FDA Approves New Vaccine for Babies : MenHibrix by FDA

[Guest guest]

http://articles.mercola.com/sites/articles/archive/2012/07/24/new-vaccines-for-babies.aspx

Story at-a-glance

A study by the Oregon Health Authority and the U.S. Centers for

Disease Control concluded that about 10 percent of parents in Portland,

Oregon are making independent decisions about how many vaccines their

babies should get and when they should get them. Public health doctors

refer to such parents as “shot limiters,” and it has become fashionable

in medical journals and media circles to demonize these parents On June 14, the FDA awarded GlaxoKline (GSK) a license to sell

MenHibrix, a new vaccine that combines two meningitis vaccines into one

shot, without asking the agency’s own vaccine advisory committee for an

opinion, despite the fact the FDA had rejected the license in 2010 and

2011 because GSK had trouble proving the vaccine actually worked The CDC’s Advisory Committee on Immunization Practices (ACIP) is

rumored to vote on a recommendation for the MenHibrix in October

....FDA Licenses New Combo Vaccine for Babies

Ironically, on June 14, the FDA awarded

GlaxoKline (GSK) a license to sell MenHibrix,

a new vaccine that combines two meningitis vaccines into one

shot.5,6 The FDA had

rejected the license in 2010 and 2011 because, reportedly, the British

drug company giant was having trouble proving the vaccine actually

worked. 7

This time, FDA staff did not bother to ask for

an opinion from the agency's own vaccine advisory committee before giving

GSK the green light to market MenHibrix in the U.S. for babies as young

as 6 weeks old. In a letter, FDA official n Gruber, PhD, told the

company that: " We did not refer your application to an additional

VRBPAC [review] because our review of information submitted in your

BLA, including the clinical study design and trial

results, did not raise particular concerns or controversial issues which

would have benefited from an advisory committee discussion. " 8

Really? Sounds like some FDA officials didn't want Advisory Committee

members to ask the drug company lots of questions about this new vaccine,

just like CDC and AAP officials don't want parents to ask lots of

questions about ANY vaccine.

Nine or 10 Vaccines Given on Same Day: Where's the

Science?

MenHibrix has not yet

been studied in combination with every one of the other vaccines already

given to babies simultaneously.9 But that is not

likely to stop pediatricians from assuming safety and throwing

MenHibrix into the mix, for a grand total of nine

or 10 vaccines given to tiny babies on the same day.10

Even premature babies weighing less than four

and a half pounds are subjected to the mindless one-size-fits all

" no exceptions " vaccine schedule.11,12

Where is the solid scientific evidence that it is safe or effective to

give eight or nine vaccines to an eight or nine pound newborn?

Where is the solid evidence that babies, who

get more than two-dozen doses of vaccines by age six months, are

healthier as they grow up than those, who get fewer vaccines or fewer

vaccines on one day? No large, prospective studies have been done

comparing the long-term health outcomes of children, who are vaccinated

according to the CDC schedule, with those, who

are not.13

It is no wonder that smart parents – like the

ones in Oregon - are challenging the wisdom of the bloated and expensive

vaccine schedule and are telling doctors and legislators: " Show Us

the Science, and Give Us the

Choice. " 14...

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 August 2

[Guest guest]

Of all of my five children, only one of them is still young enough to be seen by their pediatrician, who does not see his previous patients once they have reached/passed 18 years of age. At times, during the past few years when I took my daughter to his office for various ailments, he did ask whether her vaccines were up to date. I told him, already a few years ago, that I had my younger kids exempted from any further vaccines. Now, when we see him, he still needs a few reminders about my decision. It seems that after we stopped the vaccinations, we see our pediatrician much less often. However, when we do see him, he and I seem to have reached a level of mutual respect. Our pediatrician does not question why I had my children

