Ad26.COV2.S

also known as JNJ-78436735 · COVID-19 Vaccine Janssen · Jansen · Janssen · Johnson \& Johnson Vaccine · VAC31518

Developed for: COVID-19 · severe acute respiratory syndrome
Investigated by: Janssen Vaccines & Prevention B.V. · Bio Analytical Research Corporation · BioVac · Biocair · Clinical Laboratory Services · Dis-Chem Pharmacy
+32 more
· Fred Hutchinson Cancer Center · Hutchinson Center Research Institute of South Africa (HCRISA) · International Vaccine Institute · KwaZulu-Natal Research Innovation and Sequencing Platform - KRISP · National Department of Health of South Africa · National Institute of Allergy and Infectious Diseases (NIAID) · Right to Care · Wits Health Consortium (Pty) Ltd · ANRS, Emerging Infectious Diseases · APHP · Autoimmunity Centers of Excellence · CEPI · Center for Vaccine Development - Mali · French National Institute of Health and Medical Research · Giselle Guerra · Harvard University · Heidelberg University · Innovative clinical research network in vaccinology (IREIVAC) · Institute of Infectious Disease and Molecular Medicine · Instituto Nacional de Saúde, Mozambique · International Centre for Diarrhoeal Disease Research, Bangladesh · Janssen Pharmaceutical K.K. · Janssen Pharmaceuticals · Janssen Research & Development, LLC · Mahidol University · National Institute for Communicable Diseases, South Africa · National Institute of Communicable Diseases - NICD · National Vaccine Institute, Thailand · Rho Federal Systems Division, Inc. · The Coalition for Epidemic Preparedness Innovations (CEPI) · University Hospital of Saint-Etienne · University of Antananarivo

Trials 21

today NCT05409261 · Ph 2 NCT04998240 · Ph 2 NCT05109559 · Ph 1/2 NCT05148845 · Ph 3 NCT05091307 · Ph 3 NCT05007080 · Ph 2 NCT05037266 · Ph 4 NCT05047640 · Ph 3 NCT04765384 · Ph 2 NCT05000216 · Ph 2 NCT04999111 · Ph 2 NCT04908722 · Ph 3 NCT04889209 · Ph 1/2 NCT04894305 · Ph 1 NCT04838795 · Ph 3 NCT04614948 · Ph 3 NCT04505722 · Ph 3 NCT04535453 · Ph 2 NCT04509947 · Ph 1 NCT04436276 · Ph 1/2

