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Is the COVID-19 Booster Vaccination Safe in Early Pregnancy?

  • Authors: News Author: Jay Croft; CME Author: Charles P. Vega, MD
  • CME / ABIM MOC / CE Released: 7/5/2023
  • Valid for credit through: 7/5/2024, 11:59 PM EST
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Target Audience and Goal Statement

This activity is intended for primary care clinicians, obstetricians, nurses/nurse practitioners, pharmacists, and other clinicians who care for women considering pregnancy.

The goal of this activity is for learners to be better able to assess the risk for spontaneous abortion associated with the COVID-19 booster vaccine.

Upon completion of this activity, participants will:

  • Compare vaccine effectiveness of the monovalent and bivalent boosters of the COVID-19 vaccine
  • Assess the risk for spontaneous abortion associated with the COVID-19 booster vaccine
  • Outline implications for the healthcare team


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News Author

  • Jay Croft

    Freelance writer, Medscape


    Jay Croft has no relevant financial relationships.

CME Author

  • Charles P. Vega, MD

    Health Sciences Clinical Professor of Family Medicine
    University of California, Irvine School of Medicine


    Charles P. Vega, MD, has the following relevant financial relationships:
    Consultant or advisor for: Boehringer Ingelheim Pharmaceuticals, Inc.; GlaxoSmithKline; Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Editor/Compliance Reviewer

  • Amanda Jett, PharmD, BCACP

    Associate Director, Accreditation and Compliance, Medscape, LLC


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  • Leigh Schmidt, MSN, RN, CNE, CHCP

    Associate Director, Accreditation and Compliance, Medscape, LLC


    Leigh Schmidt, MSN, RN, CNE, CHCP, has no relevant financial relationships.

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This activity has been peer reviewed and the reviewer has no relevant financial relationships.

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Is the COVID-19 Booster Vaccination Safe in Early Pregnancy?

Authors: News Author: Jay Croft; CME Author: Charles P. Vega, MDFaculty and Disclosures

CME / ABIM MOC / CE Released: 7/5/2023

Valid for credit through: 7/5/2024, 11:59 PM EST


Note: The information on the coronavirus outbreak is continually evolving. The content within this activity serves as a historical reference to the information that was available at the time of this publication. We continue to add to the collection of activities on this subject as new information becomes available. It is the policy of Medscape Education to avoid the mention of brand names or specific manufacturers in accredited educational activities. However, manufacturer names related to the approved COVID-19 vaccines are provided in this activity in an effort to promote clarity. The use of manufacturer names should not be viewed as an endorsement by Medscape of any specific product or manufacturer.

Clinical Context

The bivalent booster vaccines against COVID-19 were approved for emergency use by the FDA on August 31, 2022, but uptake of these vaccines has been slow despite their promise of efficacy against infections with the Omicron variant of SARS-CoV-2. So how effective are the bivalent mRNA-based vaccines? Lin and colleagues reported on their vaccine experience in one large US health system, and their results were published in the February 23 issue of The New England Journal of Medicine.[1]

Researchers compared vaccine efficacy in the prevention of severe COVID-19 requiring hospitalization across thousands of patients older than age 12 years. The study period was from September 1, 2022 to December 8, 2022. The investigators compared bivalent booster vaccine with a monovalent booster vaccine. In days 15 to 99 after receiving the vaccine dose, the vaccine effectiveness rates against severe COVID-19 with the monovalent and bivalent vaccines were 25.2% and 58.7%, respectively. The result for the comparison including either severe COVID-19 or death due to COVID-19 as outcomes was similar, as were results limited to persons older than age 65 years. Finally, the bivalent vaccine was also more effective regardless of the presence of prior COVID-19.

Still, only 17% of eligible US residents have received the bivalent booster. One concern among pregnant women is the risk for spontaneous abortion associated with the COVID-19 vaccines. The current study by Kharbanda and colleagues addresses this issue.

Study Synopsis and Perspective

COVID-19 boosters are not linked to an increased chance of miscarriage, according to a new study in JAMA Network Open.[2]

Researchers sought to learn whether a booster in early pregnancy, before 20 weeks, was associated with greater likelihood of spontaneous abortion.

