Moderna Receives FDA Fast Track Designation for Respiratory Syncytial Virus (RSV) Vaccine (mRNA-1345)
August 03 2021 - 9:10AM
Business Wire
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced
that the U.S. Food and Drug Administration (FDA) has granted Fast
Track designation for mRNA-1345, its investigational single-dose
mRNA vaccine against respiratory syncytial virus (RSV) in adults
older than 60 years of age.
“We are pursuing an mRNA RSV vaccine to protect the most
vulnerable populations – young children and older adults,” said
Stéphane Bancel, Chief Executive Officer of Moderna. “We are
studying mRNA-1345 in these populations in an ongoing clinical
trial and we look forward to sharing data when available. The Fast
Track designation for older adults underscores the urgent need for
a vaccine against RSV. With our investments in science and
manufacturing, we have taken eleven infectious disease vaccines
into human clinical trials. We have accelerated research and
development of our infectious disease therapeutic area and we will
continue to advance our mRNA vaccines into new areas of high unmet
need.”
Respiratory syncytial virus is a common respiratory virus that
generally causes cold-like symptoms. In the United States and areas
with similar climates, RSV infections occur primarily during fall,
winter, and spring. Most people recover in a week or two, but RSV
can be serious, especially for infants and older adults. RSV is the
most common cause of bronchiolitis and pneumonia in children
younger than one year of age in the United States and can result in
pneumonia and respiratory distress in older adults. According to
the U.S. Centers for Disease Control and Prevention, in the United
States, RSV leads each year, on average, to approximately 58,000
hospitalizations among children younger than five years old,
177,000 hospitalizations among adults 65 years and older and 14,000
deaths among adults 65 years and older. There is no approved
vaccine available today for RSV.
Fast Track is designed to facilitate the development and
expedite the review of therapies and vaccines for serious
conditions and that fill an unmet medical need. Programs with Fast
Track designation may benefit from early and frequent communication
with the FDA, in addition to a rolling submission of the marketing
application. The Company previously received Fast Track designation
for its COVID-19 vaccine candidate, Zika vaccine candidate
(mRNA-1893), methylmalonic acidemia (MMA) (mRNA-3704) and propionic
acidemia (PA) (mRNA-3927) programs.
The Phase 1 study of mRNA-1345 to evaluate the tolerability and
reactogenicity of mRNA-1345 in younger adults, older adults and
children is ongoing. All four cohorts of younger adults (ages 18-49
years) are fully enrolled. Dosing in the older adult cohort (ages
65-79 years) is ongoing. The age range of toddlers in this
de-escalation Phase 1 study is 12-59 months. The Company shared the
first interim analysis of the Phase 1 study of mRNA-1345, through
1-month post-vaccination, of the younger adult cohorts at its
annual Vaccines Day on April 14, 2021. Results showed the vaccine
candidate generated a geometric mean rise in neutralizing
antibodies relative to baseline of at least 11-fold.
The Company also intends to evaluate the potential of
combinations of mRNA-1345 with its vaccines against other
respiratory pathogens in children and separately in older adults.
Moderna owns worldwide commercial rights to mRNA-1345.
About mRNA-1345
mRNA-1345 is a vaccine against RSV encoding for a prefusion F
glycoprotein, which elicits a superior neutralizing antibody
response compared to the postfusion state. RSV is the leading cause
of respiratory illness in young children. Older adults (65+) are at
high risk for severe RSV infections. mRNA-1345 uses the same lipid
nanoparticle (LNP) as Moderna’s authorized COVID-19 vaccine and
contains optimized protein and codon sequences.
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
ground-breaking 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 16 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 regarding: the Company’s conduct of
clinical trials for its vaccine against RSV (mRNA-1345); and the
impact of FDA Fast Track designation for mRNA-1345. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210803005702/en/
Moderna: 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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