-19 vaccine.

References

1. ACIP Meeting Agenda December 13, 2020 - cdc.gov. MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP). https://www.cdc.gov/vaccines/acip/meetings/downloads/agenda-archive/agenda-2020-12-11.pdf. Published 2020. Accessed December 11, 2020.
2. Coronavirus (COVID-19), Pregnancy, and Breastfeeding: A Message for Patients. ACOG. https://www.acog.org/womens-health/faqs/coronavirus-covid-19-pregnancy-and-breastfeeding. Published 2020. Accessed December 11, 2020.
3. Interim Considerations for COVID-19 Vaccination of Healthcare Personnel and Long-Term Care Facility Residents. Centers for Disease Control and Prevention. https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19/clinical-considerations.html. Published December 3, 2020. Accessed December 11, 2020.
4. Society for Maternal-Fetal Medicine (SMFM) Statement: SARS-CoV-2 Vaccination in Pregnancy. December 2020. https://s3.amazonaws.com/cdn.smfm.org/media/2591/SMFM_Vaccine_Statement_12-1-20_(final).pdf
5. Vaccines and Related Biological Products Advisory Committee Meeting December 10, 2020. 2020. https://www.fda.gov/media/144245/download
6. VRBPAC December 10, 2020 Meeting Announcement. U.S. Food and Drug Administration. https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement. Published December 10, 2020. Accessed December 11, 2020.

Summarized by Emily Mack OMSIII | Edited by Rachael Duncan, PharmD