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CME / ABIM MOC / CE

Is the COVID-19 Vaccine Safe for Pregnant Women?

  • Authors: News Author: Marcia Frellick; CME Author: Laurie Barclay, MD
  • CME / ABIM MOC / CE Released: 10/7/2022
  • Valid for credit through: 10/7/2023
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  • Credits Available

    Physicians - maximum of 0.25 AMA PRA Category 1 Credit(s)™

    ABIM Diplomates - maximum of 0.25 ABIM MOC points

    Nurses - 0.25 ANCC Contact Hour(s) (0.25 contact hours are in the area of pharmacology)

    Pharmacists - 0.25 Knowledge-based ACPE (0.025 CEUs)

    Physician Assistant - 0.25 AAPA hour(s) of Category I credit

    IPCE - 0.25 Interprofessional Continuing Education (IPCE) credit

    You Are Eligible For

    • Letter of Completion
    • ABIM MOC points

Target Audience and Goal Statement

This activity is intended for internists, obstetricians/gynecologists/women’s health clinicians, family medicine/primary care physicians, public health and prevention officials, nurses, nurse practitioners, pharmacists, physician assistants, pulmonologists, and other members of the healthcare team for pregnant women considering COVID-19 vaccination.

The goal of this activity is for learners, members of the healthcare team to be better able to describe the frequency and nature of significant health events among pregnant female persons after COVID-19 vaccination compared with unvaccinated pregnant control participants and vaccinated nonpregnant individuals, according to a Canadian National Vaccine Safety Network (CANVAS) network observational cohort study set in 7 Canadian provinces and territories, including Ontario, Quebec, British Columbia, Alberta, Nova Scotia, and Yukon.

Upon completion of this activity, participants will:

  • Describe the frequency and nature of significant health events among pregnant female persons after COVID-19 vaccination compared with unvaccinated pregnant control participants and vaccinated nonpregnant individuals, according to a CANVAS network observational cohort study
  • Identify clinical and public health implications of the frequency and nature of significant health events among pregnant female persons after COVID-19 vaccination compared with unvaccinated pregnant controls and vaccinated nonpregnant individuals, according to a CANVAS network observational cohort study
  • Outline implications for the healthcare team


Disclosures

Medscape, LLC requires every individual in a position to control educational content to disclose all financial relationships with ineligible companies that have occurred within the past 24 months. Ineligible companies are organizations whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

All relevant financial relationships for anyone with the ability to control the content of this educational activity are listed below and have been mitigated. Others involved in the planning of this activity have no relevant financial relationships.


News Author

  • Marcia Frellick

    Freelance writer, Medscape

    Disclosures

    Marcia Frellick has no relevant financial relationships.

CME Author

  • Laurie Barclay, MD

    Freelance writer and reviewer
    Medscape, LLC

    Disclosures

    Laurie Barclay, MD, has the following relevant financial relationships:
    Formerly owned stocks in: AbbVie Inc.

Editor/Compliance Reviewer

  • Amanda Jett, PharmD, BCACP

    Associate Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Amanda Jett, PharmD, BCACP, has no relevant financial relationships.

Nurse Planner

  • Lisa Simani, APRN, MS, ACNP

    Associate Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Lisa Simani, APRN, MS, ACNP, has no relevant financial relationships.

Peer Reviewer

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


Accreditation Statements



In support of improving patient care, Medscape, LLC is jointly accredited with commendation by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

This activity was planned by and for the healthcare team, and learners will receive 0.25 Interprofessional Continuing Education (IPCE) credit for learning and change.

    For Physicians

  • Medscape, LLC designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 0.25 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

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    For Nurses

  • Awarded 0.25 contact hour(s) of nursing continuing professional development for RNs and APNs; 0.25 contact hours are in the area of pharmacology.

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    For Pharmacists

  • Medscape designates this continuing education activity for 0.25 contact hour(s) (0.025 CEUs) (Universal Activity Number: JA0007105-0000-22-321-H01-P).

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  • For Physician Assistants

    Medscape, LLC has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 0.25 AAPA Category 1 CME credits. Approval is valid until 10/7/2023. PAs should only claim credit commensurate with the extent of their participation.

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]


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There are no fees for participating in or receiving credit for this online educational activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 75% on the post-test.

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CME / ABIM MOC / CE

Is the COVID-19 Vaccine Safe for Pregnant Women?

