Janssen COVID-19 vaccine

"Johnson & Johnson vaccine" and "Johnson & Johnson COVID-19 vaccine" redirect here. For other J&J corporate vaccination topics, see Janssen Vaccines, Janssen Pharmaceuticals, and Johnson & Johnson.

Janssen COVID-19 vaccine
A vial of Janssen COVID-19 Vaccine
Vaccine description
TargetSARS-CoV-2
Vaccine typeViral vector
Clinical data
Trade namesJcovden[1]
Other names
AHFS/Drugs.comMultum Consumer Information
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Pregnancy
category
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
Full list of Janssen vaccine authorizations
Identifiers
CAS Number
DrugBank
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The Janssen COVID‑19 vaccine, (Ad26.COV2.S) sold under the brand name Jcovden,[1] is a COVID‑19 vaccine that was developed by Janssen Vaccines in Leiden, Netherlands,[24] and its Belgian parent company Janssen Pharmaceuticals,[25] a subsidiary of American company Johnson & Johnson.[26][27][28]

It is a viral vector vaccine based on a human adenovirus that has been modified to contain the gene for making the spike protein of the SARS-CoV-2 virus that causes COVID‑19.[5] The body's immune system responds to this spike protein to produce antibodies.[29] The vaccine requires only one dose and does not need to be stored frozen.[30][31]

Clinical trials for the vaccine were started in June 2020, with phase III involving around 43,000 people.[32] In January 2021, Janssen announced that 28 days after a completed vaccination, the vaccine was 66% effective in a one-dose regimen in preventing symptomatic COVID‑19, with an 85% efficacy in preventing severe COVID‑19[33][34][35] and 100% efficacy in preventing hospitalization or death caused by the disease.[36]

The vaccine has been granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA)[37][38][30] and a conditional marketing authorization by the European Medicines Agency (EMA)[1][39][40] and the UK Medicines and Healthcare products Regulatory Agency.[17] In June 2023, the FDA revoked the emergency use authorization for the Janssen COVID-19 vaccine at the request of its manufacturer.[20][21]

Because cases of thrombosis with thrombocytopenia syndrome and Guillain-Barré syndrome have been reported after receipt of the Janssen COVID‑19 vaccine, the US Centers for Disease Control and Prevention (CDC) recommends "preferential use of mRNA COVID‑19 vaccines over the Janssen COVID‑19 vaccine, including both primary and booster doses administered to prevent COVID‑19, for all persons aged 18 years of age and older. The Janssen COVID‑19 vaccine may be considered in some situations, including for persons with a contraindication to receipt of mRNA COVID‑19 vaccines."[41] In February 2022, Johnson & Johnson announced it has temporarily suspended production of the vaccine though they also noted that it will likely resume at some point in the future and that it will honor all pre-existing contracts that oblige Janssen to supply its vaccine by using the millions of already existing vaccine doses in its inventory where requested.[42]

