Prevnar 13????

[zachattack]

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]

My 4yo daughter is up to date on her previous Prevnar series, and I don't plan to do the new one.

[Marnica]

http://www.fda.gov/downloads/Biologi.../UCM201669.pdf

I would start by reading this in detail.

[JBaxter]

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]

RE: Prevnar13???

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]

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]

Originally Posted by Marnica

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]

Originally Posted by ma2two

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]

Originally Posted by mgg

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]

Originally Posted by ma2two

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]

Originally Posted by mgg

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]

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]

I note 3 deaths per 1,900 or so participants but then what is the mortality rate among those not receiving the vaccine (?)

[Asiago]

Originally Posted by Razz2525

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]

Originally Posted by Asiago

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]

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]

Originally Posted by carriebft

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)

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

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]

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]

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]

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.