Re: American Academy of Pediatrics Annual Meeting New Combination Vaccines for Child

January 28, 2004

In other words....the continuation of combining vaccines is really the

continuation of EXPERIMENTATION.

Kimberley

http://www.medscape.com/viewarticle/466494

> Take a look at the last paragraph.

>

> New Combination Vaccines for Childhood Diseases

>

> The current childhood immunization schedule in the United States requires 20

> injections in the first 2 years of life. Pediatricians are at times faced

> with the dilemma of having to administer 5 injections in a single health

> visit.[8] The problem is likely to worsen with the potential near-future

> development of additional vaccines for use in infancy (eg, conjugated

meningococcal and

> rotavirus vaccine). This situation has prompted the development of

> combination vaccines. Combination vaccines provide simplicity, convenience

of

> administration, easier storage, decreased number of injections and office

visits,

> increased compliance with immunization schedules, and easier record

> keeping.[9,10]

>

> However, the combination of multiple vaccine antigens presents several

> challenges. It should be recommended that the components of the vaccine be

> administered at the same time. However, the reactogenicity and potential

side

> effects of the combined antigens have not yet been determined. Since there

is the

> potential for physical and chemical interaction among the vaccine components

> and the buffers and preservatives, the immunogenicity of each component

needs

> to be addressed to determine whether these are similar to and as effective

as

> the components given individually.[10]

>

January 28, 2004

yep! maybe, we should send these pediatrician the CDC's own pfd of

excipents with the material safety data?

http://users.adelphia.net/~cdc/MSDSwithVaxInsertInfo.pdf

> In other words....the continuation of combining vaccines is really

the continuation of EXPERIMENTATION.

> Kimberley

>

> http://www.medscape.com/viewarticle/466494

>

> > Take a look at the last paragraph.

> >

> > New Combination Vaccines for Childhood Diseases

> >

> > The current childhood immunization schedule in the United

States requires 20

> > injections in the first 2 years of life. Pediatricians are at

times faced

> > with the dilemma of having to administer 5 injections in a

single health

> > visit.[8] The problem is likely to worsen with the potential

near-future

> > development of additional vaccines for use in infancy (eg,

conjugated meningococcal and

> > rotavirus vaccine). This situation has prompted the development

of

> > combination vaccines. Combination vaccines provide simplicity,

convenience of

> > administration, easier storage, decreased number of injections

and office visits,

> > increased compliance with immunization schedules, and easier

record

> > keeping.[9,10]

> >

> > However, the combination of multiple vaccine antigens presents

several

> > challenges. It should be recommended that the components of the

vaccine be

> > administered at the same time. However, the reactogenicity and

potential side

> > effects of the combined antigens have not yet been determined.

Since there is the

> > potential for physical and chemical interaction among the

vaccine components

> > and the buffers and preservatives, the immunogenicity of each

component needs

> > to be addressed to determine whether these are similar to and

as effective as

> > the components given individually.[10]

> >

>

January 29, 2004

there going to try rotavirus again?

Medlin <medlins@...> wrote:In other words....the continuation

of combining vaccines is really the continuation of EXPERIMENTATION.

Kimberley

http://www.medscape.com/viewarticle/466494

> Take a look at the last paragraph.

>

> New Combination Vaccines for Childhood Diseases

>

> The current childhood immunization schedule in the United States requires 20

> injections in the first 2 years of life. Pediatricians are at times faced

> with the dilemma of having to administer 5 injections in a single health

> visit.[8] The problem is likely to worsen with the potential near-future

> development of additional vaccines for use in infancy (eg, conjugated

meningococcal and

> rotavirus vaccine). This situation has prompted the development of

> combination vaccines. Combination vaccines provide simplicity, convenience

of

> administration, easier storage, decreased number of injections and office

visits,

> increased compliance with immunization schedules, and easier record

> keeping.[9,10]

>

> However, the combination of multiple vaccine antigens presents several

> challenges. It should be recommended that the components of the vaccine be

> administered at the same time. However, the reactogenicity and potential

side

> effects of the combined antigens have not yet been determined. Since there

is the

> potential for physical and chemical interaction among the vaccine components

> and the buffers and preservatives, the immunogenicity of each component

needs

> to be addressed to determine whether these are similar to and as effective

as

> the components given individually.[10]

>

January 29, 2004

Yep ! Take a look.

Please note following sentence!

Dr. Offit is a coholder of the patent on bovine-human reassortant

rotavirus vaccine currently being developed by Merck.

