COVID-19 infection continues to be an important cause of hospitalization and death in children.
This month in Pediatrics, we are publishing 2 articles that describe strategies to prevent and/or treat pediatric COVID-19 infection.
The first article is entitled, “Maternal COVID-19 Vaccination and Prevention of Symptomatic Infection in Infants,” and it is written by Dr. Cristina Cardemil at the National Institute of Allergy and Infectious Diseases, National Institutes of Health and colleagues who participated in the MOMI-Vax Study Group (10.1542/peds.2023-064252). These authors looked at the rates of COVID-19 infection among infants younger than 6 months of age whose mothers had received COVID-19 vaccines during pregnancy. As a reminder, infants cannot receive COVID-19 vaccinations until they are at least 6 months of age, so the passive protection transferred from the mother is important.
Dr. Cardemil and colleagues found that:
- The higher the mother’s level of antibodies against the COVID-19 spike protein (which the body makes after receiving the COVID-19 vaccine) at the time of delivery, the less likely the infant was to become infected with COVID-19 in the first 6 months of life.
- Mothers who received both the primary series and a booster dose of the COVID-19 vaccine had higher antibody levels than mothers who received the primary vaccine series only.
The second article discusses antiviral treatment for children who are hospitalized for COVID-19 infection. This article, by Dr. Amina Ahmed at Levine Children’s Hospital and colleagues from the Clinical Administration of Remdesivir After COVID-19 Diagnosis in Children (CARAVAN) Study, is entitled “Remdesivir for COVID-19 in Hospitalized Children: A Phase 2/3 Study” (10.1542/peds.2023-063775).
Of note, several of the authors are employees of Gilead Sciences, which manufactures Remdesivir and also funded the study.
Remdesivir decreases the risk of severe COVID-19 disease in adults, and it is the first antiviral medication to be approved in the US for the treatment of COVID-19 in children. This study was a Phase 2/3 study. There are generally 3 phases of clinical trials for drugs before a drug is approved by the Food and Drug Administration (FDA):
- Phase 1: The drug or treatment is tested in a small group of people for the first time to look at safety and side effects of the drug at different doses.
- Phase 2: The drug or treatment is given to a larger group of people to see how well it works and to look at safety and side effects.
- Phase 3: The new drug or treatment is given to even larger groups of people to confirm that it is effective and safe and to compare it to other existing drugs or treatments.
In this Phase 2/3 study, 53 children who were between 28 days and 17 years of age and had confirmed COVID-19 infection that required hospitalization were enrolled. Ninety-eight percent of them had pre-existing medical conditions. Remdesivir was given once daily intravenously for up to 10 days.
The authors found that:
- 83% had clinical recovery.
- The safety profile of the drug was good, with no new safety concerns identified.
These two studies provide us with more tools for prevention and treatment of COVID-19. These are data that we can use when counseling families about COVID-19 prevention and treating children who are hospitalized because of COVID-19.