Authors: News Author: Marcia Frellick; CME Author: Laurie Barclay, MDFaculty and Disclosures

CME / ABIM MOC / CE Released: 10/7/2022

Valid for credit through: 10/7/2023

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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

Changes in cardiopulmonary and immunological physiology during pregnancy increase risk for COVID-19-related hospital/intensive care unit (ICU) admission, mechanical ventilation, and death. Severe COVID-19 increases adverse pregnancy outcomes, including hypertension, preeclampsia, impaired fetal growth, and preterm birth.

CANVAS was established during the 2009 influenza pandemic to provide rapid, real-time safety data during rollout of immunization programs. It has monitored COVID-19 vaccine safety since December 2020, when these vaccines first became available in Canada.

Study Synopsis and Perspective

Pregnant women should feel confident that the BNT162b2 and mRNA-1273 vaccines against COVID-19 are safe, according to a large new study published August 11.

In fact, pregnant vaccinated women had lower odds of a significant health event, compared with nonpregnant vaccinated women, after both doses of either messenger RNA (mRNA) vaccination, the researchers reported in the journal The Lancet Infectious Diseases.

This study, conducted by the Canadian National Vaccine Safety Network, looked at data from patients in 7 Canadian provinces and territories between December 2020 and November 2021.

All vaccinated people in the study were asked to report any health events during the week after each COVID-19 vaccine dose. Individuals in the unvaccinated pregnant control group were asked to record any health problems over the 7 days before they completed the survey.

In all, 191,360 women ages 15 to 49 years old completed the first dose survey, and 94,937 completed the second dose survey.

Manish Sadarangani, from the British Columbia Children's Hospital Research Institute in Vancouver, British Columbia, Canada, led the study, which is one of the first to compare vaccine adverse effects (AEs) among 3 groups: vaccinated pregnant women, unvaccinated pregnant women, and vaccinated nonpregnant women.

Study authors noted that the pandemic has disproportionately affected pregnant women, who are at higher risk for severe COVID-19 disease compared with nonpregnant people in their age group.

Adverse Events Low Across Groups

The researchers found that 4% of pregnant women who received an mRNA vaccine reported a significant health event within a week after dose 1 and 7.3% after dose 2. The most common significant health events after dose 2 were a general feeling of being unwell, headache/migraine, and respiratory infection.

For pregnant unvaccinated women, 3.2% reported similar events in the week before taking the survey.

In the control group of nonpregnant but vaccinated women, 6.3% reported a significant health event in the week after dose 1 and 11.3% after dose 2. Serious health events were rare in all groups (< 1%) and occurred at similar rates in all 3 groups.

There was no significant difference among miscarriage/stillbirth rates among the groups.

Investigators defined "significant health event" as a new or worse health event that was enough to cause the patient to miss school or work, require medical consultation, and/or prevent daily activities in the previous week. "Serious health event" was defined as resulting in an emergency department visit and/or hospitalization in the previous week.

Sascha Ellington, PhD, and Christine Olson, MD, from the Centers for Disease Control and Prevention (CDC), who were not involved in the study, wrote in a linked editorial that the findings are consistent with a growing body of evidence that COVID-19 mRNA vaccines are safe in pregnancy.

Even With Good Science, Convincing Is Tough

Diana Gillman, MD, with the obstetrics and gynecology department of Olmstead Medical Center in Rochester, Minnesota, said even these results may not convince all pregnant women to get vaccinated because of continued, unfounded fears surrounding the vaccines.

"Unfortunately, although this study confirms what we already know about COVID vaccine in pregnancy -- it is safe and effective in preventing possible life-threatening illness in mother and baby -- many patients in the U.S. continue to be resistant to being vaccinated during pregnancy as a result of unfounded fears of fetal harm," she said.

"Patients routinely accept their medical provider's advice on everything else in pregnancy, including, in this country, receiving the Tdap vaccine at 28 weeks, which works to protect the baby from whooping cough in infancy by evoking maternal antibodies that pass to the fetus in utero, yet they resist this potentially life-saving inoculation," Gillman added.

Gillman said data on convincing parents that COVID-19 vaccines are safe will likely now need to come from experts in psychology and sociology who can pinpoint why patients resist and what strategies will work.

"Scientifically," she says, "we have it covered."

