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RSV Vaccine

Posted by on Dec. 6, 2012 at 4:00 PM
  • 9 Replies
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Anyone know anything about the RSV vaccine, Synagis? My friend's son gets this shot because *supposedly* it's GOOD for children with heart conditions... Anyway... he gets the shot MONTHLY throughout flu season. I can't find any info on it about shedding... I'm pretty sure it's not a live vaccine. I'm just concerned about having DD around him or going to their house with him getting vaccinated on a monthly basis.

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by on Dec. 6, 2012 at 4:00 PM
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Replies (1-9):
kitty8199
by Silver Member on Dec. 6, 2012 at 5:13 PM
Its not a vaccine. Its an IgG. It is the antibodies for RSV. That its why he gets so many. It is very short acting.
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nicki.hemingway
by Bronze Member on Dec. 6, 2012 at 9:54 PM

I was under the assumption that it is full of all sorts of nasty byproducts and preservatives as well.

emmy526
by New Owner on Dec. 7, 2012 at 6:36 AM

from the manufacterer:


Quote:

Synagis (palivizumab) is a humanized monoclonal antibody (IgG1κ ) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Synagis is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence was derived from the constant domains of human IgG1 and the variable framework regions of the VH genes Cor (1) and Cess (2). The human light chain sequence was derived from the constant domain of Cκ and the variable framework regions of the VL gene K104 with Jκ -4 (3). The murine sequences were derived from a murine monoclonal antibody, Mab 1129 (4), in a process that involved the grafting of the murine complementarity determining regions into the human antibody frameworks. Synagis is composed of two heavy chains and two light chains and has a molecular weight of approximately 148,000 Daltons.


Quote:

General:  

 

Synagis is for intramuscular use only. As with any intramuscular injection, Synagis should be given with caution to patients with thrombocytopenia or any coagulation disorder.

 

The safety and efficacy of Synagis have not been demonstrated for treatment of established RSV disease.

The single-dose vial of Synagis does not contain a preservative. Administration of Synagis should occur immediately after dose withdrawal from the vial. The vial should not be re-entered. Discard any unused portion.

 

Drug Interactions:

No formal drug-drug interaction studies were conducted. In Trial 1, the proportions of patients in the placebo and Synagis groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents.

 

Carcinogenesis, Mutagenesis, Impairment of Fertility:  

Carcinogenesis, mutagenesis and reproductive toxicity studies have not been performed.


http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=10895


Quote:

In 139 pediatric patients ≤ 24 months of age with hemodynamically significant CHD who received Synagis and underwent cardio-pulmonary bypass for open-heart surgery, the mean ± SD serum Synagis concentration was 98+ 52 mcg/mL before bypass and declined to 41+ 33 mcg/mL after bypass, a reduction of 58% (see DOSAGE AND ADMINISTRATION). The clinical significance of this reduction is unknown.

Specific studies were not conducted to evaluate the effects of demographic parameters on Synagis systemic exposure. However, no effects of gender, age, body weight or race on Synagis serum trough concentrations were observed in a clinical study with 639 pediatric patients with CHD (≤24 months of age) receiving five monthly intramuscular injections of 15 mg/kg of Synagis. 


Quoting nicki.hemingway:

I was under the assumption that it is full of all sorts of nasty byproducts and preservatives as well.


kitty8199
by Silver Member on Dec. 7, 2012 at 11:13 AM
Murine=mouse

Ewwww not that monkey, cow, pig, chicken is any better, but now they give mouse antibodies?

That made me super cringe for some reason. Maybe bc rodents are known vectors for disease.
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.sp4rkl3z.
by Member on Dec. 7, 2012 at 1:21 PM
Thanks for clarifying, I was like uhh, what is "murine?" And that's disgusting!

Quoting kitty8199:

Murine=mouse



Ewwww not that monkey, cow, pig, chicken is any better, but now they give mouse antibodies?



That made me super cringe for some reason. Maybe bc rodents are known vectors for disease.
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kitty8199
by Silver Member on Dec. 7, 2012 at 2:53 PM
I don't remember any others being made from mouse.

Quoting .sp4rkl3z.:

Thanks for clarifying, I was like uhh, what is "murine?" And that's disgusting!



Quoting kitty8199:

Murine=mouse





Ewwww not that monkey, cow, pig, chicken is any better, but now they give mouse antibodies?





That made me super cringe for some reason. Maybe bc rodents are known vectors for disease.
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mjrex87
by Member on Dec. 8, 2012 at 4:02 PM

Yea...that's disgusting.

Quoting kitty8199:

Murine=mouse

Ewwww not that monkey, cow, pig, chicken is any better, but now they give mouse antibodies?

That made me super cringe for some reason. Maybe bc rodents are known vectors for disease.


mjrex87
by Member on Dec. 8, 2012 at 4:08 PM

What I'm getting from this is that they have hardly done any research on this product before selling it to inject into babies' bodies. Typical.