exempted from any further vaccines. Years ago, I had to practically beg him to get my youngest son assessed for ASD, so that he could get some useful support. He assisted us with that and referred my son to agencies which did end up helping him. Around the same time, I was glad that our pediatrician was able to recognize a urinary reflux problem in one of our other sons, that eventually led to several surgeries and some kidney damage, but which could have ended up being much worse had our pediatrician not diagnosed it as early as he did. My kids and I have been dealing with the same pediatrician for most of their health woes for close to 24 years now. He has always been wonderful and attentive with my kids, and I am glad that he never brought up the issue of maybe discontinuing my kids as clients/"patients"(I don't particularly like that

term).What am I trying to say here?Perhaps not to give up on your doctors/pediatricians too easily. They can be powerful allies if you think your child may need extra support in one way or another. At the same time, we can also help educate our kids' health providers, by letting them know about what we have read or heard. It may not necessarily be well received, at first. However, I do believe that we can make an impact if we can share what we have learned, and can also share studies that can back us up. It would also be useful to share information amongst ourselves, to help build a base of studies to help bolster our points of view.Where's the "Science"? I don't know!Yet, some of us teachers are trying to teach "scientific inquiry" to young students. I am wondering about how this will play out in the long run, when "scientific inquiry" seems to be

stymied in some ways. How is that being done? Aasa To: Sent: Wednesday, August 1, 2012 7:18:52 PM Subject: FDA Approves New Vaccine for Babies : MenHibrix by FDA

http://articles.mercola.com/sites/articles/archive/2012/07/24/new-vaccines-for-babies.aspx

Story at-a-glance

A study by the Oregon Health Authority and the U.S. Centers for

Disease Control concluded that about 10 percent of parents in Portland,

Oregon are making independent decisions about how many vaccines their

babies should get and when they should get them. Public health doctors

refer to such parents as “shot limiters,†and it has become fashionable

in medical journals and media circles to demonize these parents On June 14, the FDA awarded GlaxoKline (GSK) a license to sell

MenHibrix, a new vaccine that combines two meningitis vaccines into one

shot, without asking the agency’s own vaccine advisory committee for an

opinion, despite the fact the FDA had rejected the license in 2010 and

2011 because GSK had trouble proving the vaccine actually worked The CDC’s Advisory Committee on Immunization Practices (ACIP) is

rumored to vote on a recommendation for the MenHibrix in October

....FDA Licenses New Combo Vaccine for Babies

Ironically, on June 14, the FDA awarded

GlaxoKline (GSK) a license to sell MenHibrix,

a new vaccine that combines two meningitis vaccines into one

shot.5,6 The FDA had

rejected the license in 2010 and 2011 because, reportedly, the British

drug company giant was having trouble proving the vaccine actually

worked. 7

This time, FDA staff did not bother to ask for

an opinion from the agency's own vaccine advisory committee before giving

GSK the green light to market MenHibrix in the U.S. for babies as young

as 6 weeks old. In a letter, FDA official n Gruber, PhD, told the

company that: "We did not refer your application to an additional

VRBPAC [review] because our review of information submitted in your

BLA, including the clinical study design and trial

results, did not raise particular concerns or controversial issues which

would have benefited from an advisory committee discussion."8

Really? Sounds like some FDA officials didn't want Advisory Committee

members to ask the drug company lots of questions about this new vaccine,

just like CDC and AAP officials don't want parents to ask lots of

questions about ANY vaccine.

Nine or 10 Vaccines Given on Same Day: Where's the

Science?

MenHibrix has not yet

been studied in combination with every one of the other vaccines already

given to babies simultaneously.9 But that is not

likely to stop pediatricians from assuming safety and throwing

MenHibrix into the mix, for a grand total of nine

or 10 vaccines given to tiny babies on the same day.10

Even premature babies weighing less than four

and a half pounds are subjected to the mindless one-size-fits all

"no exceptions" vaccine schedule.11,12

Where is the solid scientific evidence that it is safe or effective to

give eight or nine vaccines to an eight or nine pound newborn?

