Do you know how vaccines are evaluated for safety? Prepare to be surprised.

[LongIsland]

This is a spin-off of the VAERS thread, which will look at the safety trial methods for infant/childhood vaccines. The purpose of this thread is to show that vaccines are not properly tested for safety. In fact, many vaxers may be in for a shock. I will be using the product insert, which contains efficacy and safety data.

I'm going to begin with ActHib (Sanofi). ActHib was tested for safety by giving one group ActHib w/ DTP and the CONTROL GROUP was given Hep B w/ DTP. Here is a snippet from the product insert:


In a randomized, double-blind US clinical trial, ActHIB® was given concomitantly with DTP to more than 5,000 infants and Hepatitis B vaccine was given with DTP to a similar number.

In this large study, deaths due to sudden infant death syndrome (SIDS) and other causes were observed but were not different in the two groups.

In the first 48 hours following immunization, two definite and three possible seizures were observed after ActHIB® and DTP in comparison with none after Hepatitis B vaccine and DTP. This rate of seizures following ActHIB® and DTP was not greater than previously reported in infants receiving DTP alone. (Refer to product insert for AvP DTP.) Other adverse reactions reported with administration of other Haemophilus b conjugate vaccines include urticaria, seizures, hives, renal failure and Guillain-Barré syndrome (GBS). A cause and effect relationship among any of these events and the vaccination has not been established.

[LongIsland]

Next is the safety trial for Tripedia (DTaP) Wyeth. One group received Tripedia and the CONTROL GROUP received Aventis' whole cell DTP vaccine.

In a double-blind, comparative US trial, 673 infants were randomized to receive either 3 doses of Tripedia vaccine or AvP’s whole-cell pertussis DTP vaccine (Table 2).

Safety data are available for 672 infants, including 505 who received Tripedia vaccine and 167 who received whole-cell pertussis DTP vaccine. Following all three doses, rates for all reported local reactions, fever > 101°F, irritability, drowsiness, and anorexia were significantly less in Tripedia vaccine recipients. Reaction rates generally peaked within the first 24 hours, and decreased substantially over the next two days.2,27,28

A similar reduction in adverse events was seen in a randomized, double-blind, comparative trial conducted in the US by the NIH when Tripedia vaccine was compared to Lederle Laboratories whole-cell pertussis DTP vaccine

[LongIsland]

There are a lot more vaccines to cover in this thread, but I wanted to see if some of you are able to figure out why the FDA allows this to happen and why manufacturers use this sort of method.

This method is used in order to make sure adverse event outcomes are statistically insignificant between the two groups . . . if you can do that . . . you've got yourself a licensed vaccine, which will promptly be placed on the coveted recommended schedule of childhood immunizations.

I also want to point out that serious adverse event outcomes are particularly important to pharma . . . they need to be able to show that serious AE's between the vaccine group and the control group are statistically insignificant or else the vaccine's use in infants/children will be limited.

This is precisely why vaccines are NOT evaluated for safety on infants/children/adults prior to licensure with any known mild and serious health conditions and premature infants.

[LongIsland]

AE - adverse event

The newly licensed Gardasil (HPV) Merck. The Gardasil group had 5,088 subjects. The reason why I'm listing the number of subjects will be clear when you read the next few sentences.

The first CONTROL group received an alumiminum-containing placebo (3,470 subjects). The second control group received a saline placebo (only 320 subjects). When comparing minor AE's, Merck compared data for both placebo groups. However, when comparing data for serious AE's, Merck COMBINED the two placebo groups and then compared it to the Gardasil group.

They do not reveal the difference in serious AE's between the aluminum placebo group and the saline group.

[LongIsland]

Energix B (Hep B) Glaxo The CONTROL GROUP received plasma-derived vaccines. The vaccines administered to the CONTROL GROUP are not revealed.

Ten double-blind studies involving 2,252 subjects showed no significant difference in the frequency or severity of adverse experiences between ENGERIX-B and plasma-derived vaccines.

In 36 clinical studies, a total of 13,495 doses of ENGERIX-B were administered to 5,071 healthy adults and children who were initially seronegative for hepatitis B markers, and healthy neonates. All subjects were monitored for 4 days post-administration.

[LongIsland]

Recombivax HB (Hep B) Merck
This vaccine was not evaluated for safety using a control group.

In three clinical studies, 434 doses of RECOMBIVAX HB, 5 mcg, were administered to 147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose.

In a study that compared the three-dose regimen (5 mcg) with the two-dose regimen (10 mcg) of RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar.

In a group of studies, 3258 doses of RECOMBIVAX HB, 10 mcg, were administered to 1252 healthy adults who were monitored for 5 days after each dose.

[Amila]

It is just so f-ing unbelievable. Makes me want to move out of the USA.

[aisraeltax]

LI,
im sure im not the only one, but wanted to say i appreciate you posting this info. its very useful to me and i want to make sure you don't get discouraged by no replies.

i am not a statician and am still trying to wrap my mind around the issue of these tests. one question i have is what the significance of combining the control groups when considering the rates of serious AE's.

thanks
rach

[LongIsland]

Infanrix (DTaP) Glaxo
The CONTROL GROUP was given DTP or there was no control group.


Approximately 92,000 doses of INFANRIX have been administered in clinical studies. In these studies, 28,749 infants have received INFANRIX in primary series studies, 5,830 children have received INFANRIX as a fourth dose following 3 doses of INFANRIX, and 511 children have received INFANRIX as a fifth dose following 4 doses of INFANRIX. In addition, 439 children and 169 children have received INFANRIX as a fourth or fifth dose following 3 or 4 doses of whole-cell DTP vaccine, respectively. In comparative studies, the first 4 doses of INFANRIX have been shown to be followed by fewer of the local and systemic adverse reactions commonly associated with whole-cell DTP vaccination.

