Vaccine testing?

[Saricharity]

Can anyone explain how scientists test vaccines? Are there links to studies done? Is the research done by double blinded, randomized controlled trial? I've been reading that this is the best way to conduct research about any drug.
Thanks for putting up with all my questions.

 

[keith99]

That would be the way a new variation on a vaccine would be tested today.

IF pure knowledge was the only issue it would be the way all tests were done. However there can be other considerations.

Smallpox is a great example of conflicting ethical considerations. Fatality rates could be as high as 35%. That would raise ethical considerations with running a double blind study if there was initial evidence that the vaccine was effective.

Smallpox vaccine - Wikipedia, the free encyclopedia

The wiki article is rather interesting. I had not realized that the term vaccine comes from Variolae Vaccinae (i.e. smallpox of the cow), and originally really only was applicable to smallpox.

It looks like when it comes to Polio there was at least close to a double blind study done on at least the Salk vaccine.

Search for 'Francis Field Trial'.
Polio vaccine - Wikipedia, the free encyclopedia

I would doubt that there was anything close to some of the modern controls on the randomization processes. But such controls exist in large part to get useful results from fairly small populations. It seems the Francis Field Test was the largest such test ever done, exceeding typical study sizes by over 2 orders of magnitude.

Here is a link with at least some data regarding the Polio studies.

http://wps.aw.com/wps/media/objects/14/15269/projects/ch12_salk/index.html

Searching is a real pain as the Polio vaccine is considered to be well documented as to effectiveness and a done deal. Any link giving close to raw data is buried in a sea on historical summary links.

Do note that these vaccines were not even close to 100% effective but withing just a few years Polio was all but wiped out in the U.S. because of the impact of less people becoming infected to infect others.

 

[sfs]

Can anyone explain how scientists test vaccines? Are there links to studies done? Is the research done by double blinded, randomized controlled trial? I've been reading that this is the best way to conduct research about any drug.
Thanks for putting up with all my questions.

Here is how new Ebola vaccines are being tested -- yes, it's double blinded and randomized. (There were ethical questions about whether that approach would be adopted, given the high case fatality rate, but the decline in new Ebola cases has reduced those concerns.) Phase 1 trials were conducted in healthy volunteers (some in the U.S.) to look for adverse events and for immune response to the vaccines.

 

[Saricharity]

Thanks so much. I'm going to read these.

What about MMR., Dtap, chickenpox?

 

[essentialsaltes]

Here's a link to a study currently underway on a particular manufacturer's MMR vaccine.

The stated study design:

Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

"The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' trivalent MMR (Priorix®), comparing it to Merck's MMR vaccine (M-M-R®II), which is approved for use in the US in healthy children 12 to 15 months of age."

Since this is comparing GlaxoSmithKline's vaccine to Merck's already approved vaccine, I expect the Merck vaccine is acting as the 'control' in this case.


If you search vaccine or MMR vaccine on that site, you get a lot of studies overseen by the NIH, some in process, some completed with results.

 

[Blue Wren]

I don't want to write much here. I am adding a link, that might be helpful, to anyone else who reads this thread -

https://www.health.ny.gov/prevention/immunization/vaccine_safety/science.htm

 

[Architeuthus]

Thanks so much. I'm going to read these.

What about MMR., Dtap, chickenpox?

We only need studies such as you mention for new vaccines. For vaccines in existing use, we can do large scale retrospective studies, which are even more reliable.

For example, one of the classic "MMR does not cause autism" studies was this one: http://www.nejm.org/doi/full/10.1056/NEJMoa021134

They took account of the fact that Denmark maintains registers of who has been vaccinated, and who has been diagnosed with autism. Their study involved 537,303 children -- all children born in Denmark from January 1991 through December 1998. There was no link at all between vaccination and autism.

 

[morse86]

Most of the childhood diseases (mumps, measles, polio) were in decline before their vaccines were developed. This is due to proper hygeine (which is biblical). Unfortunetly, vaccines get all the credit.

According to the CDC, most vaccines contain the following:
Formaldehyde is used to inactivate bacterial products for toxoid vaccines, (these are vaccines that use an inactive bacterial toxin to produce immunity.) It is also used to kill unwanted viruses and bacteria that might contaminate the vaccine during production. Most formaldehyde (NOT ALL) is removed from the vaccine before it is packaged.
Aluminum gels or salts of aluminum which are added as adjuvants to help the vaccine stimulate a better response. Adjuvants help promote an earlier, more potent response, and more persistent immune response to the vaccine.
Monosodium glutamate (MSG) and 2-phenoxy-ethanol which are used as stabilizers in a few vaccines to help the vaccine remain unchanged when the vaccine is exposed to heat, light, acidity, or humidity.
Thimerosal is a mercury-containing preservative that is added to vials of vaccine that contain more than one dose to prevent contamination and growth of potentially harmful bacteria.

