Coronavirus (27) Non-replicating viral vector vaccine candidates for COVID-19 (part d)
Continued from my last blog post.
4.Ad26.COV2.S by Janssen Pharmaceutical Companies
The development of the vaccine candidate Ad26.COV2.S, also named JNJ-78436735, is another example of the collaboration between academia and industry. This vaccine was jointly developed by scientists from Janssen Pharmaceutical Companies and a leading virology and vaccine laboratory led by Dan Barouch, M.D., Ph.D. in the Beth Israel Deaconess Medical Center, Harvard Medical School.1
The name of the vaccine candidate, Ad26.COV2.S, tells us that it is basically an adenovirus type 26 viral vector expressing the Spike (S) protein of SARS-CoV-2. Janssen Pharmaceuticals and the team led by Dan Barouch started working on developing the vaccine for COVID-19 since January. At the end of March, Ad26.COV2.S was then identified, among other constructs, to be efficacious.2
It was found that a single dose of Ad26.COV2.S was able to elicit strong immune responses in rhesus macaques. None of the vaccinated animals had detectable viral loads in bronchoalveolar lavage upon infection with SARS-CoV-2. The detail preclinical data was published in Nature.3
Phase 1/2a
A multi-centre, randomized, double-blind, placebo-controlled phase 1/2a study on Ad26.COV2-S (NCT04436276) started from mid July this year in both the US and Belgium. The study includes 3 cohorts which recruited healthy adults aged 18 to 55 years (cohorts 1a and 1b, 402 participants), as well as adults aged 65 years and older (cohort 3, 403 participants).4,5 The participants received intramuscular injection of Ad26.COV2-S (at 5x1010 or 1x1011 viral particles per vaccination, in either one- or two-doses injected 8 weeks apart) or placebo (0.9% saline).
An interim report with data obtained during the first 4 weeks after the first vaccination was published as a non-peer-reviewed pre-print in medRxiv in September.5 According to the report, the most frequent adverse events among the 18-55 age groups were fatigue, headache and myalgia. Fever was reported in 76 (19%) participants, with grade 3 fever reported in 22 (5%) participants. All fevers occurred within 2 days of immunization and resolved within 1 to 2 days. The most frequent adverse events among the group of 65 years or older were headache, fatigue and myalgia. Mild or moderate fevers of grade 1 or 2 were reported in 4% of participants. This finding suggests that the vaccine candidate is less able to cause immunologic reaction in older adults.5
However, there were two severe adverse events noted in the report: one hypotension, which was later judged by the investigator not to be vaccine-related but was related to a past history of recurrent hypotension; and one hospitalized overnight with fever but recovered within 12 hours, the fever was later judged by the investigator to be vaccine related. No participant discontinued the study due to an adverse event. Therefore, according to the scientists of the study, “the safety profile is acceptable at any age, given the seriousness of the disease the vaccine can potentially protect against, and the nature of the pandemic, especially in the elderly which is the population most vulnerable to COVID-19.”5
A single dose of Ad26.COV2.S elicited strong humoral responses in the vast majority of vaccine recipients. Specific spike protein of SARS-CoV-2 antibody titers (concentration) increased from baseline to Day 29 post vaccination in 99% of the participants in cohort 1a, and 100% of the first participants in cohort 3, with either vaccine dose levels (5x1010 or 1x1011 viral particles per vaccination).5
Ad26.COV2.S also elicited cellular immune response. Spike protein specific CD8+ T cell responses were also identified after the vaccination. On the 15th days after vaccination, 51% of cohort 1a participants (18-55 years old) administered with 5x1010 viral particles, and 64% of cohort 1a participants administered with 1x1010 viral particles, showed positive CD8+ T cell response to Spike peptide stimulation. Of participants of age 65 or above, 33% had a detectable vaccine induced CD8+ T cell response for both dose level groups.
The study is still ongoing; on 4th October, J&J announced another interim analysis from it.6 The data demonstrates that a single dose of the vaccine candidates induced a strong neutralizing antibody response in nearly all participants aged 18 years and older, and was generally well-tolerated. Immune responses were similar across the age groups studied, including older adults.
Since both dose levels showed similar immunogenicity, the company decided to use lower dose (5x1010 viral particles per vaccination) for the phase 3 clinical evaluation.
