Stamaril And Yfvax: Exploring Key Differences

Stamaril and YF-Vax are both vaccines for yellow fever, a virus spread through infected mosquitoes in certain areas of Africa and South America. While YF-Vax is the only yellow fever vaccine licensed in the United States, Stamaril has been approved by the US Food and Drug Administration (FDA) for emergency use in the country during periods of YF-Vax shortage. Both vaccines are live-attenuated vaccines based on the 17D-204 substrain of the yellow fever virus, and both are manufactured by Sanofi. However, they differ in their administration methods, with YF-Vax given as an injection under the skin, and Stamaril given as an injection under the skin or into the muscle.

Stamaril and YF-Vax are both live-attenuated yellow fever vaccines

YF-Vax is the only yellow fever vaccine licensed in the United States and is widely used to vaccinate military personnel and civilian travellers. However, due to manufacturing disruptions and depletion of YF-Vax stocks, Stamaril was imported into the US under an Expanded Access Program (EAP) to meet the public health need for yellow fever vaccination. Stamaril has been approved in 102 countries globally and has been prequalified by the WHO since 1987.

While both vaccines are similar, there are some key differences. Firstly, YF-Vax is only administered as a subcutaneous injection, while Stamaril can be given as a subcutaneous or intramuscular injection. Additionally, YF-Vax contains sorbitol and gelatin, and is contraindicated in patients with allergies to any vaccine components, including eggs, egg products, and chicken protein. On the other hand, Stamaril has been reported to have a similar safety and efficacy profile to YF-Vax, with serious adverse reactions being very rare.

A study published in the Journal of Travel Medicine evaluated the safety of Stamaril among 623,285 individuals who received the vaccine between 2017 and 2021. The results showed that Stamaril was well-tolerated, with serious adverse events being rare and consistent with the vaccine's known safety profile. This study supported the use of Stamaril as an alternative to YF-Vax during periods of vaccine shortage or unavailability.

In summary, Stamaril and YF-Vax are both live-attenuated yellow fever vaccines that are produced by the same manufacturer and are based on the same virus substrain. While YF-Vax is the only licensed yellow fever vaccine in the US, Stamaril has been introduced as a safe and effective alternative during periods of YF-Vax shortage. Both vaccines have their own unique characteristics and considerations, but ultimately serve the same purpose of protecting individuals against yellow fever.

YF-Vax is the only yellow fever vaccine licensed in the US

YF-Vax, a live, attenuated vaccine based on the yellow fever (YF) substrain 17D-204, is the only yellow fever vaccine licensed in the US. It is manufactured by Sanofi Pasteur and has been available since the 1930s. The vaccine is recommended for people aged 9 months or older who are travelling to or living in areas where there is a risk of contracting the yellow fever virus, such as certain parts of Africa and South America. It is also required for entry into some countries.

Due to manufacturing disruptions and reduced availability of YF-Vax, another live, attenuated YF-17D-204 vaccine, Stamaril, was imported into the US under an investigational new drug application (IND) using an expanded access program (EAP) authorised by the US Food and Drug Administration (FDA). Stamaril, produced by the same manufacturer as YF-Vax, Sanofi, is approved in 102 countries globally and has been prequalified by the WHO since 1987.

While Stamaril has been introduced in the US to address the shortage of YF-Vax, YF-Vax remains the only yellow fever vaccine that is licensed in the country. Stamaril is considered an acceptable alternative and has been deemed safe for use, with serious adverse reactions being very rare. However, as of June 2024, YF-Vax is once again available for purchase in the United States.

YF-Vax and Stamaril are both lyophilized vaccines and are reconstituted with 0.5 ml of saline diluent for subcutaneous injection. Both vaccines are highly similar, and approximately 500,000 doses of YF-Vax are distributed annually for the vaccination of military personnel and civilian travellers.

Stamaril is not approved by the US Food and Drug Administration (FDA)

Stamaril is a yellow fever vaccine that is not approved by the US Food and Drug Administration (FDA). It is, however, approved in 102 countries globally and has been prequalified by the WHO since 1987. The vaccine is produced by Sanofi Pasteur, the same manufacturer of the US-licensed YF-VAX. Stamaril and YF-VAX are very similar 17D-204 vaccine substrains, both produced in pathogen-free chick embryos.

