Janssen COVID-19 Vaccine (Ad26.COV2-S) Description
In collaboration with Beth Israel Deaconess Medical Center, Johnson and Johnson (J&J) and Janssen Pharmaceutical research teams constructed and tested multiple vaccine candidates using the Janssen AdVac® technology and have selected its lead vaccine candidate, Ad26.COV2-S (Ad26COVS1) (Janssen COVID-19) (JNJ-78436735) recombinant for preventing coronavirus infection and COVID-19.
The Ad26.COV2-S (Janssen COVID-19) vaccine candidate leverages Janssen's AdVac and PER.C6® technologies. These are the same technologies Janssen used to develop and manufacture the Company's Ebola vaccine, Ad26.ZEBOV.
On September 25, 2020, a non-peer-reviewed study concluded 'the safety profile and immunogenicity after only a single dose supports the further clinical development of Ad26.COV2.S at a dose level of 5x1010 up, as a potentially protective vaccine against COVID-19.' J&J stated 'it anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021 as the Company progresses the clinical development of its Ad26.COV2-S vaccine candidate continues to increase manufacturing capacity and is in active discussions with global partners to ensure worldwide access.'
On October 23, 2020, Johnson & Johnson announced that it is preparing to resume recruitment in the pivotal Phase 3 ENSEMBLE trial of its investigational Janssen COVID-19 vaccine in the United States after a temporary pause.
On December 12, 2020, the European Medicines Agency's human medicines committee (CHMP) confirmed it had started a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag International N.V. The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus.
On December 17, 2020, J&J issued a press release that stated, 'Interim data from the ENSEMBLE phase 3 clinical trial is currently anticipated to be available by the end of January 2021.'
On January 13, 2021, the NEJM published Interim Results of a Phase 1–2a Trial,' which stated: 'The interim analysis of our phase 1–2a trial showed that the Ad26.COV2.S vaccine (JNJ-78436735) had an acceptable safety and reactogenicity profile and was immunogenic after a single vaccination with either the low or high dose.'
'Neutralizing-antibody titers against wild-type virus were detected in 90% or more of all participants on day 29 after the first vaccine dose (geometric mean titer [GMT], 224 to 354) and reached 100% by day 57 with a further increase in titers (GMT, 288 to 488), regardless of vaccine dose or age group. Titers remained stable until at least day 71. A second dose provided an increase in the titer by a factor of 2.6 to 2.9 (GMT, 827 to 1266). Spike-binding antibody responses were similar to neutralizing-antibody responses. On day 14, CD4+ T-cell responses were detected in 76 to 83% of the participants in cohort 1 and 60 to 67% of those in cohort 3, with a clear skewing toward type 1 helper T cells. CD8+ T-cell responses were robust overall but lower in cohort 3.'
'Our interim analysis indicates that vaccine candidate Ad26.COV2.S is safe and immunogenic in both younger and older adults. In combination with the results in preclinical challenge studies, this finding has supported our decision to proceed with two phase 3 trials to evaluate the efficacy of either a single-dose or two-dose regimen of the lower dose (5×1010 viral particles) of Ad26.COV2.S.'
J&J and Janssen Vaccines & Prevention B.V. stated it is committed to the goal of supplying more than 1 billion doses globally through the course of 2021, provided the vaccine is safe and effective.
On January 13, 2021, Johnson & Johnson stated it 'continues to develop and test its COVID-19 vaccine candidate in accordance with ethical standards and sound scientific principles. The Company is committed to transparency and sharing information related to its ongoing clinical studies – including the ENSEMBLE study protocol.'
'ENSEMBLE was initiated in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS) under Other Transaction Agreement HHSO100201700018C, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS.'
For more information on Johnson & Johnson’s Janssen COVID-19 approach to combatting the pandemic, JnJ.com. Learn more at Janssen.com.
Janssen COVID-19 Vaccine (Ad26.COV2-S) Distribution Agreements
J&J announced the European Commission (EC), acting on behalf of the European Union (EU) the Member States, has approved an Advance Purchase Agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its COVID-19 vaccine candidate to the EU Member States following approval or authorization from regulators. The EU Member States also have the option to secure up to 200 million additional doses.
Janssen COVID-19 Vaccine (Ad26.COV2-S) Indication
Janssen's vaccine candidate (Janssen COVID-19) will be indicated to prevent infection from SARS-CoV-2 coronavirus, which leads to COVID-19 disease in humans. SARS-CoV-2 belongs to a group of viruses called coronaviruses that attack the respiratory system.
