Anti-whooping cough vaccine for pregnant women

[Borlotta]

Hi, this is the first time I post on this forum but I have been following it for a while. It is very useful. I am 28 weeks pregnant, I live in London and I am confronted with the decision whether to have the anti-whooping cough vaccination or not. The midwife proposed it to me weeks ago but she said there was no rush as it can be done until week 38. Yet, I cannot make up my mind. Here the reasons: it was introduced only two years ago in a kind of energy/experimental manner. The specific vaccine used had not been tried on pregnant women before and therefore we do not know the mid to long term effects. Some women also report they had stillborns after they took it. Of course they don't have the proof but it is ver scary. Furthermore, I have just learned the vaccine which has been used until now (Repevax) will be replaced in July 2014 by another one. They say it is the same composition but produced by a different company. I still wonder why are they changing it? Also, I do wonder if it is still wise to do the anti-wp vaccine now that the emergency seems over. The number of people getting wp has decreased dramatically since 2012 (which was the peak year). I am considering to have more information about the incidence of wc in my area, how many women take it and decline it etc. I wonder if anyone here can share their experience and thoughts? Thanks

How is it supposed to be reassuring that the lack of evidence of harm (due to it not having previously been used in the group in question) means that there are no safety concerns?

Or that a different vaccine had been used for a limited time without its effects being analysed?

If this was anything other than a vaccine would you think it was acceptable?

Yes Rosewind, this is the wording they use, before going on to concede that the data were limited and the situation should be monitored. I think women would have appreciated that last part being made more clear. (As a side note I find the language used about avoiding 'false associations' worrying as this implies that the vaccine was already proven safe when, as they concede, the data were limited. They seem to have been starting off with the assumption that any adverse effects must be coincidental.)

KateG,
I am not going to wrangle about semantics, but you were wrong about what the JCVI said? They did say, as the NHS correctly reported, that it did not raise safety concerns NOT merely that there was no evidence of harm.
Cheers,
Rosewind

Bumbleymummy,
"How is it supposed to be reassuring that the lack of evidence of harm (due to it not having previously been used in the group in question) means that there are no safety concerns? "

As I've just said, the JCVI actually said it did not raise safety concerns. As I have said previously on this very thread, and as the JCVI minutes make quite clear, this was based upon a number of strands of evidence. The expert opinion of the JCVI, having considered the evidence, was that there were no safety concerns.
This new evidence is great, since it is direct evidence of the safety and efficacy of the vaccination programme.
Cheers,
Rosewind

I'm pregnant and due to have the vaccine this week however I am concerned that from this month the branded vaccine is changing to boostrix. Does anyone know why this is and if boostrix has a longer trck record than its predecessor?

Just been looking on gov.uk In 2013 there was a 60% uptake of the vaccine in pregnant women. 3 babies died and their mothers were not vaccinated.

RW, yes, and what did they base that on? The lack of evidence from it not being previously used in pregnant women and a different vaccine that was used for a limited time in the US?

This 'direct evidence' has been obtained by basically using pregnant women as guinea pigs. How ethical.

Bumbleymummy,
I wrote a response to you back in April about the sort of evidence they based their decisions upon:
"Borlotta and bumbleymummy,
Clearly with a vaccination programme aimed at pregnant women they have taken any reports of adverse effects on the pregnancy extremely seriously. It has been flagged up many times in the JCVI minutes, for example, that this is obviously something that must be monitored most carefully by the MHRA using the Yellow Card Scheme and the Clinical Practice Research Datalink
If you read these minutes, for example:
www.gov.uk/government/uploads/system/uploads/attachment_data/file/223497/JCVI_minutes_Aug_2012_Pertussis_-_final.pdf
You can see that they took the safety of the vaccine very seriously. Any adverse events are being collated and monitored. This programme was undertaken to prevent deaths and disease in newborns, it's there to protect them.
Before embarking on the immunisation programme obviously the previous studies on any effects of the immunisation on the outcome of pregnancy were investigated. Studies like this one:
www.ncbi.nlm.nih.gov/pubmed/22727350
"During a time when Tdap was not routinely recommended in pregnancy, review of reports to VAERS in pregnant women after Tdap did not identify any concerning patterns in maternal, infant, or fetal outcomes."
www.ncbi.nlm.nih.gov/pubmed/23896191
"No increase in adverse outcomes was identified in infants born to women receiving Tdap compared with infants of controls."
Things like the conclusions of expert committees:
www.ncbi.nlm.nih.gov/pubmed/23812487
"There is no evidence of adverse fetal effects from vaccinating pregnant women with an inactivated virus or bacterial vaccines or toxoids, and a growing body of robust data demonstrates safety of such use."

