Intants - FDA Grants Licensure To Expand Indication For Sanofi Pasteur's Menactra

[Guest guest]

NOT good news as it will surely be added to the already toxic schedule

for 9 months - 23 months

SICK

http://www.rttnews.com/Content/QuickFacts.aspx?Node=B1 & Id=1604875

FDA Grants Licensure To Expand Indication For Sanofi Pasteur's

Menactra

4/25/2011 8:16 AM ET

(RTTNews) - Sanofi Pasteur, the vaccines division of the Sanofi-Aventis

Group (SNY:

News

,SNYNF.PK:

News

), announced that the U.S. Food and Drug Administration, or FDA, has

granted licensure to expand the indication for its meningococcal

conjugate vaccine, Menactra, to include a two-dose schedule for infants

and children 9 months through 23 months of age.

The FDA approval of Menactra vaccine for infants was based on results of

one Phase II and three Phase III modified single-blind, controlled,

multicenter trials in which more than 3,300 infants from the United

States received Menactra vaccine using a two-dose schedule, starting as

young as 9 months of age.

Results from the above studies showed that 2 doses of Menactra vaccine

given 3 months apart elicit a robust immune response against the

serogroups included in the vaccine.

**************

Here's the package insert

https://www.vaccineshoppe.com/image.cfm?doc_id=11177 & image_type=product_pdf

" Menactra®, Meningococcal (Groups A, C, Y and W-135) Polysaccharide

Diphtheria Toxoid Conjugate Vaccine, is a sterile, intramuscularly

administered vaccine that contains Neisseria meningitidis serogroup A, C,

Y and W-135 capsular polysaccharide antigens individually conjugated to

diphtheria toxoid protein. N meningitidis A, C, Y and W-135 strains are

cultured on Mueller Hinton agar (2) and grown in Scherp (3) media.

The polysaccharides are extracted from the N meningitidis cells and

purified by centrifugation, detergent precipitation, alcohol

precipitation, solvent extraction and diafiltration. To prepare the

polysaccharides for conjugation, they are depolymerized, derivatized, and

purified by diafiltration. Corynebacterium diphtheriae cultures are grown

in a modified Mueller and medium (4) and detoxified with

formaldehyde. The diphtheria toxoid protein is purified by ammonium

sulfate fractionation and diafiltration. The derivatized polysaccharides

are covalently linked to diphtheria toxoid and purified by serial

diafiltration. The four meningococcal components, present as individual

serogroup-specific glycoconjugates, compose the final formulated vaccine.

No preservative or adjuvant is added during manufacture. Each 0.5 mL dose

may contain residual amounts of formaldehyde of less than 2.66 mcg

(0.000532%), by calculation. Potency of Menactra vaccine is determined by

quantifying the amount of each polysaccharide antigen that is conjugated

to diphtheria toxoid protein and the amount of unconjugated

polysaccharide present.

Menactra vaccine is manufactured as a sterile, clear to slightly turbid

liquid. Each 0.5 mL dose of vaccine is formulated in sodium phosphate

buffered isotonic sodium chloride solution to contain 4 mcg each of

meningococcal A, C, Y and W-135 polysaccharides conjugated to

approximately 48 mcg of diphtheria toxoid protein carrier. "

*******

Here is a good article by Jayne Donegan

http://www.whale.to/vaccines/meningitis5.html

Meningitis C Vaccine—A Look at the Disease & The New Jab------- Dr

Jayne L M Donegan, MB, BS, DRCOG, DCH, MRCGP General Medical Practitioner

(Practicing in South London)The Informed Parent

Sheri Nakken, former R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Washington State, USA

Vaccines -

http://vaccinationdangers.wordpress.com/ Homeopathy

http://homeopathycures.wordpress.com

Vaccine Dangers, Childhood Disease Classes & Homeopathy

Online/email courses - next classes start April 22

[Guest guest]

NOT good news as it will surely be added to the already toxic schedule

for 9 months - 23 months

SICK

http://www.rttnews.com/Content/QuickFacts.aspx?Node=B1 & Id=1604875

FDA Grants Licensure To Expand Indication For Sanofi Pasteur's

Menactra

4/25/2011 8:16 AM ET

(RTTNews) - Sanofi Pasteur, the vaccines division of the Sanofi-Aventis

Group (SNY:

News

,SNYNF.PK:

News

), announced that the U.S. Food and Drug Administration, or FDA, has

granted licensure to expand the indication for its meningococcal

conjugate vaccine, Menactra, to include a two-dose schedule for infants

and children 9 months through 23 months of age.

