Thoughts, comments on dT vaccine as primary series - Mothering Forums

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#1 of 8 Old 09-04-2012, 07:38 PM - Thread Starter
 
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Just wanted to get your perspective on this...including the very knowledgeable abstainers...

 

Background: neither of my children have been vaccinated to date. My main issues are 1) safety of injected aluminum (Shaw, Tomljenovic etc.) and 2) I just don't think that many of the vaccines on the schedule are necessary, okay I'll qualify that, not necessary for MY family from MY perspective.

 

We moved from somewhere where the ground was frozen solid for about six months of the year to a place that is frost-free year round. The kids are playing in the dirt year round and as they get older and are off on excursions etc., they are under the care of teachers who perhaps are not as diligent about wound care as I would be, and that concerns me.

 

Yes, I know all about how statistically, it's more likely some senior out gardening who would get tetanus, not a healthy, robust kid. I also know how incredibly rare it is. I'm familiar with that.

 

Nevertheless, we have been in discussion with our family GP about the merit in doing the dT vaccine. Reasoning...it's the one option that doesn't come with a load of other antigens I don't want (like the infant combos containing pertussis, polio, hep B and the like) and it also has the least amount of aluminum of any other option.

 

If it provides a smidge of diphtheria protection, that'd be okay too, considering the case in Queensland back in 2011 where an unvaccinated woman came down with clinical diphtheria from her vaccinated friend who had just returned from Asia and apparently infected her with the bacteria. The woman died. Yes, also incredibly rare. Yet, many of my daughter's classmates holiday regularly in Indonesia, which still has about 800 reported cases a year (according to the WHO).

 

Okay, so looking at the Australian government's Immunisation Handbook, it states that the dT can be used as a primary course (three doses).

 

Quote:
The product information for ADT Booster states that this vaccine is indicated for a booster dose only in children aged ≥5 years and adults who have previously received at least 3 doses of diphtheria and tetanus vaccines. NHMRC recommends that, where a dT vaccine is required for any person ≥8 years of age, ADT Booster can be used, including for primary immunisation against diphtheria and tetanus.

 

 

http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/Handbook-tetanus

 

But then when you look up the actual product insert for the ADT booster, it states:

 

Quote:
ADT Booster is not intended for primary immunisation against diphtheria and tetanus.

 

 

http://www.csl.com.au/docs/778/399/ADT%20Booster%20PI%20-%20approved%20Jan2010.pdf

 

Interesting. So, do you think it's worth an email to both the government and manufacturer to find out what's the deal? 

 

I did consider that it was perhaps because the antigen levels, as a booster, are so low...2 IU for diphtheria and 20 IU for tetanus (compared to 30 IU and 40 IU in the infant combos). But then I decided to check and see if there was any data on using a similar product as a primary course back in Canada and found this:

 

Quote:
The schedule for routine immunization of persons ≥ 7 years of age is a three-dose series of adolescent/adult formulation of diphtheria toxoid-containing vaccine, as noted in the Recommended Immunization Schedules chapter. The second dose is given 2 months after the first, with a third dose 6 to 12 months later to complete the course.

 

http://www.phac-aspc.gc.ca/publicat/cig-gci/p04-dip-eng.php

 

And the data for Td Adsorbed is:

 

Quote:
The immunogenicity of Td ADSORBED administered as a series of three doses for primary immunization was evaluated in 17 subjects ages 6 to 56 years in a study conducted in Canada. The first two doses were administered two months apart, followed by a third dose six to eight months after the second dose. Serum tetanus antitoxin levels were measured by an in vivo neutralizing assay, and serum diphtheria antitoxin levels were measured by an in vitro neutralizing assay. All 17 subjects had serum tetanus and diphtheria antitoxin levels pre-vaccination and 7 days post-vaccination <0.01 IU/mL, consistent with no previous immunization. Four weeks following the second dose of Td ADSORBED, all 17 subjects had a serum tetanus antitoxin level >0.1 IU/mL and a serum diphtheria antitoxin level ≥0.01 IU/mL. Four weeks following the third dose, all 17 subjects had a serum diphtheria antitoxin level >0.1 IU/mL.