  1. ^ a b c d e "Jcovden (previously COVID-19 Vaccine Janssen) EPAR". European Medicines Agency (EMA). 5 March 2021. Archived from the original on 15 March 2021. Retrieved 12 March 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  2. ^ a b c d "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. Archived from the original on 18 February 2021. Retrieved 15 February 2021.
  3. ^ a b c d "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. Archived from the original on 25 February 2021. Retrieved 26 February 2021.
  4. ^ a b Cite error: The named reference jnj was invoked but never defined (see the help page).
  5. ^ a b Cite error: The named reference Janssen CMA application was invoked but never defined (see the help page).
  6. ^ a b "COVID-19 Vaccine Janssen". Therapeutic Goods Administration (TGA). 25 June 2021. Archived from the original on 28 August 2021. Retrieved 28 August 2021.
  7. ^ Cite error: The named reference TGA provisional approval was invoked but never defined (see the help page).
  8. ^ "COVID-19 VACCINE JANSSEN Ad26.COV2.S 5x10^10 VP/0.5mL suspension for injection vial". Therapeutic Goods Administration. Australian Government. Archived from the original on 28 August 2021. Retrieved 2 June 2022.
  9. ^ "TGA grants third provisional approval to COVID-19 vaccine: Janssen". Therapeutic Goods Administration (TGA). 25 June 2021. Archived from the original on 14 October 2021. Retrieved 22 October 2021.
  10. ^ "Anvisa aprova registro definitivo de vacina da Janssen" [Anvisa approves definitive registration of Janssen vaccine]. G1 (in Brazilian Portuguese). 5 April 2022. Retrieved 21 June 2024.
  11. ^ "Janssen Jcovden (Johnson & Johnson) COVID-19 vaccine". Health Canada. 5 March 2021. Archived from the original on 23 November 2021. Retrieved 24 November 2021.
  12. ^ Cite error: The named reference CA Regulatory Decision Summary was invoked but never defined (see the help page).
  13. ^ "Regulatory Decision Summary – Janssen COVID-19 Vaccine". Health Canada. 5 March 2021. Archived from the original on 5 March 2021. Retrieved 5 March 2021.
  14. ^ "Janssen COVID-19 Vaccine monograph" (PDF). Janssen. 5 March 2021. Archived (PDF) from the original on 5 March 2021. Retrieved 5 March 2021.
  15. ^ "Summary Basis of Decision (SBD) for Janssen COVID-19 Vaccine". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  16. ^ "Janssen COVID-19 Vaccine". Health Canada. 5 March 2021. Archived from the original on 1 June 2022. Retrieved 31 May 2022.
  17. ^ a b "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.
  18. ^ "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.
  19. ^ "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.
  20. ^ a b "FDA Roundup: June 2, 2023". U.S. Food and Drug Administration (Press release). 2 June 2023. Archived from the original on 3 June 2023. Retrieved 2 June 2023.
  21. ^ a b "Revocation of EUA 27205 - Janssen COVID-19 Vaccine" (PDF). U.S. Food and Drug Administration (FDA). 1 June 2023. Archived from the original on 3 June 2023. Retrieved 3 June 2023.
  22. ^ "Johnson & Johnson Covid vaccine approved for general use in South Africa". Archived from the original on 9 May 2021. Retrieved 9 May 2021.
  23. ^ "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.
  24. ^ "Leiden developed Covid-19 vaccine submitted to EMA for approval". 16 February 2021. Archived from the original on 25 June 2021. Retrieved 15 March 2021.
  25. ^ "Clinical trial COVID-19 vaccine candidate underway". Janssen Belgium. Archived from the original on 15 January 2021. Retrieved 13 March 2021.
  26. ^ "EMA recommends Johnson & Johnson Covid vaccine for approval; Developed in Leiden". NL Times. Archived from the original on 25 June 2021. Retrieved 12 March 2021.
  27. ^ Saltzman J (12 March 2020). "Beth Israel is working with Johnson & Johnson on a coronavirus vaccine". The Boston Globe. Archived from the original on 11 April 2021. Retrieved 25 February 2021.
  28. ^ Cite error: The named reference ensemble was invoked but never defined (see the help page).
  29. ^ Malcom K (8 March 2021). "COVID Vaccines: Does it Matter Which One You Get?". Michigan Medicine. Archived from the original on 28 March 2021. Retrieved 30 March 2021.
  30. ^ a b "Fact Sheet for Healthcare Providers Administering Vaccine and EUA" (PDF). Janssen. Archived from the original on 13 April 2021. Retrieved 13 April 2021.
  31. ^ "Janssen COVID-19 Vaccine (Johnson & Johnson)". U.S. Centers for Disease Control and Prevention (CDC). 23 March 2021. Archived from the original on 29 March 2021. Retrieved 30 March 2021.
  32. ^ Cite error: The named reference FDA PR 20210227 was invoked but never defined (see the help page).
  33. ^ Salzman S (29 January 2021). "Johnson & Johnson single-shot vaccine 85% effective against severe COVID-19 disease". ABC News. Archived from the original on 1 February 2021. Retrieved 1 February 2021.
  34. ^ Gallagher J (29 January 2021). "Covid vaccine: Single dose Covid vaccine 66% effective". BBC News. Archived from the original on 29 January 2021. Retrieved 29 January 2021.
  35. ^ Sohn R (29 January 2021). "J&J's Covid vaccine is 66% effective, a weapon but not a knockout punch". Stat. Archived from the original on 29 January 2021. Retrieved 29 January 2021.
  36. ^ "Janssen COVID-19 Vaccine – ad26.cov2.s injection, suspension". DailyMed. U.S. National Institutes of Health. Archived from the original on 12 May 2021. Retrieved 27 February 2021.
  37. ^ Cite error: The named reference FDA EUA was invoked but never defined (see the help page).
  38. ^ Cite error: The named reference :1 was invoked but never defined (see the help page).
  39. ^ "EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU" (Press release). European Medicines Agency (EMA). 11 March 2021. Archived from the original on 11 March 2021. Retrieved 11 March 2021.
  40. ^ "Jcovden Product information". Union Register of medicinal products. Archived from the original on 11 March 2021. Retrieved 16 March 2021.
  41. ^ Oliver SE, Wallace M, See I, Mbaeyi S, Godfrey M, Hadler SC, et al. (January 2022). "Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices - United States, December 2021" (PDF). MMWR. Morbidity and Mortality Weekly Report. 71 (3): 90–95. doi:10.15585/mmwr.mm7103a4. PMC 8774160. PMID 35051137. Archived (PDF) from the original on 23 May 2022. Retrieved 5 February 2022. Public Domain This article incorporates text from this source, which is in the public domain.
  42. ^ "Johnson & Johnson halts production of single-dose COVID-19 vaccine, report says". CBS News. 9 February 2022. Archived from the original on 9 February 2022. Retrieved 9 February 2022.