Ad26.COV2-S SARS-CoV-2 Vaccine Description
The Johnson and Johnson (J&J) and Janssen Pharmaceutical research teams, in collaboration with Beth Israel Deaconess Medical Center, part of Harvard Medical School, constructed and tested multiple vaccine candidates using the Janssen AdVac® technology, and have selected its lead vaccine candidate Ad26.COV2-S, recombinant for prevention of coronavirus infection.
This vaccine 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.
Initially scheduled for human clinical studies of its lead vaccine candidate by September 2020, the trial is now expected to commence in the second half of July.
On June 10, 2020, J&J announced the Phase 1/2a study will evaluate the safety, reactogenicity (response to vaccination), and immunogenicity (immune response) of the investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant in 1,045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. The study will take place in the USA and Belgium.
Additionally, J&J is in discussions with the National Institutes of Allergy and Infectious Diseases with the objective to start the Phase 3 clinical trial ahead of its original schedule, pending the outcome of Phase 1 studies and approval of regulators.
The Company 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, it continues to increase manufacturing capacity and is in active discussions with global partners to ensure worldwide access. The Company committed to the goal of supplying more than 1 billion doses globally through the course of 2021, provided the vaccine is safe and effective.
For more information on Johnson & Johnson’s approach to combatting the pandemic, visit J&J.com. Learn more at www.janssen.com/emea.
Ad26.COV2-S SARS-CoV-2 Vaccine Indication
Janssen's vaccine candidate 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.
Ad26.COV2-S SARS-CoV-2 Vaccine News
- June 10, 2020 - Johnson & Johnson today that through its Janssen Pharmaceutical Companies (Janssen) it has accelerated the initiation of 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 will accelerate the availability of manufacturing capacity 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 the dedicated production of Johnson & Johnson’s investigational vaccine candidate.
- April 23, 2020 - Emergent BioSolutions Inc. announced an agreement whereby Emergent will deploy its contract development and manufacturing services to support the manufacturing of 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 is aiming 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 a number of different research stages, spanning 5 to 7 years, before a candidate is even considered for approval.
Ad26.COV2-S SARS-CoV-2 Vaccine Clinical Trials
The randomized, double-blind, placebo-controlled Phase 1/2a study will evaluate the safety, reactogenicity (response to vaccination), and immunogenicity (immune response) of the investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant in 1045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. The study will take place in the U.S. and Belgium.