Hepatitis A virus vaccine(Biolotus Biotech Ltda.)

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 hepatitis 6 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