202120222023202420252026

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 12 trials
Phase 1	NCT04894305	May → Dec 2021	—	Janssen Vaccines & Prevention B.V.	Completed	No outcome recorded
Phase 1	NCT04509947	Aug 2020 → Feb 2021	—	Janssen Pharmaceutical K.K.	Completed	No outcome recorded
Phase 1/23 trials
Phase 1/2	NCT05109559	Dec 2021 → Dec 2023	COVID-19	Mahidol University	Unknown	No outcome recorded
Phase 1/2	NCT04889209	May 2021 → Jun 2023	COVID-19	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1/2	NCT04436276	Jul 2020 → Feb 2023	—	Janssen Vaccines & Prevention B.V.	Completed	No outcome recorded
Phase 27 trials · 1 met primary
Phase 2	NCT05409261	Jun → Sep 2022	COVID-19	ANRS, Emerging Infectious Diseases	Unknown	No outcome recorded
Phase 2	NCT04998240	Dec 2021 → Sep 2022	COVID-19	International Vaccine Institute	Unknown	Mixed
Phase 2	NCT05007080	Sep 2021 → Aug 2023	COVID-19	Janssen Vaccines & Prevention B.V.	Completed	No outcome recorded
Phase 2	NCT04765384	Aug 2021 → Nov 2023	—	Janssen Vaccines & Prevention B.V.	Completed	No outcome recorded
Phase 2	NCT05000216	Aug 2021 → Jun 2023	juvenile dermatomyositis, juvenile idiopathic arthritis, pediatric multiple sclerosis, pediatric systemic lupus erythematosus +3	National Institute of Allergy and Infectious Diseases (NIAID)	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT04999111	Aug → Oct 2021	COVID-19	Janssen Vaccines & Prevention B.V.	Completed	Met primary
Phase 2	NCT04535453	Aug 2020 → Mar 2022	—	Janssen Vaccines & Prevention B.V.	Completed	No outcome recorded
Phase 37 trials · 3 met primary · 1 missed
Phase 3	NCT05148845	Nov 2021 → Jan 2022	COVID-19	Wits Health Consortium (Pty) Ltd	Completed	No outcome recorded
Phase 3	NCT05091307	Nov 2021 → Jun 2022	—	Janssen Vaccines & Prevention B.V.	Completed	Mixed
Phase 3	NCT05047640	Sep 2021 → Oct 2022	COVID-19	Giselle Guerra	Terminated	Missed primary Stop: Enrollment
Phase 3	NCT04908722	Jun 2021 → Jul 2023	—	Janssen Vaccines & Prevention B.V.	Completed	No outcome recorded
Phase 3	NCT04838795	Feb 2021 → Mar 2022	severe acute respiratory syndrome	Wits Health Consortium (Pty) Ltd	Completed	Met primary
Phase 3	NCT04614948	Nov 2020 → Jun 2023	—	Janssen Vaccines & Prevention B.V.	Completed	Met primary
Phase 3	NCT04505722	Sep 2020 → Mar 2023	—	Janssen Vaccines & Prevention B.V.	Completed	Met primary
Phase 41 trial
Phase 4	NCT05037266	Sep 2021 → Feb 2022	—	University Hospital of Saint-Etienne	Terminated	No outcome recorded
Phase not stated1 trial
—	NCT04817657	—	—	Janssen Research & Development, LLC	No longer available	No outcome recorded
Comparator or background therapy4 trials
Phase 0	NCT05081271 Comparator	Oct 2021 → May 2022	multiple sclerosis	Griffin Hospital	Terminated	No outcome recorded
Phase 2	NCT05515042 Comparator	Jul 2022 → Jun 2024 overdue	COVID-19	The Aurum Institute NPC	Active not recruiting	No outcome recorded
Phase 4	NCT05030974 Comparator	Oct 2021 → Mar 2022	COVID-19, kidney disorder	University Medical Center Groningen	Completed	No outcome recorded
—	NCT04927936 Comparator	Jun 2021 → Sep 2022	COVID-19	Erasmus Medical Center	Unknown	Met primary

