Fw: [Fwd: [NVIC] Merck Recalls HIB Vaccine: Contamination Risk]

January 9, 2008

This is interesting Dr. LANG

----- Forwarded Message ----From: Joe Todesco <joe@...>debbIE LANG <majestichealth@...>Sent: Wednesday, January 9, 2008 7:03:17 PMSubject: [Fwd: [NVIC] Merck Recalls HIB Vaccine: Contamination Risk]

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December 13, 2007

National Vaccine Information Center

NVIC E-news www.nvic.orgwww.vaccineawakening.blogspot.com

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 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. htmAt 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.htmThis 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 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+ 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 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 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

Drug giant Merck has recalled about 1 million doses of a childhood meningitis vaccine. (AP Photo)

CDC Director Gerberding testifies on Capitol Hill in Washington in this Nov. 7, 2007, file photo. Gerberding responded Wednesday to a recall of a routine vaccine for babies due to contamination risks.

"Drugmaker Merck & Co. produces about half of the nation's annual supply of 14 million doses of Hib vaccine.Merck recalled the lots after this week identifying a sterility problem in a Pennsylvania factory. It said sample vials from the recalled lots, tested before shipment, were not contaminated but the company could not assure sterility of the entire lots. "The potential for contamination of any individual vaccine is low," said Kelley Dougherty, a spokeswoman for the Whitehouse Station-based company. Dr. Gerberding, head of the Centers for Disease Control and Prevention, echoed that in a news conference."This is not a health threat in the short run, but it is an inconvenience," she said. Barbara Kuter, Merck's head of

pediatric medical affairs, told The Associated Press that the company will not be able to supply any vaccine for at least nine months. "Manufacture of vaccines is pretty complicated, and we have to basically make some changes in the process," then get approval from the Food and Drug Administration before resuming production and shipments, Kuter said. Merck hopes to restart production next fall, she said. "It's likely that there's going to be a shortage of this product," Kuter said, adding that the impact on the public is unclear." - A. , Associated Press (December 12, 2007 in Miami Herald) http://www.miamiherald.com/852/story/342264.ht ml

Recall

Certain Lots of PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] and COMVAX® [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine]NDC 0006-4897-00 and 0006-4898-00U.S. FOOD AND DRUG ADMINISTRATIONCenter for Biologics Evaluation and ResearchClick here for the URL:DATE RECALL INITIATED:December 11, 2007

PRODUCT / LOT # / EXPIRATION DATE:PedvaxHIB® 0677U 11 January 2010PedvaxHIB® 0820U 12 January 2010PedvaxHIB® 0995U 16 January 2010PedvaxHIB® 1164U 18 January 2010PedvaxHIB® 0259U 17 October 2009PedvaxHIB® 0435U 18 October 2009PedvaxHIB® 0436U 19 October 2009PedvaxHIB® 0437U 19 October 2009PedvaxHIB® 0819U 09 January 2010PedvaxHIB® 1167U 10 January 2010COMVAX ® 0376U 05 January 2010COMVAX ® 0377U 08 January 2010MANUFACTURER:Merck & Co., Inc. West Point, PAREASON:These lots of PedvaxHIB and COMVAX are being recalled due to lack of assurance of product sterility.The

information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.Updated: December 12, 2007***

Common children's vaccine recalled

Associated PressDecember 13, 2007 by A. Click here for the URL:

TRENTON, N.J. -- The recall of a routine vaccine for babies due to contamination risks could trigger a shortage and likely will alarm parents, but officials said there is no known health threat. The recall announced Wednesday covers roughly 1.2 million doses of the vaccine against Hib, which causes meningitis, pneumonia and other serious infections, and a combination vaccine for Hib and hepatitis B. The Hib vaccine is recommended for all children under 5 and is usually given in a three-shot series, starting at 2 months old.Drugmaker Merck & Co. produces about half of the nation's annual supply of 14 million doses of Hib vaccine.Merck recalled the lots after this week identifying a sterility problem in a Pennsylvania

factory. It said sample vials from the recalled lots, tested before shipment, were not contaminated but the company could not assure sterility of the entire lots."The potential for contamination of any individual vaccine is low," said Kelley Dougherty, a spokeswoman for the Whitehouse Station-based company.Dr. Gerberding, head of the Centers for Disease Control and Prevention, echoed that in a news conference."This is not a health threat in the short run, but it is an inconvenience," she said. Barbara Kuter, Merck's head of pediatric medical affairs, told The Associated Press that the company will not be able to supply any vaccine for at least nine months. "Manufacture of vaccines is pretty complicated, and we have to basically make some changes in the process," then get approval from the Food and Drug Administration before resuming production and shipments, Kuter said. Merck hopes to restart production next fall, she said. "It's

likely that there's going to be a shortage of this product," Kuter said, adding that the impact on the public is unclear.Donna Cary, spokeswoman for Sanofi Pasteur, the only other company making the vaccine for the U.S., said it was too soon to say whether it can boost production. The company, a unit of Paris-based drugmaker Sanofi-Aventis SA, makes an Hib vaccine in France that is distributed both to the U.S. and other countries."We're looking at what we can add and we're working closely with the CDC on this," to see whether some vaccine could be shifted to the U.S. from other countries, Cary said.Health officials said they already are talking about prioritizing shots for American Indian and Alaska Native children, who are considered at higher risk for Hib-caused illnesses, said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases.It was unclear how many of the 1.2 million doses were

administered to children.The recalled doses, distributed beginning in April, are considered potent, so revaccinations won't be needed, Schuchat said.Should the vaccine later prove contaminated, health officials believe most children will experience, at worst, skin irritation around the shot site. Problems could be worse for children with weakened immune systems. Any problems would have appeared within a week of vaccination, Schuchat said, and there have been no such reports.The contamination was on unspecified equipment used in making the vaccine. Kuter said a sterility test during a routine evaluation of Merck's West Point, Pa., vaccine plant determined that the equipment was contaminated with a common bacterium called Bacillus cereus, or B. cereus.It is a spore-making microorganism commonly associated with food poisoning and causes diarrhea and vomiting in people who eat contaminated foods.The recall is likely to

heighten a debate over childhood vaccines, their safety and whether too many are required. Some parents are distrustful and suspect some vaccines of being linked to autism, although scientific studies have not shown a connection.This week, New Jersey took a controversial step toward becoming the first state to require flu shots for preschoolers after a health advisory board backed new vaccine requirements over opposition from some worried parents.Merck is one of the few drugmakers that make vaccines. Company representatives could not immediately say how much revenue the Hib vaccine produces. While the company took a black eye with its September 2004 withdrawal of painkiller Vioxx due to increased heart attack risk, it has been performing well recently. It gave an upbeat assessment Tuesday in its annual briefing for analysts.Five weeks ago, Merck reached a deal to settle up to 50,000 Vioxx lawsuits for $4.85 billion, an amount

expected to save the company millions in trial costs. Its stock price has more than recovered from its post- Vioxx slump, a two-year-old restructuring plan is going well, and profits are up. Merck posted a 62 percent increase in its third-quarter profit as revenues jumped 12 percent.The company also has had an impressive seven new products approved for U.S. sale in the last two years, including three vaccines.Merck shares fell 68 cents Wednesday to close at $59.72 before the recall announcement. The shares fell 12 cents in after- hours trading.AP Medical Writer Mike Stobbe in Atlanta contributed to this report.

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NVIC E-News is a free service of the National Vaccine Information Center and is supported through membership donations.NVIC is funded through the financial support of its members and does not receive any government subsidies. Barbara Loe Fisher, President and Co- founder.Learn more about vaccines, diseases and how to protect your informed consent rights at www.nvic.org

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