Phase 3
Once the first interim result from the phase 1/2a study was out, a phase 3 trial on the vaccine candidate (NCT04505722) evaluating a single-dose regimen on a much larger scale started in September. The phase 3 trial, also called ENSEMBLE, is expected to enrol a total of 60,000 volunteers across 3 continents: Africa, South and Central America, and the United States.7 The phase 3 study in the US experienced a temporary pause once in mid October, but resumed later after about 2 weeks.8,9
Another phase 3 study with a two-dose regimen (NCT04614948) is yet to be started later this year.10 The trials taking place in the UK will recruit a total of 6000 volunteers and are expected to finish in the first quarter of 2021.11
Comments on the project
According to the UK government, Ad26.COV2.S is the third potential vaccine to enter clinical trials in the UK. The first two are the vaccines from a US biotech company Novavax and from the University of Oxford/ AstraZeneca.11
The whole project of examining the vaccine candidate is highly transparent. Reports and Interim reports were available to the public to get the data from the pre-clinical and clinical trials studies.3,5,6 The protocol of phase 3 trials is clearly written and is also available online to the public.12 However, a serious medical event experienced by one study participant in the US, which caused the temporary pause of the phase 3 study, has not been clearly described or explained. Although they obtained consent from the Data Safety and Monitoring Board (DSMB), the US Food and Drug Administration (FDA), and the Institutional Review Boards to resume the study in the US, with no clear cause yet identified, the incident is something that the public may need to be cautious of.9
Ad26.COV2.S was developed using the technology platform, AdVac®,* which was developed by Janssen Pharmaceuticals. The platform has been used to design and develop an Ebola vaccine which was later used for 2 million doses and got approval from the European Commission. Based on the safety records for the viral vaccine using the AdVac platform, there should be no safety hazard for using AdVac as the Ad26.COV2.S backbone structure.13
This project has obtained a lot of funds to support the studies. The project is sponsored by Johnson and Johnson and funded, in part, by Biomedical Advanced Research and Development Authority (BARDA) under contract HHS0100201700018C.3,5 BARDA is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health and Human Services. Under the contract, BARDA and Johnson & Johnson together have committed to invest more than $1 billion for the candidate vaccine’s research, development, and clinical testing.2 The UK government’s Vaccine Taskforce also jointly fund Johnson & Johnson to test the safety and effectiveness of the vaccine candidate.11
Since its entry into the clinical phases, the vaccine candidate has already been a purchase target of many nations. In early October, Janssen Pharmaceutical Companies signed an Advanced Purchase agreement with the European Commission to supply 200 million doses, and an extra of up to 200 million more doses of Ad26.COV2.S, to European Union Member States, following the approval or authorization from regulators.14 In early August, Janssen Pharmaceutical Companies have also agreed with the US government to deliver 100 million doses of Ad26.COV2.S for use in the United States following approval or Emergency Use Authorization by the US Food and Drug Administration (FDA). The US government may also purchase an extra 200 million doses under a subsequent agreement.15
Johnson & Johnson has a goal to supply more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.2,15 In order to meet this goal, the company has started to invest to expand its capacity to produce the viral vaccine since March this year.2 Moreover, the company is also collaborating with Aspen Pharmacare, a South African pharmaceutical company, to commercially manufacture its COVID-19 vaccine. In addition to the use of the technology platform, AdVac®* make the production of the vaccine candidate ready to be upscaled rapidly if it is being approved. In fact, using the same platform, two million of the Ebola 2-shot vaccine regimens, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo), were produced in less than one year for the Ebola epidemic in West Africa.1,13
Introduction to the organizations and companies involved in development of the vaccine
Beth Israel Deaconess Medical Center (BIDMC) is a part of the Beth Israel Lahey Health system. It is a teaching hospital of Harvard Medical School. The Director of the Center for Virology and Vaccine Research at BIDMC is Dan Barouch, M.D., Ph.D. Dr. Barouch's team is well-known for their work on the pathogenesis and immunology of viral infections and the development of vaccine strategies for global infectious diseases.1
The collaboration between the team led by Dr. Barouch and the Janssen Pharmaceuticals have been in progress much longer than the development of a vaccine for COVID-19. The two sides started collaborating since the development and preclinical work for Zika and HIV vaccine candidates a few years ago.
