Webchat with David Salisbury
This is an edited transcript of a live webchat with David Salisbury, director of immunisations at the Department of Health, on 30 Oct 2009.
Professor Salisbury, who originally trained as a paediatrician and also works extensively for the World Health Organisation including his role as chairman of the WHO Strategic Advisory Group of Experts on Vaccines, is a timely guest given that the swine flu vaccination programme is now being rolled out. Pregnant women are one of the first 'at-risk' groups being offered the jab.
Swine flu and pregnancy | Celvapan vs Pandemrix | Use of adjuvants | Testing adjuvants | Licensing squalene | Breastfeeding | Allergies | Vaccine schedule | Cost | Seasonal and swine flu vaccine timings | Vaccinating children | Mixed messages from healthcare staff
lomorising: I am 35 weeks pregnant and live in Scotland so will no doubt be offered the H1N1 vaccination very soon. The government website tells us in one sentence that most pregnant women will only get mild, normal seasonal flu symptoms and the next sentence tells us of the horrific complications we are likely to face if we contract the virus.
If it is so important and advised that I should take the H1N1 vaccine, which apparently is not that different from the seasonal flu, why have I never been offered a normal seasonal flu jab and yet am being pressured to take the swine flu jab? Which is it: just another seasonal flu or is this virus in fact much more serious?
mummyzanne: Why are some people being offered it now and others in December or later, even though we are all pregnant just using different doctors?
mumbot: What evidence can you share with us to demonstrate that the adjuvant in Pandremix is safe for pregnant women? Not the anticipated behaviour of the adjuvant but how Pandremix actually reacts in pregnancy on a large-scale population.
DavidSalisbury: We do recommend that pregnant women with flu risk factors should be vaccinated every year and we know that seasonal flu vaccine is safe in pregnant women. With H1N1 swine flu virus it is clear that younger people are more likely to get the disease as opposed to seasonal flu that mostly affects older people. Some of those younger people are going to be pregnant.
The latest WHO advice shows that between 7% and 10% of all hospitalised patients are pregnant women in their second or third trimesters and pregnant women are up to 10 times more likely to need admission into intensive care than the general population.
The WHO data also shows that between 5% and 30% of the deaths are in pregnant women. This means it is really clear that pregnant women are at risk from H1N1 swine flu and it is circulating now.
We don't test drugs or vaccines in pregnant women but we do test them on pregnant animals and this has been done with our swine flu vaccines. We also know that over 90 women became pregnant shortly after having the GSK vaccine and 50 of them have now completed their pregnancies and have normal babies. The others are still being followed up, which explains why it is so difficult to do clinical trials in pregnant women.
waitingwaiting: It appears that Celvapan may offer pregnant women immediate protection from swine flu after all, as Baxter has submitted a variation to its Celvapan H1N1 vaccine EMEA licence, seeking approval for a single dose use of this vaccine. In which case, surely Celvapan must now be the preferred choice of vaccine for pregnant women? Please can you give us the choice. I will feel so much happier having the Celvapan vaccine. If this is not possible please be so kind as to explain why.
DavidSalisbury: I would like to answer Waitingwaiting and others who have asked about choice of vaccines. If choice is neutral we have no problem about people choosing what they want, but when choice is not neutral we have to advise people to have what we believe to be the best protection.
We know that in healthy adults one dose of Pandemrix protects almost everybody with very high levels of antibodies. With Celvapan, the proportion of people who will be protected after one dose is considerably fewer. For this reason, the European Commission still recommends two doses of Celvapan. At a time when H1N1 viruses are circulating it has to be better for everybody to be protected after one dose than fewer and with lower antibodies.
The other side of the balance that we always think about when we make decisions, is whether there is risk as well as benefit. I have already answered on the adjuvant and it is correct that there is thiomersal in the GSK pandemrix. It is there for a good purpose, because it keeps the vaccine sterile after the vial has been opened.
There are now numerous studies from many countries done in different ways that all come to the same conclusion: that we cannot identify harm from thiomersal in vaccines. Indeed, the US courts threw out thiomersal as a cause of autism. One of the most compelling pieces of evidence was that when thiomersal was taken out of US childhood vaccines, autism rates continued to rise. Under those circumstances you really can't implicate thiomersal.
Of course, mercury is toxic if you were exposed to a large quantity but so is water is you drink enough of it. The minute quantities of thiomersal in vaccines have been shown not to be harmful.
tatt: Why aren't more adjuvant-free vaccines available since these would reduce local reactions in those whose immune system doesn't need adjuvants?
waitingwaiting: What concerns me the most is the use of adjuvants in Pandremix, which boosts the effectiveness of the drug. The risk with this ingredient is that it promotes the body to fight all foreign bodies in the blood. Fine for a normal person, but whilst pregnant your immune system is surpressed specifically to support your unborn child.
I think also that Celvapan would encourage more pregnant women to be vaccinated. I know that supplies are not as great as Pandremix, however when will this situation change and what is being done to make it change? Will pregnant women eventually be offered Celvanpan and within what timescale?
BoredWithWork: I am 21 weeks pregnant with my second child and have been asked to attend my doctor's surgery for a swine flu vaccination. I am concerned about the adjuvants in the Pandemrix version that is being offered.
Although the WHO are about the change their advice on it to say that adjuvants are safe for pregnant women (in July they said that they should not be used), I am still concerned about the unknown long-term side-effects on my unborn child. What is the government's policy on Celvapan? And can I demand this from my PCT? I would not hesitate to have the Celvapan vaccine if available, whereas I'm edging towards not having Pandemrix.
