Vaksin Covid-19 Janssen

Vaksin Covid-19 Janssen
	Sebuah vial dari vaksin COVID-19 Johnson & Johnson
Deskripsi vaksin
Target	SARS-CoV-2
Jenis vaksin	Vektor virus
Data klinis
Nama dagang	Janssen COVID-19 Vaccine, COVID-19 Vaccine Janssen
Nama lain	Ad26.COV2.S; JNJ-78436735; Ad26COVS1; VAC31518;
License data	US DailyMed: Janssen_COVID-19_Vaccine;
Rute; pemberian	Intraotot
Kode ATC	Tidak ada ;
Status hukum
Status hukum	CA: Schedule D; Authorized by interim order ; US: Tak disepakati (Otorisasi Pemakaian Darurat); EU: Otorisasi pemasaran kondisional diberikan ;
Pengenal
DrugBank	DB15857;
UNII	JT2NS6183B;

Vaksin COVID-19 Johnson & Johnson adalah vaksin COVID-19 vektor viral adenovirus manusia^[12] yang dikembangkan oleh Janssen Vaccines di Leiden, Belanda,^[13] dan perusahaan induknya di Belgia Janssen Pharmaceuticals,^[14] subsidier dari perusahaan Amerika Serikat Johnson & Johnson (J&J).^[15]^[16]

Vaksin tersebut berbahan dasar adenovirus manusia yang dimodifikasi untuk membuat gen untuk menciptakan spike protein terhadap virus SARS-CoV-2 yang menyebabkan COVID-19.^[3] Vaksin tersebut hanya diwajibkan satu dosis dan tak perlu disimpan beku.^[17]

Catatan

Referensi

1 2 "Janssen COVID-19 Vaccine- ad26.cov2.s injection, suspension". DailyMed. Diakses tanggal 27 February 2021.
↑ "Janssen COVID-19 Emergency Use Authorization (EUA) Official Website". Janssen. 28 February 2021. Diakses tanggal 28 February 2021.
1 2 Kesalahan pengutipan: Tag <ref> tidak sah; tidak ditemukan teks untuk ref bernama Janssen CMA application
1 2 3 4 "A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older ENSEMBLE Protocol VAC31518COV3001; Phase 3" (PDF). Janssen Vaccines & Prevention.
1 2 3 4 "A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older ENSEMBLE 2 Protocol VAC31518COV3009; Phase 3" (PDF). Janssen Vaccines & Prevention.
1 2 Kesalahan pengutipan: Tag <ref> tidak sah; tidak ditemukan teks untuk ref bernama jnj
↑ "Regulatory Decision Summary – Janssen COVID-19 Vaccine – Health Canada". Health Canada. 5 March 2021. Diakses tanggal 5 March 2021.
↑ "Janssen COVID-19 Vaccine monograph" (PDF). Janssen. 5 March 2021.
↑ "FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine". U.S. Food and Drug Administration (FDA) (Press release). 27 February 2021. Diakses tanggal 27 February 2021.
↑ https://www.fda.gov/media/146303/download
↑ "COVID-19 Vaccine Janssen EPAR". European Medicines Agency (EMA). 5 March 2021. Diakses tanggal 16 March 2021.
↑ "A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE)". ClinicalTrials.gov. Diakses tanggal 30 January 2021.
↑ "Leiden developed Covid-19 vaccine submitted to EMA for approval". 2021-02-16.
↑ "Clinical trial COVID-19 vaccine candidate underway". Janssen Belgium (dalam bahasa Inggris). Diakses tanggal 2021-03-13.
↑ "EMA recommends Johnson & Johnson Covid vaccine for approval; Developed in Leiden". NL Times.
↑ Saltzman J (12 March 2020). "Beth Israel is working with Johnson & Johnson on a coronavirus vaccine". The Boston Globe.
↑ Kesalahan pengutipan: Tag <ref> tidak sah; tidak ditemukan teks untuk ref bernama Fact sheet

Pranala luar

Scholia memiliki profil tentang Vaksin Covid-19 Janssen (Q98655215).

[Janssen_COVID-19_Vaccine_FDA_label-1] 1 2 "Janssen COVID-19 Vaccine- ad26.cov2.s injection, suspension". DailyMed. Diakses tanggal 27 February 2021.

[2] "Janssen COVID-19 Emergency Use Authorization (EUA) Official Website". Janssen. 28 February 2021. Diakses tanggal 28 February 2021.

[Janssen_CMA_application-3] 1 2 Kesalahan pengutipan: Tag <ref> tidak sah; tidak ditemukan teks untuk ref bernama Janssen CMA application

[J&J_Protocol-4] 1 2 3 4 "A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older ENSEMBLE Protocol VAC31518COV3001; Phase 3" (PDF). Janssen Vaccines & Prevention.

[J&J_ENSEMBLE_2_Protocol-5] 1 2 3 4 "A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older ENSEMBLE 2 Protocol VAC31518COV3009; Phase 3" (PDF). Janssen Vaccines & Prevention.

[jnj-6] 1 2 Kesalahan pengutipan: Tag <ref> tidak sah; tidak ditemukan teks untuk ref bernama jnj

[CA_authorization-7] "Regulatory Decision Summary – Janssen COVID-19 Vaccine – Health Canada". Health Canada. 5 March 2021. Diakses tanggal 5 March 2021.

[8] "Janssen COVID-19 Vaccine monograph" (PDF). Janssen. 5 March 2021.

[FDA_PR_20210227-9] "FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine". U.S. Food and Drug Administration (FDA) (Press release). 27 February 2021. Diakses tanggal 27 February 2021.

[FDA_EUA-10] ttps://www.fda.gov/media/146303/download

[COVID-19_Vaccine_Janssen_EPAR-11] "COVID-19 Vaccine Janssen EPAR". European Medicines Agency (EMA). 5 March 2021. Diakses tanggal 16 March 2021.

[ensemble-12] "A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE)". ClinicalTrials.gov. Diakses tanggal 30 January 2021.

[13] "Leiden developed Covid-19 vaccine submitted to EMA for approval". 2021-02-16.

[14] "Clinical trial COVID-19 vaccine candidate underway". Janssen Belgium (dalam bahasa Inggris). Diakses tanggal 2021-03-13.

[15] "EMA recommends Johnson & Johnson Covid vaccine for approval; Developed in Leiden". NL Times.

[Globe_20200312-16] Saltzman J (12 March 2020). "Beth Israel is working with Johnson & Johnson on a coronavirus vaccine". The Boston Globe.

[Fact_sheet-17] Kesalahan pengutipan: Tag <ref> tidak sah; tidak ditemukan teks untuk ref bernama Fact sheet

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