Johnson & Johnson announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date.
The two preprint study summaries have been submitted today to bioRxiv.
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, said, “We believe that our vaccine offers durable protection against COVID-19 and elicits neutralizing activity against the Delta variant. This adds to the robust body of clinical data supporting our single-shot vaccine’s ability to protect against multiple variants of concern.”
A preprint submitted by the company to bioRxiv contains a new analysis from blood samples obtained from a subset of participants in the Phase 3 ENSEMBLE study. These data showed that the Johnson & Johnson single-shot COVID-19 vaccine elicited neutralizing antibody activity against the Delta variant at an even higher level than what was recently observed for the Beta (B.1.351) variant in South Africa where high efficacy against severe/critical disease was demonstrated.
In the ENSEMBLE trial, Johnson & Johnson’s single-dose COVID-19 vaccine was 85% effective against severe/critical disease and demonstrated protection against hospitalization and death. The vaccine was consistently effective across all regions studied globally, including in South Africa and Brazil, where there was a high prevalence of rapidly emerging Beta and Zeta (P.2) variants during the study period.
Data submitted by Dan Barouch, M.D., Ph.D., of Beth Israel Deaconess Medical Center et al., to bioRxiv from a sub-study of the Johnson & Johnson Phase 1/2a COVID-19 vaccine study showed that humoral and cellular immune responses generated by the Johnson & Johnson single-shot COVID-19 vaccine lasted through at least eight months, the latest timepoint recorded in the study thus far. Data showed that T-cell responses – including CD8+ T-cells that seek out and destroy infected cells – persisted over the eight-month timeframe examined.
A single dose of the Johnson & Johnson COVID-19 vaccine generated neutralizing antibodies against a range of SARS-CoV-2 variants of concern, which increased over time (the average neutralizing titer at eight months exceeded that average at 29 days), including against the increasingly prevalent and more transmissible Delta (B.1.617.2) variant,variants and others, including the Alpha (B.1.1.7), Epsilon (B.1.429), Kappa (B.1.617.1) and D614G variants, as well as the original SARS-CoV-2 strain (WA1/2020).