The FDA approval of Menactra vaccine for infants was based on results of

one Phase II and three Phase III modified single-blind, controlled,

multicenter trials in which more than 3,300 infants from the United

States received Menactra vaccine using a two-dose schedule, starting as

young as 9 months of age.

Results from the above studies showed that 2 doses of Menactra vaccine

given 3 months apart elicit a robust immune response against the

serogroups included in the vaccine.

**************

Here's the package insert

https://www.vaccineshoppe.com/image.cfm?doc_id=11177 & image_type=product_pdf

" Menactra®, Meningococcal (Groups A, C, Y and W-135) Polysaccharide

Diphtheria Toxoid Conjugate Vaccine, is a sterile, intramuscularly

administered vaccine that contains Neisseria meningitidis serogroup A, C,

Y and W-135 capsular polysaccharide antigens individually conjugated to

diphtheria toxoid protein. N meningitidis A, C, Y and W-135 strains are

cultured on Mueller Hinton agar (2) and grown in Scherp (3) media.

The polysaccharides are extracted from the N meningitidis cells and

purified by centrifugation, detergent precipitation, alcohol

precipitation, solvent extraction and diafiltration. To prepare the

polysaccharides for conjugation, they are depolymerized, derivatized, and

purified by diafiltration. Corynebacterium diphtheriae cultures are grown

in a modified Mueller and medium (4) and detoxified with

formaldehyde. The diphtheria toxoid protein is purified by ammonium

sulfate fractionation and diafiltration. The derivatized polysaccharides

are covalently linked to diphtheria toxoid and purified by serial

diafiltration. The four meningococcal components, present as individual

serogroup-specific glycoconjugates, compose the final formulated vaccine.

No preservative or adjuvant is added during manufacture. Each 0.5 mL dose

may contain residual amounts of formaldehyde of less than 2.66 mcg

(0.000532%), by calculation. Potency of Menactra vaccine is determined by

quantifying the amount of each polysaccharide antigen that is conjugated

to diphtheria toxoid protein and the amount of unconjugated

polysaccharide present.

Menactra vaccine is manufactured as a sterile, clear to slightly turbid

liquid. Each 0.5 mL dose of vaccine is formulated in sodium phosphate

buffered isotonic sodium chloride solution to contain 4 mcg each of

meningococcal A, C, Y and W-135 polysaccharides conjugated to

approximately 48 mcg of diphtheria toxoid protein carrier. "

*******

Here is a good article by Jayne Donegan

http://www.whale.to/vaccines/meningitis5.html

Meningitis C Vaccine—A Look at the Disease & The New Jab------- Dr

Jayne L M Donegan, MB, BS, DRCOG, DCH, MRCGP General Medical Practitioner

(Practicing in South London)The Informed Parent

Sheri Nakken, former R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Washington State, USA

Vaccines -

http://vaccinationdangers.wordpress.com/ Homeopathy

http://homeopathycures.wordpress.com

Vaccine Dangers, Childhood Disease Classes & Homeopathy

Online/email courses - next classes start April 22

[Guest guest]

NOT good news as it will surely be added to the already toxic schedule

for 9 months - 23 months

SICK

http://www.rttnews.com/Content/QuickFacts.aspx?Node=B1 & Id=1604875

FDA Grants Licensure To Expand Indication For Sanofi Pasteur's

Menactra

4/25/2011 8:16 AM ET

(RTTNews) - Sanofi Pasteur, the vaccines division of the Sanofi-Aventis

Group (SNY:

News

,SNYNF.PK:

News

), announced that the U.S. Food and Drug Administration, or FDA, has

granted licensure to expand the indication for its meningococcal

conjugate vaccine, Menactra, to include a two-dose schedule for infants

and children 9 months through 23 months of age.

