[NVIC March 2006] Infant Diarrhea Vaccine

Vienna, Virginia http://www.nvic.org

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

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 Clark, D.V.M., Ph.D.,
and Paul Offit, M.D.are U.S. and international patent holders of the
vaccine. Offit and Clark 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.


Rotavirus Vaccine Urged for Babies
RotaTeq Recently Won FDA Approval

By Justin 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.

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
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. Paul Offitt, a vaccine expert and pediatrician at Children's
Hospital in Philadelphia, whose work helped in the development of the
"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
Analysts forecast peak annual sales of Rotateq will top $500 million.
GlaxoSmithKline 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
Shares of Merck (down $0.46 to $35.59, Research) edged lower in after-hours
trade Tuesday.

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