No pediatric, oncology, or pregnancy vaccine efficacy data has been disclosed.
Janssen COVID-19 Vaccine (Ad26.COV2-S) Dosage
Ad26COVS1 (JNJ-78436735) was evaluated at 2-dose levels in a phase 1 study, administered intramuscularly as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort.
The phase 2 study's primary purpose is to assess humoral immune responses of 3 dose levels of Ad26.COV2.S administered intramuscularly (IM) as a 2-dose schedule (56 days apart); Ad26.COV2.S administered IM as a single vaccination and to test both compressed and expanded 2-dose schedules of Ad26.COV2.S (28 and 84 days apart).
The phase 3 ENSEMBLE study evaluates the safety and efficacy of a single vaccine dose of Janssen COVID-19.
Janssen COVID-19 Vaccine (Ad26.COV2-S) News
January 13, 2021 - The NEJM published: Interim Results of a Phase 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine. The safety and immunogenicity profiles of Ad26.COV2.S supports the further development of this vaccine candidate.
January 13, 2021 - Interim Phase 1/2a data were published today in the New England Journal of Medicine, demonstrating that the Company’s single-dose investigational COVID-19 vaccine candidate (JNJ-78436735) – being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson – provided an immune response that lasted for at least 71 days, the duration of time measured in this study in participants aged 18-55 years. A preview of these interim data was posted on medRxiv in September 2020.
January 5, 2021 - J&J COVID-19 Update: Your Latest Questions About Johnson & Johnson's Investigational Vaccine Candidate Answered.
December 29, 2020 - The Philippines has approved a clinical trial for the Covid-19 vaccine of Johnson & Johnson's unit Janssen, the head of its Food and Drug Administration (FDA), said on Tuesday. The trials could begin in the next few weeks, FDA head Rolando Enrique Domingo told a media briefing.
December 24, 2020 - South Korea has signed a deal with Johnson & Johnson’s Janssen to import coronavirus vaccines, Prime Minister Chung Sye-kyun told a televised briefing. The government had allocated an additional 1.3 trillion won ($1.2 billion) to next year’s budget for vaccines.
December 21, 2020 - Mexico’s Deputy Health Minister Hugo Lopez-Gatell said earlier this month at a news conference that hosting the Janssen trial would give the country priority access to the vaccine. Marcelo Ebrard said that Mexico could order 22 million doses under a memorandum of understanding last week.
December 17, 2020 - J&J announced the large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) of the investigational Janssen COVID-19 single-dose vaccine candidate is now fully enrolled with approximately 45,000 participants. Interim data from the ENSEMBLE trial is currently anticipated to be available by the end of January 2021. If the data indicate the vaccine is safe and effective, the Company expects to submit an Emergency Use Authorization application to the U.S. FDA in February 2021.
December 15, 2020 - REIG JOFRE Pharmaceutical announced an agreement with the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) to execute the technology transfer to manufacture its investigational COVID-19 vaccine candidate, Ad26.COV2-S. The project candidate entails additional investment, already underway, to ensure the new facility complies with the biosafety levels required by the Ad26.COV2-S vaccine candidate. Under the terms of the agreement, REIG JOFRE will be responsible for the formulation, filling, and packaging of the vaccine candidate, then distributed by Janssen.
December 9, 2020 - Johnson & Johnson is reported to be reducing the size of its pivotal phase 3 study from 60,000 volunteers to 40,000 volunteers. The change is being made possible by the fact that Covid-19 is so pervasive across the country, according to Matthew Herper with StatNews. This study was last updated on December 3, 2020
December 1, 2020 - The European Medicines Agency's human medicines committee (CHMP) has started a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag International N.V. The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus.
November 18, 2020 - The Spanish Agency for Medicines and Health Products authorized phase III of the clinical trial in Spain of the Janssen (a Johnson & Johnson company) vaccine. This is the first phase III clinical trial for a vaccine against COVID-19 of this type authorized in Spain. Furthermore, the trials will be conducted in nine hospitals in Spain to recruit eligible volunteers, including people without any chronic diseases and people with concurrent illnesses. Twenty percent of the participants will be under 40 years old, and 30 percent will be over 60 years old, the ministry informed.
November 14, 2020 - Johnson & Johnson announced the expansion to the partnership between its Janssen Pharmaceutical Companies and the Biomedical Advanced Research and Development Authority (BARDA) for the ongoing development of Janssen's investigational COVID-19 vaccine candidate, Ad26.COV2-S.
