Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine

Submission includes data showing a booster increased protection to 94 percent against moderate to severe/critical COVID-19 in the U.S.

Substantial increase in immune response when booster was given at six months

The Company’s single-shot vaccine has demonstrated strong and long-lasting protection and durable immune responses in clinical studies

NEW BRUNSWICK, NJ, USA I October 05, 2021 I Johnson & Johnson (NYSE: JNJ) (the Company) announced it has submitted data to the U.S. Food and Drug Administration (FDA) to support use of a booster shot of the Johnson & Johnson COVID-19 vaccine in individuals 18 years of age and older.

The submission includes recent results from the Phase 3 ENSEMBLE 2 study that found a booster of the Johnson & Johnson COVID-19 vaccine given 56 days after the primary dose provided 94 percent protection against symptomatic (moderate to severe/critical) COVID-19 in the U.S. (CI, 58%-100%) and 100 percent protection (CI, 33%-100%) against severe/critical COVID-19, at least 14 days post-booster vaccination.

Also part of the submission is Phase 1/2a data showing that when a booster of the Johnson & Johnson COVID-19 vaccine was given six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster. The vaccine, when given as a booster or primary dose, was generally well-tolerated.

“Our clinical program has found that a booster of our COVID-19 vaccine increases levels of protection for those who have received our single-shot vaccine to 94 percent. We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “At the same time, we continue to recognize that a single-shot COVID-19 vaccine that provides strong and long-lasting protection remains a crucial component to vaccinating the global population.”

Last month, the Company released data reinforcing the strong and long-lasting protection of its COVID-19 vaccine. The largest real-world evidence study for a COVID-19 vaccine reported to date in the U.S. demonstrated stable vaccine effectiveness of 79 percent (CI, 77%-80%) for COVID-19-related infections and 81 percent (CI, 79%-84%) for COVID-19-related hospitalizations. There was no evidence of reduced effectiveness over the study duration conducted from March to July 31, 2021. Comparable vaccine effectiveness was demonstrated when the study was extended to August 31, 2021, including when the Delta variant became dominant in the U.S. Sequencing data were not available for analysis.

These data were consistent with the Phase 3 ENSEMBLE trial, where strong protection against severe/critical disease and death was observed at least 28 days post-final vaccination.

Interim results from a Phase 1/2a sub-study published in the New England Journal of Medicinein July demonstrated that both humoral (antibody) and cellular (T-cell) immune responses generated by the Johnson & Johnson single-shot COVID-19 vaccine were strong and stable through eight months after immunization, the length of time evaluated in the study. These peer-reviewed data provide further and deeper insights into the durable humoral and cellular immune responses elicited by the single-shot Johnson & Johnson COVID-19 vaccine, thus offering potentially a dual mechanism of protection against COVID-19 disease, including against disease caused by the Delta variant (B.1.617.2) and other SARS-CoV-2 variants of concern. The cellular immune response induced by the Company’s AdVac® platform is strong and plays a role in both protection and durability.

The Company plans to submit the data to other regulators, the World Health Organization (WHO) and National Immunization Technical Advisory Groups (NITAGs) worldwide to inform decision-making on local vaccine administration strategies, as needed.

The Johnson & Johnson single-shot COVID-19 vaccine, developed by its Janssen Pharmaceutical Companies of Johnson & Johnson, received an EUA in the United States on February 27, 2021 and Conditional Marketing Authorization (CMA) by the European Commission on March 11. The World Health Organization (WHO) issued Emergency Use Listing on March 12, and the Company received an interim recommendation by the Strategic Advisory Group of Experts (SAGE) on Immunization for the WHO on March 17. Many more authorizations have been granted in countries worldwide, and regulatory submissions are ongoing.

For more information on the Company’s multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/covid-19.

Authorized Use
The Janssen COVID-19 vaccine is authorized for use in the U.S. under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including full EUA Prescribing Information available at www.JanssenCOVID19Vaccine.com/EUA-factsheet

About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at @JanssenGlobal.

SOURCE: Johnson & Johnson

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