The FDA approval of Menactra vaccine for infants was based on results of

one Phase II and three Phase III modified single-blind, controlled,

multicenter trials in which more than 3,300 infants from the United

States received Menactra vaccine using a two-dose schedule, starting as

young as 9 months of age.

Results from the above studies showed that 2 doses of Menactra vaccine

given 3 months apart elicit a robust immune response against the

serogroups included in the vaccine.

**************

Here's the package insert

https://www.vaccineshoppe.com/image.cfm?doc_id=11177 & image_type=product_pdf

" Menactra®, Meningococcal (Groups A, C, Y and W-135) Polysaccharide

Diphtheria Toxoid Conjugate Vaccine, is a sterile, intramuscularly

administered vaccine that contains Neisseria meningitidis serogroup A, C,

Y and W-135 capsular polysaccharide antigens individually conjugated to

diphtheria toxoid protein. N meningitidis A, C, Y and W-135 strains are

cultured on Mueller Hinton agar (2) and grown in Scherp (3) media.

The polysaccharides are extracted from the N meningitidis cells and

purified by centrifugation, detergent precipitation, alcohol

precipitation, solvent extraction and diafiltration. To prepare the

polysaccharides for conjugation, they are depolymerized, derivatized, and

purified by diafiltration. Corynebacterium diphtheriae cultures are grown

in a modified Mueller and medium (4) and detoxified with

formaldehyde. The diphtheria toxoid protein is purified by ammonium

sulfate fractionation and diafiltration. The derivatized polysaccharides

are covalently linked to diphtheria toxoid and purified by serial

diafiltration. The four meningococcal components, present as individual

serogroup-specific glycoconjugates, compose the final formulated vaccine.

No preservative or adjuvant is added during manufacture. Each 0.5 mL dose

may contain residual amounts of formaldehyde of less than 2.66 mcg

(0.000532%), by calculation. Potency of Menactra vaccine is determined by

quantifying the amount of each polysaccharide antigen that is conjugated

to diphtheria toxoid protein and the amount of unconjugated

polysaccharide present.

Menactra vaccine is manufactured as a sterile, clear to slightly turbid

liquid. Each 0.5 mL dose of vaccine is formulated in sodium phosphate

buffered isotonic sodium chloride solution to contain 4 mcg each of

meningococcal A, C, Y and W-135 polysaccharides conjugated to

approximately 48 mcg of diphtheria toxoid protein carrier. "

*******

Here is a good article by Jayne Donegan

http://www.whale.to/vaccines/meningitis5.html

Meningitis C Vaccine—A Look at the Disease & The New Jab------- Dr

Jayne L M Donegan, MB, BS, DRCOG, DCH, MRCGP General Medical Practitioner

(Practicing in South London)The Informed Parent

Sheri Nakken, former R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Washington State, USA

Vaccines -

http://vaccinationdangers.wordpress.com/ Homeopathy

http://homeopathycures.wordpress.com

Vaccine Dangers, Childhood Disease Classes & Homeopathy

Online/email courses - next classes start April 22

[Guest guest]

NOT good news as it will surely be added to the already toxic schedule

for 9 months - 23 months

SICK

http://www.rttnews.com/Content/QuickFacts.aspx?Node=B1 & Id=1604875

FDA Grants Licensure To Expand Indication For Sanofi Pasteur's

Menactra

4/25/2011 8:16 AM ET

(RTTNews) - Sanofi Pasteur, the vaccines division of the Sanofi-Aventis

Group (SNY:

News

,SNYNF.PK:

News

), announced that the U.S. Food and Drug Administration, or FDA, has

granted licensure to expand the indication for its meningococcal

conjugate vaccine, Menactra, to include a two-dose schedule for infants

and children 9 months through 23 months of age.

The FDA approval of Menactra vaccine for infants was based on results of

one Phase II and three Phase III modified single-blind, controlled,

multicenter trials in which more than 3,300 infants from the United

States received Menactra vaccine using a two-dose schedule, starting as

young as 9 months of age.

