Ad26.COV2.S

Ad26.COV2.S or JNJ-78436735 is a COVID-19 vaccine candidate developed by Janssen Vaccines, which is part of Johnson & Johnson (J&J) in the Netherlands and Beth Israel Deaconess Medical Center (BIDMC).[1] It is a human adenovirus viral vector vaccine.[2] On January 29, 2021, Janssen announced that it was 66% effective in a one-dose regimen in preventing symptomatic COVID-19, with an 85% efficacy in preventing severe COVID-19.[3][4][5] It can remain stable for an estimated timeframe of two years at -20°C (-4°F). The vaccine can be stored at least for three months in a refrigerator at temperatures of 2-8°C (36°F-46°F).[6]

Ad26.COV2.S
Vaccine description
Target diseaseCOVID-19
TypeAdenovirus vector
Clinical data
Other names
  • Johnson & Johnson COVID-19 vaccine
  • Janssen COVID-19 vaccine
  • Ad26.COV2.S[1]
  • JNJ-78436735[1]
Routes of
administration		Intramuscular
ATC code
  • None
Identifiers
DrugBank
UNII
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COVID-19 pandemic
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Impact
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 COVID-19 Portal

Vaccine characteristics

The J&J vaccine can remain viable for months in a standard refrigerator.[7] Unlike the Pfizer–BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine that previously received EUAs, the J&J COVID-19 vaccine is a single dose instead of two doses, and does not need to be shipped frozen.[8]

Development

Johnson & Johnson committed over US$1 billion toward the development of a not-for-profit COVID-19 vaccine in partnership with the Biomedical Advanced Research and Development Authority (BARDA) Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS).[9][10] J&J stated that its vaccine project would be "at a not-for-profit level" as the company viewed it as "the fastest and the best way to find all the collaborations in the world to make this happen."[11]

Janssen Vaccines, in partnership with Beth Israel Deaconess Medical Center (BIDMC), is responsible for developing the vaccine candidate, based on the same technology used to make its Ebola vaccine.

Clinical trials

In June 2020, J&J and the National Institute of Allergy and Infectious Diseases (NIAID) confirmed its intention to start a clinical trials of J&J's vaccine in September 2020, with the possibility of Phase 1/2a human clinical trials starting at an accelerated pace in the second half of July.[12][13][14]

A Phase 1-2a clinical trial started with the recruitment of the first subject on July 15, 2020 and enrolled study participants in Belgium and the US. Interim results published from the Phase 1-2a trial established the safety, reactogenecity and immunogenecity of Ad26.COV2.S.[15][16]

A Phase 3 clinical trial called ENSEMBLE started enrollment in September 2020 and completed enrollment on December 17, 2020. It was designed as a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single-dose vaccine versus placebo in adults 18 years old and older. Study participants received a single intramuscular injection of Ad26.COV2.S at a dose level of 5×1010 virus particles on Day 1.[17] The trial was paused on October 12, 2020, because a volunteer became ill,[18] but the company said it found no evidence that the vaccine had caused the illness and announced on October 23, 2020 that it would resume the trial.[19][20] On January 29, 2021 Janssen announced safety and efficacy data from an interim analysis of ENSEMBLE trial data, which demonstrated the vaccine was 66% effective at preventing the combined endpoints of moderate and severe COVID-19 at 28 days post-vaccination among all volunteers. The interim analysis was based on 468 cases of symptomatic COVID-19 among 43,783 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. No deaths related to COVID-19 were reported in the vaccine group, while 5 deaths in the placebo group were related to COVID-19.[6] During the trial, no anaphylaxis was observed in participants.[6]

A second Phase 3 clinical trial called ENSEMBLE 2 started enrollment on November 12, 2020. ENSEMBLE 2 differs from ENSEMBLE in that its study participants will receive two intramuscular (IM) injections of Ad26.COV2.S vaccine, one on Day 1 and the next on Day 57.[21]

Manufacturing

In April 2020, J&J entered a partnership with Catalent who will provide large-scale manufacturing of J&J's vaccine at Catalent's Bloomington, Indiana facility.[22] In July 2020, the partnership was expanded to include Catalent's Anagni, Italy facility.[23]

In July 2020, J&J pledged to deliver up to 300 million doses of its vaccine to the U.S., with 100 million upfront and an option for 200 million more. The deal, worth more than $1 billion, will be funded by the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Defense Department.[24][25] The deal was confirmed on 5 August.[26]

In September 2020, Grand River Aseptic Manufacturing agreed with J&J to support the manufacture of the vaccine, including technology transfer and fill and finish manufacture, at its Grand Rapids, Michigan facility.[27]

In December 2020 J&J and Reig Jofre, a Spanish pharmaceutical company, entered into an agreement to manufacture the vaccine at Reig Jofre's Barcelona facility.[28] If the European Medicines Agency grants approval to the vaccine by February 2021, a European Union regulator said that J&J could start supplying vaccines to EU countries starting on April 2021.[29]

In August 2020, J&J signed a contract with the U.S. federal government for US$1 billion, agreeing to deliver 100 million doses of the vaccine to the U.S. following the U.S. Food and Drug Administration (FDA) grant of approval or emergency use authorization (EUA) for the vaccine.[25] Under its agreement with the U.S. government, J&J was targeted to produce 12 million doses by the end of February 2021, more than 60 million doses by the end of April 2021, and more than 100 million doses by the end of June 2021. However, in January 2021, J&J acknowledged manufacturing delays would likely prevent it from meeting its contract of 12 million doses delivered to the U.S. by the end of February.[30]