He is also one of the biggest promoter's and advocate for

immunizations in the world. He has his own immunization site,

although it takes some time to find out it is his, but he works for

CHOP, and the Unniveristy of PA, so there you go.

http://idinchildren.com/200306/frameset.asp?article=rotavirus.asp

Vaccine-Preventable Diseases

Rotavirus vaccines on the horizon offer some hope

Future vaccines may include bovine and attenuated human rotavirus

strains.

by Colleen Zacharyczuk

Managing Editor

June 2003

SEATTLE – Future rotavirus vaccines may include both bovine and

attenuated human rotavirus strains. They are believed to be unlikely

to induce intussusception, and should still be effective, according

to Offit, MD, who spoke here at the Pediatric Academic Societies

meeting.

Offit, of the Children's Hospital of Philadelphia, at the University

of Pennsylvania School of Medicine, said there are two new rotavirus

vaccines on the horizon that may make a dent in the tremendous

disease burden caused by rotavirus.

In developing countries, rotavirus is a deadly disease, accounting

for approximately 660,000 to 800,000 deaths a year from severe

dehydration. It is because of the disease burden that a vaccine is

needed, Offit said.

Initially, the first rotavirus vaccine, the live, oral tetravalent

RotaShield (RRV-TV, Wyeth-Ayerst) vaccine was developed using a

simian rotavirus.

The approval of RotaShield in 1998 was based on positive evaluation

of efficacy data from five, large clinical efficacy trials conducted

in the United States and Europe. Offit said that the vaccine was

about 48% to 68% protective against disease. There were some adverse

events, including fever, decreased appetite, irritability and

decreased activity after the first dose — these events were not

observed after the second dose.

Another problem noted before the vaccine was licensed was

intussusception. It was noted in five of 10,992 vaccine recipients,

and one per 4,633 placebo recipients. According to Offit, this fact

was worrisome enough to be included in the package insert.

About one year after the vaccine was licensed, a Morbidity and

Mortality Weekly Report noted 15 cases of intussusception, 13 of

which had occurred after the first dose and 11 of which had occurred

within seven days of the vaccine's administration.

The CDC suspended use of the vaccine while a case study was

performed, and after that study, researchers determined that the

relative risk was highest after the first dose, and declined after

the second dose. The risk for intussusception was about one case per

10,000 vaccine recipients. Because of the risk of intussusception,

the vaccine's manufacturer pulled the vaccine from shelves and health

officials suspended its use.

During the time that RRV-TV was available, approximately 1 million

American infants were immunized, and one child died of vaccine-

related intussusception. " One could argue the benefits of the vaccine

still outweighed its risk, " Offit said. " There would be far fewer

hospitalizations and deaths from intussusception than from rotavirus

disease. "

Vaccines in the pipelineThe fact that the vaccine has been pulled

from shelves left other companies looking for alternative vaccine

strategies. So far, most candidate vaccines against rotavirus have

been based on live, weakened animal strains of the virus. These

animal strains were used at first, in part, because they grew easily

in cell cultures. RRV-TV is based on a strain from the rhesus

macaque, but Merck has a candidate based on a bovine strain known as

WC3 (RotaTeq).

In developing countries, rotavirus is a deadly

disease, accounting for approximately 660,000 to 800,000 deaths a

year from severe dehydration.

The WC3 vaccine is a liquid, buffered vaccine that has been

administered orally on the two-, four-, six-month and two-, three-,

four-month schedule in clinical trials. It is a multivalent vaccine

with specificity against the four serotypes — G1, G2, G3 and G4, that

are responsible for more than 85% of rotavirus gastroenteritis

worldwide.

In several placebo-controlled studies done to date, WC3 and its

parent vaccines have been generally well tolerated and efficacious.

No statistically significant increase in the incidences of fever,

irritability, vomiting, or diarrhea has been observed in vaccine as

compared with placebo recipients. For example, in a study of 439

infants, 15.7% of vaccine recipients vs. 14.1% of placebo recipients

had fever during the two-week period after dose 1. The proportion of

patients who shed vaccine in stools is low, ranging from 3.3% to 4.4%

during the three to five days after vaccination.

Offit said a completed study of 1,946 infants who were followed for

gastroenteritis throughout the rotavirus season after vaccination,

suggests that RotaTeq was 68.8% to 76.6% efficacious in preventing

any rotavirus disease regardless of severity or serotype. Preliminary

immunogenicity results show a three-fold rise in serum neutralizing

antibody titer to G1 in 73.3% to 86.2% of vaccinees, and a three-fold

rise in rotavirus-specific serum IgA in >90% of vaccinees.

A large study is underway to evaluate the safety of the vaccine with

respect to serious adverse experiences such as intussusception. He

said no evidence of intussusception associated with the new vaccine

has been noted, yet, in 45,000 infants in clinical trials.

Another option for a rotavirus vaccine lies with the attenuated human

rotavirus vaccine (RotaRix, GlaxoKline). Offit said this a phase-

2 efficacy study of 215 infants had positive results, with

approximately 90% of the vaccinated infants protected from rotavirus

and a statistical significance at P<0.001. Examination of the safety

data revealed only mild transient symptoms including fever in a small

number of infants.

