YF-VAX Yellow Fever Vaccine Description
YF-VAX is prepared by culturing the 17D-204 strain of yellow fever virus in living avian leukosis-free chicken embryos. The vaccine contains sorbitol and gelatin as a stabilizer, lyophilized, and is hermetically sealed under nitrogen. No preservative is added.
The vaccine must be reconstituted immediately before using the sterile diluent provided (Sodium Chloride Injection USP - contains no preservative). After reconstitution, YF-VAX® is a slight pink-brown suspension. YF-VAX® complies with the yellow fever vaccine standards of the World Health Organization.
The U.S. FDA reported 'two live, attenuated yellow fever vaccines, strains 17D-204 and 17DD, were derived in parallel in the 1930s. Historical data suggest that these “17D vaccines” have identical safety and immunogenicity profiles. Vaccination with 17D strain vaccines is predicted to elicit an immune response identical in quality to that induced by wild-type infection. This response is presumed to result from initial infection of cells in the dermis or other subcutaneous tissues near the injection site, with subsequent replication and limited spread of virus leading to the processing and presentation of viral antigens to the immune system, as would occur during infection with wild-type yellow fever virus. The humoral immune response to the viral structural proteins, as opposed to a cell-mediated response, is most important in the protective effect induced by 17D vaccines.
Sanofi Pasteur has been working with the U.S. FDA, CDC, DOD, and other stakeholders since 2016. As a result, vaccination against yellow fever remains available for travelers, U.S. government employees, military, and other response groups.
On December 23, 2020, Sanofi Pasteur announced the U.S. FDA had licensed the new U.S. YF-VAX production facility, and doses continue to progress through manufacturing. Efforts are underway to build inventory and supply of YF-VAX and will continue to be prioritized for the U.S. military. Additionally, Sanofi Pasteur announced that effective April 5, 2021, YF-VAX® (Yellow Fever Vaccine) is available for purchase in the U.S. for authorized YF-VAX providers.
Yellow fever vaccination is required by law upon entry to certain countries irrespective of the traveler's country of origin and in other countries when travelers are coming from endemic areas. Yellow fever is an acute viral hemorrhagic disease transmitted by infected mosquitoes. The "yellow" in the name refers to jaundice that affects some patients.
NDC Code: 49281-915-01
Sanofi Pasteur, a Sanofi company, aims to support continued access to yellow fever vaccination for travelers to international destinations where the yellow fever vaccine is required or recommended. Sanofi is dedicated to supporting people through their health challenges.
YF-VAX Yellow Fever Vaccine Indication
YF-VAX is indicated for active immunization to prevent yellow fever in persons nine months of age and older who are at increased risk for yellow fever to help prevent them from getting the disease. However, vaccination with YF-VAX may not protect all individuals.
YF-VAX should not be given to an individual who has experienced a serious allergic reaction to eggs, egg products, or any vaccine component (including gelatin). A severe allergic reaction (e.g., anaphylaxis) may occur following the use of YF-VAX, even in individuals with no prior history of hypersensitivity to the vaccine components.
In addition, the following persons should not receive YF-VAX: infants younger than nine months of age due to an increased risk of inflammation of the brain (encephalitis), women who are breastfeeding infants younger than nine months of age, and individuals with a severely suppressed or compromised immune system. Rarely, the yellow fever vaccine has been associated with disease affecting multiple organs, including inflammation of the brain. These serious adverse events occur more often in individuals 60 years of age and over. Therefore, the risk of disease versus the risk of a serious adverse event should be assessed before vaccine administration.
Geriatrics: YF-VAX® is indicated in persons 60 years of age and above.
Pediatrics: YF-VAX® is indicated in persons nine months of age or older. Vaccination of infants less than 9 months of age IS CONTRAINDICATED because of the risk of encephalitis, and travel of such persons to rural areas in yellow fever endemic zones or to countries experiencing an epidemic should be postponed or avoided, whenever possible.
Pregnant Women: Pregnant women should be considered for immunization only if travel to an area with a risk of yellow fever is unavoidable. It is also not known whether the YF-VAX vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. YF-VAX vaccine should be given to a pregnant woman only if clearly needed. The seroconversion rate to 17D vaccines is markedly reduced in pregnant women.
