You are leaving Medscape Education
Cancel Continue
Log in to save activities Your saved activities will show here so that you can easily access them whenever you're ready. Log in here CME & Education Log in to keep track of your credits.
 

CME / ABIM MOC / CE

Do Male Persons Have Higher Risk for Myocarditis After COVID-19 Vaccination?

  • Authors: News Author: Steve Stiles; CME Author: Laurie Barclay, MD
  • CME / ABIM MOC / CE Released: 2/23/2022
  • Valid for credit through: 2/23/2023
Start Activity

  • 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 contact hours are in the area of pharmacology)

    Pharmacists - 0.25 Knowledge-based ACPE (0.025 CEUs)

    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 cardiologists, family medicine clinicians, infectious disease clinicians, internists, public health and prevention officials, nurses, pharmacists, and other members of the health care team for patients who have or may be at risk for myocarditis from COVID-19 vaccination.

The goal of this activity is to describe the incidence, characteristics, and demographics of adverse events (AEs), particularly myocarditis, linked to messenger RNA (mRNA)-based vaccines against SARS-CoV-2, according to a retrospective review of Israeli surveillance data from December 20, 2020 to May 31, 2021 and a separate Israeli study; a self-controlled case series study of people aged ≥ 16 years vaccinated for COVID-19 in England between December 1, 2020 and August 24, 2021; and a population-based cohort study in Denmark of persons aged ≥ 12 years, followed from October 1, 2020 and October 5, 2021.

Upon completion of this activity, participants will:

  • Describe the incidence, characteristics, and demographics of myocarditis and other AEs linked to mRNA-based vaccines against SARS-CoV-2, according to a retrospective review of Israeli surveillance data from December 20, 2020 and May 31, 2021 and a separate study from a large health organization in Israel
  • Identify the incidence, characteristics, and demographics of myocarditis and other AEs linked to mRNA–based vaccines against SARS-CoV-2, according to a self-controlled case series study of people aged ≥ 16 years vaccinated for COVID-19 in England between December 1, 2020 and August 24, 2021; and a population-based cohort study in Denmark of persons aged ≥ 12 years, followed from October 1, 2020 and October 5, 2021
  • 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 according to Medscape policies. Others involved in the planning of this activity have no relevant financial relationships.


News Author

  • Steve Stiles

    News Editor, theheart.org | Medscape Cardiology

    Disclosures

    Disclosure: Steve Stiles has disclosed no relevant financial relationships.

CME Author

  • Laurie Barclay, MD

    Freelance writer and reviewer 
    Medscape, LLC

    Disclosures

    Disclosure: Laurie Barclay, MD, has disclosed the following relevant financial relationships:
    Own stock, stock options, or bonds from the following ineligible company(ies): AbbVie Inc. (former)

Editor/CME Reviewer/Nurse Planner

  • Leigh A. Schmidt, MSN, RN, CMSRN, CNE, CHCP

    Associate Director, Accreditation and Compliance
    Medscape, LLC

    Disclosures

    Disclosure: Leigh A. Schmidt, MSN, RN, CMSRN, CNE, CHCP, has disclosed no relevant financial relationships.

CME/CE Reviewer/Nurse Planner

  • Lisa Simani, APRN, MS, ACNP

    Associate Director, Accreditation and Compliance
    Medscape, LLC

    Disclosures

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


Accreditation Statements



In support of improving patient care, Medscape, LLC is jointly accredited 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.

    Contact This Provider

    For Nurses

  • Awarded 0.25 contact hour(s) of continuing nursing education for RNs and APNs; none of these credits is in the area of pharmacology.

    Contact This Provider

    For Pharmacists

  • Medscape, LLC designates this continuing education activity for 0.25 contact hour(s) (0.025 CEUs) (Universal Activity Number JA0007105-0000-22-033-H01-P).

    Contact This Provider

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]


Instructions for Participation and Credit

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.

Follow these steps to earn CME/CE credit*:

  1. Read the target audience, learning objectives, and author disclosures.
  2. Study the educational content online or printed out.
  3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. We encourage you to complete the Activity Evaluation to provide feedback for future programming.