November 2, 2020 - South Africa-based Aspen Pharmacare Limited announced it has entered into a preliminary agreement with Janssen Pharmaceuticals, Inc. (Johnson & Johnson) for the technical transfer and proposed commercial manufacture of their COVID-19 vaccine candidate, Ad26.COV2-S. Aspen Pharmacare stated 'it will perform formulation, filling and secondary packaging of the vaccine for supply to Johnson & Johnson.
October 23, 2020 - Johnson & Johnson announced today that it is preparing to resume recruitment in the pivotal Phase 3 ENSEMBLE trial of its investigational Janssen COVID-19 vaccine in the United States after a temporary pause.
October 12, 2020 - J&J announced it temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following its guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board, as well as our internal clinical and safety physicians.
October 8, 2020 - Johnson & Johnson announced the European Commission, acting on behalf of the European Union (EU) the Member States, has approved an Advance Purchase Agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its COVID-19 vaccine candidate to the EU Member States following approval or authorization from regulators.
October 4, 2020 - J&J announced interim analysis from the ongoing Phase 1/2a clinical trial of the Janssen COVID-19 vaccine candidate (JNJ-78436735). The data demonstrate that a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all 18 years and older participants and was generally well-tolerated. Immune responses were similar across the age groups studied, including older adults.
September 26, 2020 - Interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial - Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate.
September 25, 2020 - Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: interim results of a phase 1/2a, after only a single dose, support further clinical development of Ad26.COV2.S at a dose level of 5x1010 vp, as a potentially protective vaccine against COVID-19.'
September 25, 2020 - Grand River Aseptic Manufacturing (GRAM) announced agreeing with Janssen Pharmaceuticals, Inc. to support its SARS-CoV-2 vaccine candidate's manufacture. The Johnson & Johnson vaccine candidate being manufactured at GRAM is being developed, in part, with funding from BARDA. In collaboration with JPEO-CBRND, BARDA is also funding a demonstration of manufacturing capability expected to result in 100 million doses of the investigational vaccine, which the federal government will own.
September 23, 2020 - JNJ announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies.
September 13, 2020 - Janssen Vaccines & Prevention B.V. will begin mid-stage trials of its COVID-19 vaccine in Spain. About 190 people would take part in Spain's trials, which will occur in 3 hospitals and be concluded by September 22, 2020. The Spanish study is part of Phase II trials of the vaccine being carried out in three countries, including the Netherlands and Germany. The phase 2 trials will last two months and include 550 participants in total.
September 3, 2020 - J&J reported 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.
August 26, 2020 - Johnson & Johnson has added Chile, Argentina, and Peru to the Latin nations to conduct Phase III trials for its vaccine against COVID-19 disease. The company told Reuters it was waiting for regulatory approval in Chile, Argentina, and Mexico.
August 18, 2020 - Brazil's Health regulator Anvisa said it had given the green light for a vaccine study that will see 6,000 people in Brazil volunteer to trial the vaccine contender of Johnson & Johnson’s pharmaceutical subsidiary Janssen.
August 14, 2020 - Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has agreed in principle to collaborate with the United Kingdom of Great Britain and Northern Ireland on a global Phase 3 clinical trial to explore the 2--dose regimen of Janssen’s SARS-CoV-2 vaccine candidate, Ad26.COV2.S. This global study will run parallel to the Phase 3 trial investigating the single-dose regimen of Ad26.COV2.S.
August 9, 2020 - The Kingdom of Saudi Arabia announced it would soon begin a Phase 3 clinical trial of around 5,000 people for the COVID-19 disease preventive vaccine known as Ad5-nCoV.
August 5, 2020 - J&J announced that it would develop and deliver 100 million doses of its coronavirus vaccine for the U.S. government in a deal totaling more than $1 billion. This agreement offers the U.S. the option to order an additional 200 million doses.
July 30, 2020 - The 4 Latest Facts About Johnson & Johnson’s Investigational COVID-19 Vaccine.
July 30, 2020 - A new study showed that Janssen's investigational vaccine elicited an immune response against SARS-CoV-2 in a preclinical, nonhuman study. Based on this preclinical study's positive data, the first-in-human Phase 1/2a clinical trial is now underway in the USA and Belgium, with a Phase 3 study expected to commence in September 2020.
July 17, 2020 - The NYTimes reports clinical trials of the vaccine will begin in Belgium. Dr. Barouch’s team will soon start up a trial in Boston.
