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

Sorry for typos. I meant 'emergency/experimental manner'

Hi there,
You rightly say that the vaccine was introduced in response to a serious situation, back in 2012 when the cases of whooping cough soared and there were several infant deaths.
The figures relating to whooping cough in 2012:
"There were 9,741 confirmed cases of whooping cough reported in England and Wales in 2012, according to figures published today by the Health Protection Agency (HPA). The total figure for 2012 is almost 10 times higher than the number of cases reported in 2011 (1,119) and in 2008 (902) the last peak year before this current outbreak.
The December figures show a decrease for the second month running in cases of whooping cough with 832 confirmed cases reported compared with 1,168 cases in November 2012.
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."
From here:
www.hpa.org.uk/NewsCentre/NationalPressReleases/2013PressReleases/130201Casesofwhoopingcoughdeclineafterrecordnumbers/
So, yes, two years ago the situation was pretty scary and in 2012 the JCVI made the decision to introduce the vaccination of pregnant women. The reasoning behind this was that whooping cough vaccine had not been shown to have any negative results when taken by pregnant women, and everything we know about immunity led them to believe that newborn babies would acquire some protection from their mothers (passive immunity) against this potentially fatal disease (14 deaths in babies under three months is a very serious situation). A vaccine with no known negative effects on pregnant women, with potential to offer life saving protection to new born babies, and which would be heavily monitored. The JCVI was extremely aware of the potential for reports like the ones you allude to when you say: "Some women also report they had stillborns after they took it..." Where exactly are these women saying this? Because the JCVI took the risk of such claims very seriously, but I don't seem to have seen any actual reports of cases which have been reported and medically confirmed to be in any way related to the vaccine. Could you possibly link? The MHRA has been closely monitoring the situation to date, and I understand over half a million mothers to be have received the vaccine without any cause for concern being noted.Then you also mention that they're changing the vaccine used? Could you again link to the evidence for this change? I am not currently pregnant but have been following all updates from the JCVI on this subject with interest. The current NHS page still refers to Repevax:
www.nhs.uk/Conditions/pregnancy-and-baby/Pages/whooping-cough-vaccination-pregnant.aspx
My personal feeling is that there is no evidence that the vaccine causes any harm to either mother or child, and the evidence to date appears to be that it offers protection for the newborn child against a potentially deadly disease. I'd accept it, gladly.
Cheers,
Rosewind

Rosewind, here you find information about the change from Repevax to Boostrix-ipv from July 2014 onwards.

www.gov.uk/government/uploads/system/uploads/attachment_data/file/302682/8801_PHE_VU_214_April2014_09.pdf

It is true, official sources say so far there has been no evidence the vaccine can cause any harm, though some mothers claim reduced foetal movement and even stillbirths after taking it.

Borlotta,
Thanks for the information about Boostrix-ipv, of which I am sure I will hear more in the coming months.
There has always been great awareness of the risk that pregnant women will associate the vaccine with problems with their babies. This is absolutely to be expected, as the JCVI minutes state:
"The committee advised that, as there is potential for the immunisation during pregnancy to be falsely associated with adverse events, such as intrauterine death, that occur with a relatively high background frequency, careful monitoring and assessment of the frequency and type of adverse events is important to provide reassurance about the safety of the vaccine in pregnancy.”
Pregnancy can still be a risky time, despite all the efforts of mothers and the medical community. Women will worry, which is why this programme has been carefully monitored. The point of this is to immediately identify any genuine cause for concern. So far there isn’t any such cause for concern, the vaccine is indeed safe during pregnancy for both mothers and babies, which is brilliant news for everyone. Because whooping cough does actually kill babies, and we need a way of protecting them.
Cheers,
Rosewind

I sincerely hope that the reports of stillbirths following vaccination are being taken seriously rather than being dismissed as false associations.

So do I bumbleymummy. It might well be there is no association or that a constellation of events led to that, in which perhaps the vaccination plaid a role. But it is not enough to say there is no association; they should explain why it can be entirely ruled out.

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/

Cheers,
Rosewind

Well in order to report using the yellow card scheme, the doctor would have to acknowledge that the vaccine caused the reaction. There lies the risk for under reporting due to the doctor's belief that it was a 'false association'.

Also interesting from the minutes "in the absence of a correlate of protection and any studies on the effectiveness of this approach against
infection or severity of disease, the effectiveness of prenatal immunisation against pertussis to protect young infants is uncertain. Antibody levels in the infant would be expected to wane rapidly following birth. Nevertheless, it is reasonable to assume that this approach would provide young infants with some important, although possibly not complete, protection against pertussis

There were also quite a few 'assumptions' made about whether the vaccine was safe to administer to pregnant women in those minutes as well.