 

https://www.vaccineshoppecanada.com/document.cfm?file=td_adsorbed_e.pdf

 

According to the Canadian Immunization Guide, antitoxin titres of >0.1 IU/mL are considered protective.

 

The Td Adsorbed and the ADT Booster seem to contain similar amounts of toxoids. The Canadian one is in Lf vs. IU. It also has more aluminum and 2-phenoxyethanol, residual formaldehyde (ugh, but probably in the ADT Booster as well).

 

Anyway, does anyone have any info on how Lf equates to IU and second is there good data in the US on Td being used as a primary course? 

 

Like I said, we're discussing options with the GP and I want to go into this with as much info as possible. We're not interested in any of the infant combos. They will not be getting any other vaccines until puberty, at that point we'll re-evaluate the risk and benefits of others. Again, nothing set in stone there either.

 

And yes, having not given either child any vaccines to date, I am aware, as stated, how rare either clinical diphtheria or clinical tetanus is. However, I cannot be with them all the time to ensure adequate wound care nor can I be 100% sure that their classmates don't bring home unwanted souvenirs from their last trip to Indonesia.

 

Thanks.


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#2 of 8 Old 09-04-2012, 09:24 PM
 
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5 Lf tetanus = 20 IU tetanus

http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/05vol31/asc-dcc-1/index-eng.php (see table 1 where next to tetanus, it says 10 Lf = 40 IU.

 

So the Australian diphtheria/tetanus vaccine, containing 20 IU tetanus, has the same amount of tetanus as the U.S. DT, containing 5 Lf tetanus.

http://www.csl.com.au/docs/778/399/ADT%20Booster%20PI%20-%20approved%20Jan2010.pdf

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM101500.pdf

 

The U.S. DT vaccine package insert says, "Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine (DTaP) – Tripedia®, or DTP is recommended for primary immunization of infants and persons up to 7 years of age. However, in instances where the pertussis vaccine component is contraindicated, or where the physician decides that pertussis vaccine is not to be administered, DT should be used."

Meaning, they want you to vaccinate for pertussis if you can, but you don't want to, so that doesn't apply to you.

 

The Australian diphtheria/tetanus does have less diphtheria than the U.S. DT.

 

Diphtheria conversion: multiply Lf by 1.2 to get IU.

 

6.7 Lf diphtheria = 8.04 IU diphtheria

 

Austrlian vaccine only has 2 IU. But maybe they make up for that by almost 3 times more aluminum than the U.S. DT? Aluminum is used as an adjuvant, to increase the immune response to the antigen.

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#3 of 8 Old 09-05-2012, 12:20 AM - Thread Starter
 
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Thanks for the info thumb.gif

 

Interesting...yeah, that is quite a difference in the aluminum...0.17mg to 0.5mg (which was looking better than the 1.5mg in the infant combo ones here). That is perhaps the reasoning behind the higher amount (supposedly increase the immune response). Still, it's not great.

 

The difference in the diphtheria content I suppose is the nature of the vaccines...DT vs. dT. Australia had a CDT (basically a pediatric DT similar to the States) but they discontinued it back in 2005 or 2006.

 

Hmm... I did find this product in the States, Decavac, which seems closer to what's available here:

 

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM246215.pdf

 

It has 5 Lf tetanus and 2 Lf diphtheria, 0.28 mg aluminum.

 

It states that it did provide protective levels of antibody at those levels:

 

 

 

 

Quote:
The effectiveness of primary immunization with tetanus toxoid and diphtheria toxoid used in DECAVAC vaccine was determined on the basis of an immunogenicity study, with a comparison to a serological correlate of protection (0.01 antitoxin units/mL) established by the Panel on Review of Bacterial Vaccines & Toxoids. (7) A clinical study to evaluate the serological responses was performed in 58 individuals 6-58 years of age. Of these, 46 persons had no evidence of prior immunity to tetanus toxin and 47 persons had no evidence of prior immunity to diphtheria toxin. The results indicated protective levels of antibody were achieved in greater than 90% of the study population after primary immunization with both components. (4) 

 

 

So, that I guess answers my question about comparable US products and any studies indicating that adult boosters can be used for a pediatric primary series...the fact that the Aussie ones contain a heck of a lot of aluminum by comparison though is not great.
 