July 16, 2020 - J&J's Wolk said the Phase 1 trial of Ad26COVS1 is expected to enroll more than 1,000 participants, primarily between 18 and 55 years old. However, the company also plans to include a group of people who are 65 years old or older in the early-stage trial. He also said that J&J is in talks with the National Institutes of Health to move up the timeline for the anticipated Phase 3 trial to late September 2020.
July 6, 2020 - Emergent BioSolutions Inc. announced a 5-year manufacturing services agreement with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for large-scale drug substance manufacturing for the investigational vaccine, Ad26.COV2-S. Emergent will provide contract development and manufacturing (CDMO) services valued at approximately $480 million for the first two years.
June 10, 2020 - Johnson & Johnson today that through its Janssen Pharmaceutical Companies (Janssen), it has accelerated the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant.
May 28, 2020 - A new article published in The Lancet, The starting line for COVID-19 vaccine development, identifies questions are whether responses are sustained over time and whether they correlate with clinical protection after exposure to a circulating strain of SARS-CoV-2.
April 29, 2020 - Janssen Pharmaceutical Companies of Johnson & Johnson announced Catalent’s Biologics business unit would accelerate manufacturing capacity availability and prepare for large-scale commercial manufacturing at its facility in Bloomington, Indiana, of Johnson & Johnson’s lead vaccine candidate for COVID-19. The collaboration commits joint investment to accelerate the rapid scale-up of segregated manufacturing capacity over the coming months to support Johnson & Johnson’s investigational vaccine candidate's dedicated production.
April 23, 2020 - Emergent BioSolutions Inc. announced an agreement whereby Emergent will deploy its contract development and manufacturing services to support Johnson & Johnson’s lead vaccine candidate for COVID-19 that leverages the AdVac® and PER.C6® technologies from the Janssen Pharmaceutical Companies of Johnson & Johnson. Under the agreement, valued at approximately $135 million, Emergent will provide drug substance manufacturing services with its molecule-to-market CDMO offering, supported by investments from Johnson & Johnson beginning in 2020, and will reserve certain large-scale manufacturing capacity to pave the way for commercial manufacturing of Janssen’s adenovirus-based COVID-19 vaccine beginning in 2021.
March 30, 2020 - Johnson & Johnson has identified a lead COVID-19 vaccine candidate (with two back-ups), which will progress into the first manufacturing steps. Under an accelerated timeline, the Company aims to initiate a Phase 1 clinical study in September 2020, with clinical data on safety and efficacy expected to be available by the end of the year. This could allow vaccine availability for emergency use in early 2021. For comparison, the typical vaccine development process involves several different research stages, spanning 5 to 7 years, before a candidate is even considered for approval.
Janssen COVID-19 Vaccine (Ad26.COV2-S) Clinical Trials
Janssen is investigating multiple doses and dosing regimens of its COVID-19 vaccine candidate to evaluate long-term efficacy. The Company is studying a single-dose of its vaccine candidate in the Phase 3 ENSEMBLE trial, which completed enrollment on December 17, 2020, and a two-dose regimen in the Phase 3 ENSEMBLE 2 study, which is ongoing.
Clinical Trial NCT04436276: - Phase 1/2 - last updated on January 6, 2021.
- The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26COVS1 (JNJ-78436735) at 2 dose levels, administered intramuscularly as a single-dose or 2-dose schedule, with a single booster vaccination administered in one cohort, in healthy adults aged greater than or equal to 18 to less than or equal to 55 years and in adults aged greater than or equal to 65 years in good health with or without stable underlying conditions.
- The study took place in the USA and Belgium.
- Estimated Primary Completion Date: September 15, 2021.
- NEJM analysis was published on January 13, 2021.
Clinical Trial NCT04505722: Study code: VAC31518COV3001: Phase 3 study - last updated on December 3, 2020.
- The approved clinical trial is a phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of Ad26.COV2.S prevents SARS-CoV-2-mediated Covid-19 in adults aged 18 years or older. It will be a single dose of the vaccine or placebo.
- The study foresees the inclusion of up to 60,000 volunteers, across 3 continents, with seven thousand in Brazil, distributed in several regions of the country in the states of São Paulo, Rio Grande do Sul, Rio de Janeiro, Paraná, Minas Gerais, Bahia, and Rio Grande do Norte.
- Estimated Primary Completion Date: March 10, 2023
- Protocol VAC31518COV3001; Phase 3 AMENDMENT 1 VAC31518 (JNJ-78436735).