Where is the solid evidence that babies, who

get more than two-dozen doses of vaccines by age six months, are

healthier as they grow up than those, who get fewer vaccines or fewer

vaccines on one day? No large, prospective studies have been done

comparing the long-term health outcomes of children, who are vaccinated

according to the CDC schedule, with those, who

are not.13

It is no wonder that smart parents – like the

ones in Oregon - are challenging the wisdom of the bloated and expensive

vaccine schedule and are telling doctors and legislators: "Show Us

the Science, and Give Us the

Choice."14... 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 August 2

[Guest guest]

Aasa,We have had the same experience with our pediatrician.  She is considered one of the top pediatricians in Orlando, Florida.  Two of us that belong to this EOHarm group take our children to her.  I have been taking mine since they were born (9 years now).  I have seen her stymied and unable to help us with the GERDS, constipation, “bladder infectionsâ€, night tremors, “colicky†for hours each night, etc. BTW she is both western practice and homeopathic – we only tried homeopathy and antibiotics – to no avail.  Our pediatrician was a proponent of vaccines, on a single shot, slow schedule, when we met her.  She has grown with us in experience and awareness albeit much more slowly than us – when it should be the other way around.  These pediatricians have hundreds of patients to see the effects from vaccines and to see trends that should be eye-openers.  We, the hapless parents, are left in the dark as to whether anyone else might be experiencing the same symptoms, so we think our children are having unique, inexplicable problems.  Our pediatrician’s heart has been in the right place and she has never challenged our decisions, such as not using medication for the GERDs, and our decision to discontinue vaccines at our first child’s second birthday.  While I am very angry about the damage done to my first child, I realize that we must have an advocate within the mainstream medical field and so we’ve been diligent about making it to our annual checkups.  We are very fortunate that our pediatrician has been learning and has read quite a lot that we have passed on including the GAPS diet.  It also helps that there are several of us moms that are friends, well-informed on diet, vaccines, environmental impacts to our children’s health, and are pro-homeopathy that are all seeing the same physician as it ensures she sees the positive health effects from our approach and is reminded by each of our visits.  Incidentally, she does not advocate vaccines anymore and is pleased that we continue to sign waivers.  She’s coming along! From: EOHarm [mailto:EOHarm ] On Behalf Of AasaSent: Wednesday, August 01, 2012 9:28 PMTo: EOHarm Subject: Re: FDA Approves New Vaccine for Babies : MenHibrix by FDA Of all of my five children, only one of them is still young enough to be seen by their pediatrician, who does not see his previous patients once they have reached/passed 18 years of age. At times, during the past few years when I took my daughter to his office for various ailments, he did ask whether her vaccines were up to date. I told him, already a few years ago, that I had my younger kids exempted from any further vaccines. Now, when we see him, he still needs a few reminders about my decision. It seems that after we stopped the vaccinations, we see our pediatrician much less often. However, when we do see him, he and I seem to have reached a level of mutual respect. Our pediatrician does not question why I had my children exempted from any further vaccines. Years ago, I had to practically beg him to get my youngest son assessed for ASD, so that he could get some useful support. He assisted us with that and referred my son to agencies which did end up helping him. Around the same time, I was glad that our pediatrician was able to recognize a urinary reflux problem in one of our other sons, that eventually led to several surgeries and some kidney damage, but which could have ended up being much worse had our pediatrician not diagnosed it as early as he did. My kids and I have been dealing with the same pediatrician for most of their health woes for close to 24 years now. He has always been wonderful and attentive with my kids, and I am glad that he never brought up the issue of maybe discontinuing my kids as clients/ " patients " (I don't particularly like that term).What am I trying to say here?Perhaps not to give up on your doctors/pediatricians too easily. They can be powerful