There is no evidence to date of any negative outcomes associated with this vaccination programme. The programme has offered previously unavailable protection to newborns from a potentially fatal disease. Let's not forget the 14 deaths that did undeniably occur in babies aged under three months 2012:
www.hpa.org.uk/NewsCentre/NationalPressReleases/2013PressReleases/130201Casesofwhoopingcoughdeclineafterrecordnumbers/"

They used the evidence available, none of which gave them grounds for concern. Now we have direct evidence from this country that this vaccine is indeed safe and effective.
Cheers,
Rosewind

Rosewind, I wasn't wrong that JCVI recommended that the situation be monitored, accepted that the data were limited, or raised the issue of blunting. I was quoting from memory and was not trying to quote verbatim, if it came across this way I apologise. It was the gist I was going for. The NHS failed to mention that the situation would be monitored as data was lacking, which was very relevant to women making the decision of whether to not to have the jab. You have no opinion on any of the other points I raised?

There is also a question here of whether or not you put absolute faith in 'expert committees'. I don't personally, as experts are people exactly like me with biases and limitations and I can think of one example off the top of my head of where the 'experts' got safety assumptions completely wrong (gene therapy trials). In this case they were also dealing with limited evidence and external political pressure to do something quickly, so no matter how thorough they were there is no way to be sure that their advice was 'right'. It is unreasonable to expect them to be infallible when they are working with limited information. It was their opinion that the vaccine was probably safe (but should be monitored as data were lacking) but this doesn't necessarily make it so. It's worth noting that at the time, which is what we're primarily talking about, none of the strands of evidence were from patients using this vaccine.

This new evidence is certainly supportive, but as I've said above, there is a danger of overstating what has been shown. There is still no data on longer term effects (on the immune system, as the causes of blunting are still unknown, or on neurological development for example) and the authors of the safety study concede that this was just one study (and more are needed to 'prove' safety), as well as the fact that they didn't look at confounders. It also doesn't excuse any previous fudging of the facts to persuade women to have the vaccine.

KateG,
No, I have comments on the rest of your points too. I was limited by time.
"I do think that the NHS advice has been given a spin to make it reassuring to patients rather than accurately reflect risks. "
I don't agree. I think it makes a good job of trying to present quite a complicated situation to a group of people who will be very concerned about any safety concerns.
"For instance:
"Why does thepatient information leaflet for Repevax say that the vaccine should not be used in pregnant women?
This is because pregnant women are routinely excluded from clinical trials. It is not because there are any specific safetyconcerns or evidence of harm in pregnancy.
As pregnant women do not usually take part in clinical trials, there can be limited evidence on safety in pregnancy."
This gives the impression that it's merely some kind of bureaucratic oversight that pregnant women aren't included in trials, rather than it being a sensible precaution with good reasons behind it. "

I again don't agree. They are resenting the situation. The vaccine wasn't tested on pregnant women due to any specific concerns. In fact the evidence, even preceding these recent results all indicate no reason for specific concern.

"Also:
"A similar vaccine (without the component that protects against polio) has been used in America in pregnant women, and there is no evidence of risk to the health of the pregnant woman or the baby."
This implies that the use of the similar vaccine in pregnancy in America is well established, which is how my GP interpreted it (telling me it had been used for many years with no side effects), whereas at the time it had only been in use for 11 months and the CDC hadn't yet compiled data on it so didn't actually know whether it was safe or effective. "

You are inferring that the vaccine has been used for some time. It doesn't actually say this. I have only your report that your healthy care providers gave you incorrect information. If they had specified that the vaccine had been in use since 2011 with no evidence of risk to the pregnant woman or the baby, would you have been happy?
www.acog.org/Resources_And_Publications/Committee_Opinions/Committee_on_Obstetric_Practice/Update_on_Immunization_and_Pregnancy_Tetanus_Diphtheria_and_Pertussis_Vaccination
The link above gives the American rationale for the introduction of the programme, again pointing out that the evidence indicated no evidence of adverse fetal effects from vaccinating pregnant women with this sort of vaccine.

