Prevnar 13???? - Mothering Forums

Prevnar 13????

zachattack's Avatar zachattack (TS)
07:28 PM Liked: 98
#1 of 30
06-07-2010 | Posts: 61
Joined: Jul 2009
Our 11 month old son has received a total of 6 shots. We did decide to give prevnar8 at 8 months. I am petrified of vaccines and the damage they have done on this "autistic generation". We did look closely and have decided to give him a few vaccines-one at a time startin at5 months. I am not sure about prevnar13. It is new which disturbs me. Any advice ? Btw my sin was nursed for 2 months. Help
DiannaK's Avatar DiannaK
10:05 PM Liked: 11
#2 of 30
06-07-2010 | Posts: 1,844
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My 4yo daughter is up to date on her previous Prevnar series, and I don't plan to do the new one.
Marnica's Avatar Marnica
01:57 PM Liked: 10222
#3 of 30
06-08-2010 | Posts: 5,470
Joined: Oct 2008
http://www.fda.gov/downloads/Biologi.../UCM201669.pdf

I would start by reading this in detail.
JBaxter's Avatar JBaxter
02:36 PM Liked: 28
#4 of 30
06-08-2010 | Posts: 4,243
Joined: Apr 2005
5.4 Premature Infants
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including Prevnar 13, to infants born prematurely should be based on consideration of the individual infant’s medical status, and the potential benefits and possible risks of vaccination.

Hummm wonder how often this is shared
Razz2525's Avatar Razz2525
12:46 PM Liked: 0
#5 of 30
07-26-2010 | Posts: 56
Joined: Apr 2007
This is a late reply to your query, but since I just had Prevnar13 done on Wednesday with my 9-month-old, he developed a fever on Saturday morning (not sure if this is too remote for the vaccine or if he just caught a virus coincidentally) that hasn't gone away.

I've brought it down from 101 to 97 through use of Tylenol or Infant Motrin every several hours in addition to an occasional lukewarm bath which he loved but each morning, he's hot. I called the nurse today and I'm waiting to a callback. I'm sure she's going to tell me it has nothing to do with the vaccine. Granted, he had had a runny nose on and off before the vaccine but my husband really wanted him to get it due to his ear infection leading to permanent hearing loss and my older son's predilection to middle ear infections. But I really do *not* want to continue this series. I'm on a selective schedule and he tolerated DTap and HIB without an issue. This is the first one where he hasn't been "himself" since then (crying a lot more than usual, inconsolable, even more jumpy/startled when everyone considers him a "buddha" baby).

Struggling with a lot of remorse now even though we did talk at length about this as a family and I was following Dr Sears schedule.....
mgg's Avatar mgg
02:35 PM Liked: 11
#6 of 30
07-27-2010 | Posts: 55
Joined: Jul 2010
A little clarification. From a clinical standpoint, PCV13 is not really a "new" immunization. The difference between PCV7 and PCV13 is that it contains different serotypes of the pneumococcal organism.

This is akin to the various serotypes that are interchanged in the flu vaccine every year. The difference is that while there is regular shift in influenza anitgenicity, requiring annual projections for which serotypes are going to be prevalent, the pneumococcal antigenic shift has been much slower.

As a result, after many years of immunizing with PCV7, there has (as one would anticipate) been a change in the specific serotypes of pneumococcal organisms seen in the community. Naturally, the one's for which PCV7 protected (those that had been the "big players" per se), had a much smaller seroprevalence, while previously less significant serotypes were becoming more common.

It was for this reason that the additional serotypes were added. It does not affect the immunogenicity, or side effect profile of the medication. The change, while significant from an epidemiologic perspective, is miniscule and insignificant from a microbiological perspective.
ma2two's Avatar ma2two
07:25 AM Liked: 57445
#7 of 30
07-28-2010 | Posts: 1,475
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Quote:
Originally Posted by Marnica View Post
http://www.fda.gov/downloads/Biologi.../UCM201669.pdf

I would start by reading this in detail.
Where's the placebo? Side effects of Prevnar 13, the type and frequency, are compared to the old Prevnar vaccine. How can someone know whether the risks are acceptable to them, if the vaccine is not compared to a true saline placebo?

So, I thought I might work backward. Look at the safety studies of the old Prevnar vaccine. Guess what? The safety studies for the old Prevnar vaccine also did not use placebos. The controls in those studies were also other vaccines.

How in the world are we supposed to make informed decisions with this junk science?
mgg's Avatar mgg
11:13 AM Liked: 11
#8 of 30
07-28-2010 | Posts: 55
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Quote:
Originally Posted by ma2two View Post
Where's the placebo? Side effects of Prevnar 13, the type and frequency, are compared to the old Prevnar vaccine. How can someone know whether the risks are acceptable to them, if the vaccine is not compared to a true saline placebo?

