COPENHAGEN, Denmark, June 28, 2022 – Bavarian Nordic A/S (OMX: BAVA) introduced right now that the European Medicines Company (EMA) has granted entry to its precedence medicines (PRIME) scheme for MVA-BN® RSV in energetic immunization for the prevention of decrease respiratory tract illness (LRTD) brought on by Respiratory Syncytial Virus (RSV) in adults ≥60 years of age. There aren’t any permitted vaccines for RSV, and entry to PRIME has been granted upon an evaluation that the out there medical information total present the potential of MVA-BN-RSV to deal with the unmet medical want within the proposed goal inhabitants.
PRIME is a scheme launched by EMA to reinforce assist for the event of medicines that focus on an unmet medical want. By way of PRIME, EMA gives early assist to medication builders to optimize the technology of sturdy information on a medication’s advantages and dangers and allow accelerated evaluation of medicines functions. This may assist sufferers to learn as early as potential from therapies which will considerably enhance their high quality of life. In accordance with EMA, only one in 4 requests for PRIME eligibility are granted.
For extra data on the PRIME scheme, see https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines
Paul Chaplin, President and CEO of Bavarian Nordic, mentioned: “Following the grant of a Breakthrough Remedy Designation from the US Meals and Drug Administration (FDA) earlier this yr, we’re proud to obtain eligibility for PRIME entry for our RSV vaccine candidate, enabling us to pursue accelerated improvement and evaluation processes with the regulatory authorities in each US and Europe. These grants spotlight the potential of our vaccine to satisfy the numerous unmet want for a preventative remedy, notably for the aged who could also be in danger from severe issues from RSV. As we proceed the enrollment into the worldwide Part 3 trial of the vaccine, we sit up for working carefully with each EMA and the FDA on accelerating the pathway in direction of approval.”
About Respiratory Syncytial Virus (RSV)
RSV is a standard virus that often causes delicate, cold-like signs, however in severe circumstances can result in extreme lung infections, together with bronchiolitis and pneumonia, which in the end can result in dying. At-risk people usually embody infants and aged / immunocompromised people.
It’s estimated that every yr RSV-induced infections result in roughly 177,5251 hospitalizations and 14,0001 deaths in adults aged 65 years and older within the US, just like influenza. Accordingly, stopping RSV-induced infections is a high precedence for governments and medical professionals globally. At present there is no such thing as a permitted vaccine in opposition to RSV. As such, RSV constitutes a big and demanding unmet medical want and a possible multi-billion-dollar vaccines market yearly.
About MVA-BN RSV
MVA-BN RSV, Bavarian Nordic’s vaccine candidate for the prevention of RSV, is being developed to be used in aged people. The vaccine incorporates 5 distinct RSV antigens to stimulate a broad immune response in opposition to each RSV subtypes (A and B), thus mimicking the immune response noticed following a pure response to an RSV an infection. The incorporation of 5 antigens differentiates MVA-BN RSV from different RSV vaccine candidates presently in improvement.
In 2021, Bavarian Nordic reported sturdy outcomes from a Part 2 double-blinded, placebo-controlled trial, which enrolled wholesome grownup medical volunteers, 18-50 years of age who had been randomized to obtain both a single vaccination of MVA-BN RSV or placebo . Volunteers had been challenged intranasally with an RSV kind A pressure 28 days after vaccination. A complete of 61 topics had been evaluable.
The examine demonstrated a big discount in viral load in vaccinated topics (n=30) versus placebo (n=31), thus assembly the first endpoint of this pivotal examine. On the similar time, the vaccinated topics confirmed a big discount in medical signs usually related to RSV infections. The MVA-BN RSV vaccine demonstrated a vaccine efficacy of as much as 79% in stopping symptomatic RSV infections2.
Bavarian Nordic has additionally beforehand reported sturdy outcomes from a Part 2 trial of MVA-BN RSV in 421 aged topics aged 55 years and older, demonstrating that the vaccine was well-tolerated and induced each broad and sturdy antibody and T-cell responses in opposition to RSV , in addition to mucosal immune responses which may be necessary for defense in opposition to RSV. The Part 2 program in aged topics included a revaccination of topics after one yr, following which the immune responses had been quickly and considerably elevated, notably in topics with the weakest immunity previous to the booster vaccination3.
The vaccine candidate relies on Bavarian Nordic’s proprietary MVA-BN® platform expertise, additionally used within the firm’s permitted vaccines for smallpox, monkeypox and Ebola.
In February 2022, the US Meals and Drug Administration (FDA) granted Breakthrough Remedy Designation for MVA-BN RSV, for energetic immunization for prevention of decrease respiratory tract illness brought on by respiratory syncytial virus (RSV) in adults aged 60 years or older.
In April 2022, Bavarian Nordic initiated a world, randomized, double-blind Part 3 trial (VANIR) of MVA-BN RSV, deliberate to enroll 20,000 adults aged 60 years and older. The trial is being carried out at roughly 115 websites throughout the US and Germany and is designed to run via the RSV season 2022/2023 with topline outcomes anticipated mid 2023 if the pre-defined variety of lower-respiratory tract illness occasions has occurred.
About Bavarian Nordic
Bavarian Nordic is a completely built-in vaccines firm centered on the event, manufacturing and commercialization of life-saving vaccines. We’re a world chief in smallpox vaccines and have been a long-term provider to the US Authorities of a non-replicating smallpox vaccine, which has been permitted by the FDA, additionally for the safety in opposition to monkeypox. The vaccine can be permitted for defense in opposition to smallpox and monkeypox in Canada, and as a smallpox vaccine in Europe. Our business product portfolio additionally accommodates market-leading vaccines in opposition to rabies and tick-borne encephalitis. Utilizing our stay virus vaccine platform expertise, MVA-BN®, we now have created a various portfolio of proprietary and partnered product candidates designed to save lots of and enhance lives by unlocking the ability of the immune system, together with an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Corporations of Johnson & Johnson. We’re additionally dedicated to the event of a subsequent technology COVID-19 vaccine. Go to for extra data www.bavarian-nordic.com.
This announcement contains forward-looking statements that contain dangers, uncertainties and different components, lots of that are outdoors of our management, that might trigger precise outcomes to vary materially from the outcomes mentioned within the forward-looking statements. Ahead-looking statements embody statements regarding our plans, targets, objectives, future occasions, efficiency and/or different data that isn’t historic data. All such forward-looking statements are expressly certified by these cautionary statements and every other cautionary statements which can accompany the forward-looking statements. We undertake no obligation to publicly replace or revise forward-looking statements to mirror subsequent occasions or circumstances after the date made, besides as required by regulation.
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, [email protected]Tel: +1 781 686 9600
1 Falsey AR, Hennessey PA, Formica MA, Cox C, Walsh EE. Respiratory syncytial virus an infection in aged and high-risk adults. N Engl J Med. 2005 Apr 28;352(17):1749-59
3 Jordan E et al. 2010. J. Infect, Dis. 28:223(6). 1062-1072