allies if you think your child may need extra support in one way or another. At the same time, we can also help educate our kids' health providers, by letting them know about what we have read or heard. It may not necessarily be well received, at first. However, I do believe that we can make an impact if we can share what we have learned, and can also share studies that can back us up. It would also be useful to share information amongst ourselves, to help build a base of studies to help bolster our points of view.Where's the " Science " ? I don't know!Yet, some of us teachers are trying to teach " scientific inquiry " to young students. I am wondering about how this will play out in the long run, when " scientific inquiry " seems to be stymied in some ways. How is that being done? Aasa To: Sent: Wednesday, August 1, 2012 7:18:52 PMSubject: FDA Approves New Vaccine for Babies : MenHibrix by FDA http://articles.mercola.com/sites/articles/archive/2012/07/24/new-vaccines-for-babies.aspx Story at-a-glanceA study by the Oregon Health Authority and the U.S. Centers for Disease Control concluded that about 10 percent of parents in Portland, Oregon are making independent decisions about how many vaccines their babies should get and when they should get them. Public health doctors refer to such parents as “shot limiters,†and it has become fashionable in medical journals and media circles to demonize these parents On June 14, the FDA awarded GlaxoKline (GSK) a license to sell MenHibrix, a new vaccine that combines two meningitis vaccines into one shot, without asking the agency’s own vaccine advisory committee for an opinion, despite the fact the FDA had rejected the license in 2010 and 2011 because GSK had trouble proving the vaccine actually worked The CDC’s Advisory Committee on Immunization Practices (ACIP) is rumored to vote on a recommendation for the MenHibrix in October ...FDA Licenses New Combo Vaccine for BabiesIronically, on June 14, the FDA awarded GlaxoKline (GSK) a license to sell MenHibrix, a new vaccine that combines two meningitis vaccines into one shot.5,6 The FDA had rejected the license in 2010 and 2011 because, reportedly, the British drug company giant was having trouble proving the vaccine actually worked. 7 This time, FDA staff did not bother to ask for an opinion from the agency's own vaccine advisory committee before giving GSK the green light to market MenHibrix in the U.S. for babies as young as 6 weeks old. In a letter, FDA official n Gruber, PhD, told the company that: " We did not refer your application to an additional VRBPAC [review] because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise particular concerns or controversial issues which would have benefited from an advisory committee discussion. " 8 Really? Sounds like some FDA officials didn't want Advisory Committee members to ask the drug company lots of questions about this new vaccine, just like CDC and AAP officials don't want parents to ask lots of questions about ANY vaccine. Nine or 10 Vaccines Given on Same Day: Where's the Science?MenHibrix has not yet been studied in combination with every one of the other vaccines already given to babies simultaneously.9 But that is not likely to stop pediatricians from assuming safety and throwing MenHibrix into the mix, for a grand total of nine or 10 vaccines given to tiny babies on the same day.10 Even premature babies weighing less than four and a half pounds are subjected to the mindless one-size-fits all " no exceptions " vaccine schedule.11,12 Where is the solid scientific evidence that it is safe or effective to give eight or nine vaccines to an eight or nine pound newborn? Where is the solid evidence that babies, who get more than two-dozen doses of vaccines by age six months, are healthier as they grow up than those, who get fewer vaccines or fewer vaccines on one day? No large, prospective studies have been done comparing the long-term health outcomes of children, who are vaccinated according to the CDC schedule, with those, who are not.13 It is no wonder that smart parents – like the ones in Oregon - are challenging the wisdom of the bloated and expensive vaccine schedule and are telling doctors and legislators: " Show Us the Science, and Give Us the Choice. " 14...Sheri Nakken, former R.N., MA, Hahnemannian Homeopath Vaccination Information & Choice Network, Washington State, USAVaccines - http://vaccinationdangers.wordpress.com/ Homeopathy http://homeopathycures.wordpress.comVaccine Dangers, Childhood Disease Classes & Homeopathy Online/email courses - next classes start August 2

[Guest guest]

