Bavarian Nordic Provides Update on COVID-19 Booster Vaccine Program
31 Août 2023 - 5:08PM
Bavarian Nordic Provides Update on COVID-19 Booster Vaccine Program
- ABNCoV2 and the comparator vaccine demonstrated a reduced level
of neutralizing antibodies against a circulating variant (Omicron
XBB.1.5) in Phase 3 study.
- cVLP platform has proven its ability to induce strong and
lasting immunity against the target virus, but Bavarian Nordic sees
no commercial opportunity for the vaccine, as the platform is not
suitable for quick adaptions to emerging variants.
- The Company will continue its dialogue with authorities on how
best to leverage the learnings about the platform in a potential
future pandemic situation.
COPENHAGEN, Denmark, August 31,
2023 – Bavarian Nordic A/S (OMX: BAVA) today reported
additional Phase 3 results and provided an update on the
development program for its cVLP-based COVID-19 booster vaccine
candidate, ABNCoV2.
As previously reported, two weeks post a booster
vaccination with ABNCoV2, the levels of neutralizing antibodies
against the original SARS-CoV-2 variant (Wuhan index virus) were
non-inferior to those stimulated in people vaccinated with
Comirnaty® and this result met the primary objective of the Phase 3
study. The Wuhan variant is no longer the primary concern, as the
virus has mutated creating new circulating variants, such as
Omicron XBB.1.5. In a follow-up analysis, when looking at this more
distant variant, the levels of neutralizing antibodies induced by
ABNCoV2 were lower than those stimulated by the non-adapted
Wuhan-based Comirnaty, and fewer people had detectable antibodies
following ABNCoV2 (64%) versus Comirnaty (85%). The levels of
neutralizing antibodies induced by both vaccines were much lower
than against the Wuhan variant.
A 6-month follow-up analysis will be conducted
to evaluate the durability of the antibody responses from booster
vaccination with ABNCoV2 and Comirnaty, which, if the Phase 2
durability results for ABNCoV2 are confirmed, may confirm an
advantage over the comparator vaccine.
While safety data from the Phase 3 study will
continue to be collected for 6 months, safety data from 4,205
individuals followed up for 2 months post vaccination showed
ABNCoV2 to be well-tolerated with no serious adverse events being
reported.
These data support the current position of many
of the regulators (e.g. FDA, EMA and WHO) that request
variant-specific COVID vaccines that will likely have to be adapted
each year like flu vaccines. Unfortunately, ABNCoV2 cannot be
readily adapted within the seasonal timeframe and as such ABNCoV2
no longer represents a commercial opportunity for Bavarian
Nordic.
Despite the lack of efficacy against distant and
less virulent variants, the data generated in the overall
development of ABNCoV2 may support the use of the cVLP platform in
future pandemics, and the Company will discuss with the authorities
how best to leverage the learnings from this development
program.
Paul Chaplin, President and CEO of Bavarian
Nordic said: “The world is in a different place now, and COVID-19
is no longer a public health crisis. However, as the disease
continues to evolve, innovations in vaccine development are still
warranted. We have generated robust data, so far demonstrating a
favorable safety profile for the vaccine along with the ability to
induce a strong and persistent immune response against earlier and
more virulent strains, confirming the viability of the cVLP
platform. We would like to thank our partners and everyone taking
part in the Phase 3 study, and not least the Danish Ministry of
Health for their support in this development that has validated a
new vaccine platform for future pandemics.”
About ABNCoV2ABNCoV2 is a
COVID-19 booster vaccine candidate, initially developed by AdaptVac
using their proprietary capsid virus like particle (cVLP)
technology. Bavarian Nordic licensed the vaccine in 2020 and has
sponsored the clinical development beyond Phase 1, which was
conducted under a Horizon 2020 EU grant to AdaptVac and the
PREVENT-nCoV consortium.
Results from a Phase 2 trial, which enrolled
individuals that were previously vaccinated with approved mRNA
vaccines, demonstrated the ability of ABNCoV2 to significantly
boost the existing levels of SARS-CoV-2 neutralizing antibodies
against both the Wuhan variant and former variants of concern
(Alpha, Beta, Delta and Omicron) to levels reported to be highly
efficacious (>90%)1 against SARS-CoV-2. A follow-up study of a
subset of individuals in the study showed that 12 months post the
booster with ABNCoV2, neutralizing antibodies against the Wuhan
strain and former variants of concern remained at levels known to
be associated with a high level of protection.
The Phase 3 study was designed to demonstrate
non-inferiority of ABNCoV2 to Comirnaty® measured by neutralizing
antibodies against the SARS-CoV-2 virus (Wuhan wild type). The
study enrolled a total of 4,205 adults who either previously
completed primary vaccination or had already received one booster
dose of a licensed COVID-19 vaccine. The active, controlled part
enrolled 622 participants who were randomized to receive either a
single 100 µg dose of ABNCoV2, or a single 30 µg adult booster dose
of Comirnaty. The second part of the study evaluated the safety and
tolerability of a single 100 µg dose of ABNCoV2 in 3,583
participants.
The Phase 3 development of ABNCoV2 was partly
funded through an agreement with the Danish State.
About Bavarian NordicBavarian
Nordic is a fully integrated vaccine company focused on the
research and development, manufacturing and commercialization of
life-saving vaccines. We are a global leader in smallpox and mpox
vaccines, which have been developed through our long-standing
partnership with the U.S. Government 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, Tel: +45 61 77 47
43US: Graham Morrell, Paddock Circle Advisors,
graham@paddockcircle.com, Tel: +1 781 686 9600
Company Announcement no. 32 / 2023
1 P. B. Gilbert et al., Science
10.1126/science.abm3425 (2021)
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