Whooping Cough Vaccination for Pregnant Women: Neat Idea, Missed Opportunity

New medical advice is transmitted at such lightning speed these days that GPs and their patients often have to work their way through it in tandem. This was illustrated to me quite starkly on Friday morning with the announcement of a new, temporary vaccination programme in the UK for pregnant women to protect their children from whopping cough. The first I heard about the proposal was on the radio over breakfast, by mid-morning I learnt that all GPs had been sent an e-mail with the new instructions, and before lunch I was trying my best to advise one of my pregnant patients on the issue. Funny how you can feel reasonably up-to-date on Thursday evening, and behind the times only 12 hours later!

Having had the luxury of the weekend to actually read the information from the Department of Health I feel a little more prepared to advise women in the coming week – and this is what is required of a GP these days. It is not sufficient simply to adhere to the Government line on these matters; patients expect, and deserve, a doctor who will consider medical advice carefully and be willing to give thoughtful guidance. And my conclusions? In a nutshell, it’s a great idea, but why, oh why, oh why are the Department of Health not conducting a proper clinical trial?

The proposal is to vaccinate all pregnant women between 28 and 38 weeks gestation against Pertussis (whooping cough) as a temporary programme in response to the significant rise in infection rates in the last 2 years. And whatever else we think, it is certainly a neat idea. We do have a problem with Pertussis at the moment, both in the UK and worldwide. The number of confirmed cases so far in the UK in 2012 is nearly 5000, compared with around 1000 for the whole of 2011. There is no doubt that this is in part due to greater awareness of Pertussis at the moment on the part of doctors (myself included) and so increased diagnosis of cases in adults that would previously have been missed. However, this seems to be more than just an artefact, since there has been a sharp rise in the number of cases in infants under the age of 3 months, many of whom become very unwell and in whom diagnosis will always have been much more accurate. It is the very young who are the concern with Pertussis, since they will not yet have immunity from the vaccination programme, and their small lungs are especially vulnerable. So far in 2012 there have been 9 deaths in babies in the UK, and many more will have been seriously unwell.

How best to protect these babies? Well if everyone was immunised then there would be no-one to transmit the infection to them (the protection afforded by herd immunity), but this is extremely difficult with Pertussis since the protection afforded by vaccination wanes within a few years. Unlike the recent measles epidemics where poor uptake of MMR is clearly to blame, most cases of Pertussis in older children and adults occur in people who have been fully vaccinated. A programme where everyone was immunised every 5-10 years would work, but the cost of this would be enormous.

The beauty of vaccinating pregnant women is that we know the woman will make antibodies against the disease, and that these can cross the placenta in late pregnancy, be taken up by the baby and could afford protection in those crucial early weeks until the childhood vaccinations have kicked in. A single vaccine therefore protects exactly the at risk individual, and there is no need to depend on herd immunity. When a mother chooses to accept the vaccine she is choosing to protect her own child – the personal potential benefit is very clear.

We have good reason to think the vaccine is safe. It is a killed vaccine, which means it cannot possibly cause active infection, and these vaccines have reliably been shown to be safe in pregnancy. The vaccine also contains diphtheria, Tetanus and Polio vaccination (there is no single Pertussis vaccine so the combination has to be used) and the first two of these have often been used in pregnant women without difficulty. While there is not much data for this exact vaccine it seems extremely unlikely that there are any risks other than local reactions in the arm and very rare allergic reactions, and only vaccine conspiracy theorists are likely to argue against this.

It is also likely to work. I agree with the conclusions of the expert committee that:

…it is reasonable to assume that this approach would provide young infants with some important, although possibly not complete, protection against pertussis, and it is likely to be the most effective immunisation strategy to provide protection to young infants.

The report also state, however, that

the effectiveness of prenatal immunisation against pertussis to protect young infants is uncertain.

There are reasons to think it might not work. Will the maternal antibodies be sufficient to truly protect? Is there any risk that the antibodies might actually interfere with the response to the infant vaccination programme, and lead to reduced immunity later in childhood? So what should a scientist do when he or she has a good hypothesis which is uncertain: Test the hypothesis with a trial. There is such an opportunity here to answer this question for both the current and future generations – we need to conduct a Government funded, blinded, randomised clinical trial. Instead of rolling out this temporary programme as a knee jerk reaction, pregnant women could be offered the chance to be in the trial. They would receive either the vaccine or a placebo injection, meaning adverse reactions in the pregnancy could be compared, as could infection rates and outcomes in the babies.