– Make that at least three families from this group J  We have been with her practice for 10 years and much appreciate her willingness to support the parents’ decisions.  She has grown in her understanding and listens and learns from her patient-families – we are much-blessed to have her on our side; the only down-side is how long it takes to get in for our visits…Ultimately it does not matter as they are only visits to say hello J Liz P From: EOHarm [mailto:EOHarm ] On Behalf Of Sent: Wednesday, August 08, 2012 12:32 AMTo: EOHarm Subject: RE: FDA Approves New Vaccine for Babies : MenHibrix by FDA Aasa,We have had the same experience with our pediatrician. She is considered one of the top pediatricians in Orlando, Florida. Two of us that belong to this EOHarm group take our children to her. I have been taking mine since they were born (9 years now). I have seen her stymied and unable to help us with the GERDS, constipation, “bladder infectionsâ€, night tremors, “colicky†for hours each night, etc. BTW she is both western practice and homeopathic – we only tried homeopathy and antibiotics – to no avail. Our pediatrician was a proponent of vaccines, on a single shot, slow schedule, when we met her. She has grown with us in experience and awareness albeit much more slowly than us – when it should be the other way around. These pediatricians have hundreds of patients to see the effects from vaccines and to see trends that should be eye-openers. We, the hapless parents, are left in the dark as to whether anyone else might be experiencing the same symptoms, so we think our children are having unique, inexplicable problems. Our pediatrician’s heart has been in the right place and she has never challenged our decisions, such as not using medication for the GERDs, and our decision to discontinue vaccines at our first child’s second birthday. While I am very angry about the damage done to my first child, I realize that we must have an advocate within the mainstream medical field and so we’ve been diligent about making it to our annual checkups. We are very fortunate that our pediatrician has been learning and has read quite a lot that we have passed on including the GAPS diet. It also helps that there are several of us moms that are friends, well-informed on diet, vaccines, environmental impacts to our children’s health, and are pro-homeopathy that are all seeing the same physician as it ensures she sees the positive health effects from our approach and is reminded by each of our visits. Incidentally, she does not advocate vaccines anymore and is pleased that we continue to sign waivers. She’s coming along! From: EOHarm [mailto:EOHarm ] On Behalf Of AasaSent: Wednesday, August 01, 2012 9:28 PMTo: EOHarm Subject: Re: FDA Approves New Vaccine for Babies : MenHibrix by FDA Of all of my five children, only one of them is still young enough to be seen by their pediatrician, who does not see his previous patients once they have reached/passed 18 years of age. At times, during the past few years when I took my daughter to his office for various ailments, he did ask whether her vaccines were up to date. I told him, already a few years ago, that I had my younger kids exempted from any further vaccines. Now, when we see him, he still needs a few reminders about my decision. It seems that after we stopped the vaccinations, we see our pediatrician much less often. However, when we do see him, he and I seem to have reached a level of mutual respect. Our pediatrician does not question why I had my children exempted from any further vaccines. Years ago, I had to practically beg him to get my youngest son assessed for ASD, so that he could get some useful support. He assisted us with that and referred my son to agencies which did end up helping him. Around the same time, I was glad that our pediatrician was able to recognize a urinary reflux problem in one of our other sons, that eventually led to several surgeries and some kidney damage, but which could have ended up being much worse had our pediatrician not diagnosed it as early as he did. My kids and I have been dealing with the same pediatrician for most of their health woes for close to 24 years now. He has always been wonderful and attentive with my kids, and I am glad that he never brought up the issue of maybe discontinuing my kids as clients/ " patients " (I don't particularly like that term).What am I trying to say here?Perhaps not to give up on your doctors/pediatricians too easily. They can be powerful allies if you think your child may need extra support in one way or another. At the same time, we can also help educate our