What are good, scientific sources about human vaccines ?

[koti]

Two problems; firstly, yes some idiots do try to use it to treat things that are serious and secondly, I'm a taxpayer and I don't want my money wasted on utter shit.

The set of circumstances where homeopathy is valid is the same as the set of circumstances where it works.

Both sets are empty.

The only good thing about it is the supply of jokes it provides

http://xkcd.com/765/

 

Incidentally, this has little or nothing to do with the OP's question

 

For what it's worth, I'm the OP and I don't mind. I did a week worth of research on vaccines concerning our 6 month old and both me and wife'y are in agreement to vaccinate him on basically everything.

[Delta1212]

You can't spend the same money twice.

No, but you can spend money on more than one thing at a time.

 

I would love to be saddled with the problem that some of my tax money that is slated for healthcare purposes gets wasted on ineffective practices.

[StringJunky]

 

For what it's worth, I'm the OP and I don't mind. I did a week worth of research on vaccines concerning our 6 month old and both me and wife'y are in agreement to vaccinate him on basically everything.

That's cool.

[koti]

Yeah, not even a slight temperature rise nor any other side effect so far. In fact, he's 6 months and he hasn't had a single case of anything even remotely mild in his life. Both me and the wife had a flu for a week now and he's holding up great. Breast feeding is just so awesome for childs immunology.

Edited November 2, 2016 by koti

[koti]

A med student asked me to do a survey on vaccines today. It was asking where you get your information on vaccines, which vaccines you used on your child, etc. After it was done I asked her how many surveys she did so far and what are the results. She did about 400 so far, I asked how many of those 400 people present a firm pro vaccine stance like mine, she replied not more than 10 people. Plus majority of doctors mentioned in the survey have little vaccine knowledge.

[StringJunky]

Plus majority of doctors mentioned in the survey have little vaccine knowledge.

Jenner and Pasteur must be turning in their graves.

[koti]

Our 10 month old had a fever for the first time in his life which ended up in a 2 minute seizure - shakes with distorted respiration, jis eys turned and he turned blue so I called an ambulance and were in the hospital since tuesday. After all the xrays, eeg, chest usg, blood and urine work and various other tests turned out he's got a common 3 day virus and theyre keeping him for observation untill the fever goes away. It turned out that in our particular situation if he wasnt vaccinated for pneumococial diseases they would have to puncture his lower spine to take a sample of a fluid from there. The doctor said hes obligated to perform that procedure if a child is not vaccinated and has symptoms like that - to exclude meningitis. Its not a particularly dificult or dangerous procedure but Id rather my 10 month old not to have his spine punctured.

[koti]

Any pediatricians that are reading this please formulate a second opinion for me:

 

Meningococcal vaccine "Bexsero" is qualified by my government to vaccinate starting from 2 months of age. The CDC qualifies it as appropriate from 10 years to 25 years of age.
I spoke to our pediatrician, she agreed with me that the disproportion is awful but she doesn't really know what to say. She also acknowledges the CDC as a valid source.

Any thoughts ?

11 month old male.

Edited March 21, 2017 by koti

[StringJunky]

I'm no paediatrician but all these links are to official national and international medical bodies It's approved paediatrically by:

 

UK NHS: http://www.nhs.uk/Conditions/vaccinations/Pages/men-acwy-vaccine.aspx

 

Canada: http://www.health.gov.on.ca/en/pro/programs/immunization/docs/meningococcal_b_hcp_qa_en.pdf

 

European Medicines Agency (EMA): http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002333/human_med_001614.jsp&mid=WC0b01ac058001d124

 

The last one gives you all you need to know and is the main body for our respective countries.

 

It would appear that the FDA haven't conducted any studies or are in the process of doing so for paediatric use.

Edited March 21, 2017 by StringJunky

[CharonY]

It think String is right. The FDA itself does not conduct studies, but reviews the submission of the manufacturers. Most likely the manufacturers only requested approval for the 10-25 version (which requires two injections) and not the 2-10 one. The other version (which is single injection for younger children) was either not filed or is still under review.

 

Edit: actually I found the paperwork. Essentially it states that all the requirement for the 10-25 submission are fulfilled and thereby approved, but require two additional studies for the younger groups. The main reasons are regulatory differences between the USA and Europe, especially with regard to infant testing (i.e. you cannot just submit the data from a test group you had in Europe).

Edited March 21, 2017 by CharonY

[koti]

Thank you both String and Charon, looks like 2 months is the age for Canada, UK and the EU which makes the decision clear to us. What you wrote CharonY seems to make sense despite lack of sources.

Thank you again both.

[StringJunky]

Thank you both String and Charon, looks like 2 months is the age for Canada, UK and the EU which makes the decision clear to us. What you wrote CharonY seems to make sense despite lack of sources.

Thank you again both.

CharonY wouldn't say anything unless he knew he could back it up and would state the degree of confidence, especially in a matter like this.

