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Janssen COVID-19 Vaccine FDA Approval Status

Last updated by Judith Stewart, BPharm on Sep 12, 2021.

FDA Approved: No (Emergency Use Authorization)
Brand name: Janssen COVID-19 Vaccine
Generic name: SARS-CoV-2 vaccine
Dosage form: Injection
Previous Name: Ad26.COV2-S
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Prevention of COVID-19

The Janssen COVID-19 Vaccine (Ad26.COV2-S) is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19.

  • The Janssen COVID-19 Vaccine (Ad26.COV2-S) is a monovalent vaccine composed of a recombinant, replication incompetent adenovirus serotype 26 (Ad26) vector, constructed to encode the SARS-CoV-2 virus spike (S) protein.
  • Efficacy and safety data from the Phase 3 ENSEMBLE clinical trial demonstrated that the investigational single-dose COVID-19 vaccine was 72% effective in the U.S. and 66% effective overall at preventing moderate to severe COVID-19, 28 days after vaccination.
  • The U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the single-dose Janssen COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older on February 27, 2021.

Development timeline for Janssen COVID-19 Vaccine

DateArticle
May  5, 2022Johnson & Johnson Updates U.S. COVID-19 Vaccine Fact Sheet
Apr  8, 2022U.S. FDA Approves Extended Shelf Life up to 11 Months for the Johnson & Johnson COVID-19 Vaccine
Apr  4, 2022World Health Organization Updated Emergency Use Listing Recommends Johnson & Johnson COVID-19 Vaccine for Booster Use
Dec 16, 2021Johnson & Johnson Statement on its COVID-19 Vaccine Following CDC ACIP Meeting
Dec  9, 2021World Health Organization Strategic Advisory Group of Experts (SAGE) Interim Recommendation Supports Use of Johnson & Johnson COVID-19 Vaccine as a Booster
Nov 29, 2021Johnson & Johnson to Evaluate Its COVID-19 Vaccine Against New Omicron COVID-19 Variant
Oct 21, 2021U.S. CDC Advisory Committee Unanimously Recommends Johnson & Johnson COVID-19 Vaccine as a Booster for All Eligible Individuals Who Receive Authorized COVID-19 Vaccines
Oct 20, 2021Johnson & Johnson COVID-19 Vaccine Booster Shot Authorized for Emergency Use by U.S. FDA
Oct 15, 2021Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
Oct  5, 2021Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine
Sep 21, 2021Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.
Aug 18, 2021Statement on Boosting with the Johnson & Johnson COVID-19 Vaccine
Jul 28, 2021Johnson & Johnson Statement on U.S. FDA Approval of Shelf Life Extension for Company’s COVID-19 Vaccine
Jul 14, 2021Johnson & Johnson Single-Shot COVID-19 Vaccine Demonstrated a Durable Immune Response and Elicited Dual Mechanisms of Protection Against Delta and Other SARS-CoV-2 Variants of Concern in Data Published in New England Journal of Medicine
Jul 12, 2021Johnson & Johnson Statement on COVID-19 Vaccine Following Reports of Guillain-Barré Syndrome
Jul  1, 2021Positive New Data for Johnson & Johnson Single-Shot COVID-19 Vaccine on Activity Against Delta Variant and Long-lasting Durability of Response
Jun 10, 2021Johnson & Johnson Statement on FDA Approval of Shelf Life Extension for Company’s COVID-19 Vaccine
Apr 23, 2021Johnson & Johnson Single-Shot COVID-19 Vaccinations to Resume in the U.S. for All Adults Aged 18 and Older Following CDC and FDA Decision
Apr 21, 2021Johnson & Johnson Single-Shot COVID-19 Vaccine Phase 3 Data Published in New England Journal of Medicine
Apr 13, 2021Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
Apr  3, 2021Johnson & Johnson Statement on U.S. COVID-19 Vaccine Manufacturing
Mar 12, 2021Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization
Feb 27, 2021Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use - First Single-Shot Vaccine in Fight Against Global Pandemic
Feb 26, 2021Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
Feb 19, 2021Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
Feb 16, 2021Johnson & Johnson Announces Submission of European Conditional Marketing Authorisation Application to the EMA for its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
Feb  4, 2021Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate
Jan 29, 2021Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial
Nov 15, 2020Johnson & Johnson Initiates Second Global Phase 3 Clinical Trial of its Janssen COVID-19 Vaccine Candidate
Nov 14, 2020Johnson & Johnson and U.S. Department of Health & Human Services Expand Agreement to Support Next Phase of COVID-19 Vaccine Candidate Research and Development
Oct 23, 2020Johnson & Johnson Prepares to Resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate in the U.S.
Oct 12, 2020Johnson & Johnson Temporarily Pauses All Dosing in Our Janssen COVID-19 Vaccine Candidate Clinical Trials
Sep 25, 2020Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate
Sep 23, 2020Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen’s COVID-19 Vaccine Candidate
Sep  3, 2020Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies
Aug  5, 2020Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine
Jul 30, 2020Single Dose of Johnson & Johnson COVID-19 Vaccine Candidate Demonstrates Robust Protection in Pre-Clinical Studies
Jun 10, 2020Johnson & Johnson Announces Acceleration of its COVID-19 Vaccine Candidate; Phase 1/2a Clinical Trial to Begin in Second Half of July
Mar 30, 2020Johnson & Johnson Announces a Lead Vaccine Candidate for COVID-19; Landmark New Partnership with U.S. Department of Health & Human Services; and Commitment to Supply One Billion Vaccines Worldwide for Emergency Pandemic Use
Mar 13, 2020Johnson & Johnson Announces Collaboration with the Beth Israel Deaconess Medical Center to Accelerate COVID-19 Vaccine Development
Feb 18, 2020Johnson & Johnson to Expand Partnership with U.S. Department of Health & Human Services to Accelerate the Discovery of Potential COVID-19 Treatments
Feb 11, 2020Johnson & Johnson Announces Collaboration with U.S. Department of Health & Human Services to Accelerate Development of a Potential Novel Coronavirus Vaccine

Further information

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