In the United States, Stamaril is considered investigational and is not licensed by the FDA. However, due to manufacturing disruptions and depletion of the YF-VAX supply in 2017, Stamaril was imported into the US under an Expanded Access Investigational New Drug (IND) program authorized by the FDA. This program allowed for the importation and use of alternative yellow fever vaccines to meet the public health need for YF vaccination. The safety and efficacy of Stamaril were evaluated through enhanced safety surveillance and clinical studies.

The results of these studies support the utility of Stamaril as an alternative solution for the YF vaccine shortage in the US. Serious adverse reactions to Stamaril were found to be very rare and consistent with its known safety profile. However, as of May 6, 2021, shipments of Stamaril as part of the US Expanded Access Program were discontinued.

While Stamaril is not FDA-approved, it has been licensed and distributed in approximately 70 countries worldwide since 1986. Sanofi Pasteur France manufactures both multidose and single-dose vials of Stamaril for global yellow fever outbreak responses and vaccination campaigns. As of December 2021, approximately 634 million doses of Stamaril have been distributed globally, providing long-lasting immunity for most individuals.

Stamaril was authorised for distribution in the US during a YF-Vax shortage

Stamaril, a yellow fever vaccine, was authorised for distribution in the US during a YF-Vax shortage in 2017. YF-Vax is a live, attenuated yellow fever vaccine based on the YF substrain 17D-204, and it is the only YF vaccine licensed in the US. However, in 2016, manufacturing problems and interruptions led to a depletion of YF-Vax stocks, resulting in a vaccine shortage.

To address this shortage and ensure continuous vaccine supply, the US Food and Drug Administration (FDA) authorised the importation and use of Stamaril under an expanded access investigational new drug program (eIND). Stamaril, manufactured by Sanofi Pasteur in France, is also a live, attenuated 17D-204 strain-based vaccine with comparable safety and efficacy to YF-Vax. It has been licensed and distributed in approximately 70 countries worldwide since 1986.

The eIND protocol included a systematic process for selecting clinic sites to provide the Stamaril vaccine. By April 2017, approximately 250 clinics were targeted for inclusion, a significant reduction from the 4,000 civilian clinics providing YF-Vax. Sanofi Pasteur collaborated with the CDC to develop an effective communication plan and conducted training for personnel at participating sites.

The use of Stamaril as an alternative to YF-Vax during the shortage was supported by safety surveillance studies. These studies found that Stamaril had a favourable safety profile, with serious adverse reactions being very rare and consistent with its known characteristics. The overall safety of Stamaril has been demonstrated through case studies, clinical reports, and post-marketing surveillance, with approximately 634 million doses distributed globally as of December 2021.

Stamaril is approved in 102 countries globally and has been prequalified by the WHO

Stamaril, a yellow fever vaccine, has been approved in 102 countries worldwide and has been prequalified by the WHO since 1987. It is produced by Sanofi in France and is a widely distributed live, attenuated YF-17D-204 vaccine.

The vaccine was introduced in the US under an Expanded Access Investigational New Drug Program (EAP) to address the shortage of the YF-VAX vaccine, the only YF vaccine licensed in the US. Stamaril is very similar to YF-VAX, and both are lyophilized vaccines reconstituted with 0.5 ml of saline diluent.

Stamaril has been deemed safe and effective, with serious adverse reactions being very rare. As of December 2021, approximately 634 million doses of Stamaril have been distributed globally, with over 80 million people in Africa being vaccinated between 2023 and 2024. Clinical trials have been conducted to assess the safety and efficacy of the vaccine, including in children and HIV-positive adults.

The WHO strategy, driven by PAHO, aims to vaccinate nearly one billion people by 2026. Stamaril is expected to play a crucial role in achieving this goal, as it is a safe and effective alternative to YF-VAX. The vaccine is recommended to be administered at least ten days before entering an endemic area, as protective immunity may take up to that time to develop.

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