Regulatory approval process

Beginning on December 1, 2020, clinical trial of the vaccine candidate has been undergoing a "rolling review" process by the European Medicines Agency's Committee for Medicinal Products for Human Use, a step to expedite EMA consideration of an expected conditional Marketing Authorisation Application.[29][31]

On February 4, 2021, J&J applied to the U.S. Food and Drug Administration (FDA) for an EUA and the FDA announced that its Vaccines and Related Biological Products Advisory Committee would meet on February 26 to consider the application.[7][8][32] J&J previously announced that it planned to ship the vaccine immediately following authorization.[6]

References
  1. "Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen's COVID-19 Vaccine Candidate". www.jnj.com. Retrieved 23 September 2020.
  2. "A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE)". clinicaltrials.gov. Retrieved 30 January 2021.
  3. Salzman, Sony (29 January 2021). "Johnson & Johnson single-shot vaccine 85% effective against severe COVID-19 disease". ABC News.
  4. "Covid vaccine: Single dose Covid vaccine 66% effective". BBC News. 29 January 2021. Retrieved 29 January 2021.
  5. Sohn R (29 January 2021). "J&J's Covid vaccine is 66% effective, a weapon but not a knockout punch". Stat. Retrieved 29 January 2021.
  6. "Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial". www.jnj.com. Retrieved 1 February 2021.
  7. Carolyn Y. Johnson & Laurie McGinley (4 February 2021). "Johnson & Johnson seeks emergency FDA authorization for single-shot coronavirus vaccine". Washington Post.
  8. Chander, Vishwadha (4 February 2021). "J&J files COVID-19 vaccine application with U.S. FDA". Reuters. Retrieved 4 February 2021.
  9. Vecchione A (13 March 2020). "J&J collaborates to accelerate COVID-19 vaccine development". NJBIZ. Retrieved 22 April 2020.
  10. "Prisma Health collaborates with Ethicon Inc. to make, distribute VESper Ventilator Expansion Splitter Device". WSPA 7News. 6 April 2020. Retrieved 22 April 2020.
  11. "Coronavirus: Johnson & Johnson vows to make 'not-for-profit' vaccine". Sky News. Retrieved 22 April 2020.
  12. Coleman J (10 June 2020). "Final testing stage for potential coronavirus vaccine set to begin in July". TheHill. Retrieved 11 June 2020.
  13. "Moderna, AstraZeneca and J&J coronavirus shots rev up for NIH tests beginning in July: WSJ". FiercePharma. Retrieved 11 June 2020.
  14. "Johnson & Johnson to start human testing of COVID-19 vaccine next week". FiercePharma. Retrieved 20 July 2020.
  15. Sadoff, Jerald; et al. (13 January 2021). "Interim Results of a Phase 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine". New England Journal of Medicine. doi:10.1056/NEJMoa2034201. PMC 7821985. PMID 33440088. Retrieved 30 January 2021.
  16. "Johnson & Johnson COVID-19 Vaccine Candidate Interim Phase 1/2a Data Published in New England Journal of Medicine". www.jnj.com. Retrieved 16 January 2021.
  17. "Fourth large-scale COVID-19 vaccine trial begins in the United States". www.nih.gov. Retrieved 30 January 2021.
  18. Hughes V, Thomas K, Zimmer C, Wu KJ (12 October 2020). "Johnson & Johnson halts coronavirus vaccine trial because of sick volunteer". The New York Times. ISSN 0362-4331. Retrieved 12 October 2020.
  19. "Johnson & Johnson Prepares to Resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate in the U.S." Johnson & Johnson. 23 October 2020. Retrieved 28 October 2020.
  20. Edwards E, Miller SG (23 October 2020). "AstraZeneca, Johnson & Johnson resume late-stage Covid-19 vaccine trials". NBC News. Retrieved 28 October 2020.
  21. "A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults (ENSEMBLE 2)". clinicaltrials.gov. Retrieved 30 January 2021.
  22. Vecchione A (29 April 2020). "Catalent to lead US manufacturing for J&J's lead COVID-19 vaccine candidate". NJBIZ. Retrieved 13 November 2020.
  23. "J&J expands COVID-19 vaccine pact with Catalent for finishing work at Italian facility". FiercePharma. Retrieved 13 November 2020.
  24. "HHS, DOD Collaborate With Johnson & Johnson to Produce Millions of COVID-19 Investigational Vaccine Doses". HHS.gov (Press release). 5 August 2020. Retrieved 6 August 2020.
  25. "Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine". Johnson & Johnson (Press release). Retrieved 6 August 2020.
  26. "US to Pay Johnson and Johnson $1 Billion for COVID-19 Vaccine". Voice of America. Retrieved 5 August 2020.
  27. "Ramping Up COVID-19 Vaccine Fill and Finish Capacity". Contract Pharma. 3 November 2020.
  28. Allen, Joan Faus, Nathan (15 December 2020). "Spain's Reig Jofre to manufacture J&J's COVID-19 vaccine, shares soar". Spain.
  29. Guarascio, Francesco (13 January 2021). "J&J COVID-19 vaccine could be available in Europe in April: source". Reuters.
  30. Zimmer C, LaFraniere S, Weiland N (13 January 2021). "Johnson & Johnson Expects Vaccine Results Soon but Lags in Production". The New York Times.
  31. "Johnson & Johnson Announces Initiation of Rolling Submission for its Single-dose Janssen COVID-19 Vaccine Candidate with the European Medicines Agency" (Press release). Johnson & Johnson. 1 December 2020.
  32. "FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.'s COVID-19 Vaccine Candidate" (Press release). U.S. Food & Drug Administration. 4 February 2021. Retrieved 4 February 2021.
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