Rotavirus Propaganda

[Guest guest]

Here is what the " professionals " have to say about rotavirus. It is

approved in the U.S. only and I can't see it been approved in Canada

anytime soon!! It is a big problem in developing countries but not so much

in the U.S. though they won't tell you that. The part I " love " is that it

is the vaccine is derived from an attenuated rhesus monkey rotavirus

strain, isn't that nice!!! Something they never mention is that most cases

happen in artifically fed babies and NOT breastfed ones. It is very rare

to have a breastfed child that gets really sick wit this. So breastfed

your babies and wash your hands and you should be fine. Yes to Lana's

question, this vaccine is live so it can be passed like OPV though since it

is so new we don't know what will happen.

Hope this info helps and read it with a grain of salt!!lol

1. How much of a health problem is rotavirus

disease?

Rotavirus is the most common cause of severe dia

rrhea in children in the United States. Virtually all children have one or

more rotavirus infections in the first 5 years of life. Each year in the

United States, rotavirus is responsible for approximately 500,000 physician

visits and 50,000 hospitalizations (30-50% of all hospitalizations for

diarrhea in children under 5 years of age). Children aged 3 to 24 months

have the highest rates of severe disease and hospitalization.

2. What causes rotavirus disease?

The etiologic agents of rotavirus disease are the

group A rotaviruses which are wheel-shaped (therefore named rota-) RNA

viruses. Human strains are present worldwide; related species of

rotaviruses affect other mammalian species. The clinical manifestations of

infection with human rotaviruses range from asymptomatic shedding to

life-threatening gastroenteritis with severe vomiting and diarrhea.

Although multiple human rotavirus serotypes have been identified, virtually

all disease in the United States appears to be caused by four serotypes.

3. How is rotavirus transmitted?

Rotavirus is highly infectious; a dose of a very

small number (<100) of virus particles is enough to infect a person and

lead to disease. Fecal-oral transmission is the likely major mode of

transmission; the roles of droplet or direct transmission have not yet been

well characterized.

4. How can disease from rotavirus be prevented or

managed?

Preventing spread of rotavirus by hygienic measures

has not been very successful in the United States and other developed

countries as documented by the near-universal infection of young children.

A rotavirus vaccine has been developed and is near licensure in the United

States. Appropriate management of childhood gastroenteritis with

rehydration therapy is usually effective in preventing dehydration.

Nevertheless, many children in the United States continue to be

hospitalized for dehydration despite widespread over-the-counter

availability of rehydration solutions.

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5. What is the availability of the rotavirus

vaccine that has been developed?

Wyeth Lederle Laboratories (Pearl River, New York)

has applied to the FDA for licensure of an oral live rotavirus vaccine

(RotaShield ). The FDA Advisory Committee has judged that it is a safe and

efficacious. Licensure by the FDA is expected in the near future. Another

manufacturer is also developing a rotavirus vaccine, but licensure of this

product is not expected this year.

6. Where does the vaccine come from?

The vaccine is derived from an attenuated rhesus

monkey rotavirus strain (RRV-1). RRV-1 is antigenically similar to one of

the major human rotavirus serotypes. Three additional strains of RRV-1 have

been developed which contain genes from the other human rotavirus serotypes

commonly found in the United States. Given as a single tetravalent vaccine

(RotaShield ), these four strains produce an immune response against the

four human rotavirus serotypes which are responsible for almost all of

rotavirus disease in the United States.

7. How effective is this vaccine?

In four placebo-controlled randomized trials, three

doses of vaccine gave a vaccine efficacy of about 50% against any diarrhea

caused by rotavirus and 70-95% against severe rotavirus diarrhea. In the

one clinical trial large enough to study hospitalizations, the vaccine was

100% effective against hospitalization due to rotavirus diarrhea.

8. Will the vaccine prevent all diarrhea in small

children?

Although rotavirus vaccine is highly effective

against severe rotavirus disease, a large number of milder cases of

rotavirus diarrhea will still occur and childhood diarrhea from other

causes will not be prevented by vaccination. Fifty to seventy percent of

hospitalizations for diarrhea are due to non-rotaviral etiologies. Parents

will need to be educated that this vaccine does not prevent all childhood

diarrhea.

9. Once the vaccine is available, what will be the

recommended schedule?

The recommended schedule for routine administration

is expected to be a series of three doses orally at 2, 4, and 6 months of

age. The first dose may be given as early as 6 weeks of age and the minimum

interval between doses is 3 weeks. The first dose is not recommended to be

given to infants older than 6 months of age due to a preliminary study

which found a higher incidence of fever with first doses given to infants

over this age. The second and third doses are not recommended to be given

to children older than 1 year of age due to a lack of data on use in this

age group.

10. How is the vaccine provided? What are the

storage requirements for the vaccine?

The recommended dose is 2.5 cc of reconstituted

vaccine. The vaccine is supplied in boxes of 12 doses as lyophilized powder

in individual-dose bottles and 12 individual droppers with pre-measured

diluent. Although manufacturer data suggest that the vaccine is stable for

extended periods at room temperatures, it is not yet known whether the FDA

will allow the vaccine to be stored at room temperature; if room

temperature storage is not approved, the vaccine will have to be stored at

refrigerator temperature (+4OC).

11. How many doses of vaccine are needed to provide

protection?

Available data indicate that three doses reliably

provide a high degree of protection from severe rotavirus disease. Earlier

studies, in which only one dose was given, did not find a high degree of

protection. No studies were conducted using a two-dose schedule, and it is

unknown if children who receive two doses of vaccine will be protected.

