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

Were these mothers-to-be being used as guinea-pigs?

Given that the vaccine wasn't licensed for pregnant women and hasn't been used on the previously it would certainly seem that way! Shame that they weren't told that.

I seem to recall that the recommendation came in the midst of a whooping cough outbreak that ultimately claimed the lives of a dozen infants.

CatherinaJTV,
Yes, that's right, over a dozen:
"One further death in an infant with laboratory confirmed whooping cough was reported in December bringing the 2012 total number of deaths in babies under three months to 14."
www.hpa.org.uk/NewsCentre/NationalPressReleases/2013PressReleases/130201Casesofwhoopingcoughdeclineafterrecordnumbers/
It was a pretty worrying situation. Luckily there was a vaccine available which all available evidence indicated would be safe and effective at protecting vulnerable infants by way of passive immunity. These results show that the vaccine programme put in place was indeed safe, and effective.
Cheers,
Rosewind

This situation does appear to be somewhat ethically dubious, given that informed consent is the basis of any clinical trial, and I was certainly given the impression from all HCPs I spoke to that the vaccine was proven safe and there were no question marks over it whatsoever. (From reading these boards it appears a lot of people had the same experience.) It may be proven safe in due course, but this really isn't the point. It wasn't at the time it was given to women, and the uncertainty in the situation not only wasn't made clear, but was actively denied. I have also never been told about the yellow card system and wouldn't be aware of it had I not read these boards.

The results of the latest study are encouraging and certainly support the safety assertions in that there was no significant increase in adverse effects short term (a period of weeks postpartum if I recall correctly). But let's not overstate what's been presented here - as the authors themselves concede this is one study looking at short term effects with some limitations (spelled out by the authors), and doesn't tell us anything about longer term effects. Additionally, it DOESN'T prove that the vaccine programme was effective as this wasn't looked at in this study. As the authors state this will be published subsequently. There is no way of knowing whether the decrease in cases would have occurred anyway, given the cyclical nature of WC outbreaks.

thank you Rosewind - 14 - man, that is tough :(

KateG,
I think the piece you're looking for on effectiveness is this paper:
www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60686-3/abstract
"Findings
The monthly total of confirmed cases peaked in October, 2012 (1565 cases), and subsequently fell across all age groups. For the first 9 months of 2013 compared with the same period in 2012, the greatest proportionate fall in confirmed cases (328 cases in 2012 vs 72 cases in 2013, ?78%, 95% CI ?72 to ?83) and in hospitalisation admissions (440 admissions in 2012 vs 140 admissions in 2013, ?68%, ?61 to ?74) occurred in infants younger than 3 months, although the incidence remained highest in this age group. Infants younger than 3 months were also the only age group in which there were fewer cases in 2013 than in 2011 (118 cases in 2011 vs 72 cases in 2013), before the resurgence. 26 684 women included in the Clinical Practice Research Datalink had a livebirth between Oct 1, 2012 and Sept 3, 2013; the average vaccine coverage before delivery based on this cohort was 64%. Vaccine effectiveness based on 82 confirmed cases in infants born from Oct 1, 2012, and younger than 3 months at onset was 91% (95% CI 84 to 95). Vaccine effectiveness was 90% (95% CI 82 to 95) when the analysis was restricted to cases in children younger than 2 months.
Interpretation
Our assessment of the programme of pertussis vaccination in pregnancy in England is consistent with high vaccine effectiveness. This effectiveness probably results from protection of infants by both passive antibodies and reduced maternal exposure, and will provide valuable information to international policy makers."
I also beg to differ with you about how the information about the vaccine was communicated to pregnant women. I wrote this back in September last year:
"Thank you everyone for some interesting reading on this thread. People are clearly concerned about receiving vaccinations during pregnancy, which considering how careful most of us are of our diets etc. is unsurprising. Some have expressed concern at the manner in which the situation regarding the pertussis vaccination during pregnancy is being communicated. Whilst I appreciate this, I would also like to point out that this rather goes against the oft repeated claim that health care providers just say that vaccination is safe, with no qualifications. The message being communicated here with the pertussis vaccine is clearly not this; there are limitations about what we know about giving this vaccine during pregnancy. What we do know indicates that it will provide protection to the newborn against a very dangerous illness. What we do know indicates that the vaccine is highly unlikely to result in any complications for the mother and her developing child. All data so far indicates it is safe, and will be beneficial. There is no evidence at all to indicate any problems, but the wording is cautious. Because it is honest.
For what it is worth, if I was pregnant and offered this vaccine all the information I have read would lead me to accept the vaccination with enthusiasm."

I think health care providers were admirably transparent, which led to some interesting discussions.
Cheers,
Rosewind

So, were pregnant women, prior to being given the jab, given any warnings about it? That it was, in effect, a trial?

Rosewind, thank you for the link. That does appear to be the paper I was waiting for. I can only see the abstract from the link, so will have to log onto my work server for the full text and will read the whole paper with interest.

I can only speak to my experiences of attempting to discuss this with various HCPs (my GP, MW and consultant). All told me it was proven totally safe and totally effective, and when I tried to discuss uncertainty or the fact this was an off-label use of the vaccine all seemed genuinely unaware of this. In all honesty I was unable to find an HCP who was able to discuss the issues, as none I spoke to seemed to be aware of them. (Issues such as the impact of the blunting effect, lack of long term safety data or the effectiveness of the vaccine in previously unvaccinated women (Repevax, offered at the time, is only a booster, and the product insert clearly states it's unlikely to be effective without primary immunisation).) I got the impression they were just reciting the official NHS advice (which I had already read as it was freely available online). Perhaps this differs across the country and I was just unlucky, but others I have spoken to have reported the same thing. It would seem to me that for significant numbers of women the discussions were far from transparent.

