Moderna Announces Strategy to Address Omicron (B.1.1.529) SARS-CoV-2 Variant
November 26 2021 - 03:31PM
Business Wire
Company testing three existing COVID-19 vaccine
booster candidates against the Omicron variant
Company announcing a new variant-specific
vaccine candidate against Omicron (mRNA-1273.529)
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced
updates to its strategy to address SARS-CoV-2 variants of concern,
given the emergence of the B.1.1.529 (Omicron) variant.
The recently described Omicron variant includes mutations seen
in the Delta variant that are believed to increase transmissibility
and mutations seen in the Beta and Delta variants that are believed
to promote immune escape. The combination of mutations represents a
significant potential risk to accelerate the waning of natural and
vaccine-induced immunity. A booster dose of an authorized vaccine
represents the only currently available strategy for boosting
waning immunity. The Moderna COVID-19 vaccine (mRNA-1273) is
authorized as a booster for many populations at the 50 µg dose
level. The Company is working rapidly to test the ability of the
current vaccine dose to neutralize the Omicron variant and data is
expected in the coming weeks.
Since early 2021, Moderna has advanced a comprehensive strategy
to anticipate new variants of concern. This strategy includes three
levels of response should the currently authorized 50 µg booster
dose of mRNA-1273 prove insufficient to boost waning immunity
against the Omicron variant.
First, Moderna has already tested a higher dose booster of
mRNA-1273 (100 µg) in healthy adults. Moderna has completed
dosing of 306 participants in a safety and immunogenicity study of
this high dose (100 µg) booster. The 100 µg dose of mRNA-1273 has
also recently been studied by the National Institutes of Health
(NIH) in the U.S. and has generally resulted in the highest
neutralizing titers against prior SARS-CoV-2 strains. Moderna is
working to rapidly test sera from its high dose booster recipients
in neutralizing assays to determine if the 100 µg dose provides
superior neutralizing protection against Omicron.
Second, Moderna is already studying two multi-valent booster
candidates in the clinic that were designed to anticipate mutations
such as those that have emerged in the Omicron variant.
The first candidate (mRNA-1273.211) includes several mutations
present in the Omicron variant that were also present in the Beta
variant of concern1. The Company has completed dosing in a
potentially pivotal safety and immunogenicity study of
mRNA-1273.211 at the 50 µg (N=300) and 100 µg (N=584) dose levels.
A second multi-valent candidate (mRNA-1273.213) includes many of
the mutations present in the Omicron variant that were also present
in the Beta and Delta variants2. The Company has completed dosing
at the 100 µg (N=584) dose level and also plans to explore the 50
µg dose level in approximately 584 participants. Moderna will
rapidly expand testing of sera from completed and ongoing
multi-valent booster studies to determine if these multi-valent
candidates are able to provide superior neutralizing protection
against Omicron.
Third, Moderna will rapidly advance an Omicron-specific
booster candidate (mRNA-1273.529). This candidate is part of
the Company’s strategy to advance variant-specific candidates for a
subset of variants of significant concern. During 2021 this has
already included Beta- and Delta-specific boosters. The Company has
repeatedly demonstrated the ability to advance new candidates to
clinical testing in 60-90 days.
“From the beginning, we have said that as we seek to defeat the
pandemic, it is imperative that we are proactive as the virus
evolves. The mutations in the Omicron variant are concerning and
for several days, we have been moving as fast as possible to
execute our strategy to address this variant,” said Stéphane
Bancel, Chief Executive Officer of Moderna. “We have three lines of
defense that we are advancing in parallel: we have already
evaluated a higher dose booster of mRNA-1273 (100 µg), second, we
are already studying two multi-valent booster candidates in the
clinic that were designed to anticipate mutations such as those
that have emerged in the Omicron variant and data is expected in
the coming weeks, and third, we are rapidly advancing a
Omicron-specific booster candidate (mRNA-1273.529).”
About Moderna
In 10 years since its inception, Moderna has transformed from a
science research-stage company advancing programs in the field of
messenger RNA (mRNA), to an enterprise with a diverse clinical
portfolio of vaccines and therapeutics across six modalities, a
broad intellectual property portfolio in areas including mRNA and
lipid nanoparticle formulation, and an integrated manufacturing
plant that allows for both clinical and commercial production at
scale and at unprecedented speed. Moderna maintains alliances with
a broad range of domestic and overseas government and commercial
collaborators, which has allowed for the pursuit of both
groundbreaking science and rapid scaling of manufacturing. Most
recently, Moderna’s capabilities have come together to allow the
authorized use of one of the earliest and most effective vaccines
against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic
and applied mRNA science, delivery technology and manufacturing,
and has allowed the development of therapeutics and vaccines for
infectious diseases, immuno-oncology, rare diseases, cardiovascular
diseases and auto-immune diseases. Moderna has been named a top
biopharmaceutical employer by Science for the past seven years. To
learn more, visit www.modernatx.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including regarding: the Company’s development of
a vaccine against the SARS-CoV-2 virus (mRNA-1273); the Company’s
efforts to develop vaccines against variants of the SARS-CoV-2
virus, including the Omicron variant (mRNA-1273.529); the potential
timing for developing a variant-specific vaccine candidate; the
testing of the Company’s existing vaccine candidates (including 100
µg boosters) against the Omicron variant and the timing for
assessment of effectiveness of those variant-specific strains; and
the mutations in the Omicron variant and their similarity to
mutations in other variants and their potential impact on waning
immunity. The forward-looking statements in this press release are
neither promises nor guarantees, and you should not place undue
reliance on these forward-looking statements because they involve
known and unknown risks, uncertainties, and other factors, many of
which are beyond Moderna’s control and which could cause actual
results to differ materially from those expressed or implied by
these forward-looking statements. These risks, uncertainties, and
other factors include those other risks and uncertainties described
under the heading “Risk Factors” in Moderna’s most recent Annual
Report on Form 10-K filed with the U.S. Securities and Exchange
Commission (SEC) and in subsequent filings made by Moderna with the
SEC, which are available on the SEC’s website at www.sec.gov.
Except as required by law, Moderna disclaims any intention or
responsibility for updating or revising any forward-looking
statements contained in this press release in the event of new
information, future developments or otherwise. These
forward-looking statements are based on Moderna’s current
expectations and speak only as of the date hereof.
1 Identical or similar S mutations (n=4): K417N, E484K/A, N501Y,
D614G 2 Identical or similar S mutations (n=8): T95I, G142D, K417N,
T478K, E484K/A, N501Y, D614G, P681R/H
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version on businesswire.com: https://www.businesswire.com/news/home/20211126005595/en/
Media: Colleen Hussey Director, Corporate Communications
617-335-1374 Colleen.Hussey@modernatx.com
Investors: Lavina Talukdar Senior Vice President & Head of
Investor Relations 617-209-5834 Lavina.Talukdar@modernatx.com
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