J&J’s Janssen Accelerates Planned Launch of COVID-19 Vaccine Trial
The company Johnson & Johnson (J&J) stated that it’s Janssen Pharmaceutical Companies will accelerate the launch of its planned phase I/IIa clinical trial analyzing its lead COVID-19 vaccine candidate by 2 months. The first-in-human research of Ad26.COV2-S, recombinant, will begin in the 2nd half of July, which was scheduled in September.
Paul Stoffels, MD, vice chairman of the executive committee and CSO at J&J said, “we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, based upon the strength of the preclinical information we have seen up until now and interactions with the regulatory authorities”. “Our aim is to ensure we can deliver a vaccine to the entire people of the world and protect them from COVID-19”.
The Phase I/IIa study – double-blind, randomized, placebo-controlled, will certainly be designed to evaluate the safety, response to the vaccine, as well as immunogenicity of Ad26.COV2-S, recombinant, in 11,045 healthy adults aged 18-55 years, as well as adults of 65 years and also older. The research will be carried out in the U. S and Belgium.
Additionally, J&J’s Janssen revealed, it is in talks with the NIH’s National Institutes
of Allergy and Infectious Diseases to accelerate the launch of its planned COVID-19 vaccine’s Phase III trial, based on the results of Phase I/IIa study as well as authorization from regulators.Ad26.COV2-S, recombinant, emerged from vaccine constructs developed as well as tested by J&J with Beth Israel Deaconess Medical Center, part of Harvard Medical School, using Janssen’s AdVac ® and PER.C6 ® vaccine technology systems, designed for speeding up vaccine development.
AdVac is based upon the growth as well as the production of adenovirus vectors (gene carriers), and also can be used along with Janssen’s PER.C6 technology to develop recombinant vaccines against life-threatening contagious diseases.
“Front runner” candidate
Among 18 “front runner” candidates, amongst other 230+ COVID-19 therapeutics outlined in GEN’s updated “COVID-19 Drug & Vaccine Candidate Tracker” Ad26.COV2-S, recombinant, is one of the candidates.
Initially, J&J claimed that it intended to launch its Phase I trial assessing its COVID-19 vaccine in September.
Acceleration of Janssen’s clinical trial timetable comes virtually 2 months after Stoffels provided upbeat information on Janssen’s COVID-19 vaccine program to experts on J&J’s quarterly earnings conference call.
Stoffels said, “In humans, the Adeno26 viral vector system induces potent and resilient humoral and cellular immune responses. Additionally, based upon the immune reactions observed throughout the programs, this method has really reduced to no threat to respiratory disease improvement”.
Stoffels included, Janssen’s PER.C6 cell line, developed to provide a high-yielding vaccine manufacturing system, “is scalable as well as completely industrialized giving us the capacity to make thousands of countless vaccines annually”.
Stoffels stated, while the capacity of J&J’s Leiden-based vaccines release center is as high as 300 million dosages annually, the firm intends to generate around 600-900 million doses of the vaccine by the end of the first quarter of next year.
Stoffels claimed J&J has committed to the objective of providing more than 1 billion dosages worldwide via 2021’s program, “provided the vaccine is risk-free and efficient”.
Stoffels added, “At the same time, we are proceeding our initiatives to build crucial international partnerships and invest in our vaccine manufacturing innovation and production abilities”.
$456M BARDA – Biomedical Advanced Research and Development Authority commitment
Amongst the most crucial collaborations concentrated on speeding up development as well as manufacturing of its vaccine is the one Janssen has formed with the BARDA. BARDA has committed more than $456.2 million towards supporting Ad26.COV2-S, recombinant, from development through licensure, as per its COVID-19 Medical Countermeasure Portfolio website.
John R. Mascola, MD, Director of NIAID’s Dale and Betty Bumpers Vaccine Research Center (VRC) said, Ad26.COV2-S, recombinant, is one of 3 COVID-19 vaccine candidates that will be fast-tracked towards crucial tests starting this summer. Moderna’s mRNA-1273 and AZD1222, being developed by AstraZeneca, the College of Oxford, and partners are other 2 candidates.
The mRNA-1273 and AZD1222 have signed up with J&J/ Janssen’s vaccine candidate among “front runners” on GEN’s COVID-19 Tracker, which provides roughly 100 vaccines candidates.
Anthony S. Fauci, MD, NIAID director while addressing BIO Digital, said “There’s going to be more than 1 winner in the vaccine field since we’re going to need billions and billions of vaccine dosages for the entire world”. BIO Digital is the online 2020 BIOGRAPHY International Convention being held this week by the Biotechnology Innovation Organization. “I’m almost certain that we’re going to have numerous candidates that make it to the goal line, obtain approval, as well as get used extensively”.
Anthony S. Fauci informed participants that he as well as NIAID staffers began work on the vaccine just one day after Chinese researchers uploaded the SARS-CoV-2 virus sequence onto a public database – on January 11, 2020.
Fauci recalled, “On January 11, I called a conference at the Vaccine Research Center of my staff and said ‘We have to proceed on this to start developing a vaccine‘”. “Currently we have something that certainly ends up being my worst problem, something that’s highly transmissible in a period – it has ravaged the globe, in a period of 4 months”.
