[NVIC] Infant Diarrhea Vaccine

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" Protecting the health and informed consent rights of children since 1982. "

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BL Fisher Note:

Infant diarrhea, properly managed, rarely fatal in the US and children who

recover from rotavirus infection have immunity.

Merck's live rotavirus vaccine (RotaTeq) contains five human-bovine (cow)

reassortment rotaviruses. Stanley Plotkin, M.D., Fred , D.V.M., Ph.D.,

and Offit, M.D.are U.S. and international patent holders of the

vaccine. Offit and are on the faculty of the Children's Hospital of

Philadelphia. Plotkin is also a patent holder of the rubella vaccine and is

associated with the Wistar Institute.

By adding a diarrhea (rotavirus) vaccine to the routine childhood vaccine

schedule, American children will now be subjected to 57 doses of 15 vaccines

by age 12. By 8 weeks old, an infant will have received 9 doses of 8

vaccines and 8 of those doses can be given on a single day.

Were there long term studies of RotaTeq in combination with 7 other

vaccines? Was there an evaluation of antibody response and adverse events

relative to genetic or other biological differences between children? Was

there any long term follow up to determine whether there are long term

negative effects on the developing immune system and brain of infants when

they are given RotaTeq along with 7 other vaccines on a single day twice in

the first four months of life and once with 8 other vaccines on a single day

at age 6 months - compared to infants who receive no vaccines at all?

The answer is no.

http://www.washingtonpost.com/wp-dyn/content/article/2006/02/21/AR2006022101

720.html

Rotavirus Vaccine Urged for Babies

RotaTeq Recently Won FDA Approval

By Gillis

Washington Post Staff Writer

Wednesday, February 22, 2006; A08

Every healthy newborn in the United States should receive a new vaccine

designed to protect against an intestinal germ called rotavirus, a federal

advisory panel decided yesterday as it set aside theoretical concerns about

the vaccine's safety.

The decision means that pediatricians are likely to recommend three doses of

the oral vaccine for nearly every child at age 2 months, 4 months and 6

months, beginning almost immediately. The vaccine won approval from the Food

and Drug Administration on Feb. 3, and some doctors have received supplies

of it.

The recommendation for universal use of the vaccine was approved at a

meeting of the Advisory Committee on Immunization Practices, the federal

panel that sets vaccination policy in the United States. It comes nearly

seven years after an earlier rotavirus vaccine was withdrawn from the market

for causing a potentially life-threatening form of intestinal blockage in

some babies.

Vaccine-safety advocates are urging parents to be wary of the new vaccine

because of that history. The federal Centers for Disease Control and

Prevention and the manufacturer, Merck & Co. Inc. of Whitehouse Station,

N.J., have promised elaborate studies to catch any safety problems. Merck is

selling the vaccine under the brand name RotaTeq.

Merck has tested the vaccine in about 70,000 babies in 11 countries, one of

the biggest vaccine trials ever conducted. That test ruled out a safety

problem similar to the one that felled RotaShield, an earlier rotavirus

vaccine developed by Wyeth, a drugmaker in Madison, N.J. But doctors said it

is impossible to design a test big enough to catch all possible side effects

that might show up once the product is used in millions of children.

RotaTeq " generally appears to have a better safety profile than the earlier

vaccine, " said Umesh D. Parashar, a medical epidemiologist at the CDC. " But

at the same time it's something we'll continue to look at, and hopefully

confirm absence of risk. "

RotaTeq is expected to be one of the most expensive vaccines ever marketed,

with Merck listing it at $187.50 wholesale for the three-dose series. That

means many doctors are likely to charge more than $300 retail, putting the

Merck product in league with Prevnar, an expensive Wyeth vaccine that has

been widely used in the United States for five years. Prevnar, which

protects children against certain types of pneumonia, became the first

vaccine to meet the pharmaceutical industry's standard for a blockbuster

product, with sales exceeding $1 billion a year.