"And:
"Experts at the Joint Committee on Vaccination and Immunisation (JCVI) looked into the risk of whooping cough in young babies, and looked into the available evidence on the whooping cough vaccine, and concluded that they had no concerns over the safety of the vaccine for the mother or her baby."
Actually they said there was no evidence of harm, but they wanted to monitor the situation to assess whether it was safe and effective, and spelled out how this would take place. I note that nowhere does it mention this in the advice. The wording here implied that the JCVI said it was safe, whereas 'no evidence of harm' does't mean quite the same thing. (If there is insufficient evidence either way of course there will be no evidence of harm.)"

As I have already pointed out, this is incorrect.

The last bit regarding blunting etc. I will come back to later.
Cheers,
Rosewind

Not resenting, representing. Autocorrect!

Yes, RW, I think I remember having quite a long discussion about whether or not side effects were always being reported or whether or not they would be dismissed as coincidence. (As is the case for many other vaccines)

I know it's not scientific or anything but....

In 2013 I had the whooping cough vaccine when I was pregnant with my daughter. No side effects at all.

A woman I knew through work decided not to have the vaccination. Very sadly her baby was one of those who died.

Like I said not scientific, but as I'm now pregnant with dc2 I will definitely be having the vaccine again.

LadyN, that's very sad for your friend.

By the above figures, 40% of pregnant women did not get the WC vaccine. Of the 60% who did, it would not have induced immunity in a certain percentage.

How well has this "vaccine for each pregnancy" recommendation been tested? Or is this another 'experiment' that women are unknowingly taking part in?

Bumbleymummy,
Oh yes, I do remember the ADR discussion. I've been perusing that one, hopefully back at some point soon with some interesting stuff.
Cheers,
Rosewind

KateG,
Next up:
"They have also selectively omitted other things that the JCVI said (such as the concern that was raised about the blunting effect and the supposition at the time that early protection was being obtained at the expense of longer term protection - they fully expected an increase in cases up to a year old as a whole due to blunting). They have also ignored the recommendation that the JCVI made to immunise health care workers in contact with small babies, so called 'cocooning' as is recommended in the US, to give an extra layer of protection. Recent JCVI minutes state that the Department of Health has deemed this too expensive."

What the JCVI actually said about possible blunting was:
"Impact on routine immunisations
12. The committee noted that there is conflicting evidence on the potential for the blunting of the immune responses to the first routine infant immunisation following immunisation during pregnancy. Thus, it was possible that immunisation in pregnancy could lead to immunity from the primary immunisations waning more quickly, possibly leaving children more susceptible to disease prior to the administration of the pre-school booster dose of dTaP/IPV or DTaP/IPV vaccines. Whilst the committee agreed that the potential for blunting was not a reason not to proceed with the immunisation of pregnant women, it would be very important to study the impact of the temporary programme on routine immunisations both in terms of immune responses and, if possible, on the clinical effectiveness of the primary immunisations in children up to three years of age."

Pertussis is most dangerous to the very young, and most infant cases occurring in the

Thanks for taking the time to reply Rosewind. This discussion is getting a little unwieldy so I'll try to be succinct in my responses!

Firstly as to how to NHS website represented the situation, I was talking about the overall tone which I found overly simplistic and a little patronising. I do think the wording of 'no evidence of risk' and 'no specific safety concerns' was chosen deliberately as most lay people (and most of the HCPs I've come into contact with) interpret this as 'totally safe'. You appear to have a scientific background and so clearly understand that this isn't the case, but some pregnant women I've spoken to have clearly come away with this impression. My sister-in-law was adamant that our region must be using a different vaccine as the one she was offered had been used in other countries for years and had been proven totally safe - her midwife had assured her of this. This is the kind of misunderstanding that has arisen in my experience anyway.

