Real-World Evidence Shows Strong Protection from COVID-19 with J&J Vaccine and Booster

Johnson & Johnson (J&J) announced new data that reinforced the long-lasting protection of the company’s COVID-19 vaccine in a Sept. 21, 2021, press release. Moreover, this data showed increased protection against COVID-19 following a booster shot of the Johnson & Johnson vaccine. The safety profile of the vaccine remained consistent and was generally well-tolerated when administered as a booster.

The real-world evidence study for a COVID-19 vaccine demonstrated stable vaccine effectiveness of 79% for COVID-19-related infections and 81% 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 US.

Included in the study were 390,000 people who received the J&J COVID-19 vaccine versus approximately 1.52 million unvaccinated people, who were matched on age, sex, time, three-digit zip code, and comorbidities and predictors for COVID-19 infection severity. The study was conducted from March to late July 2021. The data was consistent with the Phase III ENSEMBLE trial.

In the Phase III ENSEMBLE 2 study, another J&J COVID-19 vaccine (booster) given at 56 days following the first shot provided:

• 100% protection against severe/critical COVID-19 (at least 14 days post-final vaccination)

• 75% protection against symptomatic (moderate to severe/critical) COVID-19 globally and 94% in the United States

Additionally, when a J&J booster was given two months after the first shot, antibody levels were four to six times higher than observed after the single shot.

“Our large real-world evidence and Phase III studies confirm that the single-shot Johnson & Johnson vaccine provides strong and long-lasting protection against COVID-19-related hospitalizations. Additionally, our Phase III trial data further confirm protection against COVID-19-related death,” said Mathai Mammen, global head, Janssen research and development, J&J, in the 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.”

“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, vice chairman of the executive committee and chief scientific officer, J&J, in the press release. “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.”

Source: Johnson & Johnson