FDA Releases Guidance on Moderna Vaccine Dosage, Association of COVID-19 and RSV With Pediatric Patients, and More
FDA Guidance on Correct Moderna COVID-19 Vaccine Dosage For Pediatric Patients1
In November 2023, the FDA released what it deemed “important information” for clinicians on the correct dosage and administration of the Moderna COVID-19 vaccine for pediatric patients aged from 6 months to 11 years old.
The FDA became aware that health care providers were incorrectly withdrawing the entire contents of the vaccine vial to administer to individual patients. “However, the volume of a single dose of Moderna COVID-19 Vaccine (2023-2024 Formula) is only 0.25 mL,” the authors wrote.
Further, the FDA did not identify any safety risk with administering a higher dose of the Moderna vaccine to patients aged 6 months through 11 years old. There were no serious adverse events reported related to administering the higher dose.
Association of COVID-19 Outcomes for Patients With Hypertension and Diabetes2
For patients with hypertension and diabetes who were diagnosed with COVID-19, there is a high chance of severe COVID-19 outcomes, according to a retrospective cohort study.
To determine the association between the level of control of hypertension, researchers categorized blood pressure (BP) as < 130/80, 130-139/80-89, 140-159/90-99, or ≥160/100 mm Hg and diabetes as glycated hemoglobin , < 7%, 7% to < 9%, ≥ 9%. In their study, researchers identified close to 1.5 million adults with COVID-19 from March 2020 to February 2022. In total, 43 United States health systems in the National Patient-Centered Clinical Research Network were used to gather data.
Among the total patients, 43% had hypertension and 12% had diabetes. Of the total patients with hypertension, researchers found that the highest baseline BP was associated with greater odds of hospitalization, critical care, and mechanical ventilation, but not mortality. Among those with diabetes, glycated hemoglobin was associated with greater odds of hospitalization, critical care, mechanical ventilation, and mortality.
“[Our] findings suggest that adults with poorest control of hypertension or diabetes might benefit from efforts to prevent and initiate early treatment of COVID‐19,” the researchers concluded.
Additionally, some studies have reported that new-onset hypertension in patients is associated with COVID-19 infection at high rates.
To learn more, Michael J. Bloch, MD, associate professor at the University of Nevada School of Medicine, and the Medical Director of Vascular Care at the Renown Institute for Heart and Vascular Health in Reno Nevada, wrote a piece on this topic for Consultant360.
COVID-19 Association With RSV Infections in Young Pediatric Patients3
Pediatric patients aged 0 to 5 years old who are diagnosed with COVID-19 are at an increased risk of developing respiratory syncytial virus (RSV), according to a retrospective population-based cohort study.
Researchers investigated the association between COVID-19 and the risk of RSV among young pediatric patients in 2022, as there may be a link between the disease and the surge of severe RSV cases in the United States that same year.
For their retrospective population-based cohort study, researchers used a nationwide, multicenter database of electronic health records of 61.4 million patients in the United States, which included 1.7 million children aged 0 to 5. Five outcomes were examined: (1) overall RSV infection, (2) positive lab test-confirmed RSV infection, (3) clinically diagnosed RSV diseases, (4) RSV-associated bronchitis, and (5) unspecified bronchitis.
In total, 228,940 children with no prior RSV infection who had medical encounters in October 2022 were included in the study. Findings were compared with a separate study population of 370,919 children of the same age range with no prior RSV infection who had medical encounters in July 2021 through August 2021.
The risk for RSV infection during October 2022 to December 2022 was 6.4% for children with prior COVID-19 infection. Further, the overall risk for children aged 0 to 1 years old was 7.9%. For the 2021 population, RSV risk was 4.85% for children with prior COVID-19 infection, while the overall risk for children aged 0-1 years old was 7.3%.
“COVID-19 was associated with a significantly increased risk for RSV infections among children aged 0–5 years in 2022. Similar findings were replicated for a study population of children aged 0–5 years in 2021,” the researchers concluded. “Our findings suggest that COVID-19 contributed to the 2022 surge of RSV cases in young children through the large buildup of COVID-19-infected children and the potential long-term adverse effects of COVID-19 on the immune and respiratory system.”
References:
- Important information about the correct dosage and administration of Moderna COVID-19 vaccine (2023-2024) for individuals 6 months through 11 years of age. News release. US Food and Drug Administration; November 2, 2023. www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-information-about-correct-dosage-and-administration-moderna-covid-19-vaccine-2023-2024?utm_medium=email&utm_source=govdelivery
- Jackson SL, Woodruff RC, Nagavedu K, et al. Association between hypertension and diabetes control and COVID-19 severity: national patient-centered clinical research network, United States, March 2020 to February 2022. J Am Heart Assoc. doi: 10.1161/JAHA.122.030240
- Wang L, Davis PB, Berger N, Kaelber DC, Volkow N, Xu R. Association of COVID-19 with respiratory syncytial virus (RSV) infections in children aged 0-5 in the USA in 2022: a multicentre retrospective cohort study. Fam Med Community Health. Published online October 13, 2023. doi:10.1136/fmch-2023-002456