News releases announcing trial results or a regulatory action · 62

Date	Issuer	Release
2022-05-05	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Updates U.S. COVID-19 Vaccine Fact Sheet jnj.com ↗
2022-04-04	Janssen Research & Development, LLC	Regulatory World Health Organization Updated Emergency Use Listing Recommends Johnson & Johnson COVID-19 Vaccine for Booster Use jnj.com ↗ The World Health Organization (WHO) has issued an updated Emergency Use Listing (EUL) for the Johnson & Johnson COVID-19 vaccine, recommending the vaccine for use in boosted regimens in persons aged 18 years and older.
2022-01-06	Janssen Research & Development, LLC	Results Real World Evidence Shows Johnson & Johnson COVID-19 Vaccine Demonstrates Durable Protection Against Breakthrough Infection, Hospitalization, and Intensive Care Unit Admission in the United States jnj.com ↗ Johnson & Johnson (NYSE: JNJ) (the Company) today announced new results from the largest study to date on the durability of COVID-19 vaccines in the United States (U.S.), showing that a single shot of the Johnson & Johnson COVID-19 vaccine resulted in long-lasting protection for up to six months against COVID-19 breakthrough infections, hospitalizations, and intensive care unit (ICU) admissions.
2021-12-30	Janssen Research & Development, LLC	Results Johnson & Johnson COVID-19 Vaccine Demonstrates 85 Percent Effectiveness against Hospitalization in South Africa when Omicron was Dominant jnj.com ↗ The study, conducted by the South African Medical Research Council (SAMRC), showed that the Johnson & Johnson booster reduced the risk of hospitalization from COVID-19 among healthcare workers in South Africa after Omicron became the dominant variant.
2021-12-30	Janssen Research & Development, LLC	Results Johnson & Johnson COVID-19 Vaccine Demonstrates 85 Percent Effectiveness against Hospitalization in South Africa when Omicron was Dominant jnj.com ↗ Johnson & Johnson (NYSE: JNJ) (the Company) today announced new preliminary results from the South African Phase 3b Sisonke study which showed that a homologous (same vaccine) booster shot of the Johnson & Johnson COVID-19 vaccine (Ad26.COV2.S) demonstrated 85 percent effectiveness against COVID-19-related hospitalization.
2021-12-15	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Announces Positive CHMP Opinion for a Booster Shot of its COVID-19 Vaccine jnj.com ↗ We are pleased with today’s Positive Opinion from the CHMP supporting the use of our COVID-19 vaccine as a booster for eligible individuals in Europe
2021-12-15	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Announces Positive CHMP Opinion for a Booster Shot of its COVID-19 Vaccine jnj.com ↗ Johnson & Johnson Announces Positive CHMP Opinion for a Booster Shot of its COVID-19 Vaccine
2021-12-09	Janssen Research & Development, LLC	Regulatory World Health Organization Strategic Advisory Group of Experts (SAGE) Interim Recommendation Supports Use of Johnson & Johnson COVID-19 Vaccine as a Booster jnj.com ↗ SAGE recommended that the Johnson & Johnson COVID-19 vaccine can be used for homologous (same vaccine) boosting, using the Company’s vaccine for both primary vaccination and the booster shot.
2021-12-09	Janssen Research & Development, LLC	Regulatory World Health Organization Strategic Advisory Group of Experts (SAGE) Interim Recommendation Supports Use of Johnson & Johnson COVID-19 Vaccine as a Booster jnj.com ↗ The WHO recommend the booster shot should be administered two to six months after the primary vaccination.
2021-12-05	Janssen Research & Development, LLC	Results Johnson & Johnson COVID-19 Booster, Administered Six Months After Two-Dose Regimen of BNT162b2, Shows Substantial Increase in Antibody and T-cell Responses jnj.com ↗ These results demonstrate the potential benefits of heterologous boosting (mix-and-match).
2021-12-05	Janssen Research & Development, LLC	Results Johnson & Johnson COVID-19 Booster, Administered Six Months After Two-Dose Regimen of BNT162b2, Shows Substantial Increase in Antibody and T-cell Responses jnj.com ↗ Johnson & Johnson booster increased neutralizing and binding antibodies, similar to boosting with BNT162b2, and showed strong increase in T-cell responses
2021-11-24	Janssen Research & Development, LLC	Regulatory Johnson & Johnson COVID-19 Vaccine Fully Approved by Health Canada to Prevent COVID-19 in Individuals 18 years and Older jnj.com ↗ Toronto ON, 24 November 2021–The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canadahas approved its single-shot COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
2021-11-24	Janssen Research & Development, LLC	Regulatory Johnson & Johnson COVID-19 Vaccine Fully Approved by Health Canada to Prevent COVID-19 in Individuals 18 years and Older jnj.com ↗ The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved its single-shot COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
2021-10-20	Janssen Research & Development, LLC	Regulatory Johnson & Johnson COVID-19 Vaccine Booster Shot Authorized for Emergency Use by U.S. FDA jnj.com ↗ “We welcome the FDA’s decision to authorize emergency use of our COVID-19 vaccine as a booster,”
2021-10-20	Janssen Research & Development, LLC	Regulatory Johnson & Johnson COVID-19 Vaccine Booster Shot Authorized for Emergency Use by U.S. FDA jnj.com ↗ Johnson & Johnson COVID-19 Vaccine Booster Shot Authorized for Emergency Use by U.S. FDA
2021-10-15	Janssen Research & Development, LLC	Regulatory Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee jnj.com ↗
2021-10-15	Janssen Research & Development, LLC	Regulatory Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee jnj.com ↗ Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee
2021-10-05	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine jnj.com ↗ Johnson & Johnson (NYSE: JNJ) (the Company) announced it has submitted data to the U.S. Food and Drug Administration (FDA) to support use of a booster shot of the Johnson & Johnson COVID-19 vaccine in individuals 18 years of age and older.
