Vaccine Info

MVA-BN RSV Vaccine

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Staff
Last reviewed
June 5, 2022
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MVA-BN® RSV Vaccine Description For 2022

Bavarian Nordic A/S's MVA-BN® RSV vaccine incorporates five different respiratory syncytial viruses (RSV) antigens to stimulate a broad immune response against both RSV subtypes (A and B), thus mimicking the immune response observed following a natural reaction to an RSV infection. In addition, the incorporation of five antigens differentiates MVA-BN RSV from other RSV vaccine candidates.

The vaccine candidate is based on Bavarian Nordic's proprietary MVA-BN® platform technology, also used in the Company's approved vaccines for smallpox and Ebola. 

The U.S. Food and Drug Administration granted Breakthrough Therapy Designation for MVA-BN RSV targeting seniors 60 years +. Paul Chaplin, President and CEO of Bavarian Nordic, commented on February 14, 2022, 'Based on the encouraging results demonstrated in a human challenge trial last year, we recently announced our plans to initiate a Phase 3 study this year (2022) and look forward to working closely with the FDA on our path towards licensure of the vaccine."

The Company confirmed on March 21, 2022, a Phase 3 trial to support regulatory approval of MVA-BN RSV in China. The Chinese target population for an RSV vaccine is estimated to be nearly 400 million people aged 60 years or older, with an estimated annual growth rate of 3%. This study will be conducted separately from the Company’s own Phase 3 trial planned for initiation later in the first half of 2022 to support a U.S. Biologics License Application. 

As of May 10, 2022, there are no U.S. FDA-approved vaccines to prevent RSV.

Denmark-based Bavarian Nordic A/S (OMX: BAVA) is a fully integrated vaccines company focused on developing, manufacturing, and commercializing life-saving vaccines.

MVA-BN RSV Indication

The MVA-BN-RSV Vaccine is indicated to prevent RSV, a highly infectious and the most common cause of lower respiratory tract infection in infants and children worldwide, resulting in many hospitalizations. RSV infections are also a serious health concern in the elderly and adults with cardiopulmonary disease. RSV is a common virus that usually causes mild, cold-like symptoms but, in serious cases, can cause severe lung infections, including bronchiolitis and pneumonia.

According to the U.S. CDC, those at risk are typically young infants, the elderly, and people with weakened immune systems.

MVA-BN RSV Side Effects

No vaccine-related serious adverse events were observed in a recent phase 2 study. In addition, the vaccine was well-tolerated, consistent with the safety profile previously reported in phase 1 and phase 2 clinical studies announced by the Company.

Nuance Pharma Agreement

Founded by Mark Lotter in 2014, Nuance has built a late clinical-stage innovative portfolio while maintaining a self-sustainable commercial operation. Under the terms of the agreement announced on March 21, 2022, Bavarian Nordic will receive an upfront payment of USD 12.5 million and is eligible to receive future milestone payments of up to USD 212.5 million that are triggered upon achievement of certain clinical, regulatory, and commercial milestones, in addition to tiered, double-digit royalties on future net sales. Nuance Pharma will assume all costs and responsibility for the clinical development, regulatory filings, and commercialization of the vaccine in territories covered by the agreement. Subject to Chinese regulatory authority National Medical Products Administration (NMPA) approval, Phase 1 and Phase 3 trials are planned for the vaccine approval in China. The parties have also entered into a supply agreement by which Bavarian Nordic will assume future commercial manufacturing and supply of the vaccine.

MVA-BN RSV News For 2016 - 2022

May 9, 2022 - Bavarian Nordic A/S announced business progress for the first three months of 2022. The Phase 3 clinical trial of MVA-BN RSV against RSV plans to enroll approximately 20,000 adults, aged 60 years or older across approximately 115 sites in the U.S. and Germany. The trial is designed to run through the RSV season 2022/2023 with topline results expected mid-2023 if the pre-defined number of lower-respiratory tract disease events has occurred.

