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Four israelis die after flu shots

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   http://haaretz.com/hasen/spages/777902.html

http://haaretz.com/hasen/spages/777902.html

Last update - 01:42 23/10/2006
Health Minister: No direct link between flu shots and deaths

By Ron Reznik, Haaretz Correspondent and Haaretz Service

The Health Ministry has stopped the administration of flu vaccines after four people died this week and last week shortly after receiving the inoculations. Three of the four individuals were inoculated at the Leumit Health Maintenance Organization (HMO) in Kiryat Gat. All three suffered from several chronic ailments, including heart disease and diabetes.

The fourth recipient, a 67-year-old man, was insured at the Meuhedet HMO in Petah Tikva and suffered from serious heart disease. He was given the shot on Thursday by his wife, a dentist. A few hours later he was found dead on a city street.

The four persons who died are Shimon Amar, 76, from Kiryat Gat; Yitzhak Azoulay, 68, Kiryat Gat; Nadav Yerushalmi, 53, Moshav Shekef; and Ziggo Kalenstein, 67, of Petah Tikva. The Health Ministry said Sunday that all four were inoculated with vaccine from the same series and purchased from the same manufacturer, the French pharmaceutical firm Sanofi-Aventis, which markets the vaccine all over the world.

Health Minister Yacov Ben-Yizri said Sunday the ministry had asked Sanofi-Aventis whether unexplained fatalities had been reported in any other country. An answer is expected today, and if no other reports had come in, the HMOs would be allowed to continue inoculations, Ben-Yizri said.

The shots were being given last week only to patients at high risk from heart, lung or respiratory disease, high blood pressure, cancer or AIDS.

The decision to call a halt to the inoculations was made by Ben-Yizri and ministry heads Sunday afternoon, after the Kiryat Gat HMO reported the three deaths.

Two of the three were inoculated last Sunday. One died a day later, and the second over the weekend. The third person was inoculated on Monday and died three days later.

The report of the fourth death came while Ben-Yizri was giving a press conference, a few minutes after he told reporters "no connection has been found between the tragedy and the flu inoculations."

The three men from Kiryat Gat who died had all been inoculated in previous years.

The Health Ministry has started an investigation into possible sources of contamination but so far none has been found in the vaccine; some 140,000 people were inoculated over the last week. The Health Ministry also investigated the medical team at the Kiryat Gat clinic. THe shots were administered to all three Kiryat Gat recipients by the same nurse.

The vaccines were supplied to the clinic after the Health Ministry conducted its usual standards and quality tests.

Ben-Yizri noted that the decision to halt the inoculations was taken out of "great sensitivity and concern for the maximum safety of those receiving inoculations."

However, he added, ministry experts had advised him to order the renewal of vaccinations Sunday.

In trying to find any connection between the Kiryat Gat recipients and in response to a question from Haaretz, Dr. Yitzhak Berlovitch, deputy director of the Health Ministry, said "the three were vaccinated by the same nurse, although over a period of days."

Berlovitch, who is also head of the ministry's medical administration, said no cases have ever been documented either in Israel or abroad of people dying after flu inoculations. The deaths could also be explained as being due to the chronic illnesses from which they suffered, he said.

Berlovitch said no autopsies had been carried out because "the Health Ministry has no justification for doing so."

Apparently no additional testing of the vaccine series will be carried out.

The head of the national center for disease monitoring in the Health Ministry, Professor Manfred Green, on Sunday tried to provide a statistical explanation for the four deaths: "About 100 people die every day in Israel from chronic diseases. These four individuals could be part of that group."

The Health Ministry said it would open a hot-line jointly with the HMOs today, from noon until 2 P.M., to calm the public by answering questions about inoculations.

The ministry said anyone who received a flu shot and felt unwell should see his or her family doctor.

A total of 1.2 million vaccine doses were purchased ahead of this year's winter flu season, to combat the five strains of flu against which the World Health Organization and the Health Ministry recommends inoculation: A, B, Caledonian, Wisconsin and Malaysian. Only about a 10th of all inoculations needed by the public are available at present because of delays in growing the virus cultures by the two major vaccine manufacturers in the U.S. and France. The Health Ministry therefore recommends the shots first be given to those whose chronic diseases put them at high risk of complications from the flu, first and foremost the elderly and the chronically ill.



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