ᱡᱚᱱᱥᱚᱱ ᱮᱱᱰ ᱡᱚᱱᱥᱚᱱ ᱠᱳᱵᱷᱤᱰ-᱑᱙ ᱴᱤᱠᱟᱹ

ᱡᱚᱱᱥᱚᱱ ᱮᱱᱰ ᱡᱚᱱᱥᱚᱱ ᱠᱳᱵᱷᱤᱰ-᱑᱙ ᱴᱤᱠᱟᱹ
	A vial of Janssen COVID-19 Vaccine
ᱴᱤᱠᱟᱹ ᱨᱮᱭᱟᱜ ᱵᱚᱨᱱᱚᱱ
ᱡᱚᱥ ᱟᱡᱟᱨ	SARS-CoV-2
ᱞᱮᱠᱟᱱ	viral
ᱠᱞᱤᱱᱤᱠᱟᱞ ᱰᱮᱴᱟ
ᱵᱮᱯᱟᱨ ᱧᱩᱛᱩᱢᱠᱚ	Janssen COVID-19
ᱮᱴᱟᱜ ᱧᱩᱛᱩᱢ	Ad26.COV2.S; VAC31518;
ᱮ.ᱮᱭᱤᱪ.ᱮᱯᱷ.ᱮᱥ/ᱰᱨᱟᱜᱥ.ᱠᱚᱢ	Multum Consumer Information
ᱰᱮᱴᱟ	EU EMA: yes; US DailyMed: Janssen_COVID-19_Vaccine;
ᱦᱚᱲᱢᱚᱜ; ᱛᱷᱚᱠ	AU: B1 ; ;
ᱵᱮᱵᱷᱟᱨ ᱨᱮᱱᱟᱜ; ᱴᱷᱟᱶ	Intramuscular
ᱮ.ᱴᱤ.ᱥᱤ ᱠᱳᱰ	None;
ᱟᱹᱱᱟᱹᱨᱤ ᱦᱟᱞᱚᱛ
ᱟᱹᱱᱟᱹᱨᱤ ᱦᱟᱞᱚᱛ	AU: S4 (Prescription only) ; CA: Schedule D; Authorized by interim order ; UK: Conditional marketing authorization granted ; US: Standing Order; Unapproved ; EU: Conditional marketing authorization granted ; ZA: Authorized;
ᱩᱯᱨᱩᱢᱤᱭᱟᱹ
ᱰᱨᱟᱜᱵᱮᱸᱠ	DB15857;
ᱭᱩ.ᱮᱱ.ᱟᱭ.ᱟᱭ	JT2NS6183B;
ᱠᱮ.ᱤ.ᱡᱤ.ᱡᱤ	D12129;

ᱡᱚᱱᱥᱚᱱ ᱮᱱᱰ ᱡᱚᱱᱥᱚᱱ ᱠᱳᱵᱷᱤᱰ-᱑᱙ ᱴᱤᱠᱟᱹ ᱫᱚ ᱱᱮᱫᱟᱨᱞᱮᱱᱰᱥ ᱨᱮᱱᱟᱜ ᱞᱟᱭᱰᱮᱱ ᱡᱮᱱᱥᱮᱱ ᱵᱷᱮᱠᱥᱤᱱᱥ ᱟᱨ ᱵᱮᱞᱡᱤᱭᱟᱢ ᱨᱮᱱᱟᱜ ᱡᱮᱱᱥᱮᱱ ᱯᱷᱟᱨᱢᱟᱥᱤᱣᱴᱤᱠᱮᱞᱥ, ᱟᱢᱮᱨᱤᱠᱟᱱ ᱜᱚᱸᱲᱚ ᱥᱚᱯᱚ ᱡᱚᱱᱥᱚᱱ ᱮᱱᱰ ᱡᱚᱱᱥᱚᱱ ᱟᱜ ᱵᱮᱱᱟᱣ ᱟᱠᱟᱱ ᱢᱤᱫᱴᱮᱱ ᱠᱳᱵᱷᱤᱰ-᱑᱙ ᱴᱤᱠᱟᱹ ᱠᱟᱱᱟ ᱾

