In­for­ma­tion on Hep­ati­tis A Vaccines Vaq­ta and Vaq­ta K pro in­fan­tibus

• What happened?
• What does this mean for the Protection by these Vaccines?
• What is the extent of the risk? Will many people be affected?
• How Dangerous is Hepatitis A as an Illness?

What happened?

• In stability tests performed by the company, it was found that in some ready-to-use syringes there is no adequate efficacy throughout the shelf life. This phenomenon only occurs bit by bit.

• According to Aventis Pasteur MSD, small quantities of hydrogen peroxide (H2O2), which is used as disinfectant, enter some of the ready-to-use syringes during the filling process.

• It is assumed that these H2O2 traces by and by interfere with the efficacy of the antigen so that one has to expect that the vaccine fails to protect the vaccinee in isolated cases.

• H2O2 does not present any harm for the vaccinee. Therefore, no other adverse effects are to be expected, which go beyond the information contained in the package leaflet.

• All batches affected were tested by the Paul-Ehrlich-Institut as effective and were released. It can be assumed that there was appropriate efficacy at first, and that efficacy deteriorated during the shelf-life of the ready-to-use syringes.

What does this mean for the Protection by these Vaccines?

• There are certain defined risk groups for which Hepatitis A presents a permanent hazard. These include the staff of purification plants, individuals who travel to countries in which Hepatitis A is wide-spread, e.g. for professional reasons (to developing countries etc.), patients with chronic liver damage and immunocompromised individuals. Individuals who receive or received vaccinations because of one single period of travel are only exposed to a short-term risk.

• Vaccinees from the above-mentioned risk groups who have been vaccinated with Vaqta in ready-to-use syringes and are exposed to a permanent hazard, should be informed, so that the protection obtained by the vaccine can be tested by means of antibody titre determination. In cases where protection is inadequate, a booster vaccination is indicated.

What is the extent of the risk? Will many people be affected?

• Various factors indicate that the number of those persons whose protection against Hepatitis A is inadequate is small.

• Within the framework of its spontaneous recording, the Paul-Ehrlich-Institut has not yet obtained the notification of a failure after Vaqta vaccination.

• Not all individuals who have received Hepatitis A vaccination are affected, since in addition to ready-to-use syringes other Hepatitis A vaccines are available

• According to Aventis Pasteur MSD GmbH, the number of doses affected is less than 1 million. Since two doses are required for a complete vaccination, the number of persons in whom a post-vaccination check-up should be considered is well below one million.

How Dangerous is Hepatitis A as an Illness?

• Hepatitis A is an illness communicated by faecal-oral transmission, i.e. through so-called smear infections, contaminated drinking water or contaminated food. Clinical manifestation depends on age. It is clinically non-symptomatic in 90% of all children under 5 years of age. Chronic manifestations of Hepatitis A have never been observed. The pathological process can take up to 6 months in rare cases (10%). Very rarely can the illness take a very severe course or result in death.

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