[NVIC] Merck Recalls HIB Vaccine: Contamination Risk

[Guest guest]

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

PVH

Drug giant Merck has recalled about 1 million doses of a childhood

meningitis vaccine. (AP Photo)

JGCDC

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.

http://ap.google.com/article/ALeqM5iGAbaEn2I-4TEgFdrye5Hx4h9RbwD8TG8NG82

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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[Guest guest]

Merck is racing to create a vaccine to combat Bacillus cereus found in

their Hib vaccine. It is expected to clear FDA hurdles at 3:17am

tomorrow and your pediatrician will have his supply in the early

morning FEDEX delivery. Your children will not be able to attend school

until you've gotten them jabbed. Marck's marketing department, which

is now in charge of all vaccines for the company, tells us that name of

this vaccine for Bacillus cereus is Vaccillus Serious. Hurry, one

free painted the Tank Engine as your free gift with vaccination

while supplies last.

And with that I'm off to bed. Snow day today. 3 kids tumbling around

the house since 5:48am. I. AM. FRIED.

KS

[Guest guest]

Not if I don't get the engine with the lead solder on the

magnet, dammit. My kids are tough and take their risky crap vaccines

with lead chasers.

>

> Merck is racing to create a vaccine to combat Bacillus cereus

found in

> their Hib vaccine. It is expected to clear FDA hurdles at 3:17am

> tomorrow and your pediatrician will have his supply in the early

> morning FEDEX delivery. Your children will not be able to attend

school

> until you've gotten them jabbed. Marck's marketing department,

which

> is now in charge of all vaccines for the company, tells us that

name of

> this vaccine for Bacillus cereus is Vaccillus Serious. Hurry,

one

> free painted the Tank Engine as your free gift with

vaccination

> while supplies last.

>

> And with that I'm off to bed. Snow day today. 3 kids tumbling

around

> the house since 5:48am. I. AM. FRIED.

>

> KS

>

[Guest guest]

Per Cruella's team, it's not a health threat for a potential million

infants to have been injected with food poisoning. After all, we wanna

toughen up the little critters, and what better time than to start

with an 8 wk old. Let's hope the pediatricians follow their usual

incompetency and jab a few premies, that would really help 'em develop

a strong immune system. That might help their lungs with RSV come

January...And, after all, no one ever dies from food

poisoning...except those who will need the food poisoning vaccine,

complete with the 50 most lethal puke/crap bugs known.

.... 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

>

>