Candice Long, President – US Infectious Diseases & Vaccines,

JANSSEN PHARMACEUTICALS

"In vaccines, we are progressing late-stage programs of break-through vaccines against diseases where vaccines are not currently available, such as RSV and multidrug resistant bacterial infections, including ExPEC and Staphylococcus aureus."

What are the most important initiatives that have been undertaken by Janssen’s infectious diseases & vaccines segment within the past year?

We have been focused on multiple areas in the vaccine space, including RSV, Covid-19, and antimicrobial resistance.

We see an incredible opportunity in the respiratory infection space, including solutions for both Covid-19 and respiratory syncytial virus, or RSV, which affects over 64 million people worldwide per year, yet no vaccines or antiviral treatments currently exist. For our Covid-19 vaccine, we implemented a development plan that studied our vaccine in diverse populations in Asia, Africa, Latin America, the US and Europe. We also made a commitment to make up to 900 million vaccine doses available to the African Union and COVAX Facility, combined, through 2022.

Another area of focus for us is antimicrobial resistance, or AMR, which is one of the top ten threats to global health and is quickly becoming one of the leading infectious disease-related causes of death worldwide. Our investigational extra-intestinal pathogenic E. Coli vaccine candidate (ExPEC9V) is currently in Phase 3 development for the prevention of invasive ExPEC disease.

Finally, we are working on developing a functional cure for chronic hepatitis B as well as focusing on steps that can be taken to mitigate the stigma associated with the disease. We are investigating multiple promising modalities, including combining antivirals with immunomodulators to transform how infectious disease pathogens such as the hepatitis B virus (HBV) are managed by achieving high rates of functional cure.

We developed a long-acting injectable HIV treatment regimen in partnership with ViiV Healthcare to reduce the frequency of treatment. We are currently working to expand our partnership with ViiV Healthcare to explore our long-acting rilpivirine and cabotegravir regimen as both a monthly self-administered regimen and an ultra-long-acting regimen, administered every three months or more.

For influenza, we believe that pre-exposure prophylaxis has the potential to revolutionize the prevention of seasonal respiratory viral infections in the most vulnerable populations.

In antimicrobial resistance, we are targeting multidrug resistant bacterial infections through a variety of approaches, including via CRISPR-Cas3 engineered bacteriophage cocktails, aiming for first-in-class precision medicine in the fight against AMR.

In vaccines, we are progressing late-stage programs of break-through vaccines against diseases where vaccines are not currently available, such as RSV and multidrug resistant bacterial infections, including ExPEC.

How does Janssen leverage innovative technology for vaccine R&D?

Our Covid-19 vaccine program leverages Janssen’s AdVac technology, which is the same technology used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and to construct both our RSV and HIV vaccine candidates.

Our AdVac technology is based on the development and production of adenovirus vectors, or gene carriers. Adenovirus vectors are genetically altered forms of an adenovirus that lack the DNA needed to replicate, so the vaccine cannot cause a cold. In the case of the Covid-19 vaccine, the immune system of someone who receives our vaccine recognizes the Covid spike protein as foreign once it enters their cells, producing antibodies and activating T cells to target it. This allows the individual’s immune system to recognize the SARS-CoV-2 spike protein and be ready to defend against it.

Could you provide insight into Janssen’s recent agreement with Aspen SA Operations and the impact you anticipate this having for Covid-19 relief efforts in Africa?

The agreement enables the first Covid-19 vaccine to be manufactured and made available by an African company for people living in Africa. Currently only about 12 percent of people in Africa are fully vaccinated, well below the WHO’s targets.

What is your prediction for the long-term impacts that Covid-19 will have on public perception of infectious diseases and the importance of vaccines?

Covid-19 gave us a close look at our capacity for preparedness and rapid response when an infectious disease outbreak becomes a pandemic. It illuminated the gaps in public understanding about the development and safety of vaccines. We know vaccines can lead to higher quality, longer lives, but wide acceptance and uptake, in addition to an adequate supply chain and access, need to occur for vaccines to be effective for the global community.