Stamaril® Yellow Fever Vaccine Clinical Trials, Dosage, Efficacy, Side Effects, Usage
Sanofi Stamaril® (17D-YFV, 17D-213) is a live, attenuated yellow fever vaccine containing the active Yellow fever virus 17D-204 strain produced in specified pathogen-free chick embryos. This yellow fever vaccine contains less than one mmol sodium (23 mg) per dose, essentially "sodium-free," and less than one mmol potassium (39 mg) per dose. In addition, this yellow fever vaccine contains approximately 8 mg of sorbitol per dose. Efficacy results from neutralizing antibodies and a robust T-cell response were reported in a peer-reviewed 2016 study. In addition, the humoral and cellular immunity elicited by 17D has been well characterized in humans, according to the World Health Organization (WHO).
The duration of protection against yellow fever after administering one 0.5 mL dose of Stamaril is expected to be at least ten years. The 17D line of yellow fever virus vaccines is among the most effective vaccines ever created, according to a 2017 study. Stamaril is considered investigational in the U.S. and is not a U.S. Food and Drug Administration (FDA) licensed product. As of May 6, 2021, shipments of Stamaril as part of the U.S. Expanded Access Program were discontinued. Product information is available in Canada, Australia, and the U.K. On July 4, 2021, the European Medicines Agency (EMA) published EMEA/169383/2006). Various E.U. countries authorize Stamaril. Stamaril's ATC code is J07BL; the Drugbank Accession Number is DB10805.
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Stamaril Vaccine Price
UNICEF published that yellow fever vaccine prices range from 4.85 USD to 16.70 USD. Additional yellow fever vaccine price and discount information is posted at InstantRx™.
Stamaril Vaccine Availability 2024
As of November 2024, the Stamaril is available in 70 countries. Sanofi Pasteur's Stamaril has been offered in Europe, Scotland, the U.K., Uganda, Nigeria, New Zealand, the Republic of Congo, and throughout the Region of the Americas. During 2023 and 2024, over 80 million people were protected in Africa through vaccination campaigns. In April 2024, Uhanda's Karamoja, Teso, Masaka, Ankole, and Kampala Metropolitan regions where 14 million persons are being vaccinated. The WHO strategy driven by PAHO seeks to vaccinate nearly one billion people by 2026. From January 2021 to August 2022, a total of 3,991,568 persons were vaccinated with Stamaril.
Stamaril Coadministration
A non-peer-reviewed study conducted by researchers in Europe performed an open-label, non-randomized clinical trial evaluating the safety and immunogenicity following simultaneous delivery of the Yellow fever virus (YFV) vaccine with Tick-borne encephalitis virus (TBEV) and Japanese encephalitis virus (J.E.) virus vaccines. Published on July 11, 2022, the Conclusions are: Inactivated TBEV or JEV vaccines can be coadministered with the live attenuated YFV vaccine without an increased risk of adverse events and reduced development of nAbs to the respective viruses. Furthermore, the vaccines can safely be delivered in the same upper arm without adverse outcomes.
Stamaril Indication
Stamaril vaccination is indicated for active immunization against yellow fever for adults and children aged nine months and older when traveling to, passing through, or living in an endemic area, traveling to any country that requires an International Certificate of Vaccination for entry (which may or may not depend on the previous itinerary), and handling potentially infectious materials (e.g., laboratory personnel). The vaccine should be given at least ten days before entering an endemic area since protective immunity may not be achieved until at least this time has elapsed. Children aged six months up to 9 months should only be vaccinated under special circumstances.
On November 16, 2021, the U.K. Medicines and Healthcare Products Regulatory Agency published a standardized pre-vaccination checklist to ensure the yellow fever vaccine is indicated for the intended travel destination and to enable vaccinators to identify existing contraindications or precautions in individuals before vaccination.
