FDA Amends Booster Recommendations for Young Children, Rise in Myocardial Infarction Deaths During Omicron, Vaccination Lowers Risk of Major CV Events, and More

FDA Authorizes COVID-19 Booster in Children Aged 6 Months to 4 Years¹

The FDA amended its emergency use authorization of the bivalent Pfizer-BioNTech COVID-19 vaccine in pediatric patients. The change allows for the use of a single booster dose of the vaccine in children aged 6 months to 4 years at least 2 months after completing three doses of primary vaccination.

The FDA’s decision to amend its emergency use authorization followed an evaluation of immune response data from 60 children who had completed a course of primary vaccination. Children in the 6 months to 4-year age group received a single dose of the booster vaccine. The study participants demonstrated an immune response to the original SARS-CoV-2 strain and omicron BA.4/BA.5 strains 1 month after receiving the booster dose.

Additionally, the FDA reported on the safety of children in this age group receiving the booster dose of the vaccine. Based on two clinical studies, the most common adverse events included redness and swelling at the injection site, fatigue, fever, vomiting, and chills, to name a few.

Acute Myocardial Infarction Deaths Rose During Omicron Outbreak²

According to a study, the rate of mortality associated with excess acute myocardial infarction rose among adults during the omicron outbreak.

The researchers used data from the CDC’s National Vital Statistics System, where they identified more than 1.5 million acute myocardial infarction associated deaths. The authors compared deaths that occurred prepandemic and during the pandemic by age. The researchers found that, prior to the pandemic, trends related to acute myocardial infarction decreased and reversed during the pandemic. There were significant rises in acute myocardial infarction in young adults, both male and female.

The excess death rates, which is the difference between the observed and predicted mortality rates, was most pronounced for people aged 25 and 44 years compared to those in older age groups.

“The trend of mortality suggests that age and sex disparities have persisted even through the recent omicron surge, with excess acute myocardial infarction-associated mortality being most pronounced in younger-aged adults,” the researchers concluded.

Diabetes Risk After COVID-19 Infection³

A study has found that COVID-19 infection is associated with an increased risk of diabetes and that risk persisted as the omicron variant became predominant.

The researchers conducted a large cohort study that included 23,709 patients with one or more COVID infection. After analysis, diabetes had the highest odds postinfection (2.35; [95% CI, 1.94 – 2.89]; p < 0.001). The next highest odds were new-onset hypertension, benchmark diagnoses, and hyperlipidemia.

Further, the researchers found that the risk of diabetes was higher among individuals who were unvaccinated when compared with those who were vaccinated. Although there was a difference, the researchers did note that “the interaction term between vaccination status and diabetes was not statistically significant.”

“Mechanisms contributing to postinfection diabetes risk remain unclear, although persistent inflammation contributing to insulin resistance is a proposed pathway,” the researchers concluded.

Full, Partial Vaccination For COVID-19 Associated with Low Risk of Major CV Event⁴

In a research letter, a group of researchers found that vaccination against COVID-19 is associated with fewer major cardiovascular events such as myocardial infarction and stroke.

The researchers analyzed data from the National COVID Cohort Collaborative (N3C) that included patients aged 18 to 90 years who were infected with COVID-19 from early 2020 to early 2022 (n = 1,934,294). They then compared characteristics between individuals with and without a major cardiovascular event by using the chi-square test. Of the total, 195,136 were fully vaccinated, 22,707 were partially vaccinated, and 1,716,451 were not vaccinated.

Major cardiovascular events were observed among 13,948 patients with 12,733 (0.7%) cases occurring among nonvaccinated patients, 160 (0.7%) in partially vaccinated patients, and 1,055 (0.5%) in fully vaccinated patients. Further, in total, 3175 patients died following a major cardiovascular event.

References:

1. Coronavirus (COVID-19) update: FDA authorizes bivalent Pfizer-BioNTech COVID-19 vaccine as booster dose for certain children 6 months through 4 years of age. News release. US Food and Drug Administration; March 14, 2023. Accessed April 19, 2023. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-bivalent-pfizer-biontech-covid-19-vaccine-booster-dose?utm_medium=email&utm_source=govdelivery
2. Yeo YH, Wang M, He X, et al. Excess risk for acute myocardial infarction mortality during the COVID-19 pandemic. J Med Virol. Published online September 29, 2022. doi:10.1002/jmv.28187
3. Kwan AC, Ebinger JE, Botting P, Navarrette J, Claggett B, Cheng S. Association of COVID-19 vaccination with risk for incident diabetes after COVID-19 infection. JAMA Netw Open. Published online February 14, 2023. doi:10.1001/jamanetworkopen.2022.55965
4. Jiang J, Chan L, Kauffman J, et al. Impact of vaccination on major adverse cardiovascular events in patients with COVID-19 infection. J Am Coll Cardiol. Published online February 20, 2023. doi:10.1016/j.jacc.2022.12.006