ᱱᱚᱣᱟ ᱫᱚ ᱦᱚᱲᱟᱜ ᱮᱰᱤᱱᱳᱵᱷᱟᱭᱨᱟᱥ ᱥᱮᱞᱮᱫ ᱢᱤᱫᱴᱮᱱ ᱵᱷᱟᱭᱨᱟᱞ ᱵᱷᱮᱠᱴᱚR ᱴᱤᱠᱟᱹ ᱠᱟᱱᱟ ᱡᱟᱸᱦᱟᱸ ᱫᱚ ᱠᱳᱵᱷᱤᱰ-᱑᱙ ᱠᱷᱟᱹᱛᱤᱨ ᱮᱥ ᱮ ᱟᱨ ᱮᱥ-ᱠᱳᱵᱷᱤ-᱒ ᱵᱷᱟᱭᱨᱟᱥ ᱨᱮᱱᱟᱜ ᱮᱥᱯᱟᱭᱤᱠ ᱯᱨᱳᱴᱤᱱ ᱵᱮᱱᱟᱣ ᱫᱟᱨᱟᱭᱛᱮ ᱦᱚᱲᱢᱚ ᱨᱮᱱᱟᱜ ᱡᱤᱱ ᱨᱮᱱᱟᱜ ᱵᱚᱫᱞᱟᱣ ᱮ ᱟᱹᱜᱩᱭᱟ᱾ ᱱᱚᱣᱟ ᱴᱤᱠᱟᱹ ᱨᱮᱱᱟᱜ ᱫᱚ ᱢᱤᱫᱴᱮᱱ ᱰᱳᱡᱽ ᱜᱮ ᱞᱟᱜᱟᱜᱼᱟ ᱟᱨ ᱱᱚᱣᱟ ᱴᱤᱠᱟᱹ ᱫᱚ ᱨᱮᱭᱟᱲ ᱡᱟᱜᱟ ᱨᱮ ᱫᱚᱦᱚ ᱦᱚᱸ ᱵᱟᱝ ᱞᱟᱜᱟᱜᱼᱟ᱾

᱒᱐᱒᱐ ᱥᱮᱨᱢᱟ ᱨᱮᱱᱟᱜ ᱡᱩᱱ ᱪᱟᱸᱫᱚ ᱱᱚᱣᱟ ᱴᱤᱠᱟᱹ ᱨᱮᱱᱟᱜ ᱵᱮᱵᱷᱟᱨ ᱮᱛᱦᱟᱵ ᱟᱠᱟᱱᱟ᱾ ᱡᱚᱱᱥᱚᱱ ᱮᱱᱰ ᱡᱚᱱᱥᱚᱱ ᱮ ᱢᱮᱱ ᱟᱠᱟᱫᱟ ᱡᱮ ᱱᱚᱣᱟ ᱴᱤᱠᱟᱹ ᱮᱢ ᱒᱘ ᱢᱟᱦᱟᱸ ᱛᱟᱭᱚᱢ ᱦᱚᱲᱢᱚᱨᱮ ᱠᱳᱵᱷᱤᱰ-᱑᱙ ᱨᱩᱠᱷᱤᱭᱟᱹ ᱮᱱᱴᱤᱵᱚᱰᱤ ᱛᱮᱭᱟᱨᱚᱜᱼᱟ᱾

ᱱᱚᱣᱟ ᱴᱤᱠᱟᱹ ᱫᱚ ᱢᱟᱨᱠᱤᱱ ᱡᱚᱢ ᱟᱨ ᱨᱟᱱ ᱵᱤᱵᱷᱟᱜᱽ ᱠᱷᱚᱱ ᱡᱟᱹᱨᱩᱲ ᱵᱮᱵᱷᱟᱨ ᱞᱟᱹᱜᱤᱛ ᱤᱣᱨᱳᱯᱤᱭᱟᱱ ᱢᱮᱰᱤᱥᱤᱱ ᱮᱡᱮᱱᱥᱤ ᱫᱟᱨᱟᱭᱛᱮ ᱠᱤᱪᱷᱩᱜᱟᱱ ᱥᱚᱨᱛᱚ ᱞᱮᱠᱟᱛᱮ ᱵᱟᱡᱟᱨᱡᱟᱛ ᱨᱮᱱᱟᱜ ᱟᱹᱭᱫᱟᱹᱨᱤᱭ ᱧᱟᱢ ᱟᱠᱟᱫᱟ᱾