The misinformation I was given was just one of many factors in my decision, so no, even if my GP had accurately presented this I wouldn't have just taken his word for it. But then I'm also a scientist and know full well what 'no evidence of harm' means and how limited the original research was in this case. (Although, as you've pointed out, more evidence is now emerging. I would say though that there are still many unanswered questions in my mind.)

I still maintain that the ethical thing to do in this case was to point out that the situation was being monitored because of a lack of safety/efficacy data, so that women could make an informed choice. No-one disputes that this is a serious disease, or that babies are more vulnerable than the rest of the population, but there is an air of panic about this plan in a rush to 'do something'.

As to the blunting issue - in the paragraph you quote it says that children could be more susceptible to disease before their boosters so I don't quite understand your confusion. I can try to dig out the reference stating one year old (as opposed to this which is actually older) if you like but I think this is descending into semantics. As you point out the recent evidence confirms that the blunting effect is real, but that the committee considers this to be unlikely to be of clinical significance. I would point out that again this is currently unknown, as is the mechanism by which this occurs. Why not point this out and let women decide for themselves whether they agree with the committee's view? An honest representation would be something like 'There is evidence that immunisation in pregnancy lowers infant responses to their first immunisations at 8 weeks. It is not currently understood why this is, but the JCVI thinks this is unlikely to be clinically significant'. Could it be that if the advice is not completely reassuring, women might make the 'wrong' choice? Isn't it a little patronising, and not in the spirit of 'choice', to essentially say that the experts have done all the thinking for you, so now you just do as you're told? There is certainly language to this effect in the JCVI minutes, for example the June 2014 minutes talk about 'achieving high rates of uptake'.

I actually don't disagree with the principle that there are limited resources that need to be targeted effectively, but I do think that refusing to vaccinate health care workers, and thus relying purely on maternal vaccination, is putting undue pressure on women to do this. It is also putting at risk infants whose mothers couldn't have the vaccine (even if they had wanted to), or who had the vaccine but it wasn't effective because they never had a primary immunisation. HCPs are difficult to avoid.

KateG,
You keep repeating this "no evidence of harm" phrase. As I pointed out the JCVI actually said that:
"The committee concluded that use of Repevax® during pregnancy did not raise safety concerns."
You yourself are at pains to stress that these are two different things.
There was evidence available, and this was considered by the JCVI from the scientific literature at that point. They did not make this decision based upon a hunch. I included several links to studies on the effects of this sort of vaccine on pregnancy outcomes (no negative effects observed) in previous posts.
My experience of discussing this vaccine, both face to face and online, is that the situation was well communicated. Unfortunately there was scaremongering about potential negative effects (I think there is evidence of this on this very thread, if you read through from the start). The JCVI was aware of this potential, and I feel this awareness and the transparent way they dealt with the expectation of fears was refreshing.
They knew very well that there was absolutely no evidence to lead them to expect negative outcomes, but they knew such fears were likely.
You found the communication via the NHS overly simplistic and patronising, well that is your impression.
You also have now mentioned this idea that there will be women who are immunologically naive when it comes to pertussis. I did a bit of reading around this, and (for example) the HPA guidance appears to be that such individuals should be given the Repevax vaccine initially. Their rationale is that it is quite unlikely for even a woman who has not received a primary schedule of vaccination to be genuinely immunologically naive. Do you have a basis for your apparent suggestion that this is genuinely an issue? I will come back with a link to the HPA guidance.
The minutes of the teleconference of the JCVI on the 30th August 2012 is also quite useful in that it has an annex of evidence considered. As I have now said a few times it wasn't simply a lack of evidence of harm that the JCVI based its decision upon. It was based upon several strands of evidence, all of which led them to conclude that the use of the vaccine raised no safety concerns.
Cheers,
Rosewind

That HPA link:
www.hpa.org.uk/webw/HPAweb&HPAwebStandard/HPAweb_C/1317136400742

Cheers,
Rosewind

Borlotta - congratulations on your pregnancy! These are really tricky decisions to make, and I really understand the dilemma. Personally I chose to get the whooping cough vaccinations (and boosters in subsequent pregnancies), following discussions with my GP and because I knew a family who had lost a child following whooping cough and it was awful - but I did choose not to get the flu vaccine.

