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Is there any known risk associated with the dtap and IPV vaccine given before starting school?

6 replies

stressed2007 · 15/06/2010 22:22

My daughter is due to have the dtap and IPV vaccination at age 4 very soon. I am very wary of all injections. She had the "baby" versions of this at 3,4 and 5 months. Is this just a booster and has anyone heard of any side effects.

Also can someone please link me to a current list of what vaccinations children should have and when? I have found this site but want to doube check it is up to date.

www.euvac.net/graphics/euvac/vaccination/unitedkingdom.html

Thank you.

OP posts:
amcardle · 27/06/2010 13:27

Hi there, this is the NHS timetable of recommended vaccines: www.nhs.uk/Planners/vaccinations/Pages/Vaccinationchecklist.aspx

Here's the NHS page on the vaccines you mention (it includes a link to the safety information)
www.nhs.uk/conditions/dtap-ipv-hib-vaccination/pages/introduction.aspx

Bear in mind that we have a very rigorous system of checks to ensure licensed medicines are safe to use. They undergo large trials to identify the most obscure side effects, and doctors maintain a database of side effects to detect new problems as soon as they arise. The diseases that the vaccines you mention prevent are:
diphtheria
tetanus
pertussis (whooping cough)
polio (IPV is inactivated polio vaccine)
Hib (Haemophilus influenzae type b)

These are all very serious diseases, some of which are life threatening. Vaccines are one of the safest and most effective ways to prevent these diseases, and any possible risk of the vaccine is greatly outweighed by the benefits of the vaccine.

Vaccines can be scary, after all who wants to see a needle placed in their child. But take comfort in the fact that the vaccines are exhaustively tested, and that driving to the doctors is much more dangerous than getting the vaccine! Be confident in the quality of our medical regulatory bodies, and the skill of our doctors and nurses to administer vaccines safely.

bubbleymummy · 28/06/2010 20:22

If you are unsure about getting boosters you could have her immunity levels tested to see if she even needs them. While the diseases can be dangerous, they are also EXTREMELY rare so taking your time to make a decision that you are comfortable with is not a bad thing. Read as much as you can, not only about the vaccines but also about the diseases themselves, incidence, treatment, etc. There are a lot of misconceptions out there about some of them e.g that you can catch tetanus from eating soil or that most polio cases result in paralysis so it is worth reading up on them all to help you make an informed decision. Good luck!

MariaBN6 · 29/06/2010 12:23

amcardle, you sound like you are a medical professional. Something you mention -
"the vaccines are exhaustively tested" - is of enormous interest and concern to me. Could you please provide a link to the result of such tests and who they are tested on? surely not on children? I have been looking for professional info for a long time, if you could provide a link it would be very useful to many I am sure.

amcardle · 29/06/2010 23:33

Hi there MariaBN6. I'm flattered that you think I sound like a medical professional, but I am not. As a result you should feel free to distrust anything I say, and take the opportunity to verify my statements for yourself.

For any drug to be administered or sold in the UK (or most developed countries) it must go through a series of clinical trials. The most common are phase 1, 2 and 3 trials. In the phase 1 trials a small group of healthy volunteers are given the drug, and the scientist test to see if it is dangerous. If it is not then the phase 2 trial starts. The drug is given to about 300 volunteers to test for the safety and efficacy of the drug. If the drug passes this stage (most don't) it goes on to a phase three trial. In this trial the drug is tested against either the current best drug (its rival) or a placebo if no similar drug exitst. This is a double blind trial (neither the doctor nor patient know which person receives the drug) performed on around 3000 people. This trial tests for the efficacy and safety of the drug. Normally several of these phase 3 trials are performed.

The results of the trials are then analysed by a regulatory body (the MHRA in the UK, the FDA in the US) and the drug, if it can be shown to be effective and safe, is given a license to be sold. This same body oversees the trials, ensuring they are ethical and effective.

After the drug is licensed the testing does not stop. Doctors are encouraged to, and do, report any adverse reactions, regardless of how minor, to the yellow card scheme. This scheme, run by the MHRA, is used to monitor trends in drug reactions to identify any problems not detected in the clinical trials. This may seem rather reckless, using the public as a way of testing drugs, but it isn't. No drug is 'perfectly safe', but the benefits of the drug outweighs the risks. The same is true of vaccines. No vaccine is 'perfectly safe', but the diseases that they prevent are more than enough justification to use them. If we avoided licensing drugs until they had been through thousands of trials we would have much fewer drugs, drugs would be much more expensive, and out lives would all be worse as a result. The clinical trials detect nearly all of the major problems associated with drugs, and the yellow card scheme catches the more minor and rarer problems.