ᱥᱟ.ᱠᱷᱭᱟ.ᱛ

↑ "COVID-19 Vaccine Janssen". Therapeutic Goods Administration (TGA). 25 June 2021. Archived from the original on 28 August 2021. Retrieved 28 August 2021.
↑ "Janssen COVID-19 Emergency Use Authorization (EUA) Official Website". Janssen. 28 February 2021. Archived from the original on 1 March 2021. Retrieved 28 February 2021.
↑ "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". Janssen Vaccines & Prevention. Archived from the original (PDF) on 18 February 2021. Retrieved 15 February 2021.
↑ "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". Janssen Vaccines & Prevention. Archived from the original (PDF) on 25 February 2021. Retrieved 26 February 2021.
↑ "Archive copy". Archived from the original on 2021-08-28. Retrieved 2021-09-20.{{cite web}}: CS1 maint: archived copy as title (link)
↑ "Regulatory Decision Summary – Janssen COVID-19 Vaccine – Health Canada". Health Canada. 5 March 2021. Archived from the original on 5 March 2021. Retrieved 5 March 2021.
↑ "Janssen COVID-19 Vaccine monograph" (PDF). Janssen. 5 March 2021. Archived from the original (PDF) on 5 March 2021. Retrieved 5 March 2021.
↑ "COVID-19 Vaccine Janssen EPAR". European Medicines Agency (EMA). 5 March 2021. Archived from the original on 15 March 2021. Retrieved 16 March 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
↑ "Regulatory approval of COVID-19 Vaccine Janssen". Medicines and Healthcare products Regulatory Agency (MHRA). 28 May 2021. Archived from the original on 28 May 2021. Retrieved 29 May 2021.
↑ "One-dose Janssen COVID-19 vaccine approved by the MHRA" (Press release). Medicines and Healthcare products Regulatory Agency (MHRA). 28 May 2021. Archived from the original on 28 May 2021. Retrieved 29 May 2021.
↑ "Summary of Product Characteristics for COVID-19 Vaccine Janssen". Medicines and Healthcare products Regulatory Agency (MHRA). 28 May 2021. Archived from the original on 28 May 2021. Retrieved 29 May 2021.
↑ "FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine". U.S. Food and Drug Administration (FDA) (Press release). 27 February 2021. Archived from the original on 18 March 2021. Retrieved 27 February 2021.
↑ "FDA Letter of Authorization". 27 February 2021. Archived from the original (PDF) on 10 March 2021. Retrieved 28 February 2021. ...letter is in response to a request from Janssen Biotech, Inc. that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA)...
↑ "Janssen COVID-19 Vaccine (Johnson & Johnson) Standing Orders for Administering Vaccine to Persons 18 Years of Age and Older" (PDF). U.S. Centers for Disease Control and Prevention (CDC). Archived from the original (PDF) on 16 April 2021. Retrieved 16 April 2021.
↑ "Johnson & Johnson Covid vaccine approved for general use in South Africa". Archived from the original on 9 May 2021. Retrieved 9 May 2021.
↑ "J&J Covid-19 Vaccine Approved in South Africa for Wider Use". Bloomberg.com. 1 April 2021. Archived from the original on 9 April 2021. Retrieved 9 May 2021.

[COVID-19_Vaccine_Janssen_APM_summary-1] "COVID-19 Vaccine Janssen". Therapeutic Goods Administration (TGA). 25 June 2021. Archived from the original on 28 August 2021. Retrieved 28 August 2021.

[2] "Janssen COVID-19 Emergency Use Authorization (EUA) Official Website". Janssen. 28 February 2021. Archived from the original on 1 March 2021. Retrieved 28 February 2021.

[J&J_Protocol-3] "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". Janssen Vaccines & Prevention. Archived from the original (PDF) on 18 February 2021. Retrieved 15 February 2021.

[J&J_ENSEMBLE_2_Protocol-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". Janssen Vaccines & Prevention. Archived from the original (PDF) on 25 February 2021. Retrieved 26 February 2021.

[5] "Archive copy". Archived from the original on 2021-08-28. Retrieved 2021-09-20.{{cite web}}: CS1 maint: archived copy as title (link)

[CA_authorization-6] "Regulatory Decision Summary – Janssen COVID-19 Vaccine – Health Canada". Health Canada. 5 March 2021. Archived from the original on 5 March 2021. Retrieved 5 March 2021.

[7] "Janssen COVID-19 Vaccine monograph" (PDF). Janssen. 5 March 2021. Archived from the original (PDF) on 5 March 2021. Retrieved 5 March 2021.

[COVID-19_Vaccine_Janssen_EPAR-8] "COVID-19 Vaccine Janssen EPAR". European Medicines Agency (EMA). 5 March 2021. Archived from the original on 15 March 2021. Retrieved 16 March 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

[UK_approval-9] "Regulatory approval of COVID-19 Vaccine Janssen". Medicines and Healthcare products Regulatory Agency (MHRA). 28 May 2021. Archived from the original on 28 May 2021. Retrieved 29 May 2021.

[UK_PR-10] "One-dose Janssen COVID-19 vaccine approved by the MHRA" (Press release). Medicines and Healthcare products Regulatory Agency (MHRA). 28 May 2021. Archived from the original on 28 May 2021. Retrieved 29 May 2021.

[COVID-19_Vaccine_Janssen_SmPC-11] "Summary of Product Characteristics for COVID-19 Vaccine Janssen". Medicines and Healthcare products Regulatory Agency (MHRA). 28 May 2021. Archived from the original on 28 May 2021. Retrieved 29 May 2021.

[FDA_PR_20210227-12] "FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine". U.S. Food and Drug Administration (FDA) (Press release). 27 February 2021. Archived from the original on 18 March 2021. Retrieved 27 February 2021.

[FDA_EUA-13] "FDA Letter of Authorization". 27 February 2021. Archived from the original (PDF) on 10 March 2021. Retrieved 28 February 2021. ...letter is in response to a request from Janssen Biotech, Inc. that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA)...

[CDC_standing_order-14] "Janssen COVID-19 Vaccine (Johnson & Johnson) Standing Orders for Administering Vaccine to Persons 18 Years of Age and Older" (PDF). U.S. Centers for Disease Control and Prevention (CDC). Archived from the original (PDF) on 16 April 2021. Retrieved 16 April 2021.

[15] "Johnson & Johnson Covid vaccine approved for general use in South Africa". Archived from the original on 9 May 2021. Retrieved 9 May 2021.

[16] "J&J Covid-19 Vaccine Approved in South Africa for Wider Use". Bloomberg.com. 1 April 2021. Archived from the original on 9 April 2021. Retrieved 9 May 2021.

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