Avaxim Junior is now available to prevent infection with hepatitis A in children aged 12 months to 15 years in the UK following approval from the medicines regulator, including through pharmacies, the company confirmed.
It is given as two vaccine doses injected by the intramuscular route six months to 36 months apart, but can be given up to seven years apart, Sanofi said.
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Clinical trial data from 20 studies in 14 countries, including in Europe, of more than 6,200 children showed that the vaccine produces an effective response in two weeks in over 95% of individuals.
By the time of the booster dose at six months, this had risen to almost 100%, Sanofi said in its statement launching the vaccine this week (April 24).
The Avaxim vaccine was already available as an adult version for those over the age of 16 years.
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Rebecca Catterick, UK and Ireland Sanofi vaccines general manager, said that “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 prevalent travel-related vaccine-preventable diseases”, she added.
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The vaccine joins three other hepatitis A vaccines suitable for use in children in the UK. The Green Book also lists Havrix Junior Monodose, Vaqta Paediatric and a combined hepatitis A and B vaccine called Twinrix Paediatric.
Hepatitis A is more common in countries outside Northern and Western Europe, North America, Australia and New Zealand but travel abroad is a common risk factor for sporadic cases in the UK, the Green Book said.
The highest risk areas for those travelling from the UK are the Indian subcontinent, Middle East, Africa and South East Asia, but the risk now extends to Eastern Europe, it added.