The development of such high-priced vaccines is causing strains,

particularly in state-sponsored vaccination programs for certain low-income

children. But it is also drawing new manufacturers into the vaccine market,

which many drug companies had abandoned in the 1980s and 1990s, citing too

little profit.

RotaShield appeared on the market in late 1998 but was pulled less than a

year later after a handful of babies that received it developed a serious

intestinal problem called intussusception, a type of bowel obstruction that

occurs when the intestine folds in on itself, like a collapsing telescope.

The problem occurs naturally, albeit rarely; it showed up at a sharply

elevated rate in babies who received RotaShield. Intussusception is

life-threatening for some babies, though doctors can usually treat it.

Many people have never heard of rotavirus, but it is one of the most common

causes of childhood illness -- many ailments that parents or pediatricians

describe as " stomach flu " are caused by rotavirus infection. Virtually every

child in the world contracts the virus repeatedly by age 5, gradually

building immunity.

Most children get over rotavirus at home, but at least 55,000 American

children are hospitalized every year after becoming dehydrated from vomiting

and diarrhea associated with the infection. Fifty to 60 of them die, but it

is a different story overseas, where babies often do not receive good

medical care and hundreds of thousands die every year.

RotaTeq contains live, but weakened, strains of rotavirus designed to build

immunity without causing illness.

REUTERS

Advisers want Merck's rotavirus vaccine for infants

Merck's vaccine to protect against rotavirus infection should become a

routine immunization, advisers say.

February 21, 2006: 5:21 PM EST

WASHINGTON (Reuters) - A new oral rotavirus vaccine that protects 98 percent

of infants against the worst cases of diarrhea should be added to the

schedule of immunizations for babies and young children, U.S. advisers said

Tuesday.

But it must be given in infancy, when babies are the least susceptible to a

rare but sometimes fatal complication of the bowels, the panel said.

The Advisory Committee on Immunization Practices, which advises the Centers

for Disease Control and Prevention, voted unanimously after hearing from

researchers who tested the vaccine.

They said Merck and Co.'s Rotateq vaccine, licensed earlier this month by

the Food and Drug Administration, does not cause the same problems seen in

an earlier vaccine withdrawn from the market in 1999.

Rotavirus is the leading cause of severe diarrhea in infants and young

children and kills 500,000 young children a year globally. In the United

States it affects 2.7 million children in an average year and 75 percent of

children get diarrhea from rotavirus by the time they are 5 years old.

" People assume it is a more severe disease in the developing world. It is

not, " said Dr. Offitt, a vaccine expert and pediatrician at Children's

Hospital in Philadelphia, whose work helped in the development of the

vaccine.

" One out of five children, regardless of where you are, will have severe

disease in the first five years of life. Here we can put in IVs (intravenous

lines). We keep children from dying in this country because we have the

resources, but the diseases is severe everywhere. "

Rotavirus puts between 55,000 and 70,000 children into the hospital in the

United States each year and kills between 20 and 60 very young children.

The Food and Drug Administration licensed Merck's Rotateq on Feb. 3 for use

in U.S. infants. It prevented any kind of rotavirus disease in 74 percent of

babies tested and prevented the most severe illness in 98 percent.

During the testing, Rotateq was not seen to cause any severe events,

including intussusception, a rare type of bowel obstruction. Wyeth's

rotavirus vaccine was withdrawn because it apparently raised the risk of

this complication.

The Merck vaccine is not given by needle but squeezed out of a tube into the

infant's mouth. Three doses will be given between 6 weeks and 8 months of

age.

Analysts forecast peak annual sales of Rotateq will top $500 million.

GlaxoKline Plc (Research) is expected to seek a license for a roval

rotavirus vaccine, called Rotarix, later this year. Rotarix may be more

potent and may require only two oral doses one or two months apart.

Rotarix was approved last summer in Mexico.

The ACIP also discussed a vaccine that prevents a sexually transmitted wart

infection linked to cervical cancer but did not vote on it. On Wednesday, it

was due to discuss broadening recommendation on who should get the influenza

vaccine.

Shares of Merck (down $0.46 to $35.59, Research) edged lower in after-hours

trade Tuesday.

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