COVID-19 vaccine in children 5 to 11 years of age

As a pharmacist, you’ll get more questions about COVID-19 vaccines for kids, now that the Pfizer-BioNTech vaccine is authorized down to age 5. Early evidence in 2300 kids age 5 to 11 suggests this vaccine has about 90% efficacy at preventing symptomatic COVID-19. Plus data in 4600 kids suggest side effects are similar to those seen in older patients.

     Give 2 doses, 3 weeks apart (the same as adults). For now, additional doses or boosters are NOT recommended for kids 5 to 11. Ensure your staff are prepping the right dose and formulation. Use a lower dose for kids 5 to 11 (10 mcg IM) from the ORANGE-capped vials. For patients 12 and older, continue to give (30 mcg IM) from the PURPLE-capped vials.

Do NOT prep the 10 mcg dose from purple-capped vials. It’s a different concentration and can lead to dosing errors. Tell parents of kids who are close to turning 12 not to wait for the higher dose. Base each dose on the current age NOT weight. For example, give an 11-year-old 10 mcg for dose 1, but 30 mcg for dose 2 if they’ve turned 12, per CDC guidance. If the child gets 10 mcg for both doses, still consider them fully vaccinated after 2 weeks.

Clarify benefits and risks of vaccinating kids age 5 and up. Parents may hear that about 40% of kids have had COVID-19. But some evidence in adults suggests vaccine-induced immunity protects against REinfection 5 times better than infection-induced immunity. Also point out that vaccinating kids likely reduces transmission. 

Most kids who get COVID-19 have mild illness. But emphasize that serious complications are possible and vaccine risks are rare. For instance, about 1 in 12 kids have “long-haul” COVID-19 symptoms (fatigue, etc). Plus over 5500 kids with COVID-19 have had multisystem inflammatory syndrome in children (MIS-C), a possibly deadly condition that can cause severe myocarditis and organ damage. On the other hand, postvaccination myocarditis is mild and rare, about 70 in 1 million males age 12 to 17, with a much lower risk in females. There are no cases in kids under 12 yet and studies are ongoing. Give COVID-19 vaccines with other vaccines (flu, etc) if needed.

REFERENCES

  • Walter EB, Talaat KR, Sabharwal C, Gurtman A, Lockhart S, Paulsen GC, Barnett ED, Muñoz FM, Maldonado Y, Pahud BA, Domachowske JB, Simões EAF, Sarwar UN, Kitchin N, Cunliffe L, Rojo P, Kuchar E, Rämet M, Munjal I, Perez JL, Frenck RW Jr, Lagkadinou E, Swanson KA, Ma H, Xu X, Koury K, Mather S, Belanger TJ, Cooper D, Türeci Ö, Dormitzer PR, Åžahin U, Jansen KU, Gruber WC; C4591007 Clinical Trial Group. Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. N Engl J Med. 2021 Nov 9:NEJMoa2116298. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2116298

    Woodworth, K.R., Moulia, D., Collins, J.P., Hadler, S.C., Jones, J.M., Reddy, S.C., Chamberland, M., Campos-Outcalt, D., Morgan, R.L., Brooks, O., Talbot, H.K., Lee, G.M., Bell, B.P., Daley, M.F., Mbaeyi, S., Dooling, K. and Oliver, S.E. (2021). The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5–11 Years — United States, November 2021. MMWR. Morbidity and Mortality Weekly Report, 70(45), pp.1579–1583. Available at: https://www.cdc.gov/mmwr/volumes/70/wr/mm7045e1.htm

    CDC (2021). Pfizer-BioNTech COVID-19 Vaccine: 5 Through 11 Years of Age. Available at: https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/Pfizer_PED_PrepAdmin.pdf

    FDA (2021). Vaccines and Related Biological Products Advisory Committee Meeting. Available at: https://www.fda.gov/media/153514/download

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