Edited March 21, 2017 by StringJunky

[koti]

CharonY wouldn't say anything unless he knew he could back it up and would state the degree of confidence, especially in a matter like this.

 

Along with the UK, EU and Canada data you linked, what CharonY wrote makes perfect sense. Thumbs up from me for both of you.

[CharonY]

CharonY wouldn't say anything unless he knew he could back it up and would state the degree of confidence, especially in a matter like this.

 

Thanks for the vote of confidence, and I should/would have linked the info if I wasn't in a rush and had the info in a linkable format. But here is the approval letter that should explain things. As you can see, it went through an accelerated pipeline (due to already being approved in the EU and fulfilling all the requirements) and had the additional studies deferred. One should be done by now and a second by 2018.

[koti]

 

Thanks for the vote of confidence, and I should/would have linked the info if I wasn't in a rush and had the info in a linkable format. But here is the approval letter that should explain things. As you can see, it went through an accelerated pipeline (due to already being approved in the EU and fulfilling all the requirements) and had the additional studies deferred. One should be done by now and a second by 2018.

 

Thanks for the find CharonY. This ecxerpt (the overdue dates) from the letter you linked makes me a little uncomfortable :

 

"A deferred pediatric study (V72_28) under PREA to evaluate the safety and immunogenicity of BEXSERO in infants 2.5 months through 11 months of age and in children 2 years through 10 years of age for the prevention of invasive group B meningococcal disease.

Final Protocol Submission: December 3, 2014

Study Completion: December 31, 2014

Final Report Submission: December 31, 2015"

[Delta1212]

 

Thanks for the find CharonY. This ecxerpt (the overdue dates) from the letter you linked makes me a little uncomfortable :

 

"A deferred pediatric study (V72_28) under PREA to evaluate the safety and immunogenicity of BEXSERO in infants 2.5 months through 11 months of age and in children 2 years through 10 years of age for the prevention of invasive group B meningococcal disease.

Final Protocol Submission: December 3, 2014

Study Completion: December 31, 2014

Final Report Submission: December 31, 2015"

What about that makes you uncomfortable?

[CharonY]

Why? The other submissions would be part of a separate (extended) approval process. I.e. that part is either not fully submitted or still under revision, or may potentially be dropped (e.g. if there is not desire to market it for use in younger children in the US).

The most likely scenario, however, is that they used the study to hit the EU market with an altered vaccination schedule. What you probably also should be aware of is that Novartis (the company that developed Bexsero) has been integrated into GlaxoSmithKline, which may have changed or delayed expansion of their product reach.

So what you see there are business and regulatory issues, but not really safety concerns.

[koti]

What about that makes you uncomfortable?

 

The timeframes seem to be long and/or overdue with this particular approval.

 

Why? The other submissions would be part of a separate (extended) approval process. I.e. that part is either not fully submitted or still under revision, or may potentially be dropped (e.g. if there is not desire to market it for use in younger children in the US).

The most likely scenario, however, is that they used the study to hit the EU market with an altered vaccination schedule. What you probably also should be aware of is that Novartis (the company that developed Bexsero) has been integrated into GlaxoSmithKline, which may have changed or delayed expansion of their product reach.

So what you see there are business and regulatory issues, but not really safety concerns.

 

Yes, I noticed...I called a Novartis customer support phone number in the US today and Glaxo picked up. They very much did not want to talk to me. I guess I shouldn't have started with "I'm calling from Europe" LoL.

I agree with you on the scenario you are proposing, it does sound highly probable.

I'm really stubborn when it comes to getting what I want and here I want to find a definite answer/reason why the US is not vaccinating people below 10 years of age with this vaccine. I will keep digging.

 

Edit: They couldn't have hit the EU market with the study they have as it doesn't contain any studies on children below 10 years of age. The whole EU seems to vaccinate children between 2 months and 10 years of age based on separate studies which is great...what I want to know is the exact reason why the US does not.

Edited March 21, 2017 by koti

[CharonY]

Well, as you know the ultimate answer is that Novartis or now GSK has not moved forward with fulfilling the requirements for vaccination below 10 years. In the light of the vaccination division changing hands it is very likely that it got stuck in limbo a bit (especially as another vaccine for that age group has recently been approved by the FDA). The relevant bit is probably to point out that the FDA and EMA have broadly similar approaches to risk evaluation and management. I should clarify that the study in question was submitted and approved in the EU. For the FDA I cannot find updates, so it could be waiting on either side.

[koti]

Well, as you know the ultimate answer is that Novartis or now GSK has not moved forward with fulfilling the requirements for vaccination below 10 years. In the light of the vaccination division changing hands it is very likely that it got stuck in limbo a bit (especially as another vaccine for that age group has recently been approved by the FDA). The relevant bit is probably to point out that the FDA and EMA have broadly similar approaches to risk evaluation and management. I should clarify that the study in question was submitted and approved in the EU. For the FDA I cannot find updates, so it could be waiting on either side.