Edited to add: I just noticed that Tenivac is actually replacing Decavac (even though both are still listed on the FDA site). They seem to be similar in composition with the antigens, although Tenivac has slightly more aluminum (1.5 mg aluminum phosphate, equivalent to 0.33 mg aluminum).

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#4 of 8 Old 09-09-2012, 07:18 PM
 
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I know of a ND here in the US who does 3 DTs as a primary series for her kids (under the age of 7) for the tetanus, same as you.  Whether or not they are different brands, etc, I don't know, I would assume so.  But I always thought if it as an option for us if we ever choose to (I worry about wound care at school, same as you mentioned, but my DD just started preschool.  I will reassess when she starts K in a few years.)


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#5 of 8 Old 09-02-2013, 04:45 PM - Thread Starter
 
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I just thought I'd bump this up. We brought the kids in yesterday thinking that we could start the series using the dT in a variation from the product info as discussed with our GP. The recently revised Immunisation Handbook says this is allowable for children 10 years of age and older. Our GP, however, appeared to have second thoughts and said that he needed to contact TPTB about using the dT as a primary series in children under 10 years of age. I mentioned to him that it seemed arbitrary that in between editions of the Immunisation Handbook (changed from when we started discussing this route), they raised the recommended age of this option from 8 years to 10 years and I didn't see the science behind why they did so. He said there must have been a reason for it. With my cynic's hat, the reason would be to "guide" more families towards the paediatric vaccines, which coincidentally, also had their age range extended from 7/8 years and younger to 10 years and younger. 

 

http://www.health.gov.au/internet/immunise/publishing.nsf/Content/handbook10-4-19

 

Our GP said he is concerned with higher risk of adverse reactions. I pointed out that between the ADT Booster (that we were planning on using) and Tripacel (the closest pediatric product that contains pertussis, which we don't want/need), the Tripacel appears to have more aluminium (1.5mg aluminium phosphate vs. 0.5 aluminium hydroxide in the ADT Booster) as well as the greater concentration of the antigens (40 IU tetanus toxoid and 30 IU diphtheria toxoid vs. 20 IU tetanus toxoid and 2 IU diphtheria toxoid in the ADT Booster). The Tripacel also has phenoxyethanol which is not in the adult booster.

 

Australia stopped making a paediatric DT about 6 or 7 years ago.

 

I also showed him the studies where an adult dT was used as a primary series (and the youngest individual was 6 years of age) and that there was a demonstrated acceptable immune response after the series was complete. 

 

So, that's where we're at. He's checking to see if he's allowed to proceed. If the answer is no, then we have to wait until the kids are 10 years old to start the series. There is no other option unless we get one of the combos that we don't want. Interesting how the manufacturers and government influence our choices, even when we're trying to do "the right thing." Frustrating.

dinahx and kathymuggle like this.

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#6 of 8 Old 09-09-2013, 07:16 PM
 
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In the US, before the whole "Let's immunize everyone for Pertussis" we used to do the series with DT for young kids and Td for the older kids all the time.  In fact, I know a clinic where they still do the Td only on older kids and the parents file an exemption for the pertussis.  The DT stopped being manufactured in the US when the recommendations changed to using exclusively DTaP.


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#7 of 8 Old 09-10-2013, 06:20 AM - Thread Starter
 
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Yeah. I didn't hear back from them yet, so I guess we're in limbo land. Ie. looks like a no to the dT until after age 10, so we'll have to wait until then.

 

It's interesting that the Australian GP here is hesitant to use the adult dT because he's wary of reactions yet when I looked at the Canadian Immunization Guide, they recommend using the adult formulas on children older than 7 years:

 

http://www.phac-aspc.gc.ca/publicat/cig-gci/p04-tet-eng.php

 

Quote:
Children 7 years of age and older should receive the adolescent/adult formulation of diphtheria-tetanus-pertussis-containing vaccine with or without polio (Tdap or Tdap-IPV) as it contains less diphtheria toxoid than preparations given to younger children and is less likely to cause reactions in older children.

