http://www.nytimes.com/2002/02/16/international/16BRAZ.html
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February 16, 2002 Merck Says Tens of Thousands May Need Another Hepatitis Shot
By REUTERS
SÃO PAULO, Brazil, Feb. 15
(Reuters) — Merck & Company A unit of the French pharmaceutical group, Aventis At the time, however, neither Merck nor the Aventis Pasteur unit indicated
how many people who had taken possibly faulty batches made between December
1999 and December 2001 would need new vaccines. Although the batches may have been ineffective in protecting against the
virus, Merck said the vaccines were not harmful. Gwen Fisher, a spokeswoman at Merck's headquarters in Whitehouse Station,
N.J., said on Friday that the possibly ineffective shots of its hepatitis A
vaccine given in the past two years include both the VAQTA K vaccine for
children and the VAQTA vaccine for adults. "Merck is offering to pay in most countries for either retesting
people to see if they are effectively vaccinated or for revaccinations,"
said Ms. Fisher, who added that she did not know Merck's potential financial
liability. Merck commented on the potential number of people affected by the faulty
vaccine in response to inquiries by Reuters following reports by local newspapers
in Brazil about the use of the possibly ineffective vaccine in Brazil. Merck sells the VAQTA K vaccine against hepatitis A for young people in
the United States, Latin America, Asia and parts of Europe. The vaccine is
put into syringes in Britain by Evans Vaccines, part of PowderJect
Pharmaceuticals. In Brazil, a spokesman for Merck's unit there, Merck Sharp & Dohme,
said about 60,000 children and adolescents in the country could need another
dose of the preventive drug. Merck said the young Brazilians were among those who took about 117,000
possibly faulty vaccines in the past two years, mostly in private clinics in
the industrialized states of São Paulo, Rio de Janeiro and Minas Gerais. Each dose of the vaccine was given twice to the Brazilian youths and,
although not harmful, it may not be potent enough to prevent the disease, the
company said. "The reaction varies from person to person and we cannot guarantee
that the doses in the problem lots will be effective," said Marcos Levy,
director of corporate affairs for Merck in Brazil. Mr. Levy said oxygenated water had seeped past the seal in pre-filled
syringes of the medicine packaged in Britain and also sent to the United
States, France, Ireland and Germany. "We recalled that lot and other lots that, although still valid, used
the same type of seal on the syringes," Mr. Levy said. He added that the Brazilian clinics which gave the vaccine are contacting
patients so that they can return for testing and perhaps a new shot. Unlike hepatitis B or C, hepatitis A is rarely deadly and only severe in
about 2 percent of cases. |
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