The data included new analysis from blood samples obtained from a subset of participants in the Phase 3 ENSEMBLE study
Janssen Pharmaceutical Companies of Johnson & Johnson. (Credit: Vysotsky/Wikipedia.)
Johnson & Johnson (J&J) announced that its single-shot Covid-19 vaccine has shown neutralising antibody activity against the Delta variant and other SARS-CoV-2 variants, in a lab study.
The vaccine, developed by J&J’s subsidiary Janssen, has produced immune responses that had lasted through at least eight months, the latest timepoint recorded in the study.
The data submitted to open access preprint repository bioRxiv included new analysis from blood samples obtained from a subset of participants in the Phase 3 ENSEMBLE study.
In the study, the vaccine resulted in superior neutralising antibody activity against the Delta variant compared to that observed for Beta (B.1.351) variant, first identified in South Africa.
The ENSEMBLE trial showed that the single-dose Covid-19 vaccine was 85% effective against severe/critical disease and demonstrated protection against hospitalisation and death.
Johnson & Johnson executive committee vice chairman and chief scientific officer Paul Stoffels said: “Today’s newly announced studies reinforce the ability of the Johnson & Johnson Covid-19 vaccine to help protect the health of people globally.
“We believe that our vaccine offers durable protection against Covid-19 and elicits neutralising 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.”
In a separate development, EMA’s committee for human medicines (CHMP) has approved a scale-up of the active substance manufacturing at Janssen Biologics.
The Netherlands-based manufacturing facility is designed to produce all active substance for the manufacture of Covid-19 Vaccine Janssen to support its supply to the EU
The CHMP approval recommends modifications to the Janssen Biologics facility, including a new building, new equipment and the introduction of additional process optimisations.
The modifications are expected to increase the manufacturing capacity and frequency of the active substance, to support the continued supply of Covid-19 Vaccine Janssen to the EU.
Furthermore, the US Food and Drug Administration (FDA) has authorised the use of an additional batch of J&J’s single-dose Covid-19 vaccine manufactured by Emergent BioSolutions at its Baltimore facility.