 

It repeats again in another subsection that children over age 7 who were not previously immunized should receive a Tdap/Tdap-IPV, NOT the infant combinations. It's frustrating that the Australian guidelines attempt to force us to pursue an avenue--using infant vaccines on our older children--that our home country does not recommend. Similar dT vaccines with almost same amounts of toxoid, yet two different sets of recommendations. :dizzy


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#8 of 8 Old 09-18-2013, 09:18 PM - Thread Starter
 
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Just browsing through the Immunisation Handbook and the product monographs again. I had asked my GP where the evidence was for raising the age from 8 years to 10 years for the ADT booster and similar adult boosters. He said, "Oh, well, there must be some reason for it." 

 

Reading the Australian Immunisation Handbook, they state that all the infant vaccines SHOULD be used on kids aged 10 years and younger. Even though Canada and the US advise against this (their upper age limit is 7 years).

 

I was looking through the Aussie product monographs. The GSK ones didn't have anything about an upper age limit (surprise, surprise), yet when I looked at the Sanofi Australian monograph for Pediacel, the info clearly states:

 

http://products.sanofi.com.au/vaccines/PEDIACEL_AUS_PI_2013-03-27.pdf

 

Quote:
The vaccine should not be administered to individuals less than 6 weeks of age or older than 7 years (see DOSAGE AND ADMINISTRATION). 

 

Okay, so looking under "Dosage":

 

 

Quote:

Do not administer to children less than 6 weeks of age or older than 7 years (See PRECAUTIONS).

For further information, refer to the current National Immunisation Handbook. 

 

 

But wait, even though the manufacturer states in no uncertain terms do not administer to children older than seven years, the Australian government has said it's okay.  :dizzy

Well, that makes me feel better.

 

Sanofi says the same about Quadracel:

 

Quote:
QUADRACEL should not be administered to children after their seventh birthday or to adults because the quantity of diphtheria toxoid and pertussis antigens may provoke enhanced local reactions, fever and malaise. 

 

http://products.sanofi.com.au/vaccines/QUADRACEL_AUS_PI.pdf

 

Yes, this is one of the vaccines listed in the Handbook as recommended for kids aged 10 and younger.

 

I'm sure if I looked through every product monograph for the infant vaccines, I'd find similar warnings about the upper age limit, yet I'm supposed to just smile and agree with the Handbook and the apparent scientific reasoning for moving the upper age limit of infant vaccines to ten years, even though my GP has no idea what it is or where the science came from. I don't even think there's clinical data on Pediacel being used in children older than age 6 (that was the highest age I could find in a manufacturer trial), yet the government is happy to use it on ten year olds. 

 

Just for fun, I compared the product monographs for the Aussie and Canadian versions of Infanrix Hexa. Same manufacturer--GSK. Same amount of antigens and same type. Similar adjuvants. Yet one does not list an upper age limit for primary vaccination although it states up to age 6 as a booster (Australian Infanrix Hexa) while the other (Canadian Infanrix Hexa) states emphatically that it cannot be used in children over age 7 because as it states under "Contraindications":

 

Quote:
should not be administered to persons 7 years of age or older because diphtheria toxoid may cause severe but transient local and febrile reactions in children and adults, the frequency increasing with age, the dose of toxoid and the number of doses given. 

 

http://www.gsk.ca/english/docs-pdf/product-monographs/Infanrix-hexa.pdf

 

Where does that leave us? Well, apparently with kids who will be without any vaccines until after age 10 because the Australian government endorses a recommendation that other countries view as contraindicated and overtly risky, and one that even goes against what one Australian manufacturer recommends in their product information--complete contradiction between the manufacturer and the Australian government. Again, where is the science? If other countries have deemed it too dangerous to give infant vaccines to older children, why not err on the side of caution (age 7) rather than pushing the age limit up to 10 years? 


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