So, I thought I might work backward. Look at the safety studies of the old Prevnar vaccine. Guess what? The safety studies for the old Prevnar vaccine also did not use placebos. The controls in those studies were also other vaccines.

How in the world are we supposed to make informed decisions with this junk science?

This is common practice, not just with vaccines, but numerous medications and treatments during studies. In order to perform a study, you need the approval of the Institutional Review Board at that facility (be it a hospital, a clinic, a university, etc...).

It's considered unethical to deny a known beneficial therapy in order to have a perfect placebo. For example, if they were studying a new blood pressure medication, the placebo would be another blood pressure medication, because you're not allowed to deny the patient the known benefit by giving him a benign placebo.

If you look at other studies for other medications, you will find this is a very common practice.
ma2two's Avatar ma2two
04:49 PM Liked: 57445
#9 of 30
07-28-2010 | Posts: 1,475
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Quote:
Originally Posted by mgg View Post
This is common practice, not just with vaccines, but numerous medications and treatments during studies. In order to perform a study, you need the approval of the Institutional Review Board at that facility (be it a hospital, a clinic, a university, etc...).

It's considered unethical to deny a known beneficial therapy in order to have a perfect placebo. For example, if they were studying a new blood pressure medication, the placebo would be another blood pressure medication, because you're not allowed to deny the patient the known benefit by giving him a benign placebo.

If you look at other studies for other medications, you will find this is a very common practice.
The fact that it is common practice does not make it good science that provides useful information.

Why wasn't the first Prevnar vaccine studied against a placebo? That would not have denied the patients a known benefit.
mgg's Avatar mgg
06:14 PM Liked: 11
#10 of 30
07-28-2010 | Posts: 55
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Quote:
Originally Posted by ma2two View Post
Why wasn't the first Prevnar vaccine studied against a placebo? That would not have denied the patients a known benefit.
Denied a known benefit? No. Provided a known potential for harm? Absolutely. Any inoculation, even sterile water or saline comes with some (albeit remote) risks. Any break to the skin can result in infection, certainly results in pain, and can (again very rarely) result in autoimmune and other reactions. While these risks are far outweighed by the benefits of the immunization, there isn't an Institutional Review Board in the world that is going to endorse the IM or SubQ administration of a placebo to infants.
ma2two's Avatar ma2two
06:24 PM Liked: 57445
#11 of 30
07-28-2010 | Posts: 1,475
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Quote:
Originally Posted by mgg View Post
Denied a known benefit? No. Provided a known potential for harm? Absolutely. Any inoculation, even sterile water or saline comes with some (albeit remote) risks. Any break to the skin can result in infection, certainly results in pain, and can (again very rarely) result in autoimmune and other reactions. While these risks are far outweighed by the benefits of the immunization, there isn't an Institutional Review Board in the world that is going to endorse the IM or SubQ administration of a placebo to infants.
Wow. So they think that saline injections are more dangerous than any vaccine? Then why not give the control subjects nothing? It wouldn't be a double blind study, but it would do the job. The studies that they did do weren't double blind, either. And it would be more realistic results. When I decide to not give my child the Prevnar vaccine, or any vaccine, I don't go out and get a saline injection instead.
carriebft's Avatar carriebft
12:20 AM Liked: 33
#12 of 30
07-29-2010 | Posts: 6,219
Joined: Mar 2007
are you saying that there were no double blind studies of prevnar 7 or 13? i would be glad to provide you with some or you can see for yourself by checking out clinicaltrials.gov.

also, you can find early phase trials that use saline as the placebo in cases where another vaccine does not exist. for example. before the HPV vaccine, there was not another one...so injecting with saline was not denying that group care and was not unethical. thus, saline placebo trials like this one:

http://cat.inist.fr/?aModele=afficheN&cpsidt=18561684


and, PCV has been tested with saline placebos; two examples I found in the 5 min I looked:

http://journals.lww.com/pidj/Fulltex...njugate.1.aspx

http://pediatrics.aappublications.or...tract/99/4/575

I think, and someone with more knowledge can correct me if I am wrong, but I assume the first PCV vaccines would have been tested against a saline placebo, as there were no other vaccines of that nature available, so care was not being denied.
Asiago's Avatar Asiago
02:14 PM Liked: 2220
#13 of 30
07-29-2010 | Posts: 1,804
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I note 3 deaths per 1,900 or so participants but then what is the mortality rate among those not receiving the vaccine (?)
Asiago's Avatar Asiago
02:27 PM Liked: 2220
#14 of 30
07-29-2010 | Posts: 1,804
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Quote:
Originally Posted by Razz2525 View Post
This is a late reply to your query, but since I just had Prevnar13 done on Wednesday with my 9-month-old, he developed a fever on Saturday morning (not sure if this is too remote for the vaccine or if he just caught a virus coincidentally) that hasn't gone away.

