Johnson & Johnson presented new data that would demonstrate the ability of its single-dose COVID-19 vaccine to generate strong and persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants.
Furthermore, the data showed that the duration of the immune response lasted for at least eight months, the time period evaluated to date. The two summaries of the pre-publication study were presented today at bioRxiv.
“The new studies announced today confirm the ability of Johnson & Johnson’s COVID-19 vaccine to offer protection for people’s health globally,” he said. Paul Stoffels, MD, Vice President of the Executive Committee and Chief Scientific Officer of Johnson & Johnson. “We believe our vaccine offers lasting protection against COVID-19 and exerts a neutralizing activity against the Delta variant. This data adds to previous clinical data that demonstrate the ability of our single-dose vaccine to protect against multiple and worrying variants ”.
“The current data so far reaches eight months of observation and shows that Johnson & Johnson’s single dose vaccine against COVID-19 generates a strong neutralizing antibody response that does not diminish over time; indeed, an increase is observed. In addition, we note a persistent and particularly robust and long-lasting cellular immune response, “said Mathai Mammen, MD, Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “With each new dataset, we strengthen the evidence base that demonstrates that our single-dose vaccine against COVID-19 plays a key role in ending the pandemic, which continues to evolve and pose new challenges to global health.” .
Demonstrated strong neutralizing antibody activity against Delta variant (B.1.617.2)
A pre-publication presented today by the Company a bioRxiv contains a new analysis of blood samples obtained from a subset of participants (n = 8) at the Phase 3 ENSEMBLE study. These data demonstrated that Johnson & Johnson’s single-dose COVID-19 vaccine elicited neutralizing antibody activity against the Delta variant at an even higher level than recently observed for the Beta variant (B.1.351) in South Africa, where it has been shown to be highly effective against severe / critical forms of the disease.
In the ENSEMBLE study, Johnson & Johnson’s single-dose COVID-19 vaccine was 85% effective against severe / critical forms of the disease and demonstrated complete protection against hospitalization and death. The vaccine proved linearly effective in all geographic areas studied globally, including in South Africa and Brazil, where there was a high prevalence of Beta and Zeta (P.2) variants that were rapidly emerging during the period of the study.
Immune responses persisted for at least eight months
Data presented by Dan Barouch, MD, Ph.D., of Beth Israel Deaconess Medical Center and others, a bioRxiv from a substudy of Johnson & Johnson’s Phase 1 / 2a COVID-19 vaccine study (n = 20) demonstrated that humoral and cellular immune responses generated by Johnson & Johnson’s single-dose COVID-19 vaccine lasted for at least eight months, the latest observation reported to date in the study. The data showed that T cell responses – including CD8 + cells that recognize and destroy infected cells – persisted over the eight months tested.
A single dose of Johnson & Johnson’s COVID-19 vaccine generated neutralizing antibodies against a number of Sars-Cov2 variants, which increased over time (the eight-month mean neutralizing titer exceeded the 29-day mean), even against the increasingly widespread and more transmissible Delta variant (B.1 .617.2), the Beta variant (B.1.351) partially resistant to neutralization, the Gamma variants (P.1) and others, including the Alpha variants (B. 1.1.7), Epsilon (B.1.429), Kappa (B.1.617.1) and D614G, as well as the original SARS-CoV-2 (WA1 / 2020) strain.