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Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC
Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC
Remarks As Prepared for the Centers for Disease Control and Prevention Meeting of the Advisory Committee on Immunization Practices (ACIP)

NEW BRUNSWICK, N.J., December 16, 2021 - Remarks made by Penny Heaton, Global R&D Head of Vaccines, Janssen Pharmaceutical Companies of Johnson & Johnson:

Good afternoon. My name is Penny Heaton, and I am the Global R&D Head for Vaccines at Janssen.

Let me state at the outset that based on data, we are confident in the positive benefit-risk profile of our vaccine. It is saving lives here in the US today and on every continent around the globe.

Our vaccine is different. It is long-lasting, it offers high levels of protection, and it provides breadth of protection. Our vaccine has flexible dosing, is easy to store and transport. In many low- and middle-income countries our vaccine is the most important and sometimes only option. Even in the U.S, given its durability, it may be the preferred choice for people who can’t or won’t return for multiple vaccinations.

The safety and well-being of those who use the Johnson & Johnson vaccine continues to be our number one priority. We strongly support education and awareness of rare events such as Thrombosis with Thrombocytopenia Syndrome—or TTS. We also have several studies underway to help us identify factors that may be associated with the development of TTS and the mechanism by which it occurs.

Although rare, we recognize that the incidence of TTS associated with the Johnson & Johnson vaccine is highest in women aged 30 to 49 years and can be fatal if not treated.

TTS continues to be a rare event, but, unfortunately, cases of COVID-19 are not – in fact, they are surging in the U.S. and around the world.

As you are aware, the pandemic continues to cause high rates of mortality and morbidity, and critically ill patients are at high risk of both venous and thromboembolic complications from COVID-19. In fact, as a recent study showed, an estimated 435 cases of CVST and PVT occur per million patients with COVID-19. These events occur more commonly in females and the risk post- COVID-19 is much higher than the risk observed post- vaccination.

As COVID-19 cases continue to rise during this holiday season, there is a pressing need to protect those at highest risk. And, although progress with vaccination coverage has been remarkable, right now, in the US, fewer than 1 person in 5 is fully vaccinated and boosted. In the setting where many people do not return for a second dose or a booster, the durability of the single shot Johnson & Johnson vaccine as a primary regimen could make a crucial difference in saving lives in the U.S. and around the world.

There have been several studies of the real-world effectiveness following a single-shot of the Johnson & Johnson vaccine. On this slide I’m showing data from one of these studies, conducted by Johnson & Johnson and recently posted as a pre-print. These data are unique, demonstrating that even a single shot of the Johnson & Johnson vaccine provides durable protection against infections and hospitalizations through at least 6 months. The study also demonstrated a durable benefit across all subgroups of age, sex and comorbidity.

As we have learned about durability of protection of the Janssen COVID-19 vaccine from real-world data across multiple studies, we are seeing the benefits, in terms of cumulative deaths and hospitalizations avoided.

As shown on this next slide, we modeled benefit risk over one year assuming 75% effectiveness across different transmission intensity scenarios. These data, modelled against being unvaccinated, showed a positive benefit risk across gender and age groups. This remains important for those who can’t or won’t return for follow up vaccination.

Efficacy against severe disease matters. Durability matters.

Just a single shot of the Johnson & Johnson COVID-19 vaccine generates strong and unique immune responses and long-lasting immune memory.

These data are reflected in the immune profile of our vaccine. As shown in this slide, antibody titers peak later than the mRNA vaccines, they persist, and they mature over time increasing in breadth. There is a 12-fold rise in antibody titer when a booster is given 6 months after the primary vaccination. We are confident in the durability of protection. Further, as shown in the bottom right of the slide, our COVID-19 vaccine has induced broad antibody responses against variants to date in clinical studies.

These data confirm the immune profile of our vaccine, both humoral and cellular, is unique. Antibody titers peak later than the mRNA vaccines, they persist, and they mature over time increasing in breadth, as demonstrated in recent publications, including The New England Journal of Medicine. The implications of the Janssen Vaccine durability data, in contrast to published data on the mRNA vaccines, have not yet been fully evaluated and discussed today by this committee in terms of their potential impact on effectiveness. And this may be CRUCIAL in the setting we are in here in the U.S - where less than 20% of the US population are vaccinated and boosted.

We note that the committee described the lower effectiveness in comparison to the mRNA vaccines. We have seen even higher efficacy post-booster in global clinical trials. The efficacy after a Johnson & Johnson booster dose was 94 percent protection against symptomatic COVID-19 in the US and 100 percent protection against severe/critical COVID-19.

We have a global vaccine, and the world is depending on us. We are one of the largest suppliers of COVID-19 vaccines to the African Union and COVAX, which enables equitable distribution of COVID-19 vaccines to the 190 participating countries, including 92 low- and lower-middle-income countries. We have already shipped hundreds of millions of doses of vaccine and we are committed to shipping hundreds of millions more in 2022.

The Johnson & Johnson COVID-19 vaccine is a life-saving tool for individuals in high-risk populations and for those where follow-up for multiple vaccinations may be challenging or available healthcare resources are low.

This week in the US, we have crossed yet another grim milestone in the history of this pandemic. More than 800,000 people in the U.S., have lost their lives to COVID-19. I have lost loved ones during the pandemic, and I am sure many of you here today have too.

We must save individuals here in the US and facilitate equitable access both here and around the world. In the setting where many people do not return for a second dose or a booster, the durability of the single shot Johnson & Johnson vaccine as a primary regimen could make a crucial difference in saving lives in the U.S. and around the globe.

Thank you.

Slides presented at ACIP

###

Cautions Concerning Forward-Looking Statements
This statement contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development, manufacture and distribution of the Johnson & Johnson COVID-19 vaccine. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2021, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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