Single booster dose of 50 µg of mRNA-1273 or
mRNA-1273.351 increased neutralizing titers against SARS-CoV-2 and
two variants of concern (B.1.351, P.1) in previously vaccinated
clinical trial participants
Booster dose of mRNA-1273.351, a strain-matched
candidate, achieved higher titers against B.1.351 than a booster
dose of mRNA-1273
mRNA-1273.351 and mRNA-1273 booster doses were
generally well tolerated
Evaluation of a multivalent vaccine booster
candidate, mRNA-1273.211, is ongoing; data expected shortly
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced
initial data from its Phase 2 study showing that a single 50 µg
dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously
vaccinated individuals increased neutralizing antibody titer
responses against SARS-CoV-2 and two variants of concern, B.1.351
(first identified in South Africa) and P.1 (first identified in
Brazil). A booster dose of mRNA-1273.351, the Company’s
strain-matched booster, achieved higher neutralizing antibody
titers against the B.1.351 variant of concern than a booster dose
of mRNA-1273. A manuscript describing these preliminary results has
been submitted as a preprint to bioRxiv and will be submitted for
peer-reviewed publication upon completion of the multivalent
mRNA-1273.211 booster arm.
“As we seek to defeat the ongoing pandemic, we remain committed
to being proactive as the virus evolves. We are encouraged by these
new data, which reinforce our confidence that our booster strategy
should be protective against these newly detected variants. The
strong and rapid boost in titers to levels above primary
vaccination also clearly demonstrates the ability of mRNA-1273 to
induce immune memory,” said Stéphane Bancel, Chief Executive
Officer of Moderna. “Our mRNA platform allows for rapid design of
vaccine candidates that incorporate key virus mutations,
potentially allowing for faster development of future alternative
variant-matched vaccines should they be needed. We look forward to
sharing data on our multivalent booster candidate, mRNA-1273.211,
which combines mRNA-1273 and mRNA-1273.351 in a single vaccine,
when available. We will continue to make as many updates to our
COVID-19 vaccine as necessary to control the pandemic.”
The initial data is from an ongoing Phase 2 study in which three
strategies for boosting neutralizing titers in previously
vaccinated participants are being evaluated: mRNA-1273.351, a
booster candidate based on the B.1.351 variant first identified in
the Republic of South Africa, mRNA-1273.211, a multivalent booster
candidate which combines a 50-50 mix of mRNA-1273, Moderna’s
authorized vaccine against ancestral strains, and mRNA-1273.351 in
a single vaccine, and a 50 µg booster dose of mRNA-1273. Today’s
update includes preliminary data two weeks following administration
of a booster dose of mRNA-1273 or mRNA-1273.351. Evaluation of
additional samples collected at later timepoints after the booster,
the Company’s multivalent vaccine candidate, mRNA-1273.211, and a
lower dose of mRNA-1273.351 are ongoing and data is expected
shortly.
Participants in the Phase 2 study were tested for pseudovirus
neutralization (PsVN) titers prior to boosting approximately 6 to 8
months after their primary vaccination series. Although titers
versus the wild-type SARS-CoV-2 virus remained high, with 37 of 40
participants having detectable titers, titers against the variants
of concern (B.1.351 and P.1) were much lower, with approximately
half of participants having titers below the assay limit of
quantification prior to boosting. Two weeks after receiving either
mRNA-1273 or mRNA-1273.351, PsVN titers were boosted in all
participants and all variants tested. Following boost, geometric
mean titers (GMT) against the wild-type, B.1.351, and P.1 variants
increased to levels similar to or higher than the previously
reported peak titers against the ancestral (D614G) strain following
primary vaccination1.
mRNA-1273.351 appeared to be more effective at increasing
neutralization titers against the B.1.351 variant when compared to
mRNA-1273, as evidenced by higher mean GMT levels already at 15
days following booster dose (GMT = 1400 for mRNA-1273.351; GMT =
864 for mRNA-1273). The relative decrease in neutralizing titers
between the wild-type (D614G) and B.1.351 assays also improved with
mRNA-1273.351 booster, from a 7.7-fold difference prior to boost to
a 2.6-fold difference 15 days after boost, suggesting a potentially
more balanced immune response against the tested variants.