In the end you will I'm sure make whatever is the right decision for your family. Please do be aware when you look at research and opinions on here that there are lots of reasonable voices with many opinions... But unfortunately the (ahem) rabid anti-vaxxers who has posted around 50% of the responses here, is in no way reflective of 50% of the opinions. Some people hang around these threads and share lots of highly unsubstantiated 'facts' and drown out other voices raising maybe more rational points on any side.

I contracted whooping cough when pregnant with my first child (vaccine not offered to pregnant women then, I had been previously vaccinated but obviously immunity had worn off) and then gave it to him as a newborn.

We were lucky as DS has no complications and no long-term side-effects. On paper this was a mild case, but even so

• I had to combine recovering from a c-section, having whooping cough myself, and looking after a sick newborn. I basically survived on about one hour's fitful sleep in every 24 hours for weeks on end. I had to carry a pillow around with me everywhere to hold it over my c-section scar when a coughing fit came on.
• DS vomited up almost every feed for two or three weeks and put on no weight at all for two months.
• DS would turn blue whenever he had a coughing fit. Once he stopped breathing until I turned him upside down and thwacked his back (this isn't the recommended first course of action, but it turns out I panic in a crisis)
• DS was in hospital on supplementary oxygen for nearly a week (hooked up to various monitors that would sound alarms every time his blood sats dropped or he kicked off the foot sensor so that the machines thought his blood sats had dropped. That particular week I got even less sleep...
• DS had a really bad cough (the sort where strangers would stop and stare in a "what is wrong with that child and why aren't his parents panicking" way for about four months and a lingering nasty cough (the sort that would have concerned me if either of my younger two had had it) for about another four months. For three or four years afterwards, every time he got a cold the nasty hacking cough eould come back and linger for a few weeks.

I really don't recommend it.

This was in January of a year not flagged up as being particularly high risk, by the way. And I reiterate that this is the good end of newborn whooping cough.

Custard, I don't think there are any rabid 'anti-vaxxers' on this thread. Just some people who look at the evidence and interpret it differently to how you do.

And 'unsubstantiated facts'? Such as the WC vaccine being 'safe' for pregnant women when it hasn't been previously been used on them? Or are those types of 'facts' ok?

Tortoise, sorry to hear about your son. Glad that he's come through it ok.

That phrasing is used on the NHS website Rosewind, which I was talking about at the time. "Firstly as to how to NHS website represented the situation..." was the clue there. We clearly have different experiences of how this was communicated, but surely if that was my experience it was for other women too? I have no doubt that the JCVI made the best decision they could based on the available evidence, but I do maintain that that evidence was limited (which is why it was important to monitor the situation), and that this should have been clearly communicated to the women involved.

The idea that women can be immunologically naive is not plucked out of thin air, it is clearly stated in the Repevax product insert. See:

www.medicines.org.uk/emc/medicine/15256.

The JCVI acknowledged this in their initial meeting before going on to state that it's highly unlikely that women would have no primary immunisation and never contract the disease (and therefore the few this would presumably apply to should be given the vaccine but it wouldn't be effective). It's not clear what this assumption is based on (or the same assumption that is asserted in the HPA link for that matter), but I for one have never had either, and my parents can't recall anyone else they knew contracting the disease either. I would question the JCVI's assumption in this case. I do note that the advice may have been updated to reflect this problem however.

I think all of the arguments have been presented on all sides now, and since the name-calling has started I will bow out unless anyone has a specific point to make. For the record I am not anti-vaxination (and certainly not rabid). My DS and I have all our immunisations and I got the Repevax jab after birth, even if it wasn't likely to work, to try and give him all the protection I could. I also had the flu jab early in my pregnancy as this is well established and I travelled on public transport extensively so I felt the risks of flu out-weighed those of the vaccine in this case. I felt the Repevax jab in pregnancy was something else however, for all of the reasons mentioned up thread, and it was my experience that the situation was not well communicated (and pressure was applied using emotive terms that blew the risks of disease well out of proportion in my opinion). Hopefully now at least any woman wondering about whether to have this will be aware of issues on the other side of the argument too, so that she can make a truly informed choice.