Results from the above studies showed that 2 doses of Menactra vaccine

given 3 months apart elicit a robust immune response against the

serogroups included in the vaccine.

**************

Here's the package insert

https://www.vaccineshoppe.com/image.cfm?doc_id=11177 & image_type=product_pdf

" Menactra®, Meningococcal (Groups A, C, Y and W-135) Polysaccharide

Diphtheria Toxoid Conjugate Vaccine, is a sterile, intramuscularly

administered vaccine that contains Neisseria meningitidis serogroup A, C,

Y and W-135 capsular polysaccharide antigens individually conjugated to

diphtheria toxoid protein. N meningitidis A, C, Y and W-135 strains are

cultured on Mueller Hinton agar (2) and grown in Scherp (3) media.

The polysaccharides are extracted from the N meningitidis cells and

purified by centrifugation, detergent precipitation, alcohol

precipitation, solvent extraction and diafiltration. To prepare the

polysaccharides for conjugation, they are depolymerized, derivatized, and

purified by diafiltration. Corynebacterium diphtheriae cultures are grown

in a modified Mueller and medium (4) and detoxified with

formaldehyde. The diphtheria toxoid protein is purified by ammonium

sulfate fractionation and diafiltration. The derivatized polysaccharides

are covalently linked to diphtheria toxoid and purified by serial

diafiltration. The four meningococcal components, present as individual

serogroup-specific glycoconjugates, compose the final formulated vaccine.

No preservative or adjuvant is added during manufacture. Each 0.5 mL dose

may contain residual amounts of formaldehyde of less than 2.66 mcg

(0.000532%), by calculation. Potency of Menactra vaccine is determined by

quantifying the amount of each polysaccharide antigen that is conjugated

to diphtheria toxoid protein and the amount of unconjugated

polysaccharide present.

Menactra vaccine is manufactured as a sterile, clear to slightly turbid

liquid. Each 0.5 mL dose of vaccine is formulated in sodium phosphate

buffered isotonic sodium chloride solution to contain 4 mcg each of

meningococcal A, C, Y and W-135 polysaccharides conjugated to

approximately 48 mcg of diphtheria toxoid protein carrier. "

*******

Here is a good article by Jayne Donegan

http://www.whale.to/vaccines/meningitis5.html

Meningitis C Vaccine—A Look at the Disease & The New Jab------- Dr

Jayne L M Donegan, MB, BS, DRCOG, DCH, MRCGP General Medical Practitioner

(Practicing in South London)The Informed Parent

Sheri Nakken, former R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Washington State, USA

Vaccines -

http://vaccinationdangers.wordpress.com/ Homeopathy

http://homeopathycures.wordpress.com

Vaccine Dangers, Childhood Disease Classes & Homeopathy

Online/email courses - next classes start April 22

[Guest guest]

"a robust immune response?" I can only imagine what "robust" looks like.

And don't you love this careful wording: "Menactra vaccine is manufactured as a sterile, clear to slightly turbid liquid." "Is manufactured as," not "is sterile."

I guess not enough of the originally targeted groups (pre-teens through college-aged) are getting it. Shades of Hep B being given to babies after the high-risk groups mostly rejected it. Go after the babies because parents who vaccinate will agree to anything without researching it first.