Janssen Pharmaceutical Companies belongs to Johnson and Johnson (J&J). J&J has been established for more than 130 years. It has the biggest market capital among the diversified medical stock. They focus on the wide areas of medicine: cardiovascular and metabolism, immunology, infectious diseases and vaccines, neuroscience, oncology, and pulmonary hypertension.
*AdVac® is based on a specific type of adenovirus, which has been genetically modified so that it can no longer replicate in humans and cause disease. The AdVac® technology helps to accelerate the development of vaccines. The technology has been used in developing Ebola (which also utilizes its MVA-BN® technology), Zika, RSV and HIV vaccines. The Ebola vaccine has now received approval by the European Commission and has been deployed in some areas in Africa. “Vaccine Technology. Janssen Pharmaceutical website. https://www.janssen.com/infectious-diseases-and-vaccines/vaccine-technology”
References
1. Johnson & Johnson announces collaboration with the Beth Israel Deaconess Medical Center to accelerate COVID-19 vaccine development. Press release from Janssen Pharmaceutical companies. Mar 13, 2020. https://www.janssen.com/johnson-johnson-announces-collaboration-beth-israel-deaconess-medical-center-accelerate-covid-19
2. Johnson & 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. Johnson & Johnson news release, March 30, 2020. jnj.com/johnson-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
3. N.B. Mercado, R. Zahn, F. Wegmann, et al. Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques. Nature, 2020 Oct;586(7830): 583-588.
4. A study of Ad26.COV2.S in adults (COVID-19). NCT04436276. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04436276
5. J. Sadoff, M. Le Gars, G. Shukarev, et al. Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial. MedRxiv, September 25, 2020. https://doi.org/10.1101/2020.09.23.20199604
6. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson news release, Oct 4, 2020. https://www.jnj.com/johnson-johnson-posts-interim-results-from-phase-1-2a-clinical-trial-of-its-janssen-covid-19-vaccine-candidate
7. A study of Ad26.COV2.S for the prevention of SARS-CoV-2-mediated COVID-19 in adult participants (ENSEMBLE). NCT04505722. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04505722
8. Johnson & Johnson temporarily pauses all dosing in our Janssen COVID-19 vaccine candidate clinical trials. Janssen Pharmaceuticals’ press release, Oct 13, 2020. https://www.janssen.com/johnson-johnson-temporarily-pauses-all-dosing-our-janssen-covid-19-vaccine-candidate-clinical-trials
9. Johnson & Johnson prepares to resume phase 3 ENSEMBLE trial of its Janssen COVID-19 vaccine candidate in the U.S. Johnson & Johnson news release, Oct 23, 2020. https://www.jnj.com/our-company/johnson-johnson-prepares-to-resume-phase-3-ensemble-trial-of-its-janssen-covid-19-vaccine-candidate-in-the-us
10. A study of Ad26.COV2.S for the prevention of SARS-CoV-2-mediated COVID-19 in adults (ENSEMBLE 2). NCT04614948. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04614948
11. Janssen to begin COVID-19 vaccine trials in the UK. Gov.UK press release, 16 November 2020. https://www.gov.uk/government/news/janssen-to-begin-covid-19-vaccine-trials-in-the-uk
12. A randomized, double-blind, placebo-controlled phase 3 study to assess the efficacy and safety of Ad26.COV2.S for the prevention of SARS-CoV-2-mediated COVID-19 in adults aged 18 years and older. https://www.jnj.com/coronavirus/covid-19-phase-3-study-clinical-protocol.
13. Vaccine technology. Janssen Pharmaceutical Companies. https://www.janssen.com/infectious-diseases-and-vaccines/vaccine-technology
14. Johnson & Johnson Announces European Commission Approval of Agreement to Supply 200 Million Doses of Janssen’s COVID-19 Vaccine Candidate. Janssen Pharmaceuticals’ news release, Oct 8, 2020. https://www.janssen.com/johnson-johnson-announces-european-commission-approval-agreement-supply-200-million-doses-janssens
15. Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 VaccineJohnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine. Janssen Pharmaceuticals’ news release, Aug 05, 2020. https://www.jnj.com/johnson-johnson-announces-agreement-with-u-s-government-for-100-million-doses-of-investigational-covid-19-vaccine
Continued from my last blog post.
