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J&J - Janssen COVID-19 Vaccine Found Very Effective

September 21, 2021 • 3:45 pm CDT
(Precision Vaccinations News)

New Jersey-based Johnson & Johnson announced new data today from a non-peer-reviewed phase 3 study reinforcing the strong and long-lasting protection of its Janssen COVID-19 vaccine. Recent data also showed that protection against COVID-19 increases when a booster 2nd shot is administered.

Moreover, the safety profile of the Janssen COVID-19 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, in a press release.

“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.”

The Company has provided available data to the U.S. FDA. In addition, it plans to submit the data to other regulators, the World Health Organization, and National Immunization Technical Advisory Groups worldwide to inform decision-making on local vaccine administration strategies, as needed.

Additionally, in the largest real-world evidence Vaccine Effectiveness (VE) study of participants receiving the Johnson & Johnson single-shot Janssen COVID-19 vaccine in the USA to date, the Janssen R&D Data Science team, Harvard University, and Aetion utilized the HealthVerity database to compare approximately 390,000 people who received the Company’s single-shot 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.

In the real-world data, the Johnson & Johnson single-shot COVID-19 vaccine showed a VE of 81% (CI, 79%-84%) for COVID-19-related hospitalizations and an effectiveness of 79% (CI, 77%-80%) for COVID-19-related infections. The uncorrected VE was 69% (CI, 67%-71%) for COVID-19-related infections; VE of 73% (CI, 69%-76%) for COVID-19 hospitalizations.

The Johnson & Johnson single-shot COVID-19 vaccine showed VE against COVID-19-related hospitalizations at 86% (CI, 83%-89%) for participants younger than 60 years and 78% (CI, 74%-81%) for those 60 years and older.

VE against COVID-19 infections was 81% (CI, 79%-82%) for people younger than 60 years and 75% (CI, 73%-78%) for those 60 years and older.

These results are consistent with what was observed in the ENSEMBLE study, said the Company.

The Janssen COVID-19 vaccine is authorized for use in the U.S. under an Emergency Use Authorization for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

Learn more at www.jnj.com and www.janssen.com.

Medical Review by

Our Trust Standards: Medical Advisory Committee

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