J&J expects to do human trials on potential COVID-19 vaccine this fall with hopes of early 2021 availability

Johnson & Johnson announced Monday that it has selected a lead COVID-19 vaccine candidate, that it hopes to be doing human clinical trials by September, at the latest, and — if all goes well — that it will have the first batches available for emergency use in early 2021.

J&J, in a release, said it has been working on finding a vaccine since January.

J&J Chair and CEO Alex Gorsky said the New Brunswick-based company announced the news as part of a number of updates for the company — including increased partnerships with government health agencies and increased manufacturing.

“The world is facing an urgent public health crisis, and we are committed to doing our part to make a COVID-19 vaccine available and affordable globally as quickly as possible,” he said in a release. “As the world’s largest health care company, we feel a deep responsibility to improve the health of people around the world every day.

“Johnson & Johnson is well positioned through our combination of scientific expertise, operational scale and financial strength to bring our resources in collaboration with others to accelerate the fight against this pandemic.”

The news comes at an interesting time in the race to find a vaccine. Cambridge, Massacusetts-based Moderna, which found a prospective vaccine in several hours and started clinical trials in a record 63 days, announced Monday it putting the trial on pause because social distancing has made it hard to get participants enrolled.

J&J, meanwhile, is moving forward with vigor. Gorsky said the company is expanding its global manufacturing capacity, including through the establishment of new U.S. vaccine manufacturing capabilities and scaling up capacity in other countries.

The additional capacity will assist in the rapid production of a vaccine and will enable the supply of more than 1 billion doses of a vaccine globally, J&J said. It plans to begin production imminently and is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.

J&J also announced Monday that it has undertaken a significant expansion of the existing partnership between the Janssen Pharmaceutical Cos. and the Biomedical Advanced Research and Development Authority.

BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, and Johnson & Johnson together have committed more than $1 billion of investment to cofund vaccine research, development and clinical testing.

Johnson & Johnson also said it will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts. Separately, BARDA and J&J have provided additional funding that will enable expansion of their ongoing work to identify potential antiviral treatments against the novel coronavirus.

Paul Stoffels, vice chairman of the executive committee and chief scientific officer of Johnson & Johnson, said the company greatly value the U.S. government’s confidence and support for its R&D efforts.

“Johnson & Johnson’s global team of experts has ramped up our research and development processes to unprecedented levels, and our teams are working tirelessly alongside BARDA, scientific partners, and global health authorities,” he said in a release.

“We are very pleased to have identified a lead vaccine candidate from the constructs we have been working on since January. We are moving on an accelerated timeline toward Phase 1 human clinical trials at the latest by September 2020 and, supported by the global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in early 2021.”

The following was provided by J&J:

Johnson & Johnson began efforts in January 2020, as soon as the novel coronavirus (COVID-19) sequence became available, to research potential vaccine candidates. Research teams at Janssen, in collaboration with Beth Israel Deaconess Medical Center, part of Harvard Medical School, constructed and tested multiple vaccine candidates using the Janssen AdVac technology.Through collaborations with scientists at multiple academic institutions, the vaccine constructs were then tested to identify those with the most promise in producing an immune response in preclinical testing.Based on this work, Johnson & Johnson has identified a lead COVID-19 vaccine candidate (with two backups), 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 five to seven years, before a candidate is even considered for approval.For more than 20 years, Johnson & Johnson has invested billions of dollars in antivirals and vaccine capabilities. The COVID-19 vaccine program is leveraging Janssen’s proven AdVac and PER.C6 technologies that provide the ability to rapidly develop new vaccine candidates and upscale production of the optimal vaccine candidate. The same technology was used to develop and manufacture the company’s Ebola vaccine and construct our Zika, RSV and HIV vaccine candidates, which are in Phase 2 or Phase 3 clinical development stages.

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