Within a year we would start to get a real answer to this question. If it works then this could become a permanent and valuable addition to our fight against this serious disease. If it is shown to be ineffective then we could stop wasting time and money, go back to the drawing board and look for a better solution. What is more, the vaccine itself would be protected against unfounded claims of harm. Sadly the background rate of stillbirth is sufficiently high so that the Daily Mail headline “Whooping Cough Vaccine Killed my Baby” might as well have already been written, and without the robust clinical evidence available from a randomised trial these inevitable anecdotal stories will be much harder to evaluate. Granted, the trial would need to be large and the cost would not be insignificant, but the long-term gain of truly knowing how to protect babies from this infection must surely be worth it.

So how should I advise my patients in the lack of proper trial data – well it is a shame we shall never know for sure, but the issue is important enough to take action, and the balance of risk has to be in favour of the vaccine.

22 thoughts on “Whooping Cough Vaccination for Pregnant Women: Neat Idea, Missed Opportunity

  1. Hi Martin. Do you know if there has been an analysis conducted re the number of stillbirths recorded since the programme commenced, October 2012 to May 2013, compared to the number of stillbirths recorded in the same time period one year prior, October 2011 to May 2012?
    Do you think it would be relevant for the DoH to study and share this information?

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  2. Further, has there been any analysis on the number of newborns who have contracted whooping cough despite their mothers having received the Repevax vaccination during pregnancy?

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    1. Good questions, Rebecca. I don’t know at the moment, although I beleive data is being collected. I know of someone who might know and will ask him on twitter to comment if he is able. I do think it is extremely unlikely that the vaccine would be in any way linked to still births, but how effective it is at preventing whooping cough is a very important question. The problem will be interpreting the data as it will be hard to prove cause and effect.

      Martin

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      1. Thanks Martin and Peter. I have one more question regarding this vaccine during pregnancy I hope you can answer. What is the physiological effect on a baby if a pregnant woman accepts the repevax vaccine at, for example, 37 weeks however she gives birth a few days later thus prior to the two week period to build up antibodies that may cross the placenta? Will the inactive virus’ have crossed the placenta to the fetus and stay within his/her system but with zero antibodies? I presume the virus from the vaccine crosses the placenta much ge same as rubella, for example?

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      2. Thanks for your question, Rebecca. The pertussus vaccine is quite different to rubella, which is what makes it so safe in pregnancy. The rubella vaccine (as part of MMR) is a weakened, live virus, which means it crosses the placenta and could cause a mild form of infection in both mother and unborn baby – which would never be acceptable as even mild rubella could harm the baby.

        Pertussus is a bacterium rather than a virus, and the vaccine is not a weakened live version of the bacterium, but something entirely inactive which just contains the same proteins as the bacterium, which means it can stimulate the immune response so that the immune system recognises the real bacterium when it comes along. Because of this it can never cause an actual infection in mother or baby. The only reaction is very occasionally a slight temperature can occur in the first 24hrs so I guess if you had it and gave birth within 24hrs you might have a temperature during delivery (but this in itself would not harm the baby).

        The main problem with giving it only a few days before delivery is that (as you say) the mother would not have time to develop the antibodies which would normally cross the placenta and protect the baby, so that the baby would be less protected. There would still be some protection as antibodies could be transferred after delivery in breast milk, and even if bottle fed the mother would be less likely to get whooping cough herself in the first few weeks of the baby’s life, and so less likely to transfer the infection to the baby (mothers are thought to be the main source of infection when babies get whooping cough).

        I hope that is helpful.

        Best wishes,

        Martin

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      3. Thank you kindly Martin for your answer to recent question below. What I mean to ask is: does the pertussis bacterium cross the placenta to the fetus,, and if so what happens to the bacterium (and bacterium from other virus’ in repevax) within the baby if the mother gives birth prematurely before antibodies¬†were created and transferred?

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      4. I have struggled to find out if any of the vaccine itself crosses the placenta, as most of the information is about antibodies crossing over. What is important to remember, though, is that it is not a whole bacterium and so cannot infect either mother or baby with even a mild illness. Also, it is a very small quantity of vaccine and as it is not live (like the MMR), it cannot replicate. Therefore tiny amounts will be in the blood stream of the mother even if they can cross over. You only need to have a small amount of something to trigger an antibody response, though, and so these will be produced in large amounts by the mother to cross over to the baby. The same is true for the other components of the vaccine (diphtheria and tetanus) as these are also not live and just parts of the bacterial protein.

        The only result from giving birth early, therefore, will be that the new born baby won’t have quite such good protection.

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      5. And one final question, if you don’t mind. There is an inordinate number of papers which say vaccines may cause a mild fever in some patients, however nowhere explains why. Are you able to share the reason why an inactive vaccine, such as repevax, can cause a fever?