kids' health providers, by letting them know about what we have read or heard. It may not necessarily be well received, at first. However, I do believe that we can make an impact if we can share what we have learned, and can also share studies that can back us up. It would also be useful to share information amongst ourselves, to help build a base of studies to help bolster our points of view.Where's the " Science " ? I don't know!Yet, some of us teachers are trying to teach " scientific inquiry " to young students. I am wondering about how this will play out in the long run, when " scientific inquiry " seems to be stymied in some ways. How is that being done? Aasa To: Sent: Wednesday, August 1, 2012 7:18:52 PMSubject: FDA Approves New Vaccine for Babies : MenHibrix by FDA http://articles.mercola.com/sites/articles/archive/2012/07/24/new-vaccines-for-babies.aspx Story at-a-glanceA study by the Oregon Health Authority and the U.S. Centers for Disease Control concluded that about 10 percent of parents in Portland, Oregon are making independent decisions about how many vaccines their babies should get and when they should get them. Public health doctors refer to such parents as “shot limiters,†and it has become fashionable in medical journals and media circles to demonize these parents On June 14, the FDA awarded GlaxoKline (GSK) a license to sell MenHibrix, a new vaccine that combines two meningitis vaccines into one shot, without asking the agency’s own vaccine advisory committee for an opinion, despite the fact the FDA had rejected the license in 2010 and 2011 because GSK had trouble proving the vaccine actually worked The CDC’s Advisory Committee on Immunization Practices (ACIP) is rumored to vote on a recommendation for the MenHibrix in October ...FDA Licenses New Combo Vaccine for BabiesIronically, on June 14, the FDA awarded GlaxoKline (GSK) a license to sell MenHibrix, a new vaccine that combines two meningitis vaccines into one shot.5,6 The FDA had rejected the license in 2010 and 2011 because, reportedly, the British drug company giant was having trouble proving the vaccine actually worked. 7 This time, FDA staff did not bother to ask for an opinion from the agency's own vaccine advisory committee before giving GSK the green light to market MenHibrix in the U.S. for babies as young as 6 weeks old. In a letter, FDA official n Gruber, PhD, told the company that: " We did not refer your application to an additional VRBPAC [review] because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise particular concerns or controversial issues which would have benefited from an advisory committee discussion. " 8 Really? Sounds like some FDA officials didn't want Advisory Committee members to ask the drug company lots of questions about this new vaccine, just like CDC and AAP officials don't want parents to ask lots of questions about ANY vaccine. Nine or 10 Vaccines Given on Same Day: Where's the Science?MenHibrix has not yet been studied in combination with every one of the other vaccines already given to babies simultaneously.9 But that is not likely to stop pediatricians from assuming safety and throwing MenHibrix into the mix, for a grand total of nine or 10 vaccines given to tiny babies on the same day.10 Even premature babies weighing less than four and a half pounds are subjected to the mindless one-size-fits all " no exceptions " vaccine schedule.11,12 Where is the solid scientific evidence that it is safe or effective to give eight or nine vaccines to an eight or nine pound newborn? Where is the solid evidence that babies, who get more than two-dozen doses of vaccines by age six months, are healthier as they grow up than those, who get fewer vaccines or fewer vaccines on one day? No large, prospective studies have been done comparing the long-term health outcomes of children, who are vaccinated according to the CDC schedule, with those, who are not.13 It is no wonder that smart parents – like the ones in Oregon - are challenging the wisdom of the bloated and expensive vaccine schedule and are telling doctors and legislators: " Show Us the Science, and Give Us the Choice. " 14...Sheri Nakken, former R.N., MA, Hahnemannian Homeopath Vaccination Information & Choice Network, Washington State, USAVaccines - http://vaccinationdangers.wordpress.com/ Homeopathy http://homeopathycures.wordpress.comVaccine Dangers, Childhood Disease Classes & Homeopathy Online/email courses - next classes start August 2 No virus found in this message.Checked by AVG - www.avg.comVersion: 2012.0.2197 / Virus Database: 2437/5172 - Release Date: 08/02/12Internal Virus Database is out of date.