Johnson & Johnson has reached an agreement with the US government for 100 million doses of its investigational COVID-19 vaccine.
Under the terms of the deal, the US’ Biomedical Advanced Research and Development Authority (BARDA) and the US Department of Defense are committing $1bn for the first 100 million doses. The US government also has the option to purchase an additional 200 million doses under a subsequent agreement.
J&J’s Ad26.COV2.S vaccine recently demonstrated promising pre-clinical results in initial animal studies, with the vaccine inducing a robust immune response in non-human primates and successfully preventing subsequent infection. The vaccine also provided complete or near-complete protection from the SARS-CoV-2 virus, which causes COVID-19.
The pharma giant has already initiated a phase 1/2a human clinical trial of the vaccine in the US and Belgium, which is evaluating both one- and two-dose regimens of Ad26.COV2.S in over 1,000 healthy adults aged 18 to 55 years, as well as in adults aged 65 and over.
If the vaccine proves effective in a large cohort of participants, J&J hopes to start a phase 3 trial of a single dose versus placebo in September along with a parallel phase 3 study of a two-dose regimen versus placebo.
“J&J’s global team of experts has worked tirelessly alongside BARDA and scientific partners to pursue a SARS-CoV-2 vaccine that can help to stop the spread of COVID-19,” said Paul Stoffels, vice chairman of the executive committee and chief scientific officer at J&J.
“We greatly appreciate the US government’s confidence in, and support for, our R&D platform and efforts and the scalability of our vaccine technology. We are scaling up production in the US and worldwide to deliver a SARS-CoV-2 vaccine for emergency use,” he added.
The US has already signed a number of agreements with a range of companies currently developing COVID-19 vaccines. This includes a deal with Sanofi/GlaxoSmithKline for 100 million doses, as well as a $1.95bn deal for 100 million doses of Pfizer/BioNTech’s candidate and similar deals with Novavax and AstraZeneca/Oxford University.
J&J has committed to providing its vaccine on a not-for-profit basis, whereas some of its competitors are seeking to recoup on their investments by pricing their candidates for profit.
That includes vaccine frontrunner Moderna, which said in a recent quarterly earnings call that it has signed agreements for its candidate at between $32-$37 per dose, with two doses required for a full course.
Meanwhile, Pfizer/BioNTech has priced its vaccine at $19.50 per shot – $39 per course – following its $1.95bn supply deal with the US government earlier this month. In contrast, AZ/Oxford have priced their candidate at a cost price of just €2.5 ($2.96) per unit.