YF-VAX Vaccine Description
YF-VAX is prepared by culturing the 17D-204 strain of yellow fever virus in living avian leukosis virus-free chicken embryos. The vaccine contains sorbitol and gelatin as a stabilizer, is lyophilized, and is hermetically sealed under nitrogen. No preservative is added.
The vaccine must be reconstituted immediately before use with 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.
Sanofi Pasteur has been working with U.S. FDA, CDC, DOD, and other stakeholders since 2016 so that vaccination against yellow fever remains available for travelers, U.S. government employees, military, and other response groups.
Sanofi Pasteur, the manufacturer of YF-VAX licensed in the United States, announced a total depletion of YF-Vax as they transition to a new production facility.
Sanofi has worked with the FDA to distribute STAMARIL through an Expanded Access Program during the YF-VAX vaccine shortage until the production of YF-VAX vaccine resumes in its new facility.
The Stamaril vaccine, manufactured by Sanofi Pasteur in France, is a live, attenuated yellow fever vaccine that is investigational/unlicensed in the U.S., but it is registered and currently distributed in over 70 countries.
Sanofi Pasteur, a Sanofi company's goal is 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 Vaccine Indication
YF-VAX is indicated for active immunization for the prevention of yellow fever in persons 9 months of age and older who are at increased risk for yellow fever to help prevent them from getting the disease.
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.
Geriatrics: YF-VAX® is indicated in persons 60 years of age and above.
Pediatrics YF-VAX® is indicated in persons 9 months of age or older.
Pregnant Women Pregnant women should be considered for immunization only if travel to an area with risk of yellow fever is unavoidable.
YF-VAX vaccine should not be given to an individual who has experienced a serious allergic reaction to eggs, egg products, or to any component of the vaccine (including gelatin). A severe allergic reaction (eg, anaphylaxis) may occur following the use of YF-VAX vaccine, even in individuals with no prior history of hypersensitivity to the vaccine components.
In addition, the following persons should not receive YF-VAX vaccine: infants younger than 9 months of age, women who are breastfeeding infants younger than 9 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.
The most common side effects to the YF-VAX vaccine include swelling and pain at the injection site; headache, generalized muscle aches or discomfort, and fever. Other side effects may occur. Vaccination with YF-VAX vaccine may not protect all individuals.
YF-VAX 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 provides protection for 10 years for most people.
Sanofi Pasteur’s full YF-VAX Vaccine Prescribing Information is available.
YF-VAX Vaccine News
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) and the transition of production of YF-VAX continues, said Sanofi Pasteur in a statement.
March 16, 2018 - Brazil is in the midst of 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 to modify the text throughout the document to clarify and update the presented information.
YF-VAX Vaccine Clinical Trials
Phase 1 Clinical Trial NCT00254826: Yellow Fever Virus Vaccine and Immune Globulin Study (Completed)
The purpose of this Phase 1 study is to determine whether immune globulin can limit the amount of yellow fever vaccine virus present in the blood after vaccination without compromising the immunity associated with the yellow fever vaccine. The study will enroll 80 participants in two groups of 40 each. The first group will receive the yellow fever vaccine with a salt-water placebo. The second group will receive a yellow fever vaccine with immune globulin. The amount of vaccine virus and immune response in both groups will be compared. Yellow fever vaccine has been used to protect humans against Yellow Fever Vaccine disease since the 1930s.
Phase 2 Clinical Trial NCT04142086: Dose-ranging Study of an Investigational Yellow Fever Candidate Vaccine in Adults (VYF01) (Suspended due to COVID-19 pandemic). Last Update Posted: April 15, 2020.
The primary objectives of the study are:
- To describe the safety profile of each of the 3 dosages of vYF and of YF-VAX® within the 28 days post-vaccination and up to the 6 months (Day 180) post-vaccination visit
- To describe the antibody responses elicited by each of the 3 dosages of vYF and by YF-VAX on Day 0 pre-vaccination and then on Day 10, Day 14, Day 28 and 6 months (Day 180) post-vaccination overall and by baseline flavivirus serostatus
- To quantify detectable yellow fever (YF) vaccinal viremia in each vaccine group (vYF and YF-VAX) in a subset of subjects on Day 0 visit, Day 1 visit, Day 3 visit, Day 5 visit, Day 7 visit, Day 10 visit, and Day 14 visit.