Yes, they are completely transparent about those assumptions that they made. Great isn't it? Assumptions based on expert knowledge, obviously.
All the evidence to date is that their reasonable assumptions, supported as they were by expert opinion on the evidence to date were correct.
Cheers,
Rosewind

Bumbleymummy,
"Well in order to report using the yellow card scheme, the doctor would have to acknowledge that the vaccine caused the reaction. There lies the risk for under reporting due to the doctor's belief that it was a 'false association'."
No, I think anyone can report an adverse effect. Look, here:
yellowcard.mhra.gov.uk/
Cheers,
Rosewind

The limited evidence to date. Yes, all open and transparent if you read the JCVI minutes. I don't see them telling too many pregnant women in clinics that there's limited data on the safety of the aP vaccine in pregnancy but they're assuming it's ok based on what they've seen. "Expert opinion" isn't much when you don't have any data to base that opinion on!

Yes, RW, you can report it yourself - If you know about it. People are frequently being told about the Yellow Card scheme on MN. Most people don't know it exists.

In any case, if the JCVI think it's important to monitor the vaccine in use (given the limited data) then do you think it's adequate for that monitoring to take the form of reports by the mothers themselves using a system that many of them haven't been made aware of?

Bumbleymummy,
The evidence to date is all supportive of the effectiveness and safety of the immunisation programme. An immunisation programme which offers protection to newborn babies against a potentially deadly disease. The evidence is being monitored. The NHS has been extremely open about the situation with the vaccine:
www.nhs.uk/conditions/pregnancy-and-baby/pages/whooping-cough-vaccination-pregnant.aspx
I've been interested in the reaction of mums to be about this immunisation and the impression I get is that the information is well communicated.
It is in the interests of mothers and health care professionals to flag up any and all concerns about any possible concerns of side-effects from this immunisation programme. If a pregnant woman isn't aware how to report any possible side-effect I would hope that her doctor and midwife (or other health care professional) would be able to advise her how to report it. If not she can obtain information from somewhere like here, or by simply using a popular search engine to look for "how do I report a vaccine side effect UK". Which will lead to places like:
www.nhs.uk/Conditions/vaccinations/Pages/reporting-side-effects.aspx
It's not difficult. I do feel that comments like:
"Well in order to report using the yellow card scheme, the doctor would have to acknowledge that the vaccine caused the reaction. There lies the risk for under reporting due to the doctor's belief that it was a 'false association'."
Could easily lead someone to incorrectly conclude that "the doctor would have to acknowledge that the vaccine caused the reaction", which is is not correct. Which leaves a rather puzzled as to why you said it?
Just to reiterate: anyone can report a side-effect using the Yellow Card Scheme.
Cheers,
Rosewimd

I don't see the part where the NHS admitted that they started using the Repevax vaccine on pregnant women with only limited information about the safety of aP vacccines in pregnant women and zero information about the safety of the Repevax vaccine itself in pregnant women. I don't see where they have linked to the yellow card scheme to make people aware of its existence and to help them 'monitor the evidence'. Where has that information been well communicated? Yes, women can ask but most people's first point of call to report a reaction is their doctor/HCP and if that person 'reassures' them that it couldn't possibly have been the vaccine, that they are making a 'false association' then they are unlikely to take it any further or consider looking for a way to report it themselves.

The reason I mentioned the doctor in relation to the yellow card scheme is because, as I said above, most people's first point of call if they think they have reacted badly is their doctor/other HCP. If the doctor dismisses their concerns then they are unlikely to take it further or report it themselves. I can clarify my post and say "Well in order for the doctor to report using the yellow card scheme, the doctor would have to acknowledge that the vaccine caused the reaction." Yes, they could report it themselves but many people don't know it exists and, to be quite blunt, I doubt it is the uppermost thing on a mother's mind if her child has been stillborn :(

Bumbleymummy, can I ask you what did you do or have decided to do? I am 29 weeks and still in two minds…I am considering to have it because my baby is due in summer, which is precisely the peak time for whooping cough. Also, I thought I need to develop some form of trust in the system as I will have to rely upon it for the next years. Yet, I hear everything you say and I asked myself exactly the same questions. Plus, I've just found out the UK is one of the rich countries with the highest number of stillbirths. These are due apparently to the lack of, or inadequacy of, antenatal checks precisely in the third trimester!

Hi Borlotta, my children are older and the vaccine wasn't being offered when I was pregnant. In any case, I wouldn't want my decision to influence yours. :) I agree that it is a hard one to make and all you can really do is inform yourself as much as possible and go with what you think is best. x

The concerns about number of stillbirths in Britain relative to other European countries predated the introduction of the whooping fought vaccine (which is also offered routinely to pregnant women in other European countries).

And, to be blunt, "many" women reported reduced movement and had stillbirths before roll-out too.

All stillbirths are investigated in UK. Are you saying that system has been specifically manipulated in the last two years?

