MVA-BN® RSV Vaccine 2023
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. The RSV 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 (FDA) granted Breakthrough Therapy Designation for MVA-BN® RSV targeting seniors 60 years and older. It has also been granted access by the European Medicines Agency (EMA) to its priority medicines (PRIME) scheme for MVA-BN® RSV in active immunization for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults ≥60 years of age.
The peer-review Journal of Infectious Diseases published a Major Article on April 20, 2023, results from a phase 2a randomized double-blind, placebo-controlled clinical trial with adults that concluded MVA-BN-RSV vaccination resulted in lower viral load and symptom scores, fewer confirmed infections, and induced humoral and cellular responses.
On July 22, 2023, Bavarian Nordic announced that its Phase 3 clinical trial of MVA-BN® RSV did not meet all the primary endpoints of preventing LRTD from RSV. The final study results showed that the vaccine candidate had a 59% efficacy in preventing at least two pre-defined LRTD symptoms meeting one of the efficacy criteria of the study. However, when measuring more severe LRTD based on at least three pre-defined symptoms, the vaccine candidate only demonstrated a 42.9% efficacy and missed the study's co-primary endpoint. Based on this outcome, Bavarian Nordic will discontinue its RSV program, including its partnership with Nuance Pharma to develop and launch the vaccine for selected Asian markets.
Denmark-based Bavarian Nordic A/S (OMX: BAVA) is a fully integrated vaccines company focused on developing, manufacturing, and commercializing life-saving vaccines.
Nuance Pharma Agreement in China
In 2021, Nuance Pharma agreed with Bavarian Nordic, granting the Company exclusive rights to develop and commercialize MVA-BN RSV in the Chinese Mainland, Hong Kong, Macau, Taiwan, South Korea, and Southeast Asia addition on On November 13, 2022, the Company announced the Center for Drug Evaluation approved its Investigational New Drug application supporting its pivotal phase III clinical trial of the MVA-BN RSV vaccine against RSV in adults in mainland China. Founded by Mark Lotter in 2014, Nuance has built a late clinical-stage innovative portfolio.
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.
MVA-BN RSV Vaccine News 2023
July 22, 2023 - "We are disappointed that our RSV vaccine candidate was unsuccessful in this pivotal trial," said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. "While this outcome was unexpected and will impact our short-term growth expectations, we continue to have a unique commercial business, and given the recent strong brand and market growth, this provides a solid foundation for profitable growth in the years to come."
April 20, 2023 - A peer-review study concluded: The MVA-BN-RSV vaccine appears to represent a mode of action broader than other vaccine candidates focused on the production of neutralizing antibodies to the preF protein. Dependence of RSV vaccines on the activity of neutralizing antibodies against a specific epitope of one protein conformation may be risky, as such reliance may provide selective pressure for the development of mutant viruses capable of neutralizing antibody escape.
April 11, 2023 - Bavarian Nordic A/S announced that the Phase 3 clinical trial of MVA-BN® RSV has accrued the number of cases required to complete the primary efficacy analysis, which is expected around mid-2023. Adjudicated data have confirmed enough patients with both 2+ symptoms and 3+ symptoms as required in the trial.
December 22, 2022 - Bavarian Nordic A/S announced 20,000 adults aged 60 years and older had been enrolled in a phase 3 study. Topline results are anticipated in mid-2023.
November 13, 2022 - "The MVA-BN RSV vaccine holds the potential to become the first to market adult RSV vaccine in China," in a press release, commented Mark G. Lotter, CEO and Co-Founder of Nuance Pharma.
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.
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 an efficacy of up to 79% in preventing symptomatic RSV infections.
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.
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 global, randomized, placebo-controlled, double-blind Phase 3 VANIR clinical trial has enrolled more than 20,000 participants across more than 100 centers in the U.S. and Germany. The study's primary objective will assess the vaccine candidate's efficacy against LTRD caused by RSV. 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.
A 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: After receiving MVA-BN-RSV or placebo, 31 and 32 participants, respectively, were challenged. Viral load areas under the curve from nasal washes were lower (p = 0.017) for MVA-BN-RSV (median = 0.00) than placebo (median = 49.05). Total symptom scores also were lower (median = 2.50 and 27.00, respectively; p = 0.004). Vaccine efficacy against symptomatic, laboratory-confirmed, or culture-confirmed infection was 79.3% to 88.5% (p = 0.022 and 0.013). Serum immunoglobulin A and G titers increased ∼4-fold after MVA-BN-RSV vaccination. Interferon-γ-producing cells increased 4- to 6-fold after MVA-BN-RSV in response to stimulation with the encoded RSV internal antigens. Injection site pain occurred more frequently with MVA-BN-RSV. No serious adverse events were attributed to vaccination.
