Bavarian Nordic Submits Supplemental BLA Seeking U.S. FDA Approval of Freeze-Dried Formulation of Smallpox and Mpox Vaccine
COPENHAGEN, Denmark, May 31, 2024 - Bavarian
Nordic A/S (OMX:
BAVA) today announced
that it has submitted a supplemental Biologics
License Application (sBLA)
to the U.S. Food and Drug Administration (FDA) confirming approval
of the
lyophilized
formulation of JYNNEOS® for
the prevention of smallpox
and Mpox in adults aged 18 years and older.
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| Bavarian Nordic Seeks FDA Approval for Freeze-Dried Smallpox and Mpox Vaccine |
The liquid frozen formulation of
JYNNEOS® was approved by the FDA in September 2019. It remains the only approved smallpox
vaccine in the
world and the
only non-replicating smallpox vaccine approved
in the United States. While this formulation
of JYNNEOS®
has specific cold chain requirements,
the lyophilized formulation offers greater flexibility in terms
of transportation, storage
conditions and shelf
life, making it more suitable
for long-term storage.
The sBLA submission
is based on clinical data from a Phase 3 batch consistency study and
data from a Phase 2 study that demonstrated
bioequivalence of the lyophilized and
liquid frozen formulations, as well
as other clinical
and nonclinical data, including
process development data and manufacturing. Following the standard 10-month review
period for an
sBLA, approval of
the lyophilized formulation could occur
in the first quarter of 2025. "We are pleased to complete this application.
This marks an important milestone in the development
of our
next generation smallpox/mpox
vaccine and in
our partnership with
the U.S. government
to develop vaccines to address current and future public health challenges. Approval of
this new formulation,
ideal for long-term stockpiling,
should secure future orders
beyond our current contract
with the U.S.
government,
which is valued at approximately $300 million," said Paul Chaplin, president and CEO
of Bavarian Nordic.
Bavarian Nordic has
a continuing contract with the U.S. Biomedical Advanced Research
and Development Authority
(BARDA) worth $299 million to
supply lyophilized JYNNEOS® for the stockpiling.
The contract allows for the production of lyophilized doses
prior to approval of
the formulation, and the
company began manufacturing the vaccine under this contract
in the first quarter of 2024. The goal is to fulfill the first contract option, worth $119 million, during this year. This is
already factored into the company's 2024 financial
forecast, so there is no change. BARDA must exercise an option for an
additional
$180 million. Bulk vaccine to
produce freeze-dried vaccine was originally
produced under a
previous contract, but a significant
portion of this inventory was repurposed to produce liquid frozen doses
during the 2022-2023
Mpox epidemic and must
therefore be replaced with alternative new
orders to enable
fulfillment
of the remaining
freeze-dried options.
About Smallpox/MPOX Vaccine
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is a non-replicating smallpox vaccine and is the only Mpox vaccine available in the United States and Switzerland (marketed as JYNNEOS®), Canada (marketed as IMVAMUNE®), the EU/EAA and the United Kingdom (marketed as IMVANEX®). MVA-BN was originally developed in collaboration with the US Government to ensure smallpox vaccine coverage for the entire population, including immunocompromised individuals for whom vaccination with conventional replicating smallpox vaccines is not recommended. It is intended for use in the general adult population considered to be at risk for smallpox or Mpox infection.Bavarian Nordic has been a long-standing supplier of the vaccine to many countries, including the United States and Canada, as part of their national biological preparedness. During the MPOX epidemic in 2022-2023, Bavarian Nordic also supported governments and supranational organisations in expanding access to the vaccine to more than 70 countries worldwide.
Government funding support is appreciated
This project was funded in whole or in part with federal funds from the HHS Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201700019C.
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