Meditrina, can you please list the other European countries where the whooping cough vaccine is offered during pregnancy? Certainly it is not in France, nor in Italy and Germany. It is true that the number of stillbirths in the UK was high before the introduction of the vaccination and I did not find date saying it increased afterwords. I am also not suggesting any form of manipulation. What I am suggesting though, which is something that has been already said by several sources, is that antenatal care in this country is inadequate. Most hospitals give women only two scans (at 12 and 20 weeks), leaving the third trimester mostly unchecked. It is true that we have more frequent appointments with the midwife after the 33rd week, but they have been considered insufficient to detect problems. In any case, I don't mean to conflate two discussions that are separate. I am just concerned that pregnant women here are left either with poor care or with rushed up decisions to make that leave them between a rock and a hard place.

Perhaps some members of this thread would like to start a discussion about stillbirths and their causes? Though I would suggest they do it elsewhere, as this is the vaccine area of mumsnet. Unless that is they have some evidence which involves vaccination and stillbirth? In which case I'd be interested in joining a discussion of that evidence. From what I can see the major modifiable risk factors for stillbirth (in high income countries such as the UK) that have so far been identified are pretty much summarised in the paper linked to below:
"Findings
Of 6963 studies initially identified, 96 population-based studies were included. Maternal overweight and obesity (body-mass index >25 kg/m2) was the highest ranking modifiable risk factor, with PARs of 818% across the five countries and contributing to around 8000 stillbirths (≥22 weeks' gestation) annually across all high-income countries. Advanced maternal age (>35 years) and maternal smoking yielded PARs of 711% and 47%, respectively, and each year contribute to more than 4200 and 2800 stillbirths, respectively, across all high-income countries. In disadvantaged populations maternal smoking could contribute to 20% of stillbirths. Primiparity contributes to around 15% of stillbirths. Of the pregnancy disorders, small size for gestational age and abruption are the highest PARs (23% and 15%, respectively), which highlights the notable role of placental pathology in stillbirth. Pre-existing diabetes and hypertension remain important contributors to stillbirth in such countries."
The paper is here: www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)62233-7/fulltext

There was a series in the Lancet on this subject:
www.thelancet.com/series/stillbirth
Summary:
"Around 2.6 million stillbirths (the death of a baby at 28 weeks' gestation or more) occur each year. Although 98% of these deaths take place in low-income and middle-income countries, stillbirths also continue to affect wealthier nations, with around 1 in every 300 babies stillborn in high-income countries. The Series highlights the rates and causes of stillbirth globally, explores cost-effective interventions to prevent stillbirths (as well as maternal and neonatal deaths), and sets key actions to halve stillbirth rates by 2020. Also included are Comments from professional organisations and parent groups, the latter demonstrating the unique tragedy for families of the birth of a baby bearing no signs of life."

Stillbirth is, as they say above, a unique tragedy. However it is not currently linked in any causative manner to pertussis immunisation which instead protects newborn babies from a potentially fatal disease.

Cheers,
Rosewind

RW, it was Berlotta who started this thread and she mentioned her concerns about still birth and the vaccine in her OP. I think she's perfectly entitled to keep her thread here. Why are you trying to police what should be posted and where?

Sorry - Borlotta

Unless the French and German governments are both lying in their published, on the record, public information and instructions to doctor's, then it is (or should be) offered to every PG woman there. 15 EU nations do, as do US and NZ (and I think Canda and Australia) plus several Asian countries.

None appear to have reported an increase in stillbirths or other adverse outcomes since the jab was offered.

The confidential survey into stillbirth in UK is one of the earliest and most successful 'safe spaces' for investigation (including whistle blowing). I find the suggestion that it has been subverted to be an extremely serious allegation, and would like to know what action is underway to bottom it out.

Which 'published' are you referring to, Meditrina? I have checked both the French and the German sites of the health ministers and cannot find anything. On the contrary, I find a number of articles saying that the vaccination for pregnant women is not introduced in this countries (I read both languages and have friends in both countries who have had babies recently and never heard of it). The same goes for Australia; pregnant women are not invited to do it during pregnancy but immediately after giving birth. It would be great if you could provide evidence for these claims.

I don't understand what you mean by 'suggestion that it has been subverted to be an extremely serious allegation'.

Good news on the latest safety assessments of the pertussis (whooping cough) vaccine for pregnant women:
www.bmj.com/content/349/bmj.g4219
"Conclusion In women given pertussis vaccination in the third trimester, there is no evidence of an increased risk of any of an extensive predefined list of adverse events related to pregnancy. In particular, there was no evidence of an increased risk of stillbirth. Given the recent increases in the rate of pertussis infection and morbidity and mortality in neonates, these early data provide initial evidence for evaluating the safety of the vaccine in pregnancy for health professionals and the public and can help to inform vaccination policy making."
Data from just over 20,000 women.
Cheers,
Rosewind

Hmm. I would maybe find that a bit more reassuring if I hadn't heard examples of potential side effects being dismissed as "nothing to do with the vaccine".