2021-10-05	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine jnj.com ↗ Johnson & Johnson (NYSE: JNJ) announced it has submitted data to the U.S. Food and Drug Administration (FDA) to support use of a booster shot of the Johnson & Johnson COVID-19 vaccine in individuals 18 years of age and older.
2021-09-21	Janssen Research & Development, LLC	Results Johnson & 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. jnj.com ↗ Our large real-world evidence and Phase 3 studies confirm that the single-shot Johnson & Johnson vaccine provides strong and long-lasting protection against COVID-19-related hospitalizations.
2021-09-21	Janssen Research & Development, LLC	Results Johnson & 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. jnj.com ↗ Johnson & Johnson (NYSE: JNJ) (the Company) today announced new data reinforcing the strong and long-lasting protection of its COVID-19 vaccine.
2021-08-25	Janssen Research & Development, LLC	Results Johnson & Johnson Announces Data to Support Boosting its Single-Shot COVID-19 Vaccine jnj.com ↗ New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson COVID-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.
2021-08-25	Janssen Research & Development, LLC	Results Johnson & Johnson Announces Data to Support Boosting its Single-Shot COVID-19 Vaccine jnj.com ↗ New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson COVID-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.
2021-07-14	Janssen Research & Development, LLC	Results Johnson & 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 jnj.com ↗ Data showed that T-cell responses – including the important CD8+ T-cells that seek out and destroy infected cells – persisted over the eight-month timeframe examined.
2021-07-01	Janssen Research & Development, LLC	Results Positive New Data for Johnson & Johnson Single-Shot COVID-19 Vaccine on Activity Against Delta Variant and Long-lasting Durability of Response jnj.com ↗ Johnson & Johnson (NYSE: JNJ) (the Company) today announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants.
2021-07-01	Janssen Research & Development, LLC	Results Positive New Data for Johnson & Johnson Single-Shot COVID-19 Vaccine on Activity Against Delta Variant and Long-lasting Durability of Response jnj.com ↗ Johnson & Johnson (NYSE: JNJ) (the Company) today announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants.
2021-06-09	Adaptive Biotechnologies	Results New Study Published in Nature Provides Further Evidence that COVID-19 Vaccine Induced T-Cell Response Targets Known SARS-CoV-2 Variants of Concern adaptivebiotech.com ↗ Post-vaccination, results showed that the levels of neutralizing antibodies were diminished against the variants, but that the T-cell immune response was preserved, suggesting T cells may provide protection against these emerging strains.
2021-04-23	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Single-Shot COVID-19 Vaccinations to Resume in the U.S. for All Adults Aged 18 and Older Following CDC and FDA Decision jnj.com ↗ vaccinations with the Company’s COVID-19 single-shot vaccine will resume for all adults aged 18 years and older in the U.S.
2021-04-23	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Single-Shot COVID-19 Vaccinations to Resume in the U.S. for All Adults Aged 18 and Older Following CDC and FDA Decision jnj.com ↗ Johnson & Johnson Single-Shot COVID-19 Vaccinations to Resume in the U.S. for All Adults Aged 18 and Older Following CDC and FDA Decision
2021-04-21	Janssen Research & Development, LLC	Results Johnson & Johnson Single-Shot COVID-19 Vaccine Phase 3 Data Published in New England Journal of Medicine jnj.com ↗ Regardless of race and ethnicity, age, geographic location and comorbidities, these results remain consistent.
2021-04-20	Janssen Research & Development, LLC	Regulatory Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe Following European Medicines Agency (EMA) ReviewEMA Confirms Overall Benefit-Risk Profile Remains Positive jnj.com ↗
2021-04-20	Janssen Research & Development, LLC	Regulatory Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe Following European Medicines Agency (EMA) Review jnj.com ↗ Following the PRAC recommendation, the Company will resume shipment of the Janssen COVID-19 vaccine in the European Union (EU), Norway and Iceland.
2021-04-14	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Statement on CDC Advisory Committee Meeting on Company COVID-19 Vaccine jnj.com ↗ Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine.
2021-04-13	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Statement on COVID-19 Vaccine (Updated) jnj.com ↗ Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine.
2021-04-13	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Statement on COVID-19 Vaccine jnj.com ↗
2021-03-17	Janssen Research & Development, LLC	Regulatory Statement on the Interim SAGE Recommendation Supporting the Use of the Johnson & Johnson COVID-19 Vaccine jnj.com ↗ The SAGE recommendation was based on scientific evidence presented by Johnson & Johnson, including data from the Phase 3 ENSEMBLE study.
2021-03-12	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization jnj.com ↗ Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the World Health Organization (WHO) has issued Emergency Use Listing (EUL) for its single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to prevent COVID-19 in individuals 18 years of age and older.
2021-03-12	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization jnj.com ↗ Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Emergency Use Listing by the World Health Organization
2021-03-11	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Conditional Marketing Authorization by European Commission jnj.com ↗ Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the European Commission (EC) has granted a Conditional Marketing Authorization (CMA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), to prevent COVID-19 in individuals 18 years of age and older.
2021-03-11	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Announces its Single-Shot COVID-19 Vaccine Candidate Receives Positive CHMP Opinion jnj.com ↗