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      6. Whenever we have a fever it is not the infection as such which causes the rise in body temperature, but the body’s own immune response. This can therefore be in response to even an inactive vaccine. The fever tends to be very low if at all, as the stimulus to the immune system is very weak – compared with an active infection when the invading organism is replicating rapidly and present in large numbers, thereby stimulating a much larger response.

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  4. Hi,

    I’m new to this site. I recently gave birth to Robbie, my first son, who was stillborn. Since his birth I have been searching my mind for some explanation as to why my son died. I had ‘the perfect pregnancy’ according to my midwife and everyone else I know. No high blood pressure, no anaemia, hardly any morning sickness ect… Robbie’s heartbeat was always strong and whenever my midwife did my fundal measurements they were always within the ‘normal’ range. It was such a terrible shock when after going into labour at 38 weeks my son was born with no signs of life at a very tiny 4lbs 9oz. The only thing that keeps coming back to my mind is that at 32 weeks I had both the flu jab and tdap (whooping cough) vaccines. My baby’s development according to his size and weight at birth seem to have stopped at somewhere around the same time that I had these vaccinations. only after looking online did I find information that told me that the tdap vaccine was previously not advisable for use on pregnant women as there have never been clinical studies of the effect of this vaccine on unborn babies as pregnant women are excluded from clinical trials. All I am trying to find out is whether anyone else may have had a similar experience or anybody else has a suspicion that the tdap vaccine may have caused the loss of a baby. Thanks for taking the time to read this x

    R.I.P My beautiful baby boy and love to all who have lost a child xxx
    hi everyone im so sorry for you loss i lost my baby boy oscar 12 weeks ago at 37 weeks i had the most perfect pregnancy i was in good health so was oscar then i was given the whooping cough and flu jab 3 days later i lost my baby we are devasted i know this is what took him from us ,,,,,i have started up a face book group called oscars law have nearly two thousand memebers im also fighting this all the way .
    if anyone would like to join his group or talk just send me a private message love kim xxxx
    Hi, my son was born sleeping a month ago 38 weeks & 6 days and the thing that torments me is the whooping cough jab, i really didnt know what to do for the best, to have or not to have the jab… I havent seen the consultant regarding the postmortem results, hopefully they will be able to give me a cause of death. However, if I choose to have another pregnancy. I will not have the jab again regardless of the PM results.
    I personally had a stillbirth at week 39 last may and decided after being on this forum and reading different posts from mums whom have had stillbirth due to the vaccine , will not be having this jab.
    I never had it with my last pregnancy because it was not even offer to pregnant women then .
    After making my decision my consultant also agreed with my decision as I am already high risk and we re all trying to prevent anything from happening again.

    This is just my opinion xxxx
    I had the whooping cough vaccine the day I went into premature Labour and my baby was also stillborn. Postmortem says its due to infection but couldn’t pin point what infection. This was just a couple of months ago. I’m not planning on getting pregnant agein any time soon, but I hope more research is done soon. Did anyone else who’s had the vaccine and a stillbirth have an unidentifiable infection?
    I have just had a missed miscarriage, my baby died the day I had the flu jab according to the scan measurements. I wasn’t offered either jab with my Son and he is perfect. I don’t now if there is a link, but I think it is human nature to look for a cause.

    I will certainly do more research rather than just accepting everything I am offered when we are pregnant again.

    I cannot imagine your loss, it is so much greater than ours. x
    I have to many extenuating circumstances to prove the infection was from the jag BUT I was in hospital 2 days before and had no infection then but It went right through me the day I went into Labour, the day I had the vaccine. I’m all for vaccination by the way, I’m just concerned it might be safer After baby is born and can get the vaccination from breast milk. If there were a group of women who had an unidentifiable infections which resulted in stillbirth and had the vaccine they may be able to do something. But the pregnancy’s would have to be healthy in every other way to prove it. My poor wee girl had fought through months of low fluid. So I’m not really a good candidate x

