On Sept. 23, 2020, Johnson & Johnson announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial followed positive interim results from the Company’s Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development. ENSEMBLE planned to enroll up to 60,000 volunteers across three continents to study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.

Johnson & Johnson has continued the scaling up of its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year. The Company is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use and anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective.

Johnson & Johnson will develop and test its COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific principles. The Company is committed to transparency and sharing information related to the Phase 3 ENSEMBLE study – including the study protocol.

The Janssen COVID-19 vaccine candidate leverages the Company’s AdVac^® technology platform, which was also used to develop and manufacture Janssen’s European Commission approved Ebola vaccine and construct its Zika, RSV, and HIV vaccine candidates. Janssen’s AdVac^® technology platform has been used to vaccinate more than 100,000 people to date across Janssen’s investigational vaccine programs.

With Janssen’s AdVac^® technology, the vaccine, if successful, is estimated at launch to remain stable for two years at -20 °C and at least three months at 2-8° C. This makes the vaccine candidate compatible with standard vaccine distribution channels and would not require new infrastructure to get it to the people who need it.