Lancet Infect Dis. Published online August 11, 2022.[1]

Study Highlights

  • The observational cohort for this study came from 7 Canadian provinces and territories, including Ontario, Quebec, British Columbia, Alberta, Nova Scotia, Yukon, and Prince Edward Island between December 2020 and November 2021.
  • Vaccinated pregnant and nonpregnant female persons aged 15 to 49 years were eligible if they received a first COVID-19 vaccine dose within the previous 7 days.
  • Control participants were unvaccinated but fulfilled other inclusion criteria.
  • Data were collected by self-reported survey after both doses, with telephone follow-up for persons reporting any medically attended event.
  • Significant health events were defined as new or worsening of a health event sufficient to cause work or school absenteeism, medical consultation, or prevent daily activities, within 7 days of vaccination or within the past 7 days for control participants.
  • Multivariable logistic regression adjusted for age group, previous SARS-CoV-2 infection, and trimester, as appropriate.
  • As of November 4, 2021, nearly 200,000 (191,360) women with known pregnancy status had completed the first vaccine dose survey and 94,937 the second dose survey.
  • Of 6179 unvaccinated control participants, 339 were pregnant.
  • Among vaccinated pregnant female persons, 226 (4%) reported a significant health event after dose 1 and 227 (7.3%) after dose 2 vs 11 (3.2%) of 339 pregnant unvaccinated female persons.
  • General malaise or myalgia (11.4%), headache/migraine (8.5%), and respiratory infection (5.6%) were the most common significant health events after dose 2.
  • Pregnant vaccinated vs unvaccinated female persons had increased odds for a significant health event within 7 days after mRNA-1273 dose 2 (adjusted odds ratio [aOR] 4.4 [95% CI: 2.4, 8.3]) but not after mRNA-1273 dose 1 or any BNT162b2 dose.
  • Among nonpregnant vaccinated women, 6.3% reported a significant health event in the week after dose 1 and 11.3% after dose 2.
  • Pregnant vs nonpregnant vaccinated female persons had lower odds for a significant health event after both dose 1 (0.63 [95% CI: 0.55, 0.72]) and dose 2 (0.62 [95% CI: 0.54, 0.71]) of any mRNA vaccination.
  • Analyses restricted to events requiring medical attention had similar results.
  • In all 3 groups, serious health events (causing an emergency department visit and/or hospitalization) were rare (< 1%) and occurred at similar rates.
  • Miscarriage or stillbirth was the most frequently reported adverse pregnancy outcome, with similar rates between control (2.1%) and vaccinated groups (1.5%).
  • The researchers concluded that COVID-19 mRNA vaccines have a good safety profile in pregnancy, with significant health events lower in pregnant people than in age-matched non-pregnant vaccine recipients.
  • Immunologic adaptations during pregnancy include a skew towards a T-helper (Th) 2 dominant state.
  • As mRNA vaccines were specifically designed to elicit a Th1-biased immune response, the Th2-bias during pregnancy may partly explain the lower rate of significant AEs after immunization.
  • Among pregnant individuals, significant AEs after immunization were higher in persons receiving mRNA-1273 vaccine for their second dose than in unvaccinated pregnant people, with no difference seen for BNT162b2 after either dose.
  • Still, both mRNA vaccines are highly immunogenic and effective in pregnancy.
  • When restricted to events resulting in medical consultation, there was no difference between groups in any of the analyses.
  • These data can appropriately inform pregnant women regarding reactogenicity of COVID-19 vaccines during pregnancy and should be considered together with effectiveness and immunogenicity data to make appropriate recommendations about best use of COVID-19 vaccines in pregnancy.
  • Given the increased rate of significant complications associated with COVID-19 in pregnancy, high vaccine coverage in this group is important to protect the mother and newborn via passive transplacental transfer of antigen-specific immunoglobulin G antibody and via breast milk.
  • Study limitations include short follow-up, reliance on self-report, and insufficient sample to detect very rare AEs.
  • Further studies of non--COVID-19 mRNA vaccines should determine if reduced reactogenicity in pregnant people in this study is related to mRNA vaccines in general or to these specific vaccines.
  • An accompanying editorial noted that the findings are consistent with accumulating evidence of COVID-19 mRNA vaccine safety in pregnancy.
  • An expert consulted by Medscape noted that these results may not convince all pregnant women to get vaccinated because of continued, unfounded fears regarding vaccines.
  • Psychology and sociology studies are therefore needed to identify mechanisms underlying vaccine resistance and strategies to overcome barriers to vaccination.

Clinical Implications

  • COVID-19 mRNA vaccines have a good safety profile in pregnancy, with significant health events lower in pregnant people than in age-matched nonpregnant vaccine recipients.
  • These data can appropriately inform pregnant women regarding reactogenicity of COVID-19 vaccines during pregnancy.
  • Implications for the Healthcare Team: Given the increased rate of significant complications of COVID-19 in pregnancy, the healthcare team should educate patients that high vaccine coverage is important to protect the mother and newborn.

 

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