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COVID-19: Youth Vaccination Safe, At-Home Test Approved

Andrea Lugo
June 9, 2023

In a Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR) published June 9, 2023, the agency confirmed that it is safe for children ages 6 months to 5 years old to receive a third dose of an mRNA COVID-19 vaccine.

The study was based on data reported in v-safe, the CDC’s safety surveillance system established to monitor health after COVID-19 vaccination, and the Vaccine Adverse Event Reporting System, another safety surveillance system co-managed by the CDC and the Food and Drug Administration (FDA).

In v-safe, 38 percent of children had no reported reactions after a third dose, and most reported reactions were mild and transient, while vaccination errors accounted for 78 percent of events reported to the VAERS.

Overall, reports to v-safe of injection site and systemic reactions after a third dose of mRNA COVID-19 vaccine, whether monovalent or bivalent, were similar in frequency to those reported after a first or second dose.

FDA Approves First At-Home COVID-19 Test

FDA on June 6 granted marketing authorization through a traditional premarket review pathway for an at-home COVID-19 test for the first time.

The Cue COVID-19 Molecular Test also is the first ever at-home test for any respiratory illness authorized using a traditional premarket review pathway.

The test consists of a single-use Cue COVID-19 test cartridge, a single-use nasal swab, and a battery-operated cartridge reader, which is sold separately. Results are displayed using the Cue Health app.

In an FDA-reviewed study, the test correctly identified 98.7 percent of negative samples and 92.9 percent of positive samples in individuals with signs and symptoms of upper respiratory infection.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127 with questions.

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