YF-VAX- yellow fever virus strain 17d-204 live antigen injection, powder, lyophilized, for suspension DILUENT- sodium chloride

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN (UNII: PY4EET359T) (YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN - UNII:PY4EET359T)

Available from:

Sanofi Pasteur Inc.

INN (International Name):

YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN

Composition:

YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN 4.74 [PFU] in 0.5 mL

Administration route:

SUBCUTANEOUS

Therapeutic indications:

YF-VAX is indicated for active immunization for the prevention of yellow fever in persons 9 months of age and older in the following categories: While the actual risk for contracting yellow fever during travel is probably low, variability of itineraries, behaviors and seasonal incidence of disease make it difficult to predict the actual risk for a given individual living in or traveling to a known endemic or epidemic area. Greater risk is associated with living in or traveling to areas of South America and Africa where yellow fever infection is officially reported at the time of travel and with traveling outside the urban areas of countries that do not officially report the disease but that lie in a yellow fever endemic zone. Some countries require an individual to have a valid International Certificate of Vaccination or Prophylaxis (ICVP) if the individual has been in countries either known or thought to harbor yellow fever virus. The certificate becomes valid 10 days after vaccination with YF-VAX. (13) (14)

Product summary:

The vial stoppers for YF-VAX vaccine and diluent are not made with natural rubber latex. Vaccine, single dose vial (NDC 49281-915-58) supplied in a package of 5 vials (NDC 49281-915-01). Diluent, single dose vial, 0.6 mL (NDC 49281-912-59) supplied separately in a package of 5 vials (NDC 49281-912-05). Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Do not use vaccine after expiration date. YF-VAX does not contain a preservative. The following stability information for YF-VAX is provided for those countries or areas of the world where an adequate cold chain is a problem and inadvertent exposure to abnormal temperatures has occurred. Half-life is reduced from approximately 14 days at 35° to 37°C to 3-4.5 days at 45° to 47°C.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

YF-VAX- YELLOW FEVER VIRUS STRAIN 17D-204 LIVE ANTIGEN INJECTION,
POWDER,
LYOPHILIZED, FOR SUSPENSION
DILUENT- SODIUM CHLORIDE INJECTION
SANOFI PASTEUR INC.
REFERENCE LABEL SET ID: 424F6E3D-14FD-4F77-ACD5-B88EB18B2EAA
----------
YF-VAX
AHFS Category: 80:12
Rx only
Yellow Fever Vaccine
DESCRIPTION
YF-VAX , Yellow Fever Vaccine, for subcutaneous use, is prepared by
culturing the 17D-
204 strain of yellow fever virus in living avian leukosis virus-free
(ALV-free) chicken
embryos. The vaccine contains sorbitol and gelatin as a stabilizer, is
lyophilized, and is
hermetically sealed under nitrogen. No preservative is added. Each
vial of vaccine is
supplied with a separate vial of sterile diluent, which contains
Sodium Chloride Injection
USP – without a preservative. YF-VAX is formulated to contain not
less than 4.74 log
plaque forming units (PFU) per 0.5 mL dose throughout the life of the
product. Before
reconstitution, YF-VAX is a pinkish color. After reconstitution,
YF-VAX is a slight pink-
brown suspension.
The vial stoppers for YF-VAX and diluent are not made with natural
rubber latex.
CLINICAL PHARMACOLOGY
Yellow fever is an acute viral illness caused by a mosquito-borne
flavivirus. Most yellow
fever virus infections are asymptomatic. In those individuals who
develop disease, the
clinical spectrum ranges from nonspecific flu-like illness with fever,
malaise, prostration,
headache, photophobia, generalized arthralgia and myalgia, nausea,
and/or vomiting to
potentially lethal pansystemic disease, most prominently involving the
liver, kidneys, GI
tract, and brain, with recrudescing fever, jaundice, renal failure,
severe hemorrhage due
to thrombocytopenia, and shock. (1) The case-fatality rate of yellow
fever varies widely
in different studies but is typically 20% or higher. Jaundice or other
gross evidence of
severe liver disease is associated with higher mortality rates.
Two live, attenuated yellow fever vaccines, strains 17D-204 and 17DD,
were derived in
parallel in the 1930s. Historical data suggest that these "