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  5. more testing needs to be done before any more mothers go though this pain. My sisters baby died at 38wks between 19th-20th june 2013, from she got this vaccine things started going wrong with her pregnancy, everything was going to plan before this vaccine, the baby was proper weight and size with no complication then the baby stopped growing measuring weighing 4lb 1oz, she had to get steroids they told her at her last visit 12 june 2013 that the baby was measuring 7lbs 15oz and she had 3wks left to go till her due date 1st of july 2013. The doctors were monitoring her every week up until that last visit,(by the way during her pregnancy she never seen the same doctor it was always someone different). she was told they didn’t need to see her again for 3wks they were happy with the way things were going. If they had of took her in again on the wed every week like they should have been doing they may have picked up on this instead of waiting for another 3wks to see her. IN YOUR LAST FEW WEEKS OF PREGNANCY DO THEY NOT TAKE U IN EVERY WEEK TO CHECK YOU?? MY sister went into hospital thur nite 20th june couldn’t find a heart beat she was having strong sharp burning pains across her stomach that day she started having contractions. Patrick John was born 10.10 PM 21st June WEIGHING 5LBS 7OZ SO MUCH FOR 7LB 15OZ BABY THEY PREDICTED ON THE 12TH JUNE??? HE WAS BORN PREFECT NO EXPLANATIONS TO WHY THIS HAPPENED. THIS VACCINE NEEDS TO BE NOT GIVEN UNTIL THEY NO FOR CERTAIN THAT THIS IS NOT THE CAUSE OF THESE BABY’S DYING. IF THEY HAD OF TAKEN HER ON THE WED TO MONITOR HER LIKE THEY SAID THEY WOULD DO EVERY WEEK UNTIL SHE HAD THE BABY THIS MAY NOT HAVE HAPPEN, SOMETHING IS NOT RIGHT THE LAST CONSULTANT SHE SEEN SHOULD NOT HAVE BEEN SO EASY TO LET HER GO AND BE HAPPY NOT TO SEE HER FOR ANOTHER 3WKS,AFTER HOW MUCH THEY WE CONCERNED ABOUT THE BABY. TOO MANY DIFFERENT CONSULTANTS IT’S OBVIOUS UR JUST A NUMBER, I HAVE BEEN ONLINE SEARCHING FOR ANSWERS AND I HAVE SEEN A LOT OF MOTHERS AND FATHERS WORRIED ABOUT THIS VACCINE IS IT THE CAUSE OF THEIR BABIES DYING NO PARENT SHOULD HAVE TO GO THOUGH THIS AND IF THIS COULD HAVE BEEN PREVENTED BY NOT TAKING THIS VACCINE IT’S A QUESTION THAT NEEDS ANSWERED!!
    michelle

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    1. Dear Michelle,

      Thank you for these comments, which are very moving to read because of your sad loss. There is nothing that can prepare you for a stillbirth, and no-one who knows what you are going through unless they have been there themselves.

      If you have not already come across the charity called Saying Goodbye I would strongly recommend them to you as they can offer unique support for people who have suffered stillbirth or miscarriage. I have blogged about this excellent charity here: http://binscombe.net/blog/?p=440

      It is terribly hard to know what to think when you suffer a stillbirth soon after an event like receiving a vaccine, and you are right that research is very important here, as well as close monitoring of the experience of vaccination. Sadly there have always been instances of sudden, unexpected and unexplained stillbirth, and this will still happen on occasions, both to women who receive the vaccine and those who don’t. The key question is to see whether there is a higher incidence of stillbirth in women who receive the vaccine than in those who do not. If there is, then we should be concerned that the vaccine might be causing stillbirth, if there is not then we would have to conclude that the vaccine is not the cause.

      My understanding is that this has been looked at, and that there is not a higher risk of stillbirth after vaccination than without vaccination, although I don’t have the research to hand to quote to you. I also believe they are monitoring the situation very closely since the vaccine has been introduced. My own feeling is that the safety of the vaccine is quite well established, but what is less clear is whether vaccinating pregnanct women is the best way to protect babies or not.

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      1. Hi Martin,

        This was my understanding as well. However, I am unable to find the evidence and the information on these results. I need to see the clinical research results, the incidence, length and severity of side effects and the % of the pregnant women affected. I need to see the insidence of still birth, close monitoring results from those women who were affected. I got vaccinated 2 days ago and I am feeling real poorly. On top of it all, I was pressured into having the whooping cough and flu jab by the midwives, and the nurse administering the jabs did not offer detailed information on the risks. I have since read about these unfortunate stories where the pregnancy indeed seems to have been impacted by the vaccines. There is no doubt in my mind that there is a link, and it would take detailed medical reports to disprove this. My pregnancy has also been really good, with absolutely no cause for concern and a very very healthy foetus and baby. If anything does happen, I will obviously be filing a lawsuit. So my argument is, the NHS should be more prepared because at some point all these women will demand an answer. And although the NHS’s legal budget is huge, at some point a bad decision will backfire.

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  6. I was just wondering about the follow up from this test that started over a year ago. Have there been any results released yet? I believe this study was suppoed to take one year and should have been completed in Oct 2013. I would LOVE to see the results of this study. Thanks!!

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