2021-03-11	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Conditional Marketing Authorization by European Commission jnj.com ↗ Johnson & Johnson Single-Shot COVID-19 Vaccine Granted Conditional Marketing Authorization by European Commission
2021-03-11	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Announces its Single-Shot COVID-19 Vaccine Candidate Receives Positive CHMP Opinion jnj.com ↗ Johnson & Johnson Announces its Single-Shot COVID-19 Vaccine Candidate Receives Positive CHMP Opinion
2021-03-05	Janssen Research & Development, LLC	Regulatory Johnson & Johnson COVID-19 Vaccine Granted Authorization under Interim Order by Health Canada For Emergency Use jnj.com ↗ March 5, 2021 - Johnson & Johnson (the Company) announced today that Health Canada has granted an Interim Order (IO) authorization for its single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.
2021-02-28	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Announces U.S. CDC Advisory Committee Recommends First Single-Shot COVID-19 Vaccine for Adults 18 and Older in U.S. jnj.com ↗
2021-02-28	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Announces U.S. CDC Advisory Committee Recommends First Single-Shot COVID-19 Vaccine for Adults 18 and Older in U.S. jnj.com ↗ Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA).
2021-02-27	Janssen Research & Development, LLC	Regulatory Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use - First Single-Shot Vaccine in Fight Against Global Pandemic jnj.com ↗ Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.
2021-02-27	Janssen Research & Development, LLC	Regulatory Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use jnj.com ↗ Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use
2021-02-26	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee jnj.com ↗
2021-02-26	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee jnj.com ↗
2021-02-19	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate jnj.com ↗ Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen-Cilag International N.V. has submitted for Emergency Use Listing (EUL) to the World Health Organization (WHO) for the investigational single-dose Janssen COVID-19 vaccine candidate.
2021-02-19	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate jnj.com ↗ Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen-Cilag International N.V. has submitted for Emergency Use Listing (EUL) to the World Health Organization (WHO) for the investigational single-dose Janssen COVID-19 vaccine candidate.
2021-02-16	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Announces Submission of European Conditional Marketing Authorisation Application to the EMA for its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate jnj.com ↗ today announced that Janssen-Cilag International N.V., has submitted a conditional Marketing Authorisation Application (cMAA) to the European Medicines Agency (EMA) seeking authorisation for its investigational single-dose Janssen COVID-19 vaccine candidate.
2021-02-16	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Announces Submission of European Conditional Marketing Authorisation Application to the EMA for its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate jnj.com ↗
2021-02-04	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate jnj.com ↗ NEW BRUNSWICK, N.J., February 4, 2021–Johnson & Johnson (NYSE: JNJ) (the Company) today announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate.
2021-02-04	Janssen Research & Development, LLC	Regulatory Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate jnj.com ↗
2021-01-29	Janssen Research & Development, LLC	Results Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial jnj.com ↗ Among all participants from different geographies and including those infected with an emerging viral variant, Janssen’s COVID-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination.
2021-01-29	Janssen Research & Development, LLC	Results Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial jnj.com ↗ Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints.
2021-01-13	Janssen Research & Development, LLC	Results Johnson & Johnson COVID-19 Vaccine Candidate Interim Phase 1/2a Data Published in New England Journal of Medicine jnj.com ↗ The Phase 1/2a interim analysis showed that the Company’s COVID-19 vaccine candidate induced an immune response and was generally well-tolerated across all study participants.
2020-09-25	Janssen Research & Development, LLC	Results (This statement was updated on October 4, 2020 to include additional information) Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate jnj.com ↗ The data demonstrate that a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all participants aged 18 years and older and was generally well-tolerated.
2020-09-03	Janssen Research & Development, LLC	Results Johnson & Johnson Announces that Janssen’s COVID-19 Investigational Vaccine Candidate Prevents Severe Clinical Disease in Pre-clinical Studies jnj.com ↗ Janssen’s lead SARS-CoV-2 investigational vaccine candidate, Ad26.COV2.S, prevented severe clinical disease in Syrian golden hamsters, upon challenge with SARS-CoV-2, the virus that causes COVID-19 in people.
2020-07-30	Janssen Research & Development, LLC	Results Single Dose of Johnson & Johnson COVID-19 Vaccine Candidate Demonstrates Robust Protection in Pre-clinical Studies jnj.com ↗ The data, published inNature, show the Company’s investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited a robust immune response as demonstrated by “neutralizing antibodies,” successfully preventing subsequent infection and providing complete or near-complete protection in the lungs from the virus in non-human primates (NHPs) in the pre-clinical study.
2020-07-30	Janssen Research & Development, LLC	Results Single Dose of Johnson & Johnson COVID-19 Vaccine Candidate Demonstrates Robust Protection in Pre-clinical Studies jnj.com ↗ Johnson & Johnson (NYSE: JNJ) (the Company) today announced that its lead vaccine candidate protected against infection with SARS-CoV-2, the virus that causes COVID-19, in pre-clinical studies.