There is, however, an annoying problem. Drug trial results are often difficult to get your hands on. Firstly they are published in journals. Journals make their money by selling themselves to scientists and doctors, and are therefore unwilling to give away their articles freely. This means that some trial results cant be found easily. However some are accessible, or at least the abstract (part of article that outlines method and results). Use google scholar (scholar.google.co.uk) to search for trial results (type 'dtap' for example). You can also use the clinicaltrials.gov trial registry, or pubmed (www.ncbi.nlm.nih.gov/pubmed)

Another problem is that drug trials are often difficult to understand. They are packed with high level statistics and biology, and are not written for the lay-person. Regulatory bodies employ scientists and statisticians to analyse and dissect clinical trials so you don't have to. Their job is to work out which drugs are safe, and which aren't, and they're very good at it.

If you really feel like wading though the science them some general tips when reading trial results are:

  • The more people in the trial, the better
  • Look at who is running the trial (who is paying them?)
  • The more citations a article gets (shown in google scholar search results) the better it will be (generally)
  • Double blind trials are the gold standard phase 3 trials
  • Look at what journal the paper was in. The BMJ, lancet, nature. These are all good journals that generally publish good papers and revoke them if they're found to be rubbish (ie the lancet and the wakefield MMR->Autism paper).

If you are interested in learning more about clinical trials and medical research (and research in general) I would recommend 'Bad Science' by Ben Goldacre.

PS: Most of the search tools I linked in this return high-level scientific results, which may be difficult to interpret. Remember, the job of the regulatory authority is to dig through the trial results so you don't have to. Trust them in general, but know the results are there if you really want to check them.

PPS: Look out for papers by the Cochrane Collaboration, they're a wonderful organisation who combine the results from lots of trials and analyse them together. This allows them to identify problems in drugs that smaller trials are too insensitive to detect.

PPPS: Just found a paper looking at DTAP and IPV: www.ncbi.nlm.nih.gov/pmc/articles/PMC2647469/?tool=pubmed. It was published by the WHO, so its likely to be good quality.Look at the "Reactogenicity" section for safety information.

Here's another paper, 2000 infants were given either the conbination vaccine or individual dtap and ipv vaccines. It lists safety results (the gist of which was 'nothing serious, lots of sore arms') pediatrics.aappublications.org/cgi/content/full/123/1/301

More useful links:
NHS evidence: www.evidence.nhs.uk/default.aspx

bubbleymummy · 30/06/2010 01:16

amcardle, I think it's estimated that only about 10% of adverse reactions get reported. Also, the vaccine schedule itself has not been safety tested ie the number and combination of vaccines has not been shown to be safe. I'm happy to be corrected on this btw! Please post any links you find that show test results for the vaccine schedule.

amcardle · 30/06/2010 11:59

Hi bubbleymummy. I was sadly unable to find results of a trial on the safety of the vaccine schedule. However this doesn't mean that one wasn't carried out, just that im not very good at searching journals.

However two things are worth considering. Firstly all the vaccines used in the vaccine schedule are heavily tested (as i mentioned previously), and importantly they are tested on their intended recipient, ie. people in the age group for whom the vaccine is intended. This means that even though the trials aren't specifically looking at the safety of the vaccine schedule they do so anyway, because any adverse reactions associated with the vaccine schedule would be picked up whilst in the phase 3 trial of the vaccine.

Secondly the use of reporting schemes such as the yellow card scheme ensures that any problems associated with the vaccine schedule would be detected. The MHRA regularly analyses the results of the reported adverse reactions to detect any serious problems as soon as possible.

To suggest that the individual vaccines are safe but the combined vaccine schedule is not implies that there is some mechanism by which separate vaccines interfere with each other. As far as im aware no such interference exists.

Remember that the individual vaccines, by nature of their being licensed drugs, have gone through rigorous safety tests. Remember also that the vaccine schedule has been selected by the NHS and Department of Health, two groups with expert knowledge on vaccine safety. Remember finally that the reporting systems such as yellow card allow adverse reactions to be detected and dealt with as soon as possible. These three factors combined suggest the vaccine schedule is safe.

PS: Here's an article in the american journal 'Pediatrics' about vaccine and vaccine schedule safety: pediatrics.aappublications.org/cgi/reprint/123/1/e164?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=offi t&searchid=1&FIRSTINDEX=0&volume=123&issue=1&resourcetype=HWCIT It is talking about the American vaccine schedule, not the UK schedule, but the American schedule has even more vaccines than the UK one.

PPS: Even though I couldnt find a trial looking at the whole vaccine schedule, there are lots that look at specific combinations of vaccines. This one, again from 'Pediatrics', looks at the safety of simultaneous MMR and dtap vaccination and finds it as safe as separate vaccinations. Many more trials like this, looking at specific combinations of vaccines, exist. pediatrics.aappublications.org/cgi/content/abstract/81/2/237?maxtoshow=&hits=10&RESULTFORMAT=&fullte xt=vaccine+schedule&searchid=1&FIRSTINDEX=0&sortspec=relevance&resourcetype=HWCIT

PPPS: Another 'Pediatrics' paper, this one looking at the effects of the full US vaccine schedule on the neuropsychiatric health of children. It found no correlation between vaccination and poorer health: pediatrics.aappublications.org/cgi/content/abstract/peds.2009-2489v1

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