A newborn gets almost 23 vaccines just in the first year. According to wikipedia:
Thiomersal is very toxic by inhalation, ingestion, and in contact with skin (EC hazard symbol T+), with a danger of cumulative effects.

A great book on vaccines is "Dissolving Illusions" by Suzanne Humphries. She actually starts by examining the history from the begining in the 1800s and proves that these diseases were declining/non existent before the vaccine.

 

[Architeuthus]

Most of the childhood diseases (mumps, measles, polio) were in decline before their vaccines were developed. This is due to proper hygeine (which is biblical). Unfortunetly, vaccines get all the credit.

Yes, because they work. False anti-vax statements like this are responsible for the death toll among babies creeping back up again.

Formaldehyde is used to inactivate bacterial products for toxoid vaccines, (these are vaccines that use an inactive bacterial toxin to produce immunity.) It is also used to kill unwanted viruses and bacteria that might contaminate the vaccine during production. Most formaldehyde (NOT ALL) is removed from the vaccine before it is packaged.

Formaldehyde actually occurs naturally in your blood, at levels of 2–3 milligrams per litre. Any tiny traces of formaldehyde that are left in the vaccine will make no difference to that.

Aluminum gels or salts of aluminum which are added as adjuvants to help the vaccine stimulate a better response. Adjuvants help promote an earlier, more potent response, and more persistent immune response to the vaccine.

Aluminium salts are harmless. Most antacids contain huge quantities of aluminium.

Monosodium glutamate (MSG) and 2-phenoxy-ethanol which are used as stabilizers in a few vaccines to help the vaccine remain unchanged when the vaccine is exposed to heat, light, acidity, or humidity.

Small quantities of MSG do no harm either. It occurs naturally in food.

Thimerosal is a mercury-containing preservative that is added to vials of vaccine that contain more than one dose to prevent contamination and growth of potentially harmful bacteria.

According to the CDC, with the exception of some influenza (flu) vaccines, thimerosal is not used as a preservative in routinely recommended childhood vaccines.

A great book on vaccines is "Dissolving Illusions" by Suzanne Humphries. She actually starts by examining the history from the begining in the 1800s and proves that these diseases were declining/non existent before the vaccine.

That is just more anti-vax falsehoods. Here is a chart of measles cases in the USA, for example. The vaccine (and especially the use of a booster) made all the difference.

Here is a similar chart for England and Wales:

 

[PsychoSarah]

Most of the childhood diseases (mumps, measles, polio) were in decline before their vaccines were developed. This is due to proper hygeine (which is biblical). Unfortunetly, vaccines get all the credit.

According to the CDC, most vaccines contain the following:
Formaldehyde is used to inactivate bacterial products for toxoid vaccines, (these are vaccines that use an inactive bacterial toxin to produce immunity.) It is also used to kill unwanted viruses and bacteria that might contaminate the vaccine during production. Most formaldehyde (NOT ALL) is removed from the vaccine before it is packaged.
Aluminum gels or salts of aluminum which are added as adjuvants to help the vaccine stimulate a better response. Adjuvants help promote an earlier, more potent response, and more persistent immune response to the vaccine.
Monosodium glutamate (MSG) and 2-phenoxy-ethanol which are used as stabilizers in a few vaccines to help the vaccine remain unchanged when the vaccine is exposed to heat, light, acidity, or humidity.
Thimerosal is a mercury-containing preservative that is added to vials of vaccine that contain more than one dose to prevent contamination and growth of potentially harmful bacteria.

A newborn gets almost 23 vaccines just in the first year. According to wikipedia:
Thiomersal is very toxic by inhalation, ingestion, and in contact with skin (EC hazard symbol T+), with a danger of cumulative effects.

A great book on vaccines is "Dissolving Illusions" by Suzanne Humphries. She actually starts by examining the history from the begining in the 1800s and proves that these diseases were declining/non existent before the vaccine.

How are any of these worse than the disease that the vaccines prevent? You do realize that measles and chickenpox can result in death, right? And polio is extremely deadly, to this day anyone who catches it has a death sentence from it, and it primarily gets children. Also, Mercury is not a common additive in shots anymore. We wouldn't use vaccines if they were worse than the diseases that they prevented. You have a case of "fear of big science words that you don't know". I bet you would fall for the dihydrogen monoxide trick too (water). Anything can sound scary when you use official scientific labels (except with my water one, technically not incorrect, but people do not regularly use a label like that for water).

 

[trunks2k]

I bet you would fall for the dihydrogen monoxide trick too (water). Anything can sound scary when you use official scientific labels (except with my water one, technically not incorrect, but people do not regularly use a label like that for water).

In a different thread, someone posted a similar list of dangerous ingredients in vaccines. They included sodium chloride in that list. Table salt. Though in a medical setting is probably just saline solution.