I reviewed this last week for work, it's a good study. There's another one about to be published that will report on efficacy.

Sorry, just saw the link above. The vaccination programme was not a clinical trial as others have said, the study is simply an observational study. I was pregnant in 2012, and felt that there was transparency about whether the vaccine was 100% known to be safe. As with all of these things, it was a risk-benefit exercise.

LittlePeas, while not formally a clinical trial, it was still an off license use of the vaccine that from the beginning was to be assessed for efficacy and safety (as spelled out in the JCVI minutes at the time) as these weren't completely known at the time. There was evidence to suggest it would work, but at the time even the Americans (often cited to me as having used it in pregnancy 'for years') had only been doing this for 11 months and were themselves monitoring the situation. I don't think that this was honestly conveyed to all women involved, but as I've stated above this might be different depending on who/where you are.

LittlePeasMummy,
I have been in several discussions regarding the vaccination programme. My impression has been that the situation with the vaccine was very well communicated. As I said in my earlier post the situation was that people most certainly appeared aware of the limitations about what was and was not known about the vaccine. As I said, this was very much contrary to the off repeated claims that health care providers just claim vaccines are safe. I see that the NHS page has been updated to reflect the results of the new publications. I will see if I can get hold of a copy of the old version. Regarding possible adverse effects being dismissed: I would certainly hope this would not be the case. If anyone has evidence this has genuinely happened I think it needs to be widely publicised.
Cheers,
Rosewind

I seem to remember a thread/threads about this where pregnant women who had had the vaccine were unaware that the vaccine had not been licensed for use in pregnant women.

Re. The reduction in cases. How many were due to the vaccine and how many were due to the natural cycle of the disease?

The number of current whooping cases played a large part in my decision not to have the jab. I plotted the weekly number of cases for regions relevant to me over the last few years (using the weekly NOIDs published by the Health Protection Agency - more effort on my part but up to date summaries weren't available) and the disease was back down to pre-epidemic levels in places where I was / visiting family were from. DS was born in a dip in the infection cycle and I'm happy that it turned out to be the correct choice for us. At the time (earlier this year) it persisted in only a limited number of places, but I guess the advice has to be country wide for simplicity's sake. I'm continuing to keep an eye on it as we hope to have another DC in a couple of years and you'd expect the cases to peak again in the next few years (if it continues on it's usual cycle) and no-one knows whether the next peak will be as high as the 2012/2013 one. I'll assess the risk/benefit at the time in the same way I did this time around.

I had this vaccine. I nearly died as a baby so for me the proven benefits outweigh the potential unproven risks.

I think the point people are making is that it wasn't proven. Women were taking an unknown risk (that they were unaware of) for an unknown benefit.

Sure, links are below.

www.hps.scot.nhs.uk/publichealthact/WeeklyData.aspx

www.hpa.org.uk/Topics/InfectiousDiseases/InfectionsAZ/NotificationsOfInfectiousDiseases/NOIDSReportsAndTables/NoidsPreviousNOIDsReports/Noids2014NOIDSReports/

The general consensus is that previous immunity wouldn't be sufficient to protect the baby as immunity drops off after a few years. This is the basis of one of the theories about why pertussis is making a resurgence - adults and older children who have lost immunity are now able to pick up and pass on the disease, without necessarily knowing it as in adults the symptoms can be mild. If you have had the disease previously you could expect to raise a decent response to the booster if you chose to have the vaccine (Repevax is being replaced by Boostrix, also a booster). In the absence of primary immunisation or disease the booster vaccine would be unlikely to give much benefit.

I’ve just been looking at the NHS pages regarding the whooping cough vaccine from last year, since KateG stated, “I got the impression they were just reciting the official NHS advice (which I had already read as it was freely available online).”
“Is the whooping cough vaccinesafe in pregnancy?
There is no evidence to suggest that the vaccine is unsafe for mother or baby if used in pregnancy.
The vaccine, called Repevax, has not been clinically tested on pregnant women because clinical trials don’t usually involve pregnant women. For this reason, evidence on safety in pregnancy can be limited. 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.
Repevax has been used in the UK childhood immunisation programme since 2004, and has an excellent safety record. All of the components in the vaccine have been given singly or in combination to pregnant women without any evidence of harm to the mother or her baby.”

I think this is pretty clear.
They also go on to specifically address the fact that the leaflet states that the vaccine should not be given to pregnant women:
“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. Where there is limited evidence like this, it can be necessary to weigh up the risks and benefits of an intervention, such as a vaccine. 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.
Last reviewed: 24/09/2012”

So the advice was that there was no evidence the vaccine was likely to cause any harm to either mother or child, and was likely to offer protection to vulnerable newborns from a potentially fatal disease; these newly published results absolutely support the conclusions of the experts at the JCVI.
Cheers,
Rosewind

I do think that the NHS advice has been given a spin to make it reassuring to patients rather than accurately reflect risks.

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.

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.

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.)

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.

KateG,
Just a quick point.
I linked to the JCVI minutes on the previous page. You're saying they didn't say they had no concerns over safety, and that they said, instead, that there was no evidence of harm. These two things are indeed different. If you read the minutes the JCVI said:
"The committee concluded that use of Repevax® during pregnancy did not raise safety concerns."
So their conclusion was that the use of Repevax during pregnancy did not raise safety concerns.
Cheers,
Rosewind