12. Are there circumstances where using an

accelerated vaccination schedule would be of benefit?

Rotavirus is a highly seasonal disease in the

United States with the vast majority of the disease occurring in the winter

months, consistently peaking in early winter (November) in the southwestern

states and late winter/spring (April) in the northeastern states. Many of

the children born in late summer or in fall will enter the peak season of

rotavirus transmission without having received three doses of rotavirus

vaccine if immunized on the standard 2, 4, and 6 month schedule. Most of

these children could receive three doses if immunized on an accelerated

schedule. The feasibility of setting up programs to administer rotavirus

vaccine on such a schedule needs to be considered.

13. Can the rotavirus vaccine be administered

simultaneously with other vaccines?

Data show that immunogenicity against any antigen

was unaffected by simultaneous administration with DPT-Hib, OPV, IPV, or

Hepatitis B vaccines.

14. What kind of adverse events are associated with

the vaccine?

In the pre-licensure studies, the only noted side

effect was a higher rate of fever after the first dose of vaccine,

primarily on days 2-4 after administration. Higher rates of intussusception

and failure-to-thrive among vaccinees were reported initially but were not

confirmed on a more detailed analysis of the data.

15. Why is vaccination with the first dose not

recommended for children 6 months of age or older? Why is vaccination with

the second and third doses not recommended for children 12 months of age or

older?

Infants 6 months of age or older had a higher rate

of high fevers after vaccination with an initial dose of rotavirus vaccine

in a small trial. This is thought to be due to a loss of maternal antibody

in these older infants. Prelicensure studies included some children up to

one year of age who received second and third doses; fever was not a common

reaction after second and third doses of vaccine in these studies. Safety

and efficacy data are not available for children 12 months of age or older.

16. Should premature infants be vaccinated?

Although data suggest that premature infants are at

increased risk for death due to diarrhea, it is unclear whether rotavirus

disease specifically causes more severe disease in premature infants. The

very limited data available on premature infants do not show an increased

rate of febrile reactions after vaccination with RotaShield . However, if

the fevers observed in children 6 months of age or older after a first dose

of vaccine are due to a loss of maternal antibody, premature infants (who

have decreased levels of maternal antibody) would theoretically be at

increased risk for febrile reactions. Although some experts believe the

benefit from vaccination with rotavirus vaccine is greater than the

theoretical risk, available data are insufficient. It is likely that the

final recommendations will not recommend routine vaccination of premature

infants although not making prematurity an absolute contraindication.

17. How much does it cost? Is it cost-effective?

The manufacturer has not yet announced a price, but

the vaccine is likely to be cost-effective. A statement on cost-benefit

cannot be made without a price. Annual direct medical costs from rotavirus

disease are estimated at $270-450 million and annual total societal costs

(including lost parental time from work) are estimated at $ 1 billion.

18. Has the ACIP issued a recommendation on the use

of rotavirus vaccine?

At the ACIP meeting on February 11, 1998, a

majority of ACIP members went on record as being in favor of a

recommendation for routine use of rotavirus vaccine among infants when a

licensed product becomes available. When a licensed product is available,

the ACIP will vote on a recommendation for its use; however, several issues

require resolution prior to this vote. A separate vote regarding inclusion

in VFC will also be held once the vaccine is licensed.

19.How will CDC monitor the effectiveness of a

rotavirus vaccination program?

Recommendations for a rotavirus disease monitoring

system are now being developed. Because testing for rotavirus is not done

routinely on cases of childhood diarrhea, it is likely that a form of

sentinel surveillance for rotavirus will need to be implemented. In such a

program, a limited number of sites such as hospitals or large clinics would

perform routine testing for rotavirus on pediatric patients with

gastroenteritis.

?1998 GA Dept of Human Resources, Div of Public

Health

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immunization policies and practices that affect the

children and adults of Texas. Our mission is to prevent

vaccine injury and death and to promote and protect

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[Guest guest]

Welcome Everyone!! Glad you all are here, and that I'm not the only one

who questions the safety and efficacy of vaccinations.

I would just like to chime in on the Rotavirus issue...

It is true that this disease affects 130 MILLION babies and children every

year resulting in 873,000 deaths a year: 20 of which are in the US.

" While breastfeeding doesn't prevent children from contracting rotavirus,

a protein in breastmilk works to inhibit the virus from attaching to the

stomach and intestinal lining, minimizing the risk of infection and the

severity of the disease if it is contracted. "

Why would this Rotashield be subjected to every child, breastfed or not?

Although the stats are very alarming proving that this disease has cause

for concern and 'prevention', I think breastfeeding moms should be allowed

to exempt from this vaccine, in hopes of their child gaining true immunity.

I knew a one year old child who came down with rotavirus not to long ago

(my sons best-bud). He was breastfeeding and fell ill for 1 month. Not a

pretty sight, he had severe diarhea, refused to eat solids and lost 4 lbs

over the weeks. Although it was rough, he came back stronger than before.

These types of diseases (i.e. rotavirus, measles, CP) are common for

children, and they should be given a chance to let their immune systems do

the work. What scares me is that not only do I have to worry about my

child being in contact w/ others innoculated w/ OPV, but now the rotavirus

as well...when does it end?..IMO this vaccine will do more harm than good,

eventually being the sole cause for many cases of the virus in vaccinated

and unvaccinated children; just as Polio.

What's so wrong with letting nature take it's course?!!..I know alot of you

are wondering the same...it really is nice to have support for the choices

we have made to keep our son vaccine-free....while the rest (family and

some friends) just think I'm crazy.

Giving Thanks,

Lana

aka malana

mama of Cody Ukiah