Safety and tolerability profiles following third dose booster
injections of 50 µg of mRNA-1273 or mRNA-1273.351 were generally
comparable to those observed after the second dose of mRNA-1273 in
the previously reported Phase 2 and Phase 3 studies. A review of
solicited adverse events indicated that the vaccine boosters were
generally well tolerated. The majority of adverse events were mild
or moderate in severity. The frequency of any Grade 3 solicited
local or systemic adverse events was 15% after the third dose of
mRNA-1273 and 10.5% after the third dose of mRNA-1273.351. There
were no Grade 4 solicited local or systemic adverse events. The
most common solicited local adverse event was injection site pain
in both groups. The most common solicited systemic adverse events
after the third dose of mRNA-1273.351 or mRNA-1273 were fatigue,
headache, myalgia and arthralgia. In general, mRNA-1273.351 had a
lower reactogenicity profile than mRNA-1273 in this study.
In parallel, the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health (NIH)
is conducting a separate Phase 1 study of mRNA-1273.351.
About the Moderna COVID-19 Vaccine
The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19
encoding for a prefusion stabilized form of the Spike (S) protein,
which was co-developed by Moderna and investigators from the
National Institute of Allergy and Infectious Diseases’ (NIAID)
Vaccine Research Center. The first clinical batch, which was funded
by the Coalition for Epidemic Preparedness Innovations, was
completed on February 7, 2020 and underwent analytical testing; it
was shipped to the National Institutes of Health (NIH) on February
24, 2020, 42 days from sequence selection. The first participant in
the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was
dosed on March 16, 2020, 63 days from sequence selection to Phase 1
study dosing. On May 12, 2020, the U.S. FDA granted the Moderna
COVID-19 Vaccine Fast Track designation. On May 29, 2020, the first
participants in each age cohort were dosed in the Phase 2 study of
the vaccine. On July 8, 2020, the Phase 2 study completed
enrollment.
Results from the second interim analysis of the NIH-led Phase 1
study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age
groups were published on September 29, 2020 in The New England
Journal of Medicine. On November 30, 2020, Moderna announced the
primary efficacy analysis of the Phase 3 study of the vaccine
conducted on 196 cases. On November 30, 2020, the Company also
announced that it filed for Emergency Use Authorization with the
U.S. FDA and a Conditional Marketing Authorization (CMA)
application with the European Medicines Agency. On December 18,
2020, the U.S. FDA authorized the emergency use of the Moderna
COVID-19 Vaccine in individuals 18 years of age or older. Moderna
has also received authorization for its COVID-19 vaccine from
health agencies in Canada, Israel, the European Union, the United
Kingdom, Switzerland, Singapore, Qatar, Taiwan and the World Health
Organization. Additional authorizations are currently under review
in other countries and by the World Health Organization.
Preclinical data on the Company’s variant-specific booster
vaccine candidates have been submitted as a preprint to bioRxiv and
will be submitted for peer-reviewed publication. These
variant-specific vaccine candidates include mRNA-1273.351, which is
more specifically targeted against the SARS-CoV-2 variant known as
B.1.351 first identified in the Republic of South Africa, and a
multivalent booster candidate, mRNA-1273.211, which combines
mRNA-1273 (Moderna’s authorized vaccine against ancestral strains)
and mRNA-1273.351 in a single vaccine. The Company’s Phase 2 study
to evaluate three approaches to boosting is ongoing.
The Biomedical Advanced Research and Development Authority
(BARDA), part of the Office of the Assistant Secretary for
Preparedness and Response (ASPR) within the U.S. Department of
Health and Human Services (HHS) is supporting the continued
research and development of the Company’s COVID-19 vaccine
development efforts with federal funding under contract no.
75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the
allowable costs incurred by the Company for conducting the program
described in the BARDA contract. The U.S. government has agreed to
purchase supply of mRNA-1273 under U.S. Department of Defense
contract no. W911QY-20-C-0100.
AUTHORIZED USE
Moderna COVID-19 Vaccine is authorized for use under an
Emergency Use Authorization (EUA) for active immunization to
prevent coronavirus disease 2019 (COVID-19) caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18
years of age and older.
IMPORTANT SAFETY INFORMATION
- Do not administer the Moderna COVID-19 Vaccine to individuals
with a known history of severe allergic reaction (e.g.,
anaphylaxis) to any component of the Moderna COVID-19 Vaccine.
- Appropriate medical treatment to manage immediate allergic
reactions must be immediately available in the event an acute
anaphylactic reaction occurs following administration of the
Moderna COVID-19 Vaccine. Monitor Moderna COVID-19 Vaccine
recipients for the occurrence of immediate adverse reactions
according to the Centers for Disease Control and Prevention
guidelines
(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).