You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates from the CME/CE Tracker.

*The credit that you receive is based on your user profile.

CME / ABIM MOC / CE

Do Male Persons Have Higher Risk for Myocarditis After COVID-19 Vaccination?

Authors: News Author: Steve Stiles; CME Author: Laurie Barclay, MDFaculty and Disclosures

CME / ABIM MOC / CE Released: 2/23/2022

Valid for credit through: 2/23/2023

processing....

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 COVID-19 vaccines may be provided in this activity 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 risk of myocarditis after immunization in young males with mRNA-based vaccines against SARS-CoV-2 raised concerns when it came to light in early 2021. That observation has led to speculation that higher testosterone levels in adolescent boys and young men may somehow promote the adverse vaccine effect, whereas greater levels of estrogen among girls and women in the same age range may be cardioprotective.

Study Synopsis and Perspective

Evidence that such myocarditis predominates in young adult men and adolescent boys, especially following a second vaccine dose, is remarkably consistent. The predominance of vaccine-associated myocarditis among adolescent and young adult male persons is probably more about the myocarditis itself than the vaccines, observed Biykem Bozkurt, MD, PhD, who has been studying COVID-19--related myocarditis at Baylor College of Medicine, Houston, Texas. 

The risk was elevated only among mRNA-based vaccine recipients who were younger than age 40 years in the recent Nature Medicine analysis. Among that group, estimates after a second dose numbered fewer than 1 case per 100,000 for Pfizer-BioNTech and 1.5 per 100,000 for Moderna. 

In another analysis from Israel —in NEJM,[5] from Guy Witberg, MD, Rabin Medical Center, and colleagues, based on 2.5 million people aged 16 years and older with at least 1 Pfizer-BioNTech injection — 2.1 cases per 100,000 were estimated overall, but the number rose to 10.7 per 100,000 among those persons aged 16 to 29 years. 

In the Mevorach NEJM report,[2] estimates after a second Pfizer-BioNTech vaccine dose were 1 per 26,000 male persons vs 1 in 218,000 female persons, compared with 1 myocarditis case in 10,857 persons among "the general unvaccinated population." 

In a recent BMJ report[6] based on about 5 million people aged 12 years of age or older in Denmark, the estimated rates of myocarditis or pericarditis associated with Moderna immunization were 2 per 100,000 among women but 6.3 per 100,000 for men. The incidence and sex difference were much lower among those persons getting the Pfizer-BioNTech vaccine: 1.3 per 100,000 and 1.5 per 100,000 in women and men, respectively. 

Sex Hormones May Be Key

Male sex historically is associated in both epidemiologic studies and experimental models with a greater propensity for most any form of myocarditis, Bozkurt told theheart.org | Medscape Cardiology. Given that male persons aged 16 to 19 years or so appear to be at highest risk for myocarditis as a complication of SARS-CoV-2 vaccination, the mechanism may well be related to sex hormones, she said. "We don't know the mechanism, but a theory that attributes a protective role to estrogen, or a risk associated with testosterone, is reasonable. It makes sense, at least according to epidemiological data," Ammirati agreed. Still, "we do not have any direct evidence in human beings."

"Most of the myocarditis is benign, by which I mean that maybe the patients are admitted due to chest pain, but without reduction in ventricular function," Enrico Ammirati, MD, PhD, a myocarditis expert at De Gasperis Cardio Center and Transplant Center, Niguarda Hospital, Milan, Italy, told theheart.org | Medscape Cardiology.”

In male persons compared to female persons, "the heart can be more vulnerable to events such as arrhythmias or to immune-mediated phenomena. So, probably there is also higher vulnerability to myocarditis in men," Ammirati noted.