They examined more than 100,000 pregnancies at 6 to 19 weeks from 8 health systems in the Vaccine Safety Datalink (VSD). They found that receiving a COVID-19 booster shot in a 28-day or 42-day exposure window did not increase the chances of miscarriage.

"These findings support the safety of COVID-19 booster vaccination in early pregnancy," they wrote.

The VSD is a collaboration between the Immunization Safety Office of the Centers for Disease Control and Prevention and large healthcare systems. The "observational, case-control, surveillance study" was conducted from November 1, 2021 to June 12, 2022.

"COVID infection during pregnancy increases risk of poor outcomes, yet many people who are pregnant or thinking about getting pregnant are hesitant to get a booster dose because of questions about safety," said Elyse Kharbanda, MD, senior investigator at HealthPartners Institute and lead author of the study in a press release.[2]

The University of Minnesota reported, "Previous studies have shown COIVD-19 primary vaccination is safe in pregnancy and not associated with an increased risk for miscarriage. Several studies have also shown COVID-19 can be more severe in pregnancy and lead to worse outcomes for the mother."

Study Highlights

  • Researchers drew study data from the VSD, which monitors vaccine safety events on a national level. Specifically, researchers evaluated 8 US centers participating in the datalink between November 1, 2021 and June 12, 2022.
  • The primary study analysis focused on receipt of the third dose of mRNA COVID-19 vaccine before 20 weeks’ gestation and the risk for spontaneous abortion in the next 28 days. Secondary analyses expanded the study period to ≤ 42 days after any booster dose of the vaccine.
  • Overall, eight 28-day surveillance periods were included in the study, as were five 42-day surveillance periods.
  • The study analysis included women between the ages of 16 and 49 years with a pregnancy between 6 and 19 weeks’ gestation at the time of vaccination. The analysis excluded ectopic pregnancies, pregnancies complicated by trophoblastic disease, pregnancies that ended in elective abortion, and pregnancies that used assisted reproduction techniques.
  • Covariates included in the study analysis included maternal age, race/ethnicity, and the number of prenatal care visits.
  • 112,718 pregnancies had data for study evaluation. The mean maternal age of included women was 30.6 ± 5.5 years, and the study cohort was diverse in terms of race/ethnicity.
  • 4.1% of pregnancies had data on a third dose of mRNA-based COVID-19 vaccine with a ≥ 28-day window of follow-up postvaccination. Booster vaccines were more common among Asian American and Hispanic women and less common among Black women. Women between ages 16 and 24 years were also less likely to have a COVID-19 booster vaccine, although vaccination rates were fairly similar across all trimester periods.
  • 12.6% of pregnancies ended in spontaneous abortions. The rates of COVID-19 booster vaccine application within 28 days were 4.1% in ongoing pregnancy and 3.9% in pregnancies that ended in spontaneous abortion (adjusted odds ratio [aOR] 0.94 [95% CI: 0.86, 1.03]). There was no difference based on vaccine manufacturer in this outcome.
  • 93.3% of booster vaccines were third doses of COVID-19 vaccine; however, there was no evidence that second, fourth, or fifth doses of any COVID-19 booster vaccine were associated with higher rates of spontaneous abortion.
  • 6.9% of women received a COVID-19 booster vaccine with a ≥ 42-day window for follow-up. The aOR for spontaneous abortion associated with COVID-19 booster vaccine in this expanded window was 0.96 (95% CI: 0.89, 1.04). Again, results were unchanged when stratified by vaccine manufacturer.
  • The study authors discuss how the overall rate of adverse events associated with the COVID-19 booster vaccine are similar or possibly better tolerated compared with the initial 2 doses of mRNA-based vaccine.

Implications for the healthcare team:

  • In a previous study by Lin and colleagues, the bivalent COVID-19 booster vaccine was superior in the prevention of severe disease requiring hospitalization compared with the monovalent booster in September to December 2022. The results were similar in subgroup analyses based on prior COVID-19 and older age.
  • The current study by Kharbanda and colleagues failed to find any association between COVID-19 booster vaccination and the risk for spontaneous abortion, regardless of a 28- or 42-day window or vaccine manufacturer.
  • The healthcare team can reassure women in pregnancy that the COVID-19 booster vaccine does not promote a higher risk for spontaneous abortion. If appropriate, the booster should be considered.


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