Officials Halt MMR Vaccine


Vaccine injures 125 in first week


NIH official says

" these kinds of things come up all the time,"



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Company Is Investigating Possible Vaccine Problems in Brazil


The New York Times
By LAWRENCE K. ALTMAN

August 28, 2004


Aday after the Chiron Corporation said it was delaying release of its
influenza vaccine in this country because some lots were
contaminated, the company confirmed that it was investigating
possible problems with use of a different vaccine in Brazil.

Brazilian health officials stopped the use of Chiron's triple vaccine
against measles, mumps and rubella, often referred to as MMR, after
an unexpectedly high number of children who received it experienced
serious allergic reactions in an immunization program last week. The
reactions included rashes and anaphylactic shock, a potentially fatal
allergic condition. There were no deaths reported.

Chiron and Brazilian health officials are investigating the cases of
at least 125 children who experienced the reactions.

The vaccine problems raise concern because Chiron, the world's
fifth-largest vaccine manufacturer, is under contract with the United
States government to produce pilot supplies of human vaccines against
two strains of avian influenza, which has spread widely in Asia. The
pilot vaccines are needed because health officials around the world
have expressed fears that in a worst-case scenario, the avian strains
could mutate to cause a human pandemic.

The rates of adverse reactions were significantly higher among the
children receiving the Chiron vaccine, which is made in Italy, than
among children who received a vaccine made by another company, the
Brazilian representative of the Pan American Health Organization
said. The organization, part of the World Health Organization,
supplies the vaccine.

"But the situation remains unclear," said a spokeswoman for Chiron,
Alison Marquiss, because full information was not available to
determine whether the reactions were due to the vaccine, to
monitoring or to other issues.

Chiron's vaccine against the three childhood diseases is sold in
Italy, Asia and South America, but not in the United States, said Ms.
Marquiss. She said the episode in Brazil was the first time any
problems had been reported from Chiron's MMR vaccine.

Although a link between Chiron's vaccine and the reactions has not
been proved, Ms. Marquiss said that "generally speaking, when a
vaccine is quarantined in this fashion it is unlikely to return to
the Brazilian market."

In recent years, health officials in the United States and elsewhere
have had to deal with delays in distributing influenza vaccines and
shortages in the amount that could be manufactured because of
production problems.

Safety tests of the pilot human avian flu vaccines are expected to
begin in this country next winter, said Dr. Anthony S. Fauci, the
director of the National Institute of Allergy and Infectious
Diseases, the federal agency in Bethesda, Md. It has contracted with
Chiron, which is based in Emeryville, Calif., and another company,
Aventis, for the pilot vaccines.

Making vaccines "is a very tenuous field and these kinds of things
come up all the time," Dr. Fauci said.

How the company involved responds in such situations is crucial, Dr.
Fauci said, adding that he believes Chiron "is one of the groups that
can respond" because they are forthcoming and have the technological
and scientific skills to overcome such obstacles.


 http://www.nytimes.com/2004/08/28/national/28flu.html