Johnson & Johnson (J&J) has signed an advance purchase agreement with the European Commission (EC) for 200 million doses of its COVID-19 vaccine following regulatory approval.
The contract was agreed following the conclusion of exploratory discussions with the EC and enables EU member states to exercise an option to secure up to 200 million additional doses after the initial supply.
J&J is in talks with other national governments and global organisations for the supply of its COVID-19 vaccine, although the company did not disclose which stakeholders it was in ongoing discussions with.
So far, the EU has reached respective agreements with AstraZeneca/Oxford University and Sanofi/GlaxoSmithKline for their vaccines. AZ is set to provide 400 million doses of its vaccine candidate, AZD1222, while Sanofi/GSK will provide up to 300 million doses.
Last month, J&J posted the first promising phase 1/2a results for its COVID-19 vaccine candidate, JNJ-78436735/Ad26.COV2.S. In an interim analysis, a single dose of the vaccine produced a strong immune response against the novel coronavirus, SARS-CoV-2, which causes COVID-19.
The data, published on the pre-print server medRxiv, showed that 98% of participants had neutralising antibodies against SARS-CoV-2 29 days after vaccination. The levels of neutralising antibodies in the vaccine group were comparable to people who had recovered from a COVID-19 infection.
Following the positive results, J&J launched a large-scale phase 3 trial of the COVID-19 vaccine, with plans to enrol up to 60,000 volunteers across three continents. The study will investigate the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.
J&J’s candidate uses the company’s AdVac technology platform, which was also used to develop and manufacture its existing Ebola vaccine, as well as construct its other investigational candidates for Zika, RSV and HIV.
The phase 3 ENSEMBLE trial was initiated in collaboration with the US Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) and the US National Institute of Allergy and Infectious Diseases (NIAID).
In a separate principle agreement, J&J will also collaborate with the UK government on a phase 3 clinical trial in multiple countries to explore a two-dose regimen of its COVID-19 vaccine candidate.
Also as part of the UK’s principle agreement, J&J will supply 30 million doses of its vaccines, which are set to be supplied on a not-for-profit basis during the emergency pandemic.
J&J has also reached an agreement with the US government for 100 million doses of its vaccine candidate, with the US government committing $1bn for the initial supply.