Stamaril Dosage
The Stamaril yellow fever vaccine should be given at least ten days before entering an endemic area since protective immunity may not be achieved until this time has elapsed. According to the CDC, Stamarila is a single, 0.5-milliliter dose given to adults and children from 9 months of age. However, a yellow fever booster with one dose (0.5 milliliters) may be needed if you or your child had an insufficient response to the first dose or after at least ten years if required as a condition of entry in some countries, says the CDC.
Stamaril Fractional Dose
The Lancet Infectious Diseases published a study on April 28, 2023: Immunogenicity and safety of fractional doses of 17D-213 yellow fever vaccine in children: a randomized, double-blind, non-inferiority substudy of a phase 4 trial. Conclusions: Fractional doses of the 17D-213 vaccine were non-inferior to standard doses in inducing seroconversion 28 days after vaccination in children aged 9–59 months when assessed with PRNT50. However, we found fewer children seroconverted at ten days. The results support the use of fractional doses of yellow fever vaccines in WHO recommendations for outbreak response in the event of a yellow fever vaccine shortage, including in children. A study published in 2018 reported that a one-fifth fractional dose of the Stamaril yellow fever vaccine delivers protective antibodies. However, this suggestion is not FDA, CDC, or EMA-approved.
Stamaril Side Effects
According to a study published on March 31, 2023, 627.079 individuals received STAMARIL from May 2017 through June 2021; of these, 1308 (0.2%) reported at least one adverse event (AE), of which 122 reported at least one Severe AE. The following serious side effects have sometimes been reported, including Allergic reactions. In addition, reactions affecting the brain and nerves may occur within one month of the vaccination and sometimes be fatal.
Stamaril Women
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your healthcare professional for advice. You should not receive STAMARIL during pregnancy or breastfeeding unless this cannot be avoided. Also, you are recommended not to become pregnant within one month after receiving STAMARIL. Your healthcare professional can advise you on whether you must be vaccinated. If vaccination is needed, it is recommended to interrupt breastfeeding for at least two weeks after receiving STAMARIL. Consult your healthcare professional if you receive the vaccine while pregnant or breastfeeding.
The CDC says, 'the Yellow fever vaccine has been given to many pregnant women without any apparent adverse effects on the fetus. But, since the yellow fever vaccine is a live virus vaccine, it poses a theoretical risk, says the CDC. And, 'pregnant women should avoid or postpone travel to an area with a risk of yellow fever. If travel cannot be avoided, discuss vaccination with your healthcare provider before departure,' says the CDC.
Stamaril and HIV
The Lancet published a study on April 28, 2023, that provides confidence that fractional dose recommendations apply to populations with high HIV prevalence.
Stamaril Immunocompromised
Randomized and quasi-randomized clinical trials and observational studies that included immunocompromised participants (individuals with HIV infection, organ transplants, and cancer who used immunosuppressive drugs for rheumatologic diseases and those on immunosuppressive therapy for other diseases) were selected. Study Conclusions - It is impossible to affirm that immunocompromised individuals, regardless of etiology, have a higher risk of adverse events after receiving the YF vaccine.
Stamaril Vaccine News
November 8, 2024 - The Republic of Columbia recently conducted a Stamaril vaccination campaign.
April 11, 2024 - Uganda launches phase 2 yellow fever vaccinations for 14 million people.
January 4, 2024 - Phylogenetic analysis reveals a new introduction of the Yellow Fever virus in São Paulo State, Brazil, 2023.
April 28, 2023 - The Lancet published an article: Fractional dose yellow fever vaccination, coming of age.
March 15, 2023 - Uganda launched an extensive (1.9 million) vaccination program for children.
February 8, 2023—The Tribune Online reported that Nigeria's Bayelsa State Government declared a state of emergency regarding yellow fever vaccination.
January 3, 2022 - The WHO Africa reported that 4,385,320 persons were vaccinated in Cameroon, the Central African Republic, Chad, Ghana, and Kenya from 2021 through December 7, 2022.