For more information:

Offit P. New rotavirus vaccines: after Rotashield. Topic symposium

5654. Presented at the Pediatric Academic Societies meeting. May 3-6,

2003. Seattle.

Dr. Offit is a coholder of the patent on bovine-human reassortant

rotavirus vaccine currently being developed by Merck.

In other words....the

continuation of combining vaccines is really the continuation of

EXPERIMENTATION.

> Kimberley

>

> http://www.medscape.com/viewarticle/466494

January 29, 2004

Offit makes me want to puke! American Baby used himt his month to tell parents

how we are hurting their kids by not vaccinating....... drives me crazy. I

thankfully do not pay for this magazine. Generally, it comes in the mail & I

throw it out, but of course i had to torture myself with the article!

in Illinois

sahm to 13, Chase 10 & Liam 4/3/03

Former Surgeon General Dr. Antonia Novello: " It's the lucky baby, I feel, who

continues to nurse until he is two. "

Re: American Academy of Pediatrics Annual Meeting New

Combination Vaccines for Child

Yep ! Take a look.

Please note following sentence!

Dr. Offit is a coholder of the patent on bovine-human reassortant

rotavirus vaccine currently being developed by Merck.

He is also one of the biggest promoter's and advocate for

immunizations in the world. He has his own immunization site,

although it takes some time to find out it is his, but he works for

CHOP, and the Unniveristy of PA, so there you go.

http://idinchildren.com/200306/frameset.asp?article=rotavirus.asp

Vaccine-Preventable Diseases

Rotavirus vaccines on the horizon offer some hope

Future vaccines may include bovine and attenuated human rotavirus

strains.

by Colleen Zacharyczuk

Managing Editor

June 2003

SEATTLE - Future rotavirus vaccines may include both bovine and

attenuated human rotavirus strains. They are believed to be unlikely

to induce intussusception, and should still be effective, according

to Offit, MD, who spoke here at the Pediatric Academic Societies

meeting.

Offit, of the Children's Hospital of Philadelphia, at the University

of Pennsylvania School of Medicine, said there are two new rotavirus

vaccines on the horizon that may make a dent in the tremendous

disease burden caused by rotavirus.

In developing countries, rotavirus is a deadly disease, accounting

for approximately 660,000 to 800,000 deaths a year from severe

dehydration. It is because of the disease burden that a vaccine is

needed, Offit said.

Initially, the first rotavirus vaccine, the live, oral tetravalent

RotaShield (RRV-TV, Wyeth-Ayerst) vaccine was developed using a

simian rotavirus.

The approval of RotaShield in 1998 was based on positive evaluation

of efficacy data from five, large clinical efficacy trials conducted

in the United States and Europe. Offit said that the vaccine was

about 48% to 68% protective against disease. There were some adverse

events, including fever, decreased appetite, irritability and

decreased activity after the first dose - these events were not

observed after the second dose.

Another problem noted before the vaccine was licensed was

intussusception. It was noted in five of 10,992 vaccine recipients,

and one per 4,633 placebo recipients. According to Offit, this fact

was worrisome enough to be included in the package insert.

About one year after the vaccine was licensed, a Morbidity and

Mortality Weekly Report noted 15 cases of intussusception, 13 of

which had occurred after the first dose and 11 of which had occurred

within seven days of the vaccine's administration.

The CDC suspended use of the vaccine while a case study was

performed, and after that study, researchers determined that the

relative risk was highest after the first dose, and declined after

the second dose. The risk for intussusception was about one case per

10,000 vaccine recipients. Because of the risk of intussusception,

the vaccine's manufacturer pulled the vaccine from shelves and health

officials suspended its use.

During the time that RRV-TV was available, approximately 1 million

American infants were immunized, and one child died of vaccine-

related intussusception. " One could argue the benefits of the vaccine

still outweighed its risk, " Offit said. " There would be far fewer

hospitalizations and deaths from intussusception than from rotavirus

disease. "

Vaccines in the pipelineThe fact that the vaccine has been pulled

from shelves left other companies looking for alternative vaccine

strategies. So far, most candidate vaccines against rotavirus have

been based on live, weakened animal strains of the virus. These

animal strains were used at first, in part, because they grew easily

in cell cultures. RRV-TV is based on a strain from the rhesus

macaque, but Merck has a candidate based on a bovine strain known as

WC3 (RotaTeq).

In developing countries, rotavirus is a deadly

disease, accounting for approximately 660,000 to 800,000 deaths a

year from severe dehydration.

The WC3 vaccine is a liquid, buffered vaccine that has been

administered orally on the two-, four-, six-month and two-, three-,

four-month schedule in clinical trials. It is a multivalent vaccine

with specificity against the four serotypes - G1, G2, G3 and G4, that