(
I hope that he is feeling better. You can report the fever so that it is on file, even if you are unsure if it was a result of the vaccination. http://vaers.hhs.gov/esub/index

Table 4 notes the fever adverse reactions, all were within 7 days of Prevnar 13 administration. Also I read that adverse reactions were logged for more then one month. There was mention that one month is the usual in such a trial though but a longer observation period was followed for Prevnar 13.
Razz2525's Avatar Razz2525
03:01 PM Liked: 0
#15 of 30
08-02-2010 | Posts: 56
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Quote:
Originally Posted by Asiago View Post
I hope that he is feeling better. You can report the fever so that it is on file, even if you are unsure if it was a result of the vaccination. http://vaers.hhs.gov/esub/index

Table 4 notes the fever adverse reactions, all were within 7 days of Prevnar 13 administration. Also I read that adverse reactions were logged for more then one month. There was mention that one month is the usual in such a trial though but a longer observation period was followed for Prevnar 13.
Thanks, as if on a dime, he woke up one morning and was fine. He was not himself for 3 whole days, crying constantly, even startling when he is usually a calm baby, not eating well, and between 100-103 fever, so I definitely feel it was the Prevnar. Under normal circumstances with a virus, he would have some after-effects even when the fever disappeared (runny nose, cough, etc.,). Even the runny nose completely vanished when it was green and thick the day before.

It gives me serious pause to getting him the 2nd dose any time soon given his response. His responses to HIB and DTap were virtually nonexistent.
amnesiac's Avatar amnesiac
10:27 PM Liked: 102
#16 of 30
08-03-2010 | Posts: 4,879
Joined: Dec 2001
Please remain on topic for this forum & this thread. If you wish to further discuss vaccine research protocols, please start a new thread or do so privately.
mamakay's Avatar mamakay
02:44 AM Liked: 2348
#17 of 30
08-07-2010 | Posts: 8,332
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Quote:
Originally Posted by carriebft View Post
I think, and someone with more knowledge can correct me if I am wrong, but I assume the first PCV vaccines would have been tested against a saline placebo, as there were no other vaccines of that nature available, so care was not being denied.
That's what you would have thought, but:

http://www.cdc.gov/mmwr/PDF/rr/rr4909.pdf

(CDC link, no copyright)

Quote:
Vaccine Safety
Safety of Administration of PCV7 Series Among Infants

Rates and types of adverse events associated with PCV7 administered at ages 2, 4, 6, and 12–15 months are acceptable when compared with the demonstrated benefits of vaccination. In the Northern California Kaiser Permanente efficacy trial, rates of adverse events were compared between children who received PCV7 and those who received the control vaccine (investigational group C meningococcal conjugate). Routine childhood vaccines were administered concurrently with PCV7 and control vaccines.***** To assess vaccine safety, information regarding local and systemic reactions was collected at 48–72 hours and 14 days after each dose. Using telephone interviews, investigators collected adverse-event histories for two subsets of the study population — initially a group receiving DTwP (N = 6,000) and later a group receiving diphtheria toxoid-tetanus toxoid acellular pertussis (DTaP) vaccine (N = 1,500). Frequency of uncommon events requiring medical attention after vaccination was evaluated for the entire study cohort and included emergency room and outpatient clinic visits occurring <30 days and hospitalizations occurring <60 days after receiving the study vaccines.
http://www.fda.gov/downloads/Biologi.../UCM137168.pdf

Quote:
The bulk of the safety data regarding local and systemic reactions and other adverse events comes from the NCKP Efficacy study.
For safety, PCV7 was evaluated against an experimental vaccine.
carriebft's Avatar carriebft
11:07 AM Liked: 33
#18 of 30
08-07-2010 | Posts: 6,219
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those were later phase trials though. what about early phase trials, while they have smaller numbers of course, they usually have a saline group. now, obviously the children are not going to be completely unvaccinated, but I recently found one where they used an off vaccination month for the saline group but group 1 and 2 received the vaccine with others.

