Merck Recalls HIB Vaccine: Contamination Risk

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Merck Recalls HIB Vaccine: Contamination Risk

by Barbara Loe Fisher

In what appears to be a pattern involving vaccine
quality control production problems, on Dec. 12, 2007
Merck & Co. announced that it was recalling 13 Lots
containing 1.2 million doses of HIB vaccine
(PedvaxHIB and the combination COMVAX containing
HIB and hepatitis B vaccines) for possible
contamination with the common bacterium called
Bacillus cereus (B. cereus). The microorganism
makes spores that causes diarrhea and vomiting
from eating contaminated foods (also known as food
poisoning). Reportedly, a piece of equipment in
Merck's West Point, PA manufacturing facility failed a
sterility test and the bacterium was identified.
http://www.miamiherald.com/852/story/342264.ht
ml (http://rs6.net/tn.jsp?e=001_O4au ... FouJGwtURsbIz13iw==)



The CDC recommends that infants receive HIB
vaccine at two, four and 12-15 months. The 13 lots of
HIB containing vaccines began to be distributed in
April 2007 and had expiration dates of 2009 and
2010. The FDA has released a list of the HIB vaccine
Lot numbers: http://www.fda.gov/cber/recalls/merckhib121107.
htm (http://rs6.net/tn.jsp?e=001_O4au ... YS8bnvuiBrwbI0VPkw-)



At a 5 p.m. Dec. 12 press teleconference, CDC
officials reportedly said that there is no proof the 13
Lots of HIB vaccine suspected of being contaminated
are, in fact, contaminated. However, they added that if
some HIB Lots are contaminated with B. cereus
bacteria, then healthy children could experience skin
irritation around the site of the injection and children
with weakened immune systems could suffer more
serious health problems within a week of vaccination
In a media advisory, the CDC indicated that a
transcript of the press teleconference would be made
available at:
http://www.cdc.gov/od/oc/media/transcripts.htm (http://rs6.net/tn.jsp?e=001_O4au ... yiB9KFcOmjfgpCMjQ==)<br
>


This is not the first time that Merck has had a
quality control problem in its vaccine manufacturing
plants. In August 2001, Merck temporarily suspended
operations in one of its facilities manufacturing MMR
and Varicella (chicken pox) vaccines to address
issues raised by FDA inspectors during a plant
inspection and to make modifications to its facility.
According to the 2002 GAO report, the time it took to
make plant modifications and difficulties in meeting
FDA manufacturing requirements contributed to
shortages of MMR and varicella vaccines between the
end of 2001 and summer of 2002.


http://www.gao.gov/new.items/d02987.pdf (http://rs6.net/tn.jsp?e=001_O4au ... VmbYW78NjEpZTKjY4c=)



Almost all of the vaccine shortages that the U.S.
has experienced in the past two decades have been
due to vaccine manufacturer production and
government regulation compliance problems, even
though vaccine patent-holders and those advocating
mandatory use of all vaccines licensed for children
have attempted blame vaccine injury lawsuits for
vaccine shortages.
http://vaccineawakening.blogspot.co
m/search?q=At+Risk%3A+Truth+About+Vaccines%
2C+Lawsuits+%26+Shortages+ (http://rs6.net/tn.jsp?e=001_O4au ... IYCbB2UxCpS4y1MJbN9)



Merck, which produces about half of the 14
million doses of HIB vaccine administered to
American babies, will be unable to supply HIB vaccine
to the U.S. for at least nine months according to Merck
officials. French pharmaceutical giant, Sanofi-Aventis,
is reported to be considering ramping up production
of its HIB vaccine to fill in the U.S. HIB supply gap.



In the meantime, parents who have recently
gotten their infants vaccinated with HIB vaccine are left
to wonder if their babies will get sick because they got
a vaccine contaminated with bacteria. Only time will
tell. All suspected HIB vaccine reactions should be
immediately reported to the federal Vaccine Adverse
Events Reporting System (VAERS) at http://wonder.cdc.gov/wonder/help/vaers
/VAERS_brochure.pdf (http://rs6.net/tn.jsp?e=001_O4au ... sNNQkRCYgTGvfLUQjI=)



NVIC has maintained a Vaccine Reaction
Registry since 1982. To report a vaccine reaction,
injury or death to NVIC, go to

http:/
/www.nvic.org/Report/reaction.htm (http://rs6.net/tn.jsp?e=001_O4au ... XYq9Zou-MUhNKp8da8=)or to post a
vaccine reaction report that will be available to the
public on the International Memorial for Vaccine
Victims, go to
http://www.vaccinememorial.org (http://rs6.net/tn.jsp?e=001_O4au ... ZGRF_Prpb9sakTkJg==)

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简要翻译一下

美国默克制药公司12月12日在美宣布，主动召回约一百万剂可能受到污染的疫苗。据悉，其中涉及部分在华销售的疫苗。目前召回工作已在全球同步展开，但尚无不良反应报告。

默克制药公司的新闻公报说，他们“在对生产流程进行标准评估时发现某些批次的疫苗可能受到污染”，虽然潜在的污染可能性很低，但公司依然决定主动召回相关产品。默克制药公司中国区有关负责人证实，召回的疫苗中有一个批次销往中国。

据悉，这次召回的疫苗主要为Hib（B型流感嗜血杆菌）疫苗，接种对象主要为儿童。美国疾病控制和预防中心负责人朱莉·格伯丁说，尽管这批疫苗有可能受到污染，“但疫苗的效用不受影响，已经接种这些疫苗的儿童无需再次接种。”