- Pendahuluan
- Farmakologi
- Formulasi
- Indikasi dan Dosis
- Efek Samping dan Interaksi Obat
- Penggunaan pada Kehamilan dan Ibu Menyusui
- Kontraindikasi dan Peringatan
- Pengawasan Klinis
Efek Samping dan Interaksi Obat Vaksin COVID-19 Pfizer
Efek samping vaksin COVID-19 Pfizer terdiri dari reaksi lokal dan sistemik. Data dari hasil uji klinik menunjukkan bahwa efek samping yang paling sering dilaporkan adalah nyeri pada tempat injeksi, kelelahan, dan sakit kepala.[1,2,4,7]
Efek Samping
Data mengenai keamanan vaksin COVID-19 Pfizer didapat dari hasil uji klinik dengan subjek dewasa berusia 16 tahun ke atas, dan subjek remaja usia 12‒15 tahun.
Referensi
1. Fact sheet for Healthcare Providers Administering Vaccine (Vaccination Providers). 2021. FDA. https://www.fda.gov/media/144413/download
2. Fact sheet for health care providers emergency use authorization (EUA) of Comirnaty. 2021. Pusat Informasi Obat Nasional. http://pionas.pom.go.id/sites/default/files/obat_baru/Fact%20Sheet%20For%20Health%20Care_%28Bahasa%20Inggris%29_Comirnaty%20Suspensi%20Injeksi%20225%20mcg_MRNA%20OF%20SARS-COV%202%20VIRUS%20SPIKE%20PROTEIN_EUA2108602043A1%20%26%20EUA2155900143A1_2021.pdf
4. Lembar Fakta untuk Penyedia Pelayanan Kesehatan Izin Penggunaan dalam Keadaan Darurat Comirnaty. 2021. Pusat Informasi Obat Nasional. http://pionas.pom.go.id/sites/default/files/obat_baru/Fact%20Sheet%20For%20Health%20Care_%28Bahasa%20Indonesia%29_Comirnaty%20Suspensi%20Injeksi%20225%20mcg_MRNA%20OF%20SARS-COV%202%20VIRUS%20SPIKE%20PROTEIN_EUA2108602043A1%20%26%20EUA2155900143A1_2021.pdf
7. Informasi Produk untuk Peserta Vaksinasi Menggunakan Comirnaty untuk Pencegahan COVID-19 pada Usia 12 Tahun ke atas. 2021. Pusat Informasi Obat Nasional. http://pionas.pom.go.id/sites/default/files/obat_baru/Produk%20Informasi_Comirnaty%20Suspensi%20Injeksi%20225%20mcg_MRNA%20OF%20SARS-COV%202%20VIRUS%20SPIKE%20PROTEIN_EUA2108602043A1%20%26%20EUA2155900143A1_2021.pdf
9. Lee EJ, Cines DB, Gernsheimer T, Kessler C, Michel M, Tarantino MD, et al. Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination. Am J Hematol. 2021;96(5):534-7.
10. Polack P, Thomas S, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez J, et al. Safety and Efficacy of BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020.
12. Frenck RW Jr., Klein NP, Kitchin N, et al., C4591001 Clinical Trial Group. Safety, immunogenicity, and efficacy of the BNT162b2 Covid-19 vaccine in adolescents. N Engl J Med2021. doi:10.1056/NEJMoa2107456. pmid:34043894
13. Tarawneh O, Tarawneh H. Immune thrombocytopenia in a 22-year-old post Covid-19 vaccine. Am J Hematol. 2021;96(5):E133-E134. doi:10.1002/ajh.26106
14. Preparing for Your COVID-19 Vaccination. CDC. July 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/prepare-for-vaccination.html
15. Etminan M, Sodhi M, Ganjizadeh-Zavareh S. Should Antipyretics Be Used to Relieve Acute Adverse Events Related to COVID-19 Vaccines?. Chest. 2021;159(6):2171-2172. doi:10.1016/j.chest.2021.01.080
16. Mix and Match of the Second COVID-19 Vaccine Dose for Safety and Immunogenicity (MOSAIC). 2021. ClinicalTrials.gov identifier NCT04894435. https://clinicaltrials.gov/ct2/show/NCT04894435
17. Hillus D, Schwarz T, Tober L, et al. Safety, reactogenicity, and immunogenicity of homologous and heterologous prime-boost immunisation with ChAdOx1 nCoV-19 and BNT162b2: a prospective cohort study. 2021. The Lancet. https://doi.org/10.1016/S2213-2600(21)00357-X
31. Shimabukuro T. COVID-19 Vaccine safety updates, Advisory Committee on Immunization Practices (ACIP): Centers for Disease Control and Prevention; 2021. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-06/03-COVID-Shimabukuro-508.pdf.
32. Montgomery J, Ryan M, Engler R, et al. Myocarditis following immunization with mRNA COVID-19 vaccines in members of the US military. JAMA Cardiol. 2021; doi:10.1001/jamacardio.2021.2833.
33. Barda N, Dagan N, Ben-Shlomo Y, et al. Safety of the BNT162b2 mRNA Covid-19 vaccine in a nationwide setting. N Engl J Med 2021; 385: 1078-90. DOI: 10.1056/NEJMoa2110475
(Konten ini khusus untuk dokter. Registrasi untuk baca selengkapnya)