Statement on COVID-19 Vaccination in Pregnancy and Lactation

  • Pregnancy is considered high-risk condition for severe COVID-19, hospitalization, ICU admission, mechanical ventilation, and mortality.
  • Individuals who are pregnant or lactating are eligible to receive the COVID-19 vaccination in accordance with the institutional tiered administration guidelines for vaccine administration.
  • The COVID-19 Pfizer/BioNTech vaccine has been shown to confer 95% protection against COVID-19 in persons 16 years or older.
  • Under the US Food and Drug Administration Emergency Use Authorization, and with approval from the Center for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), individuals who are 16 years of age or older are candidates for the COVID-19 (Pfizer/BioNTech) vaccination
  • mRNA vaccines are not live vaccines and are rapidly degraded by normal cellular processes; thus the theoretical risk of fetal harm from mRNA vaccines is very low and Developmental and Reproductive Toxicity (DART) studies are underway with preliminary data suggesting no concerns (unpublished at this time)
  • Shared-decision making regarding COVID-19 vaccination should be made between the obstetric or primary care provider and the individual who is pregnant or lactating.
  • Counseling should balance the lack of data on vaccine safety for the fetus, risks   to pregnant women from COVID-19 infection, and a woman’ individual risk for infection and severe disease.
  • Clinical trials of the COVID-19 vaccination in individuals who are pregnant or lactating are underway and updated guidance will be provided as data emerges.

References:

Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group.  Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 10. Online ahead of print. PMID: 33301246

Ellington S, Strid P, Tong VT, Woodworth K, Galang RR, Zambrano LD, et al. Characteristics of Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status — United States, January 22–June 7, 2020. MMWR Morb Mortal Wkly Rep. 2020;69(25):769–75. 4.

Delahoy MJ, Whitaker M, O’Halloran A, et al. Characteristics and Maternal and Birth Outcomes of Hospitalized Pregnant Women with Laboratory-Confirmed COVID-19 – COVID-NET, 13 States, March 1-August 22, 2020. MMWR Morb Mortal Wkly Rep. 2020;69(38):1347-54. 5.

Panagiotakopoulous L, Myers TR, Gee J, Lipkind HS, Kharbanda EO, Ryan DS. SARSCoV-2 Infection Among Hospitalized Pregnant Women: Reasons for Admission and Pregnancy Characteristics — Eight U.S. Health Care Centers. MMWR Morb Mortal Wkly Rep. 2020;69(38):1355–9. 6.

Zambrano LD, Ellington S, Strid P, Galang RR, Oduyebo T, Tong VT, et al. Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status — United States, January 22–October 3, 2020. MMWR Morb Mortal Wkly Rep. 2020;69(44):1641–7.

Society for Maternal-Fetal Medicine (SMFM) Statement. SARS-CoV-2 Vaccination in Pregnancy.  December 10, 2020
American College of Obstetricians and Gynecologists. Practice Advisory:  Vaccinating Pregnant and Lactating Patients Against COVID-19. December 13, 2020