my problem on early trials is that, besides preliminary stuff on clinicaltrials (which show no results unless you go painstakingly searching for them) you find very little from early human phase trials.
mamakay's Avatar mamakay
04:32 PM Liked: 2348
#19 of 30
08-07-2010 | Posts: 8,332
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Quote:
those were later phase trials though. what about early phase trials, while they have smaller numbers of course, they usually have a saline group.
But how in the world did they justify using an experimental vaccine for the primary phase III trial???
carriebft's Avatar carriebft
07:22 PM Liked: 33
#20 of 30
08-07-2010 | Posts: 6,219
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the men c vaccine was licensed and used in the UK in november of 1999. what year was this trial? are we even sure it was an investigational vaccine when the UK was already using it at the time that this paper was written? hence it is written as "investigational group" not the vaccine itself is investigational. like i said, it was in use elsewhere already.
nia82
10:54 PM Liked: 22546
#21 of 30
08-07-2010 | Posts: 1,933
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My nephew received Prevnar 13 as part of a trial in 2008 in Germany. The parents were fully aware of being part of a trial. Must be the end-phase as it is obviously not double-blind.
mamakay's Avatar mamakay
11:28 PM Liked: 2348
#22 of 30
08-07-2010 | Posts: 8,332
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Quote:
Originally Posted by carriebft View Post
the men c vaccine was licensed and used in the UK in november of 1999. what year was this trial? are we even sure it was an investigational vaccine when the UK was already using it at the time that this paper was written? hence it is written as "investigational group" not the vaccine itself is investigational. like i said, it was in use elsewhere already.
It was the CDC that described the meningococcal vaccine placebo as an "investigational vaccine".
carriebft's Avatar carriebft
12:07 AM Liked: 33
#23 of 30
08-08-2010 | Posts: 6,219
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sorry i read that wrong, somehow i was reading the word group twice , as in the 'investigational group' was given the 'group c meningitis vaccine.' but i suppose i would have to ask the cdc why it was investigational when it was already been used around the world. investigational because it wasnt used in the USA maybe? maybe it was phase V when this was phase III? that still wouldn't make sense though with others using it...I have no idea. clinicaltrials and google scholar both pull up a bunch of pcv7 safety studies phase iii-V and post licensure, so there are other ones out there. I didn't go through them for placebo references though.
mamakay's Avatar mamakay
12:21 AM Liked: 2348
#24 of 30
08-08-2010 | Posts: 8,332
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Assuming it's the same meningococcal vax that was introduced in the UK in 1999...here's the trial the ACIP referenced:

http://www.fimp.org/wyeth/documenti/black1.pdf

Quote:
We report the results of the Kaiser Permanente trial
evaluating the efficacy, safety and immunogenicity of
the heptavalent pneumococcal conjugate vaccine
(Wyeth; PNCRM7) conducted in Northern California
between October, 1995, and August, 1998, and the
posttrial blinded efficacy follow-up through April 20,
1999.
So the Prevnar safety trial started 4 years before the meningococcal vax was introduced in the UK.
carriebft's Avatar carriebft
12:34 AM Liked: 33
#25 of 30
08-08-2010 | Posts: 6,219
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i dont know if there was a men c before the one in the UK, i just knew the UK date off the top of my head becuase I had been looking into men c vaccines after reading about the hib + men C combo that is being trialed at the moment for release here in the USA. a lot of the lit on Men c vaccine came from UK friends of mine, so that date stuck with me.

if the men c vaccine here was not tested before the trial with pcv 7, then that would seem very strange to me. but somehow i feel like i am not getting the whole picture...either there were other safety trials that were sufficient or the men C was considered safe through its trials. and I have no idea who you could even ask on that; i am not sure its something google degree can tell me, kwim?
mamakay's Avatar mamakay
12:37 AM Liked: 2348
#26 of 30
08-08-2010 | Posts: 8,332
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You could email the CDC?
carriebft's Avatar carriebft
12:42 AM Liked: 33
#27 of 30
08-08-2010 | Posts: 6,219
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i'm almost curious enough to just see if they would take me seriously and answer me in a coherent and educated manner (instead of simply linking me pcv7/13 page). perhaps we should take bets?

5$ on pcv7 page!

I might try tomorrow though. I need to figure out how I want to word the question
mamakay's Avatar mamakay
12:51 AM Liked: 2348
#28 of 30
08-08-2010 | Posts: 8,332
Joined: Apr 2005
I bet you'll get a good answer. A long tme ago Peter Doshi wrote about his experience emailing/calling them about their flu mortality stats, and his question got sent to someone pretty high up who explained their thinking quite well.
I've known other people who emailed them, too, and none were blown off.

Why not just email them with the MMWR link, and the quote about the investigational vaccine, and ask why a a vaccine described as "investigational" was used as the placebo?
LisaSedai's Avatar LisaSedai
01:59 AM Liked: 28
#29 of 30
08-09-2010 | Posts: 1,019
Joined: Feb 2009
I think I remember reading somewhere that the additional 6 types added to the vaccine were types common in Africa, not the US. Anyone know if there is any truth to that assertion? I will try to find where I read it and post a llink if possible.
mommaof2boyz's Avatar mommaof2boyz
09:17 PM Liked: 0
#30 of 30
06-28-2011 | Posts: 1
Joined: Jun 2011

i hope your baby is better now...i am sure the fever was from the vaccine. i only gave my first son hep B and a couple polio shots and when i did more research in depth decided to do no more. my second baby is 15 months and i gave him no shots. doctors are such liars...you can't trust them...


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