Study Highlights

  • In the retrospective review of Israeli Ministry of Health active surveillance from December 20, 2020 and May 31, 2021, ~ 5.1 million received 2 Pfizer-BioNTech doses. Of 136 definitive or probable myocarditis cases occurring after vaccination, 129 (95%) were mild; 1 fulminant case was fatal.
  • Overall risk difference between first and second doses was 1.76/100,000 persons, with largest difference in male persons ages 16 to 19 years (13.73/100,000).
  • Standardized incidence ratio (vs incidence expected from historical data) was 5.34 and was highest after second dose in male persons ages 16 to 19 years (13.6).
  • Rate ratio 30 days after second dose, vs. unvaccinated, was 2.35, highest in male persons ages 16 to 19 years (8.96; 1/6637).
  • The investigators concluded that myocarditis incidence was low but increased after vaccination, particularly among young male persons after second dose; clinical presentation was usually mild.
  • At the largest health care organization in Israel, persons vaccinated with Pfizer-BioNTech (n = 884,828) were individually matched by sociodemographic and clinical factors to unvaccinated persons. Vaccination was most strongly associated with elevated risk for myocarditis (risk ratio [RR] = , 3.24; difference, 2.7 events/100,000 persons), lymphadenopathy (RR = 2.43; difference, 78.4/100,000), appendicitis (RR = 1.40; difference, 5/100,000), and herpes zoster infection (RR = 1.43; difference, 15.8/100,000).
  • Risks for of SARS-CoV-2 infection were substantially greater for myocarditis (18.28; difference, 11.0/100,000), pericarditis, arrhythmia, deep-vein thrombosis, pulmonary embolism, myocardial infarction, intracranial hemorrhage, and thrombocytopenia.
  • Researchers concluded that the Pfizer-BioNTech vaccine was associated with excess risk myocarditis (1-5 events/100,000 persons) but not with elevated risk for of most AEs. SARS-CoV-2 infection substantially increased risk for of myocarditis and many other serious AEs.
  • Risks for of myocarditis were increased 1 to –28 days after first ChAdOx1 and BNT162b2 dose; first and second doses of mRNA-1273 vaccine; and after positive SARS-CoV-2 test.
  • Per 1 million vaccinated with ChAdOx1, BNT162b2 and mRNA-1273, estimated extra myocarditis events were 2, 1 and 6, respectively, after following first dose, and 10/1 million after mRNA-1273 second dose.
  • After a positive SARS-CoV-2 test, extra myocarditis events were 40/1 million. Risks of pericarditis and cardiac arrhythmias increased, unlike with any of the COVID-19 vaccines, except for increased arrhythmia risk following mRNA-1273 second dose.
  • In subgroup analyses, risk for myocarditis following mRNA vaccination increased only at ages < 40 years.
  • The Danish population-based cohort study followed 4,931,775 people ages ≥ 12 years from October 1, 2020 to October 5, 2021.
  • Of 3, 482,295 given Pfizer-BioNTech, 48 developed myocarditis or myopericarditis within 28 days (adjusted HR [aHR] vs. unvaccinated = 1.34; absolute rate, 1.4/100 000).
  • Among female persons only, aHR was 3.73; absolute rate, 1.3/100 000 vaccinated; among male persons, aHR = 0.82 and absolute rate, 1.5/100,000, respectively.
  • Of 498,814 individuals receiving Moderna, 21 developed myocarditis or myopericarditis within 28 days (aHR = 3.92; absolute rate, 4.2/100,000.
  • Among persons aged 12 to 39 year-olds, aHR was 5.24 and absolute rate, 5.7/100 000 vaccinated.
  • The investigators concluded that Moderna vaccination was associated with significantly increased risk for myocarditis or myopericarditis, mostly driven by individuals aged 12 to 39 years, whereas Pfizer-BioNTech was associated with significantly increased risk only among women.
  • Benefits of SARS-CoV-2 mRNA vaccination should be considered when interpreting these findings.

Clinical Implications

  • Two Israeli studies showed low but increased myocarditis incidence after vaccination, particularly among young male persons after second dose.
  • Low incidence and mild presentation of myocarditis are minimal compared with risks for of myocarditis and serious AEs from COVID-19.
  • Implications for the Health Care Team: Members of the healthcare team should provide current, evidence-based education to vaccine-eligible patients regarding the current findings which support overall safety of SARS-CoV-2 mRNA vaccines.

 

Earn Credit