Safety and immunogenicity data on the Johnson & Johnson vaccine technology was gathered during IMI EBOVAC clinical studies
A single-dose COVID-19 vaccine developed by the Janssen Pharmaceutical Companies of Johnson & Johnson was today recommended for conditional marketing authorisation by the European Medicines Agency (EMA), to prevent COVID-19 in individuals 18 years of age and older. This vaccine leverages the company's unique and proprietary AdVac® technology.
Through the EBOVAC projects, IMI funded Phase 1, 2 and 3 clinical studies that generated data on the safety of the AdVac® vaccine platform, providing evidence upon which the European regulator based today’s decision. The vaccine received Emergency Use Authorization from the U.S. Food and Drug Administration in February 2021.
According to a representative from Johnson & Johnson: “Studies specifically supported by EBOVAC played an important role supporting our successful licensure application for the Ebola vaccine with the European Medicines Agency. Additionally, they gave the company confidence to use the AdVac® platform to initiate the development of COVID-19 vaccine.”
The authorisation of the vaccine, yet another COVID-19 vaccine based on novel technology, offers a good example of the enabling power of IMI projects. Vaccines based on brand new delivery systems or manufacturing technologies require collaboration, and developing, testing, and manufacturing of these technologies, along with generating data on safety and protection, are areas in which the pharma industry has been keen to collaborate.
Like the Ebola vaccine regimen, the Johnson & Johnson COVID-19 vaccine is compatible with standard storage and distribution channels, which makes it easy to transport to and deploy in remote areas. It is the latest COVID-19 vaccine to receive acceptance to be administered in the EU.
About AdVac® and the IMI EBOVAC projects
IMI launched 12 Ebola research projects starting in 2014-2015 when an unprecedented outbreak ravaged parts of western Africa. The EBOVAC and VSV-EBOVAC projects involved studies on the safety, immunogenicity and durability of two candidate vaccines that showed the most promise in preventing infection; Merck’s Ervebo® (rVSV∆G-ZEBOV-GP) vaccine and J&J/Janssen’s combination regimen, Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo).
Johnson & Johnson‘s COVID-19 vaccine program leverages the same proprietary technology used to develop the Zabdeno® (Ad26.ZEBOV) component of the Ebola vaccine regimen, which was authorised for use by the European Commission in 2020.
To date, nearly 200,000 people have received the AdVac®-based Zabdeno® component of Janssen’s Ebola vaccine regimen in clinical studies and vaccination initiatives. These studies and initiatives indicate that the vaccine regimen is generally well-tolerated and induces immune responses to the Zaire ebolavirus species.
“The EBOVAC studies have made an important contribution to our global safety database for the platform technology. The findings on safety from these studies are consistent with data collected from trials examining the safety and efficacy of other vaccine candidates that leverage Janssen’s AdVac® technology,” according to the representative from Johnson & Johnson.
“It is also worth noting that the IMI EBODAC consortium supported the implementation of the UMURINZI vaccination program in Rwanda, which has vaccinated more than 150,000 people with the its Ebola vaccine regimen. Johnson & Johnson’s Global Public Health organisation is helping to support local health system capacity for UMURINZI through its work with EBODAC. Specifically, innovative iris scanning technology is helping to track uptake of the company’s Ebola vaccine regimen – including completion rates for the vaccine regimen’s second dose.”
The technology has also been leveraged in the development of preventive vaccine candidates for RSV, HIV and Zika. “Our investigational preventive vaccine for HIV-1 is currently being evaluated in two large-scale efficacy clinical trials, Imbokodo and Mosaico, which are being pursued across 13 countries on four continents, including Africa, Europe, and North and South America. In addition, Janssen’s COVID-19 vaccine program leverages Janssen’s AdVac® technology,” said the Johnson & Johnson representative.