December 12, 2022 - The WHO Africa reported 81 children received life-saving yellow fever vaccines in eastern Nigeria.
September 22, 2022 - The Republic of Uraguay required proof of yellow fever vaccine for certain people visiting or departing from the country.
August 5, 2022 - The Republic of the Congo launched a yellow fever vaccination campaign to vaccinate 4 million people.
March 2, 2022 - The temporary low-stock situation in the U.K. has been resolved.
December 1, 2021—The WHO reported that since November 6, 2021, a focused vaccination activity targeting 54,964 people aged six months to 60 years (excluding pregnant women) has been conducted in over 80 communities in the West and North Gonja districts in the Savannah region. The International Coordinating Group on Vaccine Provision for Yellow Fever has approved a campaign targeting 361,165 people (9 months—60 years) in five affected districts.
April 2021—The U.S. CDC confirmed Pasteur's announcement that YF-VAX is once again available for purchase in the U.S.
March 9, 2021 - The Canadian Committee to Advise on Tropical Medicine and Travel Interim Canadian recommendations for using a fractional yellow fever vaccine during a vaccine shortage.
June 25, 2020 - To help meet the continued yellow fever vaccination needs in the U.S., STAMARIL® (Yellow Fever Vaccine [Live]) will continue to be available throughout 2020.
December 23, 2019 – To help meet the continued yellow fever vaccine consumer demand in the USA, the manufacturer of the STAMARIL® vaccine announced it would continue to be available throughout 2020.
May 8, 2019 – A long-term study found no evidence that a Y.F. vaccination in dengue-endemic areas increased the risk of severe dengue fever.
May 2, 2019 – The FDA licensed a new state-of-the-art Yellow Fever Vaccine production facility in the USA.
November 27, 2018 – A study reported that a one-fifth fractional dose of the Stamaril (17D-YFV) yellow fever vaccine delivers protective antibodies for up to 10 years.
Stamaril Yellow Fever Vaccine Clinical Trials
Sanofi's Stamaril yellow fever vaccine has been involved in multiple clinical trials.
Phase 4 Clinical Trial NCT02991495: Immunogenicity and Safety of Fractional Doses of Yellow Fever Vaccines. Last Update Posted: December 17, 2020. Estimated Study Completion Date: May 31, 2021. This study aims to answer research questions that would broaden the recommendations for using fractional doses of yellow fever vaccine emergencies. The study will be conducted in Uganda and Kenya. The main objective of assessing the non-inferiority is seroconversion 28 days after vaccination of a fractional dose compared to the total amount for each WHO-prequalified manufacturer. In addition, the Safety Monitoring Board will review the main outcome vaccine results for the studies in children and HIV-positive adults.
Phase 3 Clinical Trial NCT03541694: Passive Enhanced Safety Surveillance of Stamaril Vaccine in Korea. Last Update Posted: March 26, 2019. This is passive enhanced safety surveillance of the Stamaril® vaccine in Korea. The objective is to collect suspected related adverse events following vaccination with Stamaril® in routine practice.
A Phase I, open-label, randomized, controlled clinical study where healthy adults received SII YFV intramuscularly (SII YFV IM), SII YFV subcutaneously (SII YFV SC) or STAMARIL® (Sanofi-Pasteur) in 1:1:1 ratio. They were followed for ten days of solicited reactions, 28 days of unsolicited events, and three months of serious adverse events. YF-neutralizing antibodies were measured at baseline and on Days 10, 14, and 28. A total of 60 adults were enrolled in the study. The proportion of participants with solicited reactions was 10%, 40%, and 25% in SII YFV SC, SII YFV IM, and STAMARIL® arms, respectively. No causally related unsolicited events or serious adverse events were reported. After vaccination, the seroconversion was 94.44%, 100%, and 100%, in the three arms respectively. The post-vaccination geometric mean titers were similar in the study arms. The new YFV was found safe and immunogenic by IM and SC routes. The vaccine can be tested in further phases of clinical studies.