April 20, 2022 - Bavarian Nordic announced the dosing of the first subject in the Phase 3 VANIR clinical trial of its investigational RSV vaccine candidate, MVA-BN® RSV, in older adults. 

March 21, 2022 - Bavarian Nordic A/S announced an exclusive license and supply agreement with Nuance Pharma on the development and commercialization of MVA-BN® RSV against RSV in adults in the Chinese Mainland-Hong Kong, Macau, Taiwan, South Korea, and certain Southeast Asian countries.

February 14, 2022 - The Company announced that the U.S. FDA had granted Breakthrough Therapy Designation for MVA-BN RSV for active immunization to prevent lower respiratory tract disease caused by RSV in adults aged 60 years or older. 

December 6, 2021 - Bavarian Nordic A/S formally announced its commitment to initiate a Phase 3 clinical trial of its RSV vaccine candidate, MVA-BN® RSV. Bavarian Nordic intends to fund the trial through an equity raise of up to 10% of its registered share capital.

September 1, 2021 - Bavarian Nordic A/S announced results from a human challenge trial of MVA-BN® RSV. The study demonstrated a significant reduction in viral load in vaccinated subjects (n=30) versus placebo (n=31), thus meeting the primary endpoint of this pivotal study. At the same time, the vaccinated subjects showed a significant reduction in clinical symptoms typically associated with RSV infections. As a result, the MVA-BN RSV vaccine demonstrated a vaccine efficacy of up to 79% in preventing symptomatic RSV infections. Pending further analysis of the current RSV infection rates, discussions with regulatory authorities about the Phase 3 design, and funding/partnering considerations, the Company will determine the immediate next steps and expects to communicate these during the fourth quarter of 2021.

August 8, 2018: Bavarian Nordic announced positive data from the extension study of its Phase 2 study investigating the safety and immune responses of its universal RSV vaccine, MVA-BN® RSV, in an older adult population. 

December 14, 2016: Bavarian Nordic announced that it had completed enrollment of 400 subjects in Phase 2 clinical study of MVA-BN® RSV, a novel, broad-spectrum vaccine candidate against RSV (respiratory syncytial virus). 

September 29, 2016: Bavarian Nordic announced the presentation of data from a Phase 1 study of its novel, broad-spectrum RSV (respiratory syncytial virus) vaccine candidate, MVA-BN RSV®.

MVA-BN RSV Clinical Trials

The Company developed a Phase 3 program. The VANIR trial is a global, randomized, double-blind Phase 3 trial of the recombinant MVA-BN RSV vaccine in 20,000 adults aged 60 years and older. The study's primary objective will assess the vaccine candidate's efficacy against lower-respiratory tract disease caused by RSV compared to a placebo. The Phase 3 trial is conducted at approximately 115 sites across the U.S. and Germany. The trial is designed to run through the RSV season 2022/2023, with topline results expected mid-2023 if the pre-defined number of lower-respiratory tract disease events has occurred.

Phase 2a Randomised, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Immunogenicity, and Efficacy of the Recombinant MVA-BN® RSV Vaccine Against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Participants. Clinical Trial NCT02873286:  RSV-MVA-BN Vaccine Phase II Trial in ≥ 55-Year-Old Adults. This phase 2 clinical study investigated a multivalent RSV vaccine (MVA-BN®-RSV) designed to induce broad antibody and cellular immune responses by encoding RSV surface proteins F, G (for both A and B subtypes), and internal antigens (M2, N). The study demonstrated a significant reduction in viral load in vaccinated subjects (n=30) versus placebo (n=31), thus meeting the primary endpoint of this pivotal study.

At the same time, the vaccinated subjects showed a significant reduction in clinical symptoms typically associated with RSV infections. The MVA-BN RSV vaccine demonstrated a vaccine efficacy of up to 79% in preventing symptomatic RSV infections.

Clinical Trials

No clinical trials found