Press Release: U.S. CDC Advisory Committee unanimously recommends
routine use of Beyfortus™ (nirsevimab-alip) to protect infants
against RSV disease
U.S. CDC Advisory Committee unanimously recommends
routine use of Beyfortus™ (nirsevimab-alip) to protect infants
against RSV disease
- Recommendation for use in all infants
below 8 months of age follows earlier than anticipated FDA approval
and unanimous FDA Advisory Committee vote
- Committee also voted unanimously to
include Beyfortus in the Vaccines for Children program, supporting
equitable access for all eligible infants
- Beyfortus™ is the first RSV
prevention approved to protect all infants in the U.S. through
their first RSV season and will be available ahead of the 2023-2024
RSV season
Paris,
August 3, 2023.
The U.S. Centers for Disease Control and Prevention’s (CDC)
Advisory Committee on Immunization Practices (ACIP) voted
unanimously 10 to 0 to recommend routine use of Sanofi and
AstraZeneca’s Beyfortus™ (nirsevimab-alip) for the prevention of
respiratory syncytial virus (RSV) lower respiratory tract disease
for newborns and infants below 8 months of age born during or
entering their first RSV season.
The Committee also voted unanimously 10 to 0 to
recommend routine use of Beyfortus for children aged 8 to 19 months
who are at increased risk of severe RSV disease and entering their
second RSV season.
Additionally, the ACIP voted unanimously 11 to 0
to include Beyfortus in the Vaccines for Children (VFC) program.
Beyfortus will be available in the U.S. ahead of the upcoming
2023-2024 RSV season.
Thomas Triomphe Executive Vice
President, Vaccines, Sanofi “Today, we have turned the corner on
the threat of RSV to our youngest, most vulnerable population. The
ACIP’s unanimous recommendations for routine use of Beyfortus and
inclusion in the Vaccines for Children program are critical steps
toward providing millions of parents in the U.S. with the ability
to protect their babies through their first RSV season, when they
are most susceptible to severe RSV disease. We appreciate the FDA
and CDC leadership, as well as the ACIP public health experts, for
recognizing and quickly acting on the threat RSV poses to all
infants.”
Dr Regena Spratling, PhD, RN, APRN,
CPNP-PC, FAANP, FAAN President, National Association of
Pediatric Nurse Practitioners“As front-line providers managing the
physical and emotional toll of RSV on our patients and their
families, especially during the surges of the last two years, our
community of pediatric-focused nurse practitioners welcomes the
recent approval of nirsevimab. Today’s ACIP vote to include
nirsevimab in routine immunization schedules, along with continued
efforts to educate the public about the impact of RSV prevention,
will help ensure equitable access to this immunization and help
alleviate the strain RSV disease places on babies, families, and
health care systems.”
The provisional ACIP recommendations will be
forwarded to the director of the CDC and the U.S. Department of
Health and Human Services for review and approval. The official
recommendations will be published in the CDC’s Morbidity and
Mortality Weekly Report (MMWR). Once approved, routine use of
Beyfortus would be included in the CDC’s Child and Adolescent
Immunization
Schedule.
About the U.S. ACIP and CDC recommendationsThe
ACIP is a body of independent health experts that advises the CDC
and the nation on the types of populations and circumstances for
which immunizations should be used. The CDC reviews advice from the
ACIP and publishes final recommendations in the MMWR. The
Affordable Care Act (ACA) generally requires coverage for all
immunizations administered in accordance with final CDC
recommendations. This requirement applies to all non-grandfathered
commercial plans and Medicaid expansion beneficiaries. Individuals,
or their healthcare providers, should contact their health
insurance plan to determine coverage and reimbursement requirements
as well as adoption timeframes. The Vaccines for Children (VFC)
program helps provide immunizations to children whose parents or
guardians may not be able to afford them. This helps ensure that
all children have a better chance of getting their recommended
immunizations on schedule.
About RSVRSV is a very contagious virus that can
lead to serious respiratory illness for infants, according to the
Centers for Disease Control and Prevention (CDC). RSV symptoms can
include runny nose, coughing, sneezing, fever, decrease in
appetite, and wheezing.1 Two out of three infants are infected with
RSV during their first year of life and almost all children are
infected by their second birthday.1,2 In the U.S., RSV is the
leading cause of hospitalization in infants under 12 months,
averaging 16 times higher than the annual rate for influenza.3,4
Approximately 75% of infants hospitalized for RSV are born healthy
and at term with no underlying conditions.5 Each year in the U.S.,
an estimated 590,000 RSV disease cases in infants under one require
medical care, including physician office, urgent care, emergency
room visits and hospitalizations.6
About BeyfortusIn the U.S., Beyfortus is the
first RSV prevention approved to protect all infants through their
first RSV season, including for those born healthy at term or
preterm, or with specific health conditions that make them
vulnerable to RSV disease. Beyfortus is also approved for children
up to 24 months of age who remain vulnerable to severe RSV disease
through their second RSV season.
