Bavarian Nordic A/S

FDA Approves Bavarian Nordic's Freeze-Dried JYNNEOS Vaccine for Smallpox and Mpox Prevention

2 months ago

• The U.S. FDA has approved Bavarian Nordic's freeze-dried formulation of JYNNEOS for prevention of smallpox and mpox in adults 18 years and older, offering improved storage stability and transportation advantages. • Clinical data demonstrated comparable immune responses and safety profiles between the new freeze-dried formulation and the previously approved liquid-frozen version, which has been in use since 2019. • Manufacturing of the freeze-dried JYNNEOS under a BARDA contract began in 2024, with first deliveries expected later in 2025, strengthening U.S. public health preparedness against potential outbreaks.

FDA Approves Bavarian Nordic's Vimkunya, First Chikungunya Vaccine for Adolescents

5 months ago

• The FDA has approved Vimkunya, a chikungunya vaccine developed by Bavarian Nordic, for individuals aged 12 and older. • Vimkunya is the first virus-like particle (VLP) single-dose chikungunya vaccine approved in the U.S., offering a new preventative option. • Clinical trials showed Vimkunya induced neutralizing antibodies in up to 97.8% of vaccinated individuals within 21 days. • Commercial availability of Vimkunya in the U.S. is expected in the first half of 2025, with launches in key European markets anticipated.

Bavarian Nordic's MVA-BN Mpox/Smallpox Vaccine Trial Enrolls First Children

7 months ago

• Bavarian Nordic has initiated a clinical study of its MVA-BN mpox/smallpox vaccine in children aged 2 to 11 years, with the first vaccinations administered. • The study, involving 460 participants, will assess the vaccine's safety and immunogenicity in children compared to adults, potentially supporting label expansion. • Partially funded by CEPI, the trial is being conducted in the Democratic Republic of Congo and Uganda, with results potentially extending MVA-BN's approval to younger children. • MVA-BN has already received WHO prequalification for adolescents and EMA approval for ages 12-17, and a recombinant version is approved for Ebola prevention in young children.

Bavarian Nordic Initiates Clinical Trial of Mpox Vaccine in Young Children

7 months ago

• Bavarian Nordic has begun a clinical study to assess its MVA-BN mpox vaccine in children aged 2-11 years, following approvals for adolescent use. • The trial, enrolling participants in the Democratic Republic of Congo and Uganda, will evaluate the vaccine's safety and immunogenicity compared to adults. • CEPI is partially funding the study, with results potentially supporting the expansion of MVA-BN's approval to include children aged 2 years and older. • This initiative addresses the vulnerability of children to mpox in ongoing African outbreaks, aiming to broaden access to safe and effective vaccines.

WHO Prequalifies MVA-BN Vaccine for Mpox; DOH Warns Against Unauthorized Vaccines

8 months ago

• The World Health Organization (WHO) has prequalified the MVA-BN vaccine, marking the first mpox vaccine to receive this designation, enhancing access in high-need communities. • The MVA-BN vaccine, given as a two-dose injection four weeks apart for adults over 18, shows approximately 82% effectiveness with the full regimen. • The Department of Health (DOH) Region 6 has issued a warning against unauthorized mpox vaccines lacking FDA approval, citing potential safety and efficacy risks. • WHO is also progressing with prequalification and emergency use listing procedures for two other mpox vaccines: LC-16 and ACAM2000.

WHO Prequalifies First Mpox Vaccine to Combat Outbreak in Africa

8 months ago

• The World Health Organization (WHO) has prequalified the MVA-BN vaccine, manufactured by Bavarian Nordic, as the first vaccine against mpox. • This prequalification is expected to facilitate increased access to the vaccine in communities with urgent needs, particularly in Africa, to reduce transmission. • The MVA-BN vaccine can be administered in two doses to individuals 18 years and older, with an estimated 82% effectiveness, or a single dose with 76% effectiveness. • WHO's prequalification will help accelerate procurement by governments and international agencies like Gavi and UNICEF, and fast-track regulatory approvals worldwide.