Stamaril® Yellow Fever Vaccine
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. The 17D line of yellow fever virus vaccines is among the most effective vaccines ever created, according to a 2017 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. 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.
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: DB10805.
Sanofi is a global biopharmaceutical company focused on human health and dedicated to supporting people through their health challenges.
UNICEF published Yellow fever vaccine prices ranging from 4.85 USD to 16.70 USD. Additional yellow fever vaccine price and discount information is posted at InstantRx™.
Stamaril Availability 2023
The WHO strategy driven by PAHO seeks to vaccinate nearly one billion people by 2026. From January 2021 to August 26, 2022, a total of 3,991,568 persons were vaccinated with Stamaril. As of January 2023, the Stamaril is available in 70 countries, excluding the U.S. Sanofi Pasteur's Stamaril has been offered in Europe, Scotland, the U.K., Uganda, Nigeria, New Zealand, and the Republic of Congo. As of early July 2023, the Nigerian Borno State Government launched an Integrated Yellow Fever Preventive Mass Vaccination Campaign in three of the 27 local government areas of the state.
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 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). 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.
The Yellow fever vaccine can prevent yellow fever. Yellow fever is a severe disease caused by the yellow fever virus. Most people with yellow fever virus infections will have mild disease symptoms or completely recover. But some people will develop severe diseases, says the CDC. 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.
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, Stamaril is provided as a single, 0.5-milliliter dose 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 consideration of using fractional doses of yellow fever vaccines in WHO recommendations for outbreak response in the event of a yellow fever vaccine shortage to include 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
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.
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 News For 2018 - 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 Nigeria's Bayelsa State Government declared a state of emergency on 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.
September 2, 2022 - The WHO Africa region reported the current multi-country outbreaks and active virus circulation in West, Central, and East Africa.
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.
February 14, 2022 - The U.K. government issued a statement: Sanofi Pasteur is currently experiencing temporary low stock of yellow fever vaccine (Stamaril). The situation is expected to be resolved by late February 2022.
December 1, 2021 - The WHO reported since November 6, 2021, a focused vaccination activity targeting 54,964 people aged six months to 60 years (excluding pregnant women) is being conducted in over 80 communities in the West and North Gonja districts, 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.
October 14, 2021 - Venezuela's Yellow Fever Outbreak Includes Humans and Epizootics. The WHO reported the Bolivarian Republic of Venezuela had confirmed an ongoing yellow fever disease outbreak.
April 5, 2021 - The U.S. CDC confirmed Sanofi Pasteur announced 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.
February 18, 2021 - A new study, 'Assessing the impact of preventive mass vaccination campaigns on yellow fever outbreaks in Africa: A population-level self-controlled case series study.' provides new empirical evidence of the high preventive impact on PMVCs yellow fever outbreaks. This study published by PLOS Medicine illustrates that the SCCS method can be advantageously applied at the population level to evaluate a public health intervention. Furthermore, these results may encourage rapid rescheduling of yellow fever PMVCs postponed due to the COVID-19 pandemic.
December 23, 2020 - Sanofi Pasteur announced, 'All reasonable efforts are being made to resolve the YF-VAX vaccine supply interruption.
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.
May 7, 2020 - The Lancet article: Prevention of yellow fever in travelers: an update.
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 new 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.