מתוך medicontext.co.il
FRANKFURT, Germany (Reuters Health) – Aventis Pasteur MSD, the European vaccines joint venture set up by Merck and Aventis, has urged individuals who received its VAQTA hepatitis A vaccine to be tested–at the company's cost–to ensure the vaccine was effective, according to a top company official in Germany.
Earlier this month, the company announced a recall of all stocks of the VAQTA vaccine packaged in ready-to-use syringes because of concerns that some doses did not meet potency requirements. The vaccine is made by Merck and loaded into syringes in the UK by Evans Vaccines, part of Powderject.
Dr. Erika Harzer, medical director of Aventis Pasteur MSD in Germany, told Reuters Health on Thursday that vaccines in vials were not affected by the recall.
Dr. Harzer said that as many as 700,000 people in Germany might have taken the suspect vaccine. The company "strongly encourages" all people who received the vaccine to be tested to ensure that they have been immunized against hepatitis A.
She bases the estimate of 700,000 people on the 1.1 million doses of the vaccine sold in Germany since it was introduced in early 1996. Two doses, 6 months apart, are recommended, but some people might have only taken one dose, she said.
Dr. Harzer estimated that throughout Europe between 3 million and 4 million doses of ready-to-use syringes had been sold since 1996. The top markets for the suspect vaccine doses were the UK and Ireland, Germany, and the Netherlands.
"The European market tends to prefer ready-to-use syringes," she said.
She emphasized that only a small percentage of total doses were below the specified potency of the product. But all doses had to be recalled for inspection. "We know that a much lower dosage is sufficient to elicit the immune response," she said.
No one vaccinated with VAQTA is known to have contracted hepatitis A, Dr. Harzer said. However, she could not say whether any people who took VAQTA had not been properly immunized against hepatitis A.
"It is too early to talk about this now," she said. "Testing has just begun."
She estimates that, in Germany, the company sent out between 150,000 and 200,000 notices about the recall and immunity testing to doctors, pharmacies, hospitals and other private and public medical officials.
When asked about the cost of the recall and testing to the company, Dr. Harzer said it would be in the "millions" of euros. When pressed to be more specific, she said: "I would generally think that it would be more than a one-digit amount (1 million euros), but certainly not more than a three-digit amount (100 million euros
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