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December 13, 2007

National Vaccine Information Center

NVIC E-news

www.nvic.org

www.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. htm

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

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

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 0006-4898-00

U.S. FOOD AND DRUG ADMINISTRATION

Center for Biologics Evaluation and Research

Click here for the URL:

DATE RECALL INITIATED:

December 11, 2007

PRODUCT / LOT # / EXPIRATION DATE:

PedvaxHIB® 0677U 11 January 2010

PedvaxHIB® 0820U 12 January 2010

PedvaxHIB® 0995U 16 January 2010

PedvaxHIB® 1164U 18 January 2010

PedvaxHIB® 0259U 17 October 2009

PedvaxHIB® 0435U 18 October 2009

PedvaxHIB® 0436U 19 October 2009

PedvaxHIB® 0437U 19 October 2009

PedvaxHIB® 0819U 09 January 2010

PedvaxHIB® 1167U 10 January 2010

COMVAX ® 0376U 05 January 2010

COMVAX ® 0377U 08 January 2010

MANUFACTURER:

Merck & Co., Inc. West Point, PA

REASON:

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 Press

December 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.

*********************************************************** *

National Vaccine Information Center

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