Bavarian Nordic has reported data from the Phase III efficacy study of MVA-BN (Jynneos) vaccine, which is designed to prevent smallpox and monkeypox disease in adults aged above 18 years.
The results have been published in the New England Journal of Medicine (NEJM).
Go deeper with GlobalData
Jynneos is a suspension of live, non-replicating attenuated modified vaccinia ankara (MVA) virus designed to trigger an immune response in the body.
The Phase III trial compared the safety and immunogenicity of MVA-BN to US-licensed smallpox vaccine ACAM2000.
Bavarian Nordic said that the trial met its co-primary endpoints, with the company’s vaccine producing statistically higher peak neutralising antibodies versus ACAM2000.
Primary vaccination with MVA-BN was also associated with a highly attenuated take or decrease in lesion size. Data showed that the vaccine take was prevented in most patients re-administered with ACAM2000.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataThe company noted that a single dose of its vaccine triggered neutralising antibody titers comparable to that of ACAM2000 at day 14.
This data supported the registration of Jynneos, which secured US regulatory approval in September this year. The vaccine has been assessed in a comprehensive development programme of 22 clinical trials, including two Phase III trials.
Approval of Jynneos for smallpox is based on results from the development programme, while its authorisation for monkeypox is based on survival data from challenge studies in non-human primates.
The vaccine’s safety was studied in healthy adults who previously received the smallpox vaccine, as well as vaccine-naïve healthy subjects, patients with HIV infection, and adults with atopic dermatitis.
Earlier this week, the company completed the enrolment of smallpox patients in a Phase III lot-consistency trial, which is intended to support US licensure of a long-lasting, freeze-dried formulation of the vaccine.