 

Oh well...I guess you're right. I just spoke to a PHD immunologist who works in a pediatric hospital here in Warsaw and we agreed that the reason has to be along the lines of what you propose... ultimately though she asked me to let her know if/when I find out a definite answer.

Oh...and GSK better start working on that approval and they better do it fast because I'm not comfortable with this situation

 

Edit: Fun fact...about 10 years ago I was implementing a piece of printing software in Novartis here in Warsaw. It took me two and a half months to do what I normally had done in 2 days due to their ridiculous security policies. Back then I though they're nuts, now that I have children I kinda like it.

 

 

Edited March 21, 2017 by koti

[CharonY]

Well, Pfitzer beat them to the race in the US, so I guess there is a question whether it is worthwhile to do so (I have no idea, though). One thing of note, however. There has been a recent warning in Canda that there may be increased risk of hemolysis if Bexsero is used with Soliris, a treatment for paroxysmal nocturnal hemoglobinuria.

[koti]

Well, Pfitzer beat them to the race in the US, so I guess there is a question whether it is worthwhile to do so (I have no idea, though). One thing of note, however. There has been a recent warning in Canda that there may be increased risk of hemolysis if Bexsero is used with Soliris, a treatment for paroxysmal nocturnal hemoglobinuria.

 

We recently found out that our son (11 months) has light lite anemia which I see they list as a primary symptom of paroxysmal nocturnal hemoglobinuria.

He's not taking Soliris though and will not be any time soon as I see they list it as the most expensive drug in the world? (409K USD for a yearly treatment) so no worries about him getting hemolysis in combination with the Bexsero vaccine.

His hemoglobin was 7,8 during a recent viral infection and still was a week later at 8.0 with reticulocytes going from horrific 0.0 to 16.0.

We treat his anemia with 45mg of iron per day as the doctors prescribed. It's uncomfortable that we don't know if he got the infection because he was vulnerable due to the anemia or the anemia is a result of the infection.

Oh well...10 months of not a slightest medical problem with our son recently ended up in 2 weeks in a hospital due to a severe fever attack, him going blue with shivers and eyes twisting white and us parents going ballistic. They kept him in the hospital for 2 weeks because he had a fever for 6 days straight and then they gave him an antibiotic for another week so they didn't let us out - apparently it was a nasty viral infection.

BTW...I wonder how much we would pay for those 2 weeks in a hospital in the US...they performed overall 35 scans, xrays, EKG's, EEG's, urine and what not, various types of blood work was done 5 or 6 times and various other viral/bacterial tests - all good except the the low hemoglobin. During this wonderful time I also found out that our son has an accessory spleen which apparently is pretty normal. They found people with up to 40 accessory spleens (?!)

 

Edited March 21, 2017 by koti

[koti]

OK,

I need to bring this thread up again. We have anti vaccers in our family and they are afraid that their children (one is 4 years and the other 6 months - both non vaccinated) might contract measels or rubella from our 12 month old when we vaccinate him with MMR vaccine. I'm trying to look for legitimate sources on this but am not succesful so far. Obviously the viruses in the vaccine are modified and/or deactivated genetically but I cant find any sources exploring this subject apart from moronic anti vaccer pages popping up. Can someone help out?

[StringJunky]

OK,

I need to bring this thread up again. We have anti vaccers in our family and they are afraid that their children (one is 4 years and the other 6 months - both non vaccinated) might contract measels or rubella from our 12 month old when we vaccinate him with MMR vaccine. I'm trying to look for legitimate sources on this but am not succesful so far. Obviously the viruses in the vaccine are modified and/or deactivated genetically but I cant find any sources exploring this subject apart from moronic anti vaccer pages popping up. Can someone help out?

No. From the NHS,

 

 

If my child develops a mild case of measles after their first MMR vaccine, are they contagious to non-vaccinated children?

No. Post-vaccination symptoms are not infectious, so your child will not pass anything on to non-vaccinated children.

http://www.nhs.uk/Conditions/vaccinations/Pages/mmr-questions-answers.aspx#contagious (scroll down)

[koti]

No. From the NHS,

 

If my child develops a mild case of measles after their first MMR vaccine, are they contagious to non-vaccinated children?

No. Post-vaccination symptoms are not infectious, so your child will not pass anything on to non-vaccinated children.

http://www.nhs.uk/Co...aspx#contagious (scroll down)

 

 

 

Thanks for you answer String. Let me rephrase my question though as this is the main concern of my anti vaxer family members:

Can the live strains of viruses present in the MMR II vaccine lead to a non vaccinated child contracting measles, mumps or rubella ?

 

The thing is that they say they are afraid of having contact with us for 2 months after we vaccinate our kid with MMR II vaccine because it consists of live virus strains.

Ofcourse they are not afraid of sending their unvaccinated 4 year old to kindergarden and come back home to their unvaccinated 6 month old.

Their behavior in this case is so incredibly dumb that frankly, I'm near a nervous breakdown especially that we will be forced to spend time together during upcoming family functions and a 2 week vacation in July.

Edited April 12, 2017 by koti