Sanofi Announces Launch of AVAXIM® Junior in the UK for Active Immunisation Against Infection Caused by the Hepatitis A Virus in Children Aged 12 Months to 15 Years

Rhea-AI Summary

Sanofi has launched AVAXIM® Junior in the UK, an inactive hepatitis A vaccine aimed at children aged 12 months to 15 years. The vaccination entails two doses administered intramuscularly, ideally spaced between 6 to 36 months but can extend to 7 years. The launch is supported by data from 20 clinical studies across 14 countries, involving more than 6,200 children, demonstrating over 95% efficacy in inducing a protective antibody response within two weeks. AVAXIM Junior addresses the prevalence of hepatitis A, a common travel-related disease, providing parents with reassurance when traveling to high-risk areas. Side effects typically include soreness at the injection site and general malaise. Sanofi, listed on Euronext and NASDAQ as SNY, aims to enhance global health through innovative treatments and vaccine options.

Positive

• Launch of AVAXIM Junior fills a critical gap in preventing hepatitis A for children, catering to a high-risk population.
• Clinical studies demonstrate over 95% efficacy for the vaccine, enhancing Sanofi's product portfolio and market presence.

Negative

• None.

READING, England--(BUSINESS WIRE)-- Sanofi (EURONEXT: SAN and NASDAQ: SNY) has today announced the launch of AVAXIM^® Junior in the UK, an inactive hepatitis A vaccine indicated for use in children aged 12 months to 15 years inclusive to prevent infection caused by the hepatitis A virus.¹ The vaccination schedule consists of two vaccine doses injected by the intramuscular route 6 months to 36 months apart but can be given up to 7 years apart.¹

This launch was based on data from 20 clinical studies in 14 countries across Europe, the Middle East, Asia and the Americas, involving more than 6,200 children aged 12 months to 15 years who have received at least one dose of the vaccine in the context of a clinical trial.² The data show that AVAXIM Junior is effective in inducing a protective antibody response within two weeks in over 95% of individuals, and in nearly 100% before the booster dose administered six months after the first dose.³

Rebecca Catterick, UK and Ireland Sanofi Vaccines General Manager, said:

“Hepatitis A is one of the most prevalent travel-related vaccine-preventable diseases, so the availability of effective options like AVAXIM Junior will offer parents peace of mind knowing that they can help protect their children when travelling to high-risk areas.”

Hepatitis A is one of the most common vaccine-preventable, viral infections worldwide

Hepatitis A, caused by the hepatitis A virus, is primarily transmitted through contaminated food and water or by direct contact with an infectious person.⁴ Incidence of the disease is closely related to socio-economic conditions, so it is most prevalent in developing countries with poor sanitary conditions and hygiene practices.^4,5 It is the most common form of viral hepatitis⁶ and the third most common vaccine-preventable infection among travelers.⁷

ENDS

About AVAXIM^® 80U Paediatric

AVAXIM Junior is indicated for active immunisation against infection caused by the hepatitis A virus in children aged 12 months to 15 years inclusive. It can be used for both primary and booster vaccination and should be given according to official recommendations.¹

Most commonly observed side effects include pain at the injection site, a general feeling of discomfort or being unwell (malaise), headache and abnormal crying.^1,3 Most reactions were limited to the first few days following vaccination with spontaneous recovery.^1,3

AVAXIM Junior is a ready-to-use suspension for injection containing 80 antigen units of inactivated hepatitis A virus and is available in 0.5ml unidoses of suspension in pre-filled syringes with attached needles.¹

About Sanofi

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and potentially life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the centre of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

References

¹ AVAXIM Junior SmPC. May 2021

² Sanofi Pasteur. Data on file. March 2017

³ Sanofi Pasteur. Avaxim®80U Pediatric. Clinical Core Data Sheet. 195- Pediatric Hepatitis A vaccine - CCDS – version 15 –24 September 2020

⁴ WHO. WHO position paper on Hepatitis A vaccines – June 2012. Wkly Epidemiol Rec, 2012;87(28/29):261-76.

⁵ WHO. Health Emergency and Disaster Risk Management Fact Sheets. WATER, SANITATION AND Hygiene. December 2017. Available at: https://cdn.who.int/media/docs/default-source/disaster-mngmt/risk-management-wash-december2017.pdf?sfvrsn=81ddcc1a_1&download=true [Accessed January 2023].

⁶ Luxemburger C, Dutta AK. Overlapping epidemiologies of hepatitis A and typhoid fever: the needs of the traveler. J Travel Med. 2005 Apr;12 Suppl 1:S12-21.

⁷ Steffen R, Behrens RH, Hill DR, Greenaway C, Leder K. Vaccine-preventable travel health risks: what is the evidence—what are the gaps? J Travel Med. 2015;22(1):1-12.

Job Code: MAT-XU-2300110 (V1.0)

Date of Preparation: April 2023

View source version on businesswire.com: https://www.businesswire.com/news/home/20230416005007/en/

Quiterie Mertian

UK & Ireland Sanofi Vaccines Communications Manager

+44 (0) 7740 935 217

quiterie.mertian@sanofi.com

Source: Sanofi

FAQ

What is AVAXIM Junior and who is it for?

AVAXIM Junior is an inactive hepatitis A vaccine launched by Sanofi for children aged 12 months to 15 years.

What is the efficacy of AVAXIM Junior?

AVAXIM Junior has shown over 95% efficacy in inducing a protective antibody response within two weeks.

How is AVAXIM Junior administered?

AVAXIM Junior is administered intramuscularly in two doses, ideally spaced 6 to 36 months apart, but can be given up to 7 years apart.

What are the common side effects of AVAXIM Junior?

The most common side effects include pain at the injection site, general discomfort, headache, and abnormal crying.

When was AVAXIM Junior launched in the UK?

AVAXIM Junior was launched in the UK on April 16, 2023.