JuliaGulia: My understanding of the ingredients is that this immune booster is used so that more vaccines can be made more cheaply. After finally getting pregnant with twins after 2 miscarriages, how do I know that this immune booster wont result in my body going into hyper immune response mode and then reject my babies?
DavidSalisbury: There have been a multitude of questions about swine flu vaccine and adjuvants. Tatt asks why aren't there more adjuvant-free vaccines available, Boredwithwork brings up the point that she is concerned about adjuvants being in the pandemrix. MrsTC wonders whether or not to have the swine flu vaccine.
Lets start with why the adjuvant is in the vaccine: the adjuvant first allows much less of the antigen to be used (the antigen is the bit that gives you immunity). Next, the adjuvant in vaccine will probably protect for much longer and should protect you if the flu virus mutates as flu viruses do.
People clearly want to know what is in the adjuvant; it contains a fish oil (squalene) and vitamin E - both naturally occurring products that we have in our bodies. There is also a substance called Polysorbate 80 that is a food additive and is in many medicines.
maria1212: How long has the GSK adjuvant AS03 been used in vaccines, and has it been approved previously for use in pregnant women in any other vaccine?
Whilst not jumping on the doomsday band-wagon, which would have us think that all those vaccinated with Pandemrix will either develop an autoimmune disease or damage their unborn child, I am however a little concerned that the Government mantra of 'The vaccine is safe' seems to contradict the opinions of several other governments, which refuse to license its use in pregnant women.
DavidSalisbury: Everybody asks about the testing of the adjuvant. When we started to worry about a pandemic from H5N1 virus the manufacturers developed vaccines as close to the virus strain that might cause a pandemic as possible.
The prototype vaccines with adjuvant were fully tested in adults and some children. The data on the production and results of the clinical trials were submitted to the European Medicines regulators and these vaccines were licensed.
When H1N1 emerged, the manufacturers simply switched the strain just as they do every year for seasonal flu vaccine. We know that the GSK adjuvant has been given to about 40,000 people and it has been approved for use in Europe.
We are already seeing the results on the clinical trials of the GSK vaccine in adults and children for safety and immune responses and these are in line with the safety results from seasonal flu vaccine. We are also already getting the safety results from vaccination of health workers across Europe and these are not causing concern.
PofacedandProud: I am concerned that squalene is used as an adjuvant in Europe in the swine flu vaccine but not licensed in the States, and would like to know why.
DavidSalisbury: When we first started preparations for a flu pandemic, the US Regulators took a different route to Europe. In Europe, first of all we already had a vaccine in routine use that contained squalene and about 30 million doses of a squalene-containing seasonal flu vaccine have been used in Europe and the safety profile is no different to that of seasonal flu vaccine.
Clinical trials were done with squalene containing H5N1 vaccine and this data was used for the European licensing. In the US, the strategy for dealing with a flu pandemic was built on the hope that an unadjuvanted vaccine would work. At the time of H5N1 bird flu worries, the US studies looked as if their approach was not going to work. Seasonal flu vaccines require 15 micrograms of the antigen (the bit that gives you immunity) but the H5N1 vaccine needed six times as much ie 90 micrograms to get an immune response.
As a consequence, the US Government bought large quantities of adjuvant from Europe to keep in reserve to add to the vaccine just as we had already planned to do in Europe. When H1N1 came along, in a way the US got lucky because you can get an immune response without such a huge amount of antigen, but we will be using only a quarter of the amount of antigen in out vaccines compared with the US.
Olivo: I have been offered the vaccination but am concerned as I'm breastfeeding my 10-week-old, and am unsure about passing on these nasties via my breastmilk. Will me having the vaccination be of any benefit to my breastfed daughter?
DavidSalisbury: Olivo and others have asked about breastfeeding. There is no problem about breastfeeding if you have been vaccinated. If you are vaccinated in the third trimester then we know from studies with seasonal vaccines that you will contribute to protecting your baby.
We just don't know how much of the benefit comes from the vaccine in protecting the baby during the pregnancy and how much benefit comes from antibodies in breast milk. Either way the baby benefits.
coolbeans: Are there any allergies that mean you shouldn't get the vaccine?
MGMidget: My son falls into a high priority cateogory for vaccination but he is allergic to egg. His allergy clinic have told us he should have Celvapan not Pandremix but our GP's practice say they are only getting Pandremix. Can he get the Celvapan vaccine somewhere else?
sphil: As the mother of an autistic child with asthma and many allergies I am in a complete dilemma about whether to give him the swine flu vaccination. I would also like to ask whether the vaccine is suitable for those who are allergic to eggs?
DavidSalisbury: MGMidget and others ask about allergies. If you or your child have such severe egg allergy that you have an anaphylactic reaction immediately after exposure to egg then you should not have Pandemrix but you should have Celvapan.
The reason for this is that the viruses that go into Pandemrix have been grown on eggs whilst Celvapan is made using cell culture with no egg material.
We have made supplies of Celvapan available to primary care trusts so that arrangements can be made for people who have extreme egg allergies to get that vaccine. If you or your child have more general allergies then there is no problem with having Pandemrix.
ohyoubadbadkitten: Please may I ask a question about the vaccine delivery schedule for at-risk patients following this from MrsJohnDeere in another thread (hope you don't mind MrsJD): "At my GP surgery they're not expecting to have the vaccine for 'at risk' people until late Dec, and into 2010 for others."
To me as a parