Bavarian Nordic Submits Data to EMA to Extend Mpox/Smallpox Vaccine Approval to Adolescents
August 16 2024 - 12:30AM
- Interim results from clinical study show non-inferiority of
immune responses from mpox/smallpox vaccination in adolescents and
similar safety profile compared to adults, supporting the extension
of current approval in Europe later in 2024.
COPENHAGEN, Denmark, August 16,
2024 – Bavarian Nordic A/S (OMX: BAVA) has submitted
clinical data to the European Medicines Agency (EMA) to support the
extension of the IMVANEX® (MVA-BN®) smallpox and mpox vaccine
indication to include adolescents 12 to 17 years of age.
While currently only indicated for adults 18
years and older, the vaccine was granted an Emergency Use
Authorization for use in adolescents by the FDA during the 2022
global mpox outbreak. It remains the only FDA and EMA-approved mpox
vaccine.
The submission is based on interim results from
a clinical study (NCT05740982), sponsored by the U.S. National
Institutes of Health’s (NIH) National Institutes of Allergy and
Infectious Diseases (NIAID), in 315 adolescents 12-17 years of age
and 211 adults aged 18 years and older, demonstrating
non-inferiority of the immune responses as well as a similar safety
profile, between both age groups after vaccination with two
standard doses of the MVA-BN vaccine.
Following review of the data by EMA, the
Marketing Authorisation for IMVANEX could be extended to include
use of the vaccine for adolescents during the fourth quarter of
2024.
Bavarian Nordic is also preparing for a clinical
trial to assess the immunogenicity and safety of MVA-BN in children
from 2-12 years of age, aiming to further extend the indication of
the vaccine into younger populations. The trial, partially funded
by the Coalition for Epidemic Preparedness Innovations (CEPI), is
planned for initiation in the Democratic Republic of Congo and
Uganda later this year, potentially also supporting a regulatory
approval of MVA-BN in African countries, where mpox is endemic.
“Children and adolescents are disproportionally
affected by mpox in the ongoing outbreak in Africa, highlighting
the importance and urgency to broaden the access to vaccines and
therapies for this vulnerable population. We applaud the NIH for
their work on this study and are pleased to report data that
support the use of our vaccine in adolescents, adding to the
growing pool of evidence that MVA-BN is well tolerated and able to
generate a relevant immune response in adolescent and adult
populations,” said Paul Chaplin, President and Chief
Executive Officer of Bavarian Nordic.
About the smallpox/mpox
vaccineMVA-BN or Modified Vaccinia Ankara-Bavarian Nordic
is a non-replicating smallpox vaccine and the only mpox vaccine
approved in the U.S. and Switzerland (marketed as JYNNEOS®), Canada
(marketed as IMVAMUNE®), and the EU/EEA and United Kingdom
(marketed as IMVANEX®). Originally developed in collaboration with
the U.S. government to ensure the supply of a smallpox vaccine for
the entire population, including immunocompromised individuals who
are not recommended vaccination with traditional replicating
smallpox vaccines, MVA-BN has been indicated for use in the general
adult population (18 years and older) in individuals considered at
risk for smallpox or mpox. During the 2022-2023 mpox outbreak, the
vaccine was granted an Emergency Use Authorization by the U.S. FDA
for both pre- and post-exposure use in adolescents.
Bavarian Nordic has been a long-term supplier of
the vaccine to the U.S. and Canada as well as several other
countries as part of their national biological preparedness. During
the 2022-2023 mpox outbreak, Bavarian Nordic has furthermore
supported governments and supranational organizations by expanding
access to the vaccine to more than 70 countries worldwide.
About Bavarian NordicBavarian
Nordic is a fully integrated vaccine company with a mission to
protect and save lives through innovative vaccines. We are a global
leader in smallpox and mpox vaccines, supplied to governments to
enhance public health preparedness and have a strong portfolio of
vaccines for travelers and endemic diseases. For more information
visit www.bavarian-nordic.com.
Forward-looking statements This
announcement includes forward-looking statements that involve
risks, uncertainties and other factors, many of which are outside
of our control, that could cause actual results to differ
materially from the results discussed in the forward-looking
statements. Forward-looking statements include statements
concerning our plans, objectives, goals, future events,
performance, and/or other information that is not historical
information. All such forward-looking statements are expressly
qualified by these cautionary statements and any other cautionary
statements which may accompany the forward-looking statements. We
undertake no obligation to publicly update or revise
forward-looking statements to reflect subsequent events or
circumstances after the date made, except as required by law.
ContactsEurope: Rolf Sass
Sørensen, Vice President Investor Relations,
rss@bavarian-nordic.com, Tel: +45 61 77 47 43US: Graham Morrell,
Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686
9600