Winnie Intants - FDA Grants Licensure To Expand Indication For Sanofi Pasteur's MenactraRecipient list suppressed: ;> NOT good news as it will surely be added to the > already toxic schedule for 9 months - 23 months> > SICK> > http://www.rttnews.com/Content/QuickFacts.aspx?Node=B1 & Id=1604875> > FDA Grants Licensure To Expand Indication For Sanofi Pasteur's > Menactra4/25/2011 8:16 AM ET> > (RTTNews) - Sanofi Pasteur, the vaccines division > of the Sanofi-Aventis Group (SNY: > News > ,SNYNF.PK: > News > ), announced that the U.S. Food and Drug > Administration, or FDA, has granted licensure to > expand the indication for its meningococcal > conjugate vaccine, Menactra, to include a > two-dose schedule for infants and children 9 months through 23 > months of age.> > The FDA approval of Menactra vaccine for infants > was based on results of one Phase II and three > Phase III modified single-blind, controlled, > multicenter trials in which more than 3,300 > infants from the United States received Menactra > vaccine using a two-dose schedule, starting as young as 9 months > of age.> > Results from the above studies showed that 2 > doses of Menactra vaccine given 3 months apart > elicit a robust immune response against the > serogroups included in the vaccine.> **************> > Here's the package insert> https://www.vaccineshoppe.com/image.cfm?doc_id=11177 & image_type=product_pdf> "Menactra®, Meningococcal (Groups A, C, Y and > W-135) Polysaccharide Diphtheria Toxoid Conjugate > Vaccine, is a sterile, intramuscularly > administered vaccine that contains Neisseria > meningitidis serogroup A, C, Y and W-135 capsular > polysaccharide antigens individually conjugated > to diphtheria toxoid protein. N meningitidis A, > C, Y and W-135 strains are cultured on Mueller > Hinton agar (2) and grown in Scherp (3) > media. The polysaccharides are extracted from the > N meningitidis cells and purified by > centrifugation, detergent precipitation, alcohol > precipitation, solvent extraction and > diafiltration. To prepare the polysaccharides for > conjugation, they are depolymerized, derivatized, > and purified by diafiltration. Corynebacterium > diphtheriae cultures are grown in a modified > Mueller and medium (4) and detoxified with > formaldehyde. The diphtheria toxoid protein is > purified by ammonium sulfate fractionation and > diafiltration. The derivatized polysaccharides > are covalently linked to diphtheria toxoid and > purified by serial diafiltration. The four > meningococcal components, present as individual > serogroup-specific glycoconjugates, compose the > final formulated vaccine. No preservative or > adjuvant is added during manufacture. Each 0.5 mL > dose may contain residual amounts of formaldehyde > of less than 2.66 mcg (0.000532%), by > calculation. Potency of Menactra vaccine is > determined by quantifying the amount of each > polysaccharide antigen that is conjugated to > diphtheria toxoid protein and the amount of > unconjugated polysaccharide present.> > Menactra vaccine is manufactured as a sterile, > clear to slightly turbid liquid. Each 0.5 mL dose > of vaccine is formulated in sodium phosphate > buffered isotonic sodium chloride solution to > contain 4 mcg each of meningococcal A, C, Y and > W-135 polysaccharides conjugated to approximately > 48 mcg of diphtheria toxoid protein carrier."> > *******> Here is a good article by Jayne Donegan> http://www.whale.to/vaccines/meningitis5.html> Meningitis C Vaccine—A Look at the Disease & The > New Jab------- Dr Jayne L M Donegan, MB, BS, > DRCOG, DCH, MRCGP General Medical Practitioner > (Practicing in South London)The Informed Parent> > Sheri Nakken, former R.N., MA, Hahnemannian Homeopath> Vaccination Information & Choice Network, Washington State, USA> Vaccines - > http://vaccinationdangers.wordpress.com/ > Homeopathy http://homeopathycures.wordpress.com> Vaccine Dangers, Childhood Disease Classes & > Homeopathy Online/email courses - next classes start April 22>

[Guest guest]

Did you read all the precipitations? I admit that is a little over my head but boy.. it sounds gross to me and I wouldn’t go near it! I wonder how many parents really are informed about how “wonderful” (gag) vaccines are and how they’re made?! I think it’s like some illusion. We sit here and imagine a sterile lab w/ all sorts of QC and no violations and no mishaps..and it’s all good. Then we believe our doctors on how safe it is 3300 infants! I wonder how many of those infants are OK now.. much later after the trials? Nita, mom to: 18, Jon 16, 14, 12, 9, Christian (7/16/03 to 8/22/04), 5, Isaac 3 and , born 3/1/11http://momof6.dotphoto.com for possibly current pictures and http://nitasspot.blogspot.comLearn from the mistakes of others. Trust me... you can't live long enough to make them all yourself.