Epaxal®
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Description

Epaxal® is the only aluminium-free hepatitis A vaccine on the market, offering significant advantages in terms of tolerability. It was the first product to be based on the virosome technology developed and patented by the Crucell company, Berna Biotech. It induces protective antibody levels within 10 days of primary vaccination, and provides seroprotection for at least 30 years following the second (booster) dose. In most countries the vaccine is licensed for adults and children over the age of one. It is currently licensed in more than 40 countries under the brands Epaxal®, HAVpur® and VIROHEP-A.

 

Early 2008 we launched Epaxal® Junior. Epaxal® Junior induces protective antibody levels within 10 days of primary vaccination and provides seroprotection for at least 20 years following the second (booster) dose. It can be fitted into the regular immunization schedule for babies.

About hepatitis A

Hepatitis A virus (HAV) is a highly contagious infection that causes acute inflammation of the liver. It is associated with inadequate water supplies and poor sanitation and hygiene. At least 1.5 million clinical cases occur each year, with numbers likely to increase. The burden of hepatitis A infection is greater among susceptible adults.

Morbidity and mortality

HAV has a very low rate of mortality (up to 2%), and the disease ultimately resolves itself. Extensive necrosis of the liver, occasionally occurring in the first 6-8 weeks of the illness, is quite rare; high fever, severe abdominal pain, vomiting, jaundice, and hepatic encephalopathy (with coma and seizures) can signal fulminant hepatitis, which is fatal in 70-90% of patients. In such cases mortality is highly correlated with increasing age, with survival least likely among those over 50 years of age. Mortality rates also increase considerably in patients already suffering from chronic hepatitis B or C or underlying liver disease.

Geographical distribution

HAV is found all over the world, but it is particularly frequent in countries with poor sanitary and hygienic conditions. As living conditions have improved, there has been an ‘epidemiological shift’ in many countries, resulting in a greater number of people without previous exposure to hepatitis A, and therefore lacking natural immunity. Without natural immunity, the risk of recurring and potentially devastating outbreaks is increasing, adding to national health costs and making universal mass vaccination campaigns against hepatitis A of special interest.

Transmission

HAV is generally transmitted through the fecal-oral route. Infection may occur through poorly prepared food or polluted water, as well as by direct or indirect contact with contaminated hands or surfaces. Raw or inadequately cooked shellfish from contaminated areas are an important source of infection. Hepatitis A outbreaks have also resulted from injecting or non-injecting drug use.

Symptoms

Hepatitis A infection may be symptomatic or asymptomatic after an average incubation period of 28 days. The likelihood of symptoms increases with age. The illness is characterized by an abrupt onset, which may include jaundice, fatigue, abdominal pain, nausea, diarrhea and fever. The duration of illness is usually less than 2 months, but 15-20% of patients experience a prolonged illness or relapsing symptoms over a 6-9 month period.

Treatment and prevention

No anti-viral drugs exist for the treatment of HAV, so prevention remains the most important goal. This relies upon the provision of clean water and adequate waste disposal, education concerning sanitation and hygiene, and vaccination for people at risk.

 

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