¶ Janssen COVID-19 vaccine
The Janssen COVID-19 vaccine is a genetic COVID-19 vaccine product developed by Janssen, a subsidiary of Johnson & Johnson. It is also known in various contexts as Ad26.COV2.S, the Johnson & Johnson COVID-19 vaccine, and by its brand name, Jcovden.
¶ History
On April 23, 2020, Emergent BioSolutions announced it had entered a $135 million agreement with Johnson & Johnson to "provide contract development and manufacturing services" for the Janssen COVID-19 vaccine.[1]
On July 6, 2020, Emergent BioSolutions announced an additional five-year contract with Johnson & Johnson, building on the prior agreement.[2] After the first two years, Emergent would "provide a flexible capacity deployment model to support additional drug substance batches annually."[3]
¶ Authorization
Health Canada authorized the vaccine on March 5, 2021 under interim order. The decision was made based on an interim analysis of Janssen's clinical trial data collected up to January 22, 2021.[4]
On November 22, 2021, Health Canada transitioned the regulatory status of the vaccine from being authorized under the interim order to being authorized under Division 8 of the Food and Drug Regulations.[5]
In late 2021, Johnson & Johnson neared completion of a deal to have Aspen Pharmacare manufacture the Janssen COVID-19 vaccine product in Africa.[6]
¶ End of the pandemic
On May 7, 2023, "all remaining U.S. government stock" of the Janssen product was officially declared as expired by the Centers for Disease Control and Prevention (CDC).[7] As of May 10, 2023, the product was "no longer available in the United States."[8]
¶ Documents
- February 16, 2023: Product monograph
¶ National contracts
South Africa
Between Pfizer and the National Department of Health of South Africa.
- November 19, 2020: Term Sheet (internal draft)
- February 26, 2021: Advance Purchase Agreement
- April 2021: Advance Purchase Agreement (Additional Doses)
¶ Clinical trials
- A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE)
¶ External links
Neri, M. B., & Burrows, R. G. (2020, April 23). Emergent BioSolutions Signs Agreement to be U.S. Manufacturing Partner for Johnson & Johnson’s Lead Vaccine Candidate for COVID-19. Emergent BioSolutions. http://archive.today/2023.06.14-015555/https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-signs-agreement-be-us-manufacturing?field_nir_news_date_value[min]= ↩︎
Knapp, A. (2021, March 1). Little-Known Publicly Traded Company Given Massive Deal To Manufacture One-Shot Covid-19 Vaccine. Forbes. http://archive.today/2022.05.12-231258/https://www.forbes.com/sites/alexknapp/2021/03/01/little-known-publicly-traded-company-given-massive-deal-to-manufacture-one-shot-covid-19-vaccine/?sh=95c20f232171 ↩︎
Neri, M. B., & Burrows, R. G. (2020, July 6). Emergent BioSolutions Signs Five-Year Agreement for Large-Scale Drug Substance Manufacturing for Johnson & Johnson’s Lead COVID-19 Vaccine Candidate. Emergent BioSolutions. http://archive.today/2023.06.14-014540/https://www.emergentbiosolutions.com/press/news-release-details-emergent-biosolutions-signs-five-year-agreement-large-scale-drug/ ↩︎
Regulatory Decision Summary - Janssen COVID-19 Vaccine - Health Canada. (2021, March 5). Government of Canada. http://archive.today/2023.06.10-012952/https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detailTwo.html?linkID=RDS00779 ↩︎
Regulatory Decision Summary - Janssen COVID-19 Vaccine - Health Canada. (2021, November 22). Government of Canada. https://web.archive.org/web/20230610023122/https://covid-vaccine.canada.ca/info/regulatory-decision-summary-detail.html?linkID=RDS00890 ↩︎
Jerving, S. (2021, December 6). Aspen’s COVID-19 vaccine licensing deal a “game changer” for Africa. Devex. http://archive.today/2022.01.12-214847/https://www.devex.com/news/aspen-s-covid-19-vaccine-licensing-deal-a-game-changer-for-africa-102266 ↩︎
National Center for Immunization and Respiratory Diseases. (2023, May 10). Johnson & Johnson’s Janssen COVID-19 Vaccine Information. Centers for Disease Control and Prevention. http://archive.today/2023.05.18-012306/https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/index.html ↩︎
McPhillips, D. (2023, May 15). J&J Covid-19 vaccine no longer available in the US. CNN. http://archive.today/2023.05.15-174917/https://www.cnn.com/2023/05/15/health/johnson-johnson-covid-vaccine-end/index.html ↩︎