4.Ad26.COV2.S by Janssen Pharmaceutical Companies
The development of the vaccine candidate Ad26.COV2.S, also named JNJ-78436735, is another example of the collaboration between academia and industry. This vaccine was jointly developed by scientists from Janssen Pharmaceutical Companies and a leading virology and vaccine laboratory led by Dan Barouch, M.D., Ph.D. in the Beth Israel Deaconess Medical Center, Harvard Medical School.1
The name of the vaccine candidate, Ad26.COV2.S, tells us that it is basically an adenovirus type 26 viral vector expressing the Spike (S) protein of SARS-CoV-2. Janssen Pharmaceuticals and the team led by Dan Barouch started working on developing the vaccine for COVID-19 since January. At the end of March, Ad26.COV2.S was then identified, among other constructs, to be efficacious.2
It was found that a single dose of Ad26.COV2.S was able to elicit strong immune responses in rhesus macaques. None of the vaccinated animals had detectable viral loads in bronchoalveolar lavage upon infection with SARS-CoV-2. The detail preclinical data was published in Nature.3
Phase 1/2a
A multi-centre, randomized, double-blind, placebo-controlled phase 1/2a study on Ad26.COV2-S (NCT04436276) started from mid July this year in both the US and Belgium. The study includes 3 cohorts which recruited healthy adults aged 18 to 55 years (cohorts 1a and 1b, 402 participants), as well as adults aged 65 years and older (cohort 3, 403 participants).4,5 The participants received intramuscular injection of Ad26.COV2-S (at 5x1010 or 1x1011 viral particles per vaccination, in either one- or two-doses injected 8 weeks apart) or placebo (0.9% saline).
An interim report with data obtained during the first 4 weeks after the first vaccination was published as a non-peer-reviewed pre-print in medRxiv in September.5 According to the report, the most frequent adverse events among the 18-55 age groups were fatigue, headache and myalgia. Fever was reported in 76 (19%) participants, with grade 3 fever reported in 22 (5%) participants. All fevers occurred within 2 days of immunization and resolved within 1 to 2 days. The most frequent adverse events among the group of 65 years or older were headache, fatigue and myalgia. Mild or moderate fevers of grade 1 or 2 were reported in 4% of participants. This finding suggests that the vaccine candidate is less able to cause immunologic reaction in older adults.5
However, there were two severe adverse events noted in the report: one hypotension, which was later judged by the investigator not to be vaccine-related but was related to a past history of recurrent hypotension; and one hospitalized overnight with fever but recovered within 12 hours, the fever was later judged by the investigator to be vaccine related. No participant discontinued the study due to an adverse event. Therefore, according to the scientists of the study, “the safety profile is acceptable at any age, given the seriousness of the disease the vaccine can potentially protect against, and the nature of the pandemic, especially in the elderly which is the population most vulnerable to COVID-19.”5
A single dose of Ad26.COV2.S elicited strong humoral responses in the vast majority of vaccine recipients. Specific spike protein of SARS-CoV-2 antibody titers (concentration) increased from baseline to Day 29 post vaccination in 99% of the participants in cohort 1a, and 100% of the first participants in cohort 3, with either vaccine dose levels (5x1010 or 1x1011 viral particles per vaccination).5
Ad26.COV2.S also elicited cellular immune response. Spike protein specific CD8+ T cell responses were also identified after the vaccination. On the 15th days after vaccination, 51% of cohort 1a participants (18-55 years old) administered with 5x1010 viral particles, and 64% of cohort 1a participants administered with 1x1010 viral particles, showed positive CD8+ T cell response to Spike peptide stimulation. Of participants of age 65 or above, 33% had a detectable vaccine induced CD8+ T cell response for both dose level groups.
The study is still ongoing; on 4th October, J&J announced another interim analysis from it.6 The data demonstrates that a single dose of the vaccine candidates induced a strong neutralizing antibody response in nearly all participants aged 18 years and older, and was generally well-tolerated. Immune responses were similar across the age groups studied, including older adults.
Since both dose levels showed similar immunogenicity, the company decided to use lower dose (5x1010 viral particles per vaccination) for the phase 3 clinical evaluation.
