Bavarian Nordic Announces First Half 2022 Results
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Management’s Review
Our response to the global monkeypox
outbreak
Expedited approvals for faster and broader access to the
vaccine
While Bavarian Nordic’s vaccine had already been approved for
monkeypox in the U.S. and Canada, the approval in the EU only
covered smallpox. Thus, countries within EU, but also outside,
were providing the vaccines under local exemptions, such as
emergency use provisions. Upon recommendation from the
Emergency Task Force of the European Medicines Agency (EMA),
Bavarian Nordic worked with the authorities to expedite a review
of data to support an extension of the current approval of
IMVANEX to include monkeypox. A positive opinion was adopted
by EMA’s Committee for Medicinal Products for Human Use
(CHMP) in July and shortly after, the European Commission
formally gave its approval, which is valid in all European Union
Member States as well as in Iceland, Liechtenstein, and Norway.
A new, global health crisis emerged during the second quarter
2022. Initially, like several times before in recent years, sporadic
cases of human monkeypox were reported in Europe, imported
from endemic areas in Africa, and Bavarian Nordic once again
was able to assist with supplies of its smallpox vaccine for
healthcare workers and close contacts.
However, it quickly became clear, that this outbreak was not
following the same pattern of previous years. Unrelated cases
were reported across several countries, and numbers rose
rapidly. By the end of May, more than 600 cases were reported
across nearly 30 countries. Today, this figure has increased to
more than 40,000 cases in nearly 100 countries.
In parallel, Bavarian Nordic has worked with both U.S. and EU
regulatory authorities to expedite the approval of the fill and
finish process at its own manufacturing facility. This required
among others a rescheduling of a planned pre-approval
inspection by the FDA, which was conducted early July with no
observations being made. Both the FDA and EMA have
subsequently approved the fill and finish line and the process
established for the smallpox/monkeypox vaccine.
Facing this unexpected event with no prior experience to draw
from, health authorities around the globe were challenged to
implement measures while still trying to understand the
epidemiology of this disease and how this outbreak was evolving.
As the sole manufacturer of an approved monkeypox vaccine,
Bavarian Nordic was contacted by authorities from dozens of
countries, inquiring about the vaccine. Only limited supplies
were readily available, as no commercial market had previously
existed beyond the sales to a few government stockpiles for their
biological preparedness against a related, but far more dangerous
virus: smallpox.
Scaling up manufacturing capacity
Bavarian Nordic’s manufacturing facility in Denmark has
undergone several upgrades over the past years. These include
the construction of a fill and finish facility which was put into
operations in 2021, and which initially has been qualified to
manufacture the smallpox/monkeypox vaccine. Furthermore, the
bulk facility has been expanded with an additional line to allow
for simultaneous manufacturing of different products, including
Rabipur/RabAvert and Encepur, the Company’s vaccines against
rabies and tick-bone encephalitis. To enable this expansion, the
facility was shut down for a period, but has now reopened. This
planned expansion has had no impact on Bavarian Nordic ability
to supply IMVAMUNE/IMVANEX/JYNNEOS during the first few
months of the current outbreak.
Originally, Bavarian Nordic began the development of MVA-BN as
a non-replicating smallpox vaccine suitable for immune-
compromised people who are not recommended vaccination with
traditional replicating vaccines, but since 2003 this development
was assisted by the U.S. government. These contracts later
evolved into procurement contracts and Bavarian Nordic started
delivering the vaccine in the current liquid-frozen formulation to
the U.S. in 2010 under an emergency use provision until approval
by the U.S. Food and Drug Administration in 2019, which included
the monkeypox indication. In recent years, the Company has
been contracted by the U.S. to manufacture bulk vaccine with
the purpose of supplying a freeze-dried formulation of the
vaccine with a longer shelf life.
While the original production schedule for the remainder of 2022
and onwards did not include manufacturing of
smallpox/monkeypox vaccine, other than what was previously
contracted by the U.S. and Canada, the increased demand for
the vaccine has led to a number of initiatives by the Company to
maximize its production output in the near and medium term.
These include:
Hence, bulk vaccine exists to fulfil orders from the U.S
government as well as a limited company inventory of bulk
batches that allowed Bavarian Nordic to rapidly initiate the final
drug production (fill and finish) of the vaccine as demand rose
during the first months of the outbreak.
•
•
Scaling up of the bulk production and fill/finish line
capacity by adding more manpower
Clearing the bulk production line to free up capacity for
the monkeypox vaccine, including working on outsourcing
of RSV commercial manufacturing based on a new
proprietary cell line technology
By the reporting date, numerous contracts have been signed,
ensuring access to the vaccine in 40 countries across the
Americas, Europe, Asia and Oceania during 2022. Among these
countries are also existing customers, with whom new contracts
were swiftly secured. Some countries have also started longer-
term planning, resulting in orders for 2023 and beyond. Bavarian
Nordic continues to work with governments and supranational
organizations that could ensure access to an additional 50+
countries before the end of this year and has reprioritized its
production schedule accordingly.
•
•
Transferring fill/finish to a U.S. based contract
manufacturer to complement own filling capacity
Exploring potential new collaborations with third parties
to further scale up bulk and fill/finish capacity
Company Announcement no. 32 / 2022