In the double-blind, randomized comparative trial in Italy, safety data in a 3-dose primary series are available for 4,696 infants who received at least one dose of INFANRIX and 4,678 infants who received at least one dose of US-licensed whole-cell DTP vaccine manufactured by Connaught Laboratories, Inc. All common solicited adverse events were less frequent following vaccination with INFANRIX as compared to whole-cell DTP after each 1 of the 3 doses.

[LongIsland]

MMR II Merck

The CONTROL GROUP received a monovalent or bivalent vaccine containing measles, mumps, or rubella.




.

[LongIsland]

Prevnar (Wyeth)

The majority of the safety experience with Prevnar comes from the NCKP Efficacy Trial in which 17,066 infants received 55,352 doses of Prevnar, along with other routine childhood vaccines through April 1998.

The "other routine childhood vaccine" was DTaP and CONTROL GROUPS were given Meningitis C (conjugate) vaccine.

[annalily]

Thank you for posting all this, Long Island. I love when you do this!

Originally Posted by LongIsland

There are a lot more vaccines to cover in this thread, but I wanted to see if some of you are able to figure out why the FDA allows this to happen and why manufacturers use this sort of method.

This method is used in order to make sure adverse event outcomes are statistically insignificant between the two groups . . . if you can do that . . . you've got yourself a licensed vaccine, which will promptly be placed on the coveted recommended schedule of childhood immunizations.

I also want to point out that serious adverse event outcomes are particularly important to pharma . . . they need to be able to show that serious AE's between the vaccine group and the control group are statistically insignificant or else the vaccine's use in infants/children will be limited.

This is precisely why vaccines are NOT evaluated for safety on infants/children/adults with any known mild and serious health conditions and premature infants.

I just finished reading The Anti-Depressant Fact Book by Dr Peter Breggin. In it, he says,
"The Food and Drug Administration (FDA) has forsaken its watchdog role. Instead, FDA officials climb like puppies into the lap of the drug company executives who might some day hire them at enormous salaries."

[LongIsland]

IPOL (Inactivated Polio) Sanofi

Because IPV was given in a different site but concurrently with Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP), these systemic reactions could not be attributed to a specific vaccine. However, these systemic reactions were comparable in frequency and severity to that reported for DTP given alone without IPV.

[Plummeting]

This is why it's so freakin frustrating talking to people who insist that the vaccines must be safe, since the FDA allowed them to go to market. You can't judge adverse events like autoimmune disorders or allergies by following people for a few days. And you can't judge ANYTHING by comparing your vaccine to another shot containing some of the same toxic ingredients. : That doesn't seem to bother people at all.

Apparently, they'd be happy with a study that followed people who ate nothing but twinkies for 5 days, while the control group ate nothing but brownies for 5 days. The study would conclude, after only 5 days, that no one had died or suffered any serious adverse events, and the minor reactions were equal between groups, therefore, eating nothing but twinkies must be safe. If you explain it like that, it suddenly becomes ludicrous, because *everyone* knows you can't survive on twinkies alone, but they just can't quite see how you could possibly draw a comparison between that and vaccine studies. <sigh>

[LongIsland]

Originally Posted by annalily

Thank you for posting all this, Long Island. I love when you do this!

I was jumping up and down inside when DH said he wanted to take my younger one to big brother's baseball awards get together! I was like . . . yay! I can do my thread!!!!! I'm hoping we can get this immortalized into a sticky.

Originally Posted by annalily

I just finished reading The Anti-Depressant Fact Book by Dr Peter Breggin. In it, he says,
"The Food and Drug Administration (FDA) has forsaken its watchdog role. Instead, FDA officials climb like puppies into the lap of the drug company executives who might some day hire them at enormous salaries."

[LongIsland]

Originally Posted by Plummeting

This is why it's so freakin frustrating talking to people who insist that the vaccines must be safe, since the FDA allowed them to go to market.

But of course VAERS is unreliable.

[LongIsland]

Originally Posted by aisraeltax

one question i have is what the significance of combining the control groups when considering the rates of serious AE's.

The non-serious adverse events between the saline placebo group compared to the aluminum-containing placebo group and Gardasil group WERE significant. They had no problem showing the data because they were "minor" reactions like fever, injection site swelling, etc.

Can you imagine what the comparison of serious adverse events revealed . . . and Merck doesn't want to reveal it for some reason. Not to mention what would have been revealed if the control group was ENTIRELY made up of saline placebo subjects.
This is the first time I've seen a true saline placebo used in a vaccine safety trial . . . and they only use 320 subjects . . . and then hide the serious adverse event data for those subjects.

I'm going to do RotaTeq next. I think these trials did use true placebos, but I have to dig a little more later.

[ccohenou]

More later, but suffice to say that package inserts do not contain a complete rundown of every study conducted on a drug. So putting these few out there as if This Is It is misleading.

[ERSsmom]

Thank you for your hard work L.I. I saved it to hard drive! This is beautiful-infuriating, but beautiful.

[marilynmama]

Very, very interesting LI! I would like to see a pro-vax'er defend this.

I worry more about long term effects, than short term (overall). Sore arms, fevers dont bother me. GBS, autoimmune diseases, etc bother me, that should bother everyone.