All press releases naming this drug 544 releases

Date	Issuer	Release
Show all 544 releases opens the full record — a long page

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 26 sources stand behind the page.

Field	Value	Cited text
Known as	Ad26.COV2.S	“The participants were assigned to receive no booster, an Ad26.COV2.S booster, an mRNA-1273 booster, or a BNT162b2 booster.” PMID 35045226 ↗ Jan 2022 23 “A booster dose (3rd dose) of Ad26.COV2.S as an IM injection in the deltoid muscle in adults.” NCT05109559 ↗ “This means Ad26.COV2.S if they originally received BNT162b2 or mRNA-1273 or vice versa” NCT05081271 ↗ NCT04817657 ↗ NCT04614948 ↗ NCT04908722 ↗ NCT04505722 ↗ NCT04535453 ↗ NCT04999111 ↗ NCT04509947 ↗ NCT04998240 ↗ Show 13 more sources
Known as	COVID-19 Vaccine Janssen	“COVID-19 Vaccine Janssen (Ad26.COV2-S)” NCT05037266 ↗
Known as	Jansen	“Ad26.COV2.S (Jansen) COVID-19 vaccine” NCT05148845 ↗
Known as	Janssen	“Ad26.COV2.S (Janssen) COVID-19 vaccine” NCT05148845 ↗
Known as	JNJ-78436735	“Ad26.COV2.S (VAC31518, JNJ-78436735) Vaccine, SARS-CoV-2 rS (CovovaxTM), BNT162b2 (Pfizer)” NCT05515042 ↗ 1 NCT05047640 ↗
Known as	Johnson \& Johnson Vaccine	“using two approved vaccines (Sinopharm / CNBG Vaccine (BBIBP-CorV) and Johnson \& Johnson Vaccine (Ad26.COV2.S)).” NCT04998240 ↗
Known as	VAC31518	“Ad26.COV2.S (VAC31518, JNJ-78436735) Vaccine, SARS-CoV-2 rS (CovovaxTM), BNT162b2 (Pfizer)” NCT05515042 ↗
Modality	Vaccine	“A candidate vaccine, Ad26.COV2.S, is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein.” PMID 33440088 ↗ Jan 2021
Route	Intramuscular	“Participants will receive intramuscular (IM) injection” NCT04436276 ↗