Phase 3
Once the first interim result from the phase 1/2a study was out, a phase 3 trial on the vaccine candidate (NCT04505722) evaluating a single-dose regimen on a much larger scale started in September. The phase 3 trial, also called ENSEMBLE, is expected to enrol a total of 60,000 volunteers across 3 continents: Africa, South and Central America, and the United States.7 The phase 3 study in the US experienced a temporary pause once in mid October, but resumed later after about 2 weeks.8,9
Another phase 3 study with a two-dose regimen (NCT04614948) is yet to be started later this year.10 The trials taking place in the UK will recruit a total of 6000 volunteers and are expected to finish in the first quarter of 2021.11
Comments on the project
According to the UK government, Ad26.COV2.S is the third potential vaccine to enter clinical trials in the UK. The first two are the vaccines from a US biotech company Novavax and from the University of Oxford/ AstraZeneca.11
The whole project of examining the vaccine candidate is highly transparent. Reports and Interim reports were available to the public to get the data from the pre-clinical and clinical trials studies.3,5,6 The protocol of phase 3 trials is clearly written and is also available online to the public.12 However, a serious medical event experienced by one study participant in the US, which caused the temporary pause of the phase 3 study, has not been clearly described or explained. Although they obtained consent from the Data Safety and Monitoring Board (DSMB), the US Food and Drug Administration (FDA), and the Institutional Review Boards to resume the study in the US, with no clear cause yet identified, the incident is something that the public may need to be cautious of.9
Ad26.COV2.S was developed using the technology platform, AdVac®,* which was developed by Janssen Pharmaceuticals. The platform has been used to design and develop an Ebola vaccine which was later used for 2 million doses and got approval from the European Commission. Based on the safety records for the viral vaccine using the AdVac platform, there should be no safety hazard for using AdVac as the Ad26.COV2.S backbone structure.13
This project has obtained a lot of funds to support the studies. The project is sponsored by Johnson and Johnson and funded, in part, by Biomedical Advanced Research and Development Authority (BARDA) under contract HHS0100201700018C.3,5 BARDA is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health and Human Services. Under the contract, BARDA and Johnson & Johnson together have committed to invest more than $1 billion for the candidate vaccine’s research, development, and clinical testing.2 The UK government’s Vaccine Taskforce also jointly fund Johnson & Johnson to test the safety and effectiveness of the vaccine candidate.11
Since its entry into the clinical phases, the vaccine candidate has already been a purchase target of many nations. In early October, Janssen Pharmaceutical Companies signed an Advanced Purchase agreement with the European Commission to supply 200 million doses, and an extra of up to 200 million more doses of Ad26.COV2.S, to European Union Member States, following the approval or authorization from regulators.14 In early August, Janssen Pharmaceutical Companies have also agreed with the US government to deliver 100 million doses of Ad26.COV2.S for use in the United States following approval or Emergency Use Authorization by the US Food and Drug Administration (FDA). The US government may also purchase an extra 200 million doses under a subsequent agreement.15
Johnson & Johnson has a goal to supply more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.2,15 In order to meet this goal, the company has started to invest to expand its capacity to produce the viral vaccine since March this year.2 Moreover, the company is also collaborating with Aspen Pharmacare, a South African pharmaceutical company, to commercially manufacture its COVID-19 vaccine. In addition to the use of the technology platform, AdVac®* make the production of the vaccine candidate ready to be upscaled rapidly if it is being approved. In fact, using the same platform, two million of the Ebola 2-shot vaccine regimens, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo), were produced in less than one year for the Ebola epidemic in West Africa.1,13
Introduction to the organizations and companies involved in development of the vaccine
Beth Israel Deaconess Medical Center (BIDMC) is a part of the Beth Israel Lahey Health system. It is a teaching hospital of Harvard Medical School. The Director of the Center for Virology and Vaccine Research at BIDMC is Dan Barouch, M.D., Ph.D. Dr. Barouch's team is well-known for their work on the pathogenesis and immunology of viral infections and the development of vaccine strategies for global infectious diseases.1
The collaboration between the team led by Dr. Barouch and the Janssen Pharmaceuticals have been in progress much longer than the development of a vaccine for COVID-19. The two sides started collaborating since the development and preclinical work for Zika and HIV vaccine candidates a few years ago.