As a long-acting antibody provided directly to
newborns and infants as a single dose, Beyfortus offers rapid
protection to help prevent lower respiratory tract disease caused
by RSV without requiring activation of the immune system.7
Beyfortus administration can be timed to the start of the RSV
season.
Beyfortus was granted Breakthrough Therapy and
Fast-Track designations and was approved by the FDA on July 17,
2023 following the positive recommendation of the FDA Antimicrobial
Drugs Advisory Committee. The approval was based on the extensive
Beyfortus clinical development program spanning three pivotal
late-stage clinical trials. Across all clinical endpoints, a single
dose of Beyfortus delivered high, consistent and sustained efficacy
against RSV lower respiratory tract disease extending through five
months, a typical RSV season.
In March 2017, Sanofi and AstraZeneca announced
an agreement to develop and commercialize Beyfortus. Under the
terms of the agreement, AstraZeneca leads development and
manufacturing activities and Sanofi leads commercialization
activities and records revenues. Under the terms of the global
agreement, Sanofi made an upfront payment of €120m, has paid
development and regulatory milestones of €120m and will pay up to a
further €375m upon achievement of certain regulatory and
sales-related milestones. The two companies share costs and profits
in all territories except in the U.S. where Sanofi consolidates
100% of the economic benefits in its Business Operating Income.
Beyfortus has been granted special designations
to facilitate expedited development by several regulatory agencies
around the world. These include Breakthrough Therapy Designation
and Priority Review designation by The China Center for Drug
Evaluation under the National Medical Products
Administration; Breakthrough Therapy Designation and
Fast Track Designation from the U.S. Food and Drug Administration;
access granted to the European Medicines Agency
(EMA) PRIority MEdicines (PRIME) scheme and EMA
accelerated assessment; Promising Innovative Medicine designation
by the UK Medicines and Healthcare products Regulatory Agency; and
has been named “a medicine for prioritized development” under the
Project for Drug Selection to Promote New Drug Development in
Pediatrics by the Japan Agency for Medical Research and
Development.
Beyfortus has been granted marketing
authorization in the European Union, Great Britain and Canada for
the prevention of RSV lower respiratory tract disease in newborns
and infants from birth through their first RSV season and is
currently undergoing regulatory review in China, Japan and several
other countries. In Canada, nirsevimab is also approved for
children up to 24 months of age who remain vulnerable to severe RSV
disease through their second RSV season and such indication is
under review at the EMA level.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ:
SNY
Media RelationsSandrine
Guendoul | + 33 6 25 09
14 25 | sandrine.guendoul@sanofi.comEvan
Berland | +1 215 432 0234 |
evan.berland@sanofi.comNicolas
Obrist | + 33 6 77 21 27 55
| nicolas.obrist@sanofi.com
Investor RelationsEva
Schaefer-Jansen | + 33 7 86 80 56 39
| eva.schaefer-jansen@sanofi.comArnaud
Delépine | + 33 6 73 69
36 93 | arnaud.delepine@sanofi.comCorentine
Driancourt | + 33 6 40
56 92 21 | corentine.driancourt@sanofi.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.comTarik
Elgoutni| + 1
617 710 3587 | tarik.elgoutni@sanofi.comNathalie
Pham | + 33 7 85 93 30 17 |
nathalie.pham@sanofi.com
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References
- CDC. RSV in Infants and Young
Children.
https://www.cdc.gov/rsv/high-risk/infants-young-children.html.
Accessed August 2023.
- Walsh, EE. Respiratory Syncytial
Virus Infection: An Illness for All Ages. Clinics in Chest
Medicine. 2017;38(1):29-36.
https://doi.org/10.1016/j.ccm.2016.11.010.
- Leader S, Kohlhase K. Recent trends
in severe respiratory syncytial virus (RSV) among US infants, 1997
to 2000. J Pediatr. 2003;143(5 Suppl):S127-S132.
doi:10.1067/s0022-3476(03)00510-9.
- Zhou H, et al. Clin Infect Dis.
2012;54:1427–1436.
- Esposito S, et al. RSV Prevention
in All Infants: Which Is the Most Preferable Strategy? Front
Immunol. 2022; 13: 880368. doi: 10.3389/fimmu.2022.880368.
- Rainisch G, et al. Estimating the
impact of multiple immunization products on medically-attended
respiratory syncytial virus (RSV) infections in infants. Vaccine.
2020;38(2):251-257.
https://doi.org/10.1016/j.vaccine.2019.10.023
- Centers for Disease Control and
Prevention. Vaccines & Immunizations. August 18, 2017.
https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm. Accessed
August 2023.
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