YF-VAX Yellow Fever Vaccine Side Effects
The most common side effects of YF-VAX include swelling and pain at the injection site, headache, generalized muscle aches or discomfort, and fever. Other side effects may occur. YF-VAX vaccine should not be given to an individual who has experienced a serious allergic reaction to eggs, egg products, or a vaccine component using gelatin. A severe allergic reaction (e.g., anaphylaxis) may occur following the use of the YF-VAX vaccine, even in individuals with no prior history of hypersensitivity to the vaccine components. In addition, the following persons should not receive the YF-VAX vaccine: infants younger than nine months of age, women who are breastfeeding infants younger than nine months of age, and individuals with a severely suppressed or compromised immune system. Rarely, the yellow fever vaccine has been associated with disease affecting multiple organs, including inflammation of the brain.
YF-VAX Yellow Fever Vaccine Dosage
YF-VAX is administered as a single subcutaneous injection of 0.5 mL of reconstituted vaccine. Do not administer YF-VAX by intravascular, intramuscular, or intradermal routes. A single dose protects for ten years for most people.
Sanofi Pasteur's complete YF-VAX Vaccine Prescribing Information is available. The vial stoppers for YF-VAX and diluent are not made with natural rubber latex.
YF-VAX Yellow Fever Vaccine News
September 30, 2021 - The U.S. CDC announced an outbreak of yellow fever in Nigeria, first reported in November 2020. Furthermore, 'Travelers to Nigeria should take steps to prevent yellow fever by getting vaccinated at least ten days before travel.'
April 5, 2021 - The U.S. CDC confirmed Sanofi Pasteur announced that YF-VAX is once again available for purchase in the USA. Providers with a current Yellow Fever Vaccination Stamp issued by their state or territorial health department may now order YF-VAX from the manufacturer.
December 23, 2020 - Sanofi Pasteur confirmed the US Expanded Access Investigational Drug Application Program (EAP) for STAMARIL® would continue into 2021. Therefore, when YF-VAX returns, there will be a brief period of transition to discontinue the STAMARIL EAP.
October 23, 2020 - The South Sudan Ministry of Health and other partners launched a reactive yellow fever vaccination campaign in Kajo, Keji, Central Equatoria State. The campaign aims to protect over 90,000 individuals aged nine months to 60 years from yellow fever infection.
June 25, 2020 - Sanofi Pasteur's new U.S. YF-VAX® vaccine production facility has been licensed by the U.S. FDA, and doses continue to progress through manufacturing. Efforts are underway to build vaccine supplies, and the U.S. supplies of YF-VAX will continue to be prioritized for the U.S. military. We expect to have more information on the return of YF-VAX in December 2020. The Expanded Access Investigational New Drug Application program for STAMARIL® is expected to continue through 2020. When YF-VAX returns, supplies will be limited, resulting in a gradual transition away from STAMARIL and back to YF-VAX.
December 23, 2019 - Sanofi has worked with the US Food and Drug Administration (FDA) to provide the STAMARIL vaccine through an Expanded Access Program (EAP) during the YF-VAX vaccine shortage.
August 6, 2019 - The U.S. FDA approved an Expanded Approval Letter for the YF-VAX yellow fever vaccine.
May 2, 2019 – A new state-of-the-art Yellow Fever Vaccine production facility in the USA has been licensed by the Food & Drug Administration (FDA). The transition of production of YF-VAX continues, said Sanofi Pasteur in a statement.
March 16, 2018 - Brazil is amidst a yellow fever outbreak, with the mosquito-borne virus reaching popular tourist destinations that do not normally see the disease. Since January 2018, 10 cases of yellow fever have been confirmed in international travelers visiting Brazil, including 4 deaths.
June 15, 2016 - FDA Approval Letter - To revise the YF-VAX package insert to align Booster Dosing language with recent changes to International Health Regulations and WHO/ACIP recommendations and modify the text throughout the document to clarify and update the presented information.
YF-VAX Yellow Fever Vaccine Clinical Trials
YF-VAX continues to be studied in various clinical trials.