Two-dose HepB vaccine is not associated with increased risk of acute myocardial infarction

According to the CDC, hepatitis B virus (HBV) affects approximately 296 million people worldwide.¹ This includes over 6 million children under the age of 5.¹ Hepatitis B is a serious liver infection caused by HBV, and every 30 seconds one person dies from hepatitis-related illness.²

The Advisory Committee on Immunization (ACIP) recommends that the following individuals receive the HBV vaccine:³:

・All infants

・Those under the age of 19 who have not been vaccinated

・Adults aged 19 to 59

– Adults aged 60 years or older with HBV risk factors

The World Health Organization’s goal is to eliminate hepatitis B by 2030. A white paper published by the World Hepatitis Alliance contains recommendations for preventing mother-to-child transmission.^Four Such as early pregnancy testing and education provided as part of standard prenatal care.^Four ACIP has also issued updated recommendations in 2022 that individuals over the age of 60 without HBV risk factors can also be vaccinated.^Five The recommendations emphasize that providers should offer vaccines to this population rather than waiting for patients to request them.^Five

HBV vaccine with a cytosine phosphoguanine adjuvant (HepB-CpG vaccine; Heplisav-B) is a two-dose vaccine series approved for adults 18 years and older.⁶ In clinical studies, Heplisav-B was found to provide better seroprotection than 3 doses of HBV with aluminum hydroxide adjuvant (HepB-alum vaccine; Engerix-B).⁶ Engerix-B is approved for vaccination at birth and in pediatric and adult patients.⁶ One previous clinical trial reported a higher number of acute myocardial infarction (MI) events in Heplisav-B vaccinated patients (0.25%) than in Engerix-B vaccinated patients (0.04%) it was done.⁶ Heplisav-B was approved in 2017 and the FDA requested postmarket studies to assess the risk of acute MI.⁶

Hepatitis B vaccine and acute myocardial infarction

A post-marketing study was conducted at Kaiser Permanente Southern California (KPSC) to compare the incidence of acute myocardial infarction in individuals receiving Heplisav-B and Engerix-B.⁶ In a prospective cohort noninferiority study, HBV vaccine was distributed to KPSC medical centers using a nonrandomized cluster design.⁶ Individuals included in this study were at least 18 years of age.⁶ These individuals must have received at least one dose of HBV vaccine during a primary care or medical visit between August 7, 2018 and October 31, 2019. Furthermore, this was the time frame and setting in which more than 90% of the HBV vaccine was administered.⁶ Patients on dialysis were excluded from the study.

Study participants were monitored for 13 months through an electronic medical record system. The Heplisav-B group included 31,183 patients and the Engerix-B group included 38,442 study participants.⁶ The median age in both groups was 49 years.

During the study follow-up period, 74 occult acute MI events occurred in the Heplisav-B group and 128 in the Engerix-B group.⁶ Additionally, 52 events were classified as type 1 acute myocardial infarction (definite or probable) in the Heplisav-B group.⁶ In the Engerix-B group, there were 71 events that were considered type 1 acute myocardial infarction.⁶ Furthermore, the incidence per 1000 person-years of type 1 acute myocardial infarction was 1.67 in the Heplisav-B group and 1.86 in the Engerix-B group.⁶ An analysis comparing the incidence of type 1 acute MI between groups was performed. Kaplan-Meier analysis (survival analysis) found that the cumulative incidence of type 1 acute myocardial infarction events was similar between groups (P =.56).⁶

The researchers noted some study limitations, including potential misclassification of vaccine exposure.⁶ However, the manufacturer and lot number information was checked against the brand name. In addition, a dosage chart review was also conducted. Two cardiologists reviewed all data, although the potential for misclassification of acute myocardial infarction was also marginal.⁶

The investigators in this study concluded that the Heplisav-B vaccine did not increase the risk of acute myocardial infarction compared to the Engerix-B vaccine.⁶ These results were consistent across all subgroups defined by age group, diabetes, hypertension, concomitant vaccination, and whether the index dose (first dose during the study period) was the first or subsequent HBV vaccine. was doing.⁶

References:

1. Fast facts about hepatitis B in the world. CDC. Updated 07/27/2022. Accessed 27 February 2023. https://www.cdc.gov/globalhealth/immunization/diseases/hepatitis-b/data/fast-facts.html

2. July 28th is World Hepatitis Day. World Hepatitis Alliance. Reviewed 30 March 2022. Accessed March 3, 2023. https://www.worldhepatitisday.org/

3. Hepatitis B Questions and Answers for Healthcare Professionals. CDC. Accessed 27 February 2023. https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm

4. Mothers and Babies Can’t Wait: A Call to Action to End Mother-to-Child Transmission of Hepatitis B. World Hepatitis Alliance. Accessed 3 March 2023. https://www.worldhepatitisalliance.org/news/pmtctreport/

5. Weng MK, Doshani M, Khan MA, et al. Universal hepatitis B vaccination among adults aged 19–59 years: updated recommendations of the Immunization Advisory Committee—United States, 2022. MMWR Morb Mortal Wkly Rep 2022;71(13):477-483 Doi: 10.15585/mmwr.mm7113a1

6. Bruxvoort K, Slezak J, Qian L, et al. Association between 2-dose versus 3-dose hepatitis B vaccine and acute myocardial infarction. jam. 2022;327(13):1260-1268. Doi: 10.1001/jama.2022.2540