Quoting emmy526:

from the manufacterer:


Quote:

Synagis (palivizumab) is a humanized monoclonal antibody (IgG1κ ) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Synagis is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence was derived from the constant domains of human IgG1 and the variable framework regions of the VH genes Cor (1) and Cess (2). The human light chain sequence was derived from the constant domain of Cκ and the variable framework regions of the VL gene K104 with Jκ -4 (3). The murine sequences were derived from a murine monoclonal antibody, Mab 1129 (4), in a process that involved the grafting of the murine complementarity determining regions into the human antibody frameworks. Synagis is composed of two heavy chains and two light chains and has a molecular weight of approximately 148,000 Daltons.



Quote:

General:  

 

Synagis is for intramuscular use only. As with any intramuscular injection, Synagis should be given with caution to patients with thrombocytopenia or any coagulation disorder.

 

The safety and efficacy of Synagis have not been demonstrated for treatment of established RSV disease.

The single-dose vial of Synagis does not contain a preservative. Administration of Synagis should occur immediately after dose withdrawal from the vial. The vial should not be re-entered. Discard any unused portion.


Drug Interactions:

No formal drug-drug interaction studies were conducted. In Trial 1, the proportions of patients in the placebo and Synagis groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents.


Carcinogenesis, Mutagenesis, Impairment of Fertility:  

Carcinogenesis, mutagenesis and reproductive toxicity studies have not been performed.


http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=10895




Quote:

In 139 pediatric patients ≤ 24 months of age with hemodynamically significant CHD who received Synagis and underwent cardio-pulmonary bypass for open-heart surgery, the mean ± SD serum Synagis concentration was 98+ 52 mcg/mL before bypass and declined to 41+ 33 mcg/mL after bypass, a reduction of 58% (see DOSAGE AND ADMINISTRATION). The clinical significance of this reduction is unknown.

Specific studies were not conducted to evaluate the effects of demographic parameters on Synagis systemic exposure. However, no effects of gender, age, body weight or race on Synagis serum trough concentrations were observed in a clinical study with 639 pediatric patients with CHD (≤24 months of age) receiving five monthly intramuscular injections of 15 mg/kg of Synagis. 



Quoting nicki.hemingway:

I was under the assumption that it is full of all sorts of nasty byproducts and preservatives as well.



emmy526
by New Owner on Dec. 8, 2012 at 4:37 PM

pretty much just like every other vaccine out there...

Quoting mjrex87:

What I'm getting from this is that they have hardly done any research on this product before selling it to inject into babies' bodies. Typical.

Quoting emmy526:

from the manufacterer:


Quote:

Synagis (palivizumab) is a humanized monoclonal antibody (IgG1κ ) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Synagis is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence was derived from the constant domains of human IgG1 and the variable framework regions of the VH genes Cor (1) and Cess (2). The human light chain sequence was derived from the constant domain of Cκ and the variable framework regions of the VL gene K104 with Jκ -4 (3). The murine sequences were derived from a murine monoclonal antibody, Mab 1129 (4), in a process that involved the grafting of the murine complementarity determining regions into the human antibody frameworks. Synagis is composed of two heavy chains and two light chains and has a molecular weight of approximately 148,000 Daltons.



Quote:

General:  

 

Synagis is for intramuscular use only. As with any intramuscular injection, Synagis should be given with caution to patients with thrombocytopenia or any coagulation disorder.

 

The safety and efficacy of Synagis have not been demonstrated for treatment of established RSV disease.

The single-dose vial of Synagis does not contain a preservative. Administration of Synagis should occur immediately after dose withdrawal from the vial. The vial should not be re-entered. Discard any unused portion.


Drug Interactions:

No formal drug-drug interaction studies were conducted. In Trial 1, the proportions of patients in the placebo and Synagis groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents.


Carcinogenesis, Mutagenesis, Impairment of Fertility:  

Carcinogenesis, mutagenesis and reproductive toxicity studies have not been performed.


http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=10895




Quote:

In 139 pediatric patients ≤ 24 months of age with hemodynamically significant CHD who received Synagis and underwent cardio-pulmonary bypass for open-heart surgery, the mean ± SD serum Synagis concentration was 98+ 52 mcg/mL before bypass and declined to 41+ 33 mcg/mL after bypass, a reduction of 58% (see DOSAGE AND ADMINISTRATION). The clinical significance of this reduction is unknown.

Specific studies were not conducted to evaluate the effects of demographic parameters on Synagis systemic exposure. However, no effects of gender, age, body weight or race on Synagis serum trough concentrations were observed in a clinical study with 639 pediatric patients with CHD (≤24 months of age) receiving five monthly intramuscular injections of 15 mg/kg of Synagis. 



Quoting nicki.hemingway:

I was under the assumption that it is full of all sorts of nasty byproducts and preservatives as well.




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