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    Tuesday, September 21, 2021

    COVID-19 Vaccine: Johnson & Johnson Reveals Real-World Evidence, Phase 3 Data Confirming Strong, Long-Lasting Protection of Single-Shot

    Johnson & Johnson today announced new data reinforcing the strong and long-lasting protection of its COVID-19 vaccine. New data also showed that protection against COVID-19 increases when a booster shot of the Johnson & Johnson vaccine is administered. The safety profile of the vaccine remained consistent and was generally well-tolerated when administered as a booster.

    "Our large real-world evidence and Phase 3 studies confirm that the single-shot Johnson & Johnson vaccine provides strong and long-lasting protection against COVID-19-related hospitalizations. Additionally, our Phase 3 trial data further confirm protection against COVID-19-related death," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "Our single-shot vaccine generates strong immune responses and long-lasting immune memory. And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the strength of protection against COVID-19 further increases."

    "It is critical to prioritize protecting as many people as possible against hospitalization and death given the continued spread of COVID-19. A single-shot COVID-19 vaccine that is easy to use, distribute and administer, and that provides strong and long-lasting protection is crucial to vaccinating the global population," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson. "At the same time, we now have generated evidence that a booster shot further increases protection against COVID-19 and is expected to extend the duration of protection significantly."

    The Company has provided available data to the U.S. Food and Drug Administration (FDA) and 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 data are summarized below:

    Johnson & Johnson single-shot vaccine showed strong and long-lasting protection in the real world.

    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, including when the Delta variant became dominant in the U.S. Sequencing data were not available for analysis. The study included 390,000 people who received the Johnson & Johnson COVID-19 vaccine versus approximately 1.52 million unvaccinated people matched on age, sex, time, three-digit zip code, and comorbidities and predictors for COVID-19 infection severity conducted from March to late July 2021.

    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:

    • 75 percent overall efficacy (CI, 65%-82%) against severe/critical COVID-19, across all age cohorts and all countries included in the study.
    • 74 percent efficacy in the U.S. against severe/critical COVID-19 (CI, 39%-91%); 89 percent against hospitalization (CI, 24%-100%); 83 percent against COVID-19-related death (CI, 41%-97%).

    Booster shot at two months provided 94 percent protection against COVID-19 in the U.S.

    The Phase 3 ENSEMBLE 2 study showed that another shot of the Johnson & Johnson COVID-19 vaccine given 56 days after the first provided:

    • 100 percent protection (CI, 33%-100%) against severe/critical COVID-19 – at least 14 days post-final vaccination.
    • 75 percent protection against symptomatic (moderate to severe/critical) COVID-19 globally (CI, 55%-87%).
    • 94 percent protection against symptomatic (moderate to severe/critical) COVID-19 in the U.S. (CI, 58%-100%).

    When a booster of the Johnson & Johnson COVID-19 vaccine was given two months after the first shot, antibody levels rose to four to six times higher than observed after the single shot.

    Booster shot at six months provided 12-fold increase in antibodies

    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. All rises were irrespective of age.

    The Johnson & Johnson single-shot COVID-19 vaccine, developed by its Janssen Pharmaceutical Companies of Johnson & Johnson, received an Emergency Use Authorization (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.

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