- Immunocompromised persons, including individuals receiving
immunosuppressive therapy, may have a diminished response to the
Moderna COVID-19 Vaccine.
- The Moderna COVID-19 Vaccine may not protect all vaccine
recipients.
- Adverse reactions reported in a clinical trial following
administration of the Moderna COVID-19 Vaccine include pain at the
injection site, fatigue, headache, myalgia, arthralgia, chills,
nausea/vomiting, axillary swelling/tenderness, fever, swelling at
the injection site, and erythema at the injection site.
- Severe allergic reactions, including anaphylaxis, have been
reported following administration of the Moderna COVID-19 Vaccine
during mass vaccination outside of clinical trials.
- Available data on Moderna COVID-19 Vaccine administered to
pregnant women are insufficient to inform vaccine-associated risks
in pregnancy. Data are not available to assess the effects of
Moderna COVID-19 Vaccine on the breastfed infant or on milk
production/excretion.
- There are no data available on the interchangeability of the
Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete
the vaccination series. Individuals who have received one dose of
Moderna COVID-19 Vaccine should receive a second dose of Moderna
COVID-19 Vaccine to complete the vaccination series.
- Additional adverse reactions, some of which may be serious, may
become apparent with more widespread use of the Moderna COVID-19
Vaccine.
- Vaccination providers must complete and submit reports to VAERS
online at https://vaers.hhs.gov/reportevent.html. For further
assistance with reporting to VAERS, call 1-800-822-7967. The
reports should include the words “Moderna COVID-19 Vaccine EUA” in
the description section of the report.
Click for Fact Sheet for Healthcare Providers Administering
Vaccine (Vaccination Providers) and Full EUA Prescribing
Information for more information.
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. Today, 24 development programs
are underway across these therapeutic areas, with 13 programs
having entered the clinic. Moderna has been named a top
biopharmaceutical employer by Science for the past six 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 statements regarding: the Company’s
development of a vaccine (mRNA-1273) to protect against the
SARS-CoV-2 virus, which causes COVID-19; the Company’s efforts to
develop vaccines and boosters against variants of the SARS-CoV-2
virus; the potential for vaccines and boosters, including boosters
designed for variants of concern (B.1.351 and P.1) to increase
neutralizing antibody titer responses against SARS-CoV-2 and those
particular variants; the need for booster vaccines against the
SARS-CoV-2 virus and its variants and the potential dosages for
those booster vaccines; the conduct of clinical studies for
variant-specific boosters; the duration of protection against
SARS-CoV-2 from existing vaccines; the safety and tolerability of
the Company’s booster candidates; and the ability of the Company’s
mRNA platform to facilitate the rapid design of vaccine candidates
that incorporate key virus mutations. In some cases,
forward-looking statements can be identified by terminology such as
“will,” “may,” “should,” “could,” “expects,” “intends,” “plans,”
“aims,” “anticipates,” “believes,” “estimates,” “predicts,”
“potential,” “continue,” or the negative of these terms or other
comparable terminology, although not all forward-looking statements
contain these words. 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, among others: the fact
that there has never been a commercial product utilizing mRNA
technology approved for use; the fact that the rapid response
technology in use by Moderna is still being developed and
implemented; the safety, tolerability and efficacy profile of the
Moderna COVID-19 Vaccine observed to date may change adversely in
ongoing analyses of trial data or subsequent to commercialization;
the Moderna COVID-19 Vaccine may prove less effective against
variants of the SARS-CoV-2 virus, or the Company may be
unsuccessful in developing future versions of its vaccine against
these variants; despite having ongoing interactions with the FDA or
other regulatory agencies, the FDA or such other regulatory
agencies may not agree with the Company’s regulatory approval
strategies, components of our filings, such as clinical trial
designs, conduct and methodologies, or the sufficiency of data
submitted; Moderna may encounter delays in meeting manufacturing or
supply timelines or disruptions in its distribution plans for the
Moderna COVID-19 Vaccine; whether and when any biologics license
applications and/or additional emergency use authorization
applications may be filed in various jurisdictions and ultimately
approved by regulatory authorities; potential adverse impacts due
to the global COVID-19 pandemic such as delays in regulatory
review, manufacturing and clinical trials, supply chain
interruptions, adverse effects on healthcare systems and disruption
of the global economy; and 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 https://www.nejm.org/doi/full/10.1056/NEJMc2102179
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210505006025/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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