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Nagging Questions about Safety in USA: Japan Stops Some Vaccinations After Deaths

Can it happen here? I am reprinting an article that was posted yesterday on ABC News about the situation in Japan.  The ministry suspended the use of the two vaccines on Monday following the death of four young children shortly after immunization.


All four of the children are reported to have received Prevnar, and three also received ActHIB and a combination vaccine against diphtheria, pertussis, and tetanus at the same time.


“Who cares, that is not the US.”  This is the attitude I have heard lately about this news, but I don’t know if people understand that of all the vaccines that our children take, FEW are produced in the United States (the one I found that is made in the U.S. is FluMist.)


For example, the vaccine for H1N1/09 is being made for the U.S. by Melbourne-based CSL Ltd., Sanofi-Aventis SA, based in Paris (aka Sanofi-Pasteur), London-based AstraZeneca Plc (MedImmune subsidiary), and Novartis AG based in Basel, Switzerland. GlaxoSmithKline Plc also is in the process of review by the FDA for their vaccine but it is not approved yet. They have gotten approval for one version of vaccine from the European EMEA, however, and is producing it for use in Europe.


Vaccine Companies

Novartis Vaccines

Novartis, based in Switzerland, makes several flu vaccines used around the world. These include seasonal flu vaccines Agrippal and Begrivac for adults and children and Fluad for seniors.  Fluvirin is the most common seasonal flu vaccine in the U.S.  Focetria is their H1N1 vaccine.


CSL Limited

The Australian-based pharmaceutical company CSL Limited makes Panvax H1N1, known as the Monovalent Vaccine in the United States. CSL also makes Fluvax for adults and Fluvax Junior for children.


MedImmune

MedImmune makes FluMist, a live flu virus vaccine that is sprayed into the nose. MedImmune is based in Maryland and makes the nasal spray vaccine for both the seasonal and H1N1 flu viruses.


Sanofi Pasteur

Sanofi Pasteur is a French manufacturer of both types of flu virus vaccines. Their H1N1 vaccine is sold under the name Paneza. They also make the seasonal flu virus vaccines Vaxigrip, which is not found in the United States and Fluzone which is found in the United States.


GlaxoSmithKline

The British-based GlaxoSmithKline makes different forms of the seasonal flu vaccine. Their products include Fluarix for adults and children and FluLaval for adults and children.


Japan Continues Vaccine Suspension

Two Kids’ Vaccines Halted After Four Children Die Shortly After Shots

BY TODD NEALE, MEDPAGE TODAY STAFF WRITER

March 8, 2011

(Click here for original article)


Japanese health officials have suspended the use of two pediatric vaccines as a precaution following the deaths of four young children, according to multiple media reports.

The Ministry of Health, Labor, and Welfare has said that Pfizer’s Prevnar and Sanofi Pasteur’s ActHIB cannot be used until a panel of experts concludes an investigation into whether there is a causal link between the vaccines and the deaths, which reportedly occurred in children ages 6 months to 2 years.

The panel is expected to issue a report tomorrow.

A spokesperson for Sanofi Pasteur confirmed in an e-mail that, on March 4, the Japanese health authorities suspended use of ActHIB after the deaths of four children, three of whom received ActHIB in conjunction with at least one other vaccine from another manufacturer.

Three of the four infants received Prevnar and ActHIB together, and at least two also received a combination vaccine against diphtheria, pertussis, and tetanus, according to Reuters.

The Sanofi spokesperson said that the company is fully cooperating with the Japanese investigation, noting that ActHIB has not been recalled.

“To our knowledge to date, there is no reason for such a recall, nor for the customers to return the product,” she wrote in an e-mail.

A representative from Pfizer wrote in an e-mail, “Pfizer thoroughly reviews and continually monitors all of its medicines and vaccines as safety is our top priority. No causal relationship has been established between the events reported in Japan and vaccination to date.  We are conducting a thorough evaluation of these cases in cooperation with the relevant regulatory health authorities.”

A similar incident happened last year in the Netherlands, where health officials concluded that Prevnar was not responsible for the deaths of three vaccinated infants, the Reuters report noted.


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