Johnson & Johnson to start human trial of COVID-19 vaccine by September

US-based global healthcare company Johnson & Johnson on Monday announced the selection of a lead COVID-19 vaccine candidate, adding that it expects to initiate testing of the vaccine in humans at the latest by September this year.

The first batches of a COVID-19 vaccine could be available for emergency use authorisation in early 2021, the company said.

Through a landmark new partnership, Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, and Johnson & Johnson together have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing.

Johnson & Johnson 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 Johnson & Johnson have provided additional funding that will enable expansion of their ongoing work to identify potential antiviral treatments against the novel coronavirus.

As part of its commitment, Johnson & Johnson is also expanding the company's 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 one billion doses of a safe and effective vaccine globally, the company said.

"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," Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson, said in a statement.

"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," Gorsky added.

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 Pharmaceutical Companies of Johnson & Johnson, 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 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.