Janssen Pharmaceutical Companies belongs to Johnson and Johnson (J&J). J&J has been established for more than 130 years. It has the biggest market capital among the diversified medical stock. They focus on the wide areas of medicine: cardiovascular and metabolism, immunology, infectious diseases and vaccines, neuroscience, oncology, and pulmonary hypertension.
*AdVac® is based on a specific type of adenovirus, which has been genetically modified so that it can no longer replicate in humans and cause disease. The AdVac® technology helps to accelerate the development of vaccines. The technology has been used in developing Ebola (which also utilizes its MVA-BN® technology), Zika, RSV and HIV vaccines. The Ebola vaccine has now received approval by the European Commission and has been deployed in some areas in Africa. “Vaccine Technology. Janssen Pharmaceutical website. https://www.janssen.com/infectious-diseases-and-vaccines/vaccine-technology”
References
1. Johnson & Johnson announces collaboration with the Beth Israel Deaconess Medical Center to accelerate COVID-19 vaccine development. Press release from Janssen Pharmaceutical companies. Mar 13, 2020. https://www.janssen.com/johnson-johnson-announces-collaboration-beth-israel-deaconess-medical-center-accelerate-covid-19
2. Johnson & 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. Johnson & Johnson news release, March 30, 2020. jnj.com/johnson-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
3. N.B. Mercado, R. Zahn, F. Wegmann, et al. Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques. Nature, 2020 Oct;586(7830): 583-588.
4. A study of Ad26.COV2.S in adults (COVID-19). NCT04436276. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04436276
5. J. Sadoff, M. Le Gars, G. Shukarev, et al. Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial. MedRxiv, September 25, 2020. https://doi.org/10.1101/2020.09.23.20199604
6. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson news release, Oct 4, 2020. https://www.jnj.com/johnson-johnson-posts-interim-results-from-phase-1-2a-clinical-trial-of-its-janssen-covid-19-vaccine-candidate
7. A study of Ad26.COV2.S for the prevention of SARS-CoV-2-mediated COVID-19 in adult participants (ENSEMBLE). NCT04505722. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04505722
8. Johnson & Johnson temporarily pauses all dosing in our Janssen COVID-19 vaccine candidate clinical trials. Janssen Pharmaceuticals’ press release, Oct 13, 2020. https://www.janssen.com/johnson-johnson-temporarily-pauses-all-dosing-our-janssen-covid-19-vaccine-candidate-clinical-trials
9. Johnson & Johnson prepares to resume phase 3 ENSEMBLE trial of its Janssen COVID-19 vaccine candidate in the U.S. Johnson & Johnson news release, Oct 23, 2020. https://www.jnj.com/our-company/johnson-johnson-prepares-to-resume-phase-3-ensemble-trial-of-its-janssen-covid-19-vaccine-candidate-in-the-us
10. A study of Ad26.COV2.S for the prevention of SARS-CoV-2-mediated COVID-19 in adults (ENSEMBLE 2). NCT04614948. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04614948
11. Janssen to begin COVID-19 vaccine trials in the UK. Gov.UK press release, 16 November 2020. https://www.gov.uk/government/news/janssen-to-begin-covid-19-vaccine-trials-in-the-uk
12. A randomized, double-blind, placebo-controlled phase 3 study to assess the efficacy and safety of Ad26.COV2.S for the prevention of SARS-CoV-2-mediated COVID-19 in adults aged 18 years and older. https://www.jnj.com/coronavirus/covid-19-phase-3-study-clinical-protocol.
13. Vaccine technology. Janssen Pharmaceutical Companies. https://www.janssen.com/infectious-diseases-and-vaccines/vaccine-technology
14. Johnson & Johnson Announces European Commission Approval of Agreement to Supply 200 Million Doses of Janssen’s COVID-19 Vaccine Candidate. Janssen Pharmaceuticals’ news release, Oct 8, 2020. https://www.janssen.com/johnson-johnson-announces-european-commission-approval-agreement-supply-200-million-doses-janssens
15. Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 VaccineJohnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine. Janssen Pharmaceuticals’ news release, Aug 05, 2020. https://www.jnj.com/johnson-johnson-announces-agreement-with-u-s-government-for-100-million-doses-of-investigational-covid-19-vaccine
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