FDA Approves Updated COVID-19 Vaccines with New Restrictions, Potentially Limiting Access for Healthy Children

Conflicting guidance from federal health authorities and pediatric experts has emerged as the Food and Drug Administration approved updated COVID-19 vaccines for the fall season, but with limited eligibility compared to prior seasons. The new guidance restricts access to COVID-19 vaccines for children, particularly those under 5 years old, and may exacerbate existing barriers to vaccination for families already facing difficulties.

Key Takeaways:

• The FDA revoked emergency use authorizations for COVID-19 vaccines, limiting approval to individuals at higher risk of serious illness from COVID-19 infection, such as those over 65 or with underlying health conditions.
• The agency approved two updated mRNA-based vaccines for children 6 months and older, but only for those at higher risk of serious illness.
• The Centers for Disease Control and Prevention no longer routinely recommends COVID-19 vaccines for healthy children aged 6 months to 17 years, but the American Academy of Pediatrics recommends vaccinations for all children 6 months to 23 months old and those 2 to 18 years old at higher risk.
• Pediatricians may need to pivot from using Pfizer's vaccine to Moderna's, potentially leading to supply shortages.
• Families facing barriers to vaccination, such as those in rural areas or lacking health insurance, may be disproportionately affected by these new limitations.
• Providing COVID-19 vaccines to healthy children would require pediatricians to use the vaccine "off-label," potentially creating uncertainty and liability concerns.
• The American College of Obstetricians and Gynecologists recommends updated COVID-19 vaccination during pregnancy, planning pregnancy, the postpartum period, and while lactating.
• The Advisory Committee on Immunization Practices may revise its recommendations after an upcoming meeting, further complicating access to COVID-19 vaccines for children.

Statistics:

• 96% of medications are prescribed on-label, while only 4% of medications are prescribed off-label. (Source: [PLOS ONE](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0098130))
• An estimated 1 in 5 prescriptions are off-label. (Source: [Journal of the American Medical Association](https://jamanetwork.com/journals/jama/fullarticle/1798845))
• The Centers for Disease Control and Prevention reports that COVID-19 is causing hospitalizations and deaths at rates similar to those with other illnesses for which vaccines are routinely recommended, such as influenza. (Source: [Centers for Disease Control and Prevention](https://www.cdc.gov/coronavirus/2019-ncov/variants/summary.html))
• The Vaccine Integrity Project confirmed that no new safety concerns have emerged relating to COVID-19 vaccines, and the vaccines remain effective. (Source: [Vaccine Integrity Project](https://vaccineintegrityproject.org/))

Sources:

• The Conversation -- USA (3) -- By David Higgins, Assistant Professor of Pediatrics, University of Colorado Anschutz Medical Campus
• FDA approves updated COVID-19 vaccines with new restrictions, potentially limiting access for healthy children
• https://theconversation.com/fda-approves-updated-covid-19-vaccines-with-new-restrictions-potentially-limiting-access-for-healthy-children-264098