Vaksin COVID-19 untuk Anak Usia 6 Bulan ‒ 5 Tahun: Bukti Ilmiah

Oleh :

dr.Eva Naomi Oretla

Vaksin COVID-19 yang disetujui untuk anak usia 6 bulan ‒ 5 tahun, tetapi belum direkomendasikan, adalah vaksin tipe mRNA yaitu vaksin Moderna dan vaksin Pfizer. Sebenarnya, bagaimana bukti ilmiah pemberian vaksin COVID-19 pada anak di masyarakat atau populasi lebih besar? Walaupun clinical trial terhadap kedua vaksin COVID-19 tersebut menunjukkan efikasi, keamanan, dan stimulasi antibodi pada anak usia ≥6 bulan yang serupa dengan pemberian pada dewasa.[1,3-5]

FDA telah mengeluarkan emergency use authorization (EUA) untuk penggunaan vaksin COVID-19 pada anak usia 6 bulan hingga 5 tahun. Demikian juga CDC telah merekomendasikan dan mengeluarkan jadwal imunisasi COVID-19 interim untuk usia ≥6 bulan. Vaksin yang dapat diberikan adalah vaksin Moderna (mRNA-1273) dan vaksin Pfizer (BNT162b2).[1-4]

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Referensi

1. Tian F, Yang R, Chen z. Safety and efficacy of COVID‐19 vaccines in children and adolescents: A systematic review of randomized controlled trials. J Med Virol. 2022;1–10 DOI: 10.1002/jmv.27940
2. FDA News Release. Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age. 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children
3. ACIP. ACIP Evidence to Recommendations for Use of Moderna COVID-19 Vaccine in Children Ages 6 Months – 5 Years and Pfizer-BioNTech COVID-19 Vaccine in Children Ages 6 Months – 4 Years under an Emergency Use Authorization. CDC. 2022. https://www.cdc.gov/vaccines/acip/recs/grade/covid-19-moderna-pfizer-children-vaccine-etr.html
4. Willyard C. FDA authorizes COVID vaccines for the littlest kids: what the data say. Nature. 2022. https://www.nature.com/articles/d41586-022-01689-w#ref-CR1
5. Valente E. CDC Approves COVID-19 Vaccines for Kids Under 5 Years of Age—What Parents Should Know. Stanford Medicine Children's Health. 2022. https://healthier.stanfordchildrens.org/en/covid-19-vaccines-for-kids-under-5-years-of-age-what-parents-should-know
6. Sood M, Sharma S, et al. Emerging Evidence on Multisystem Inflammatory Syndrome in Children Associated with SARS-CoV-2 Infection: a Systematic Review with Meta-analysis. SN Comprehensive Clinical Medicine. 2021;3:38–47 DOI: https://doi.org/10.1007/s42399-020-00690-6
7. Oliver S. mRNA COVID-19 vaccines in young children: Summary and Work Group interpretation. CDC. 2022;6:1-31 https://stacks.cdc.gov/view/cdc/118384
8. CDC. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE): Moderna COVID-19 Vaccine for Children Aged 6 Months–5 Years. CDC. 2022. https://www.cdc.gov/vaccines/acip/recs/grade/covid-19-moderna-vaccine-6-months-5-years.html
9. An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI). Recommendations on the use of Moderna Spikevax COVID-19 vaccine in children 6 months to 5 years of age. Public Health Agency of Canada. 2022;7:1-27 https://www.canada.ca/content/dam/phac-aspc/documents/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-moderna-spikevax-covid-19-vaccine-children-6-months-5-years.pdf
10. Das R. mRNA-1273 (Moderna COVID-19 Vaccine) in Individuals, 6 Months - 5 Years of Age. ModernaTX, Inc. 2022;6:1-32 https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-17-18/04-covid-das-508.pdf
11. Fleming-Dutra K E, Wallace M, et al. Interim Recommendations of the Advisory Committee on Immunization Practices for Use of Moderna and Pfizer-BioNTech COVID-19 Vaccines in Children Aged 6 Months–5 Years — United States, June 2022. Weekly. 2022;71(26);859–868
12. Pfizer and BioNTech Provide Update on Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age. Pfizer. 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-rolling-submission
13. COVID-19 Vaccine Interim COVID-19 Immunization Schedule for 6 Months of Age and Older. CDC. 2022. https://www.cdc.gov/vaccines/covid-19/downloads/covid-19-immunization-schedule-ages-6months-older.pdf
14. 6 Months Through 4 Years of Age Pfizer-BioNTech COVID-19 Vaccine Standing Orders for Administering Vaccine. CDC. 2022. https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/infant-standing-orders.pdf
15. World Health Organization. Interim Statement on COVID-19 Vaccination for Children. WHO. 2022. https://www.who.int/news/item/11-08-2022-interim-statement-on-covid-19-vaccination-for-children
16. ATAGI Recommendations on Use of the Pfizer COVID-19 Vaccine for Children Aged 6 Months to 4 Years. Australian Government Department of Health and Aged Care. 2022. https://www.health.gov.au/news/atagi-recommendations-on-use-of-the-pfizer-covid-19-vaccine-for-children-aged-6-months-to-4-years
17. BPOM Terbitkan Izin Penggunaan Darurat Vaksin Comirnaty Children Usia 6 Bulan hingga 11 Tahun. Kompas.com. Desember 2022. https://nasional.kompas.com/read/2022/12/27/14142731/bpom-terbitkan-izin-penggunaan-darurat-vaksin-comirnaty-children-usia-6
18. Badan Pengawasan Obat dan Makanan. Penerbitan EUA Vaksin Comirnaty Children untuk Penggunaan pada Anak Usia 6 Bulan Hingga 11 Tahun. 2022. BPOM. https://www.pom.go.id/new/view/more/pers/670/Penerbitan-EUA-Vaksin-Comirnaty-Children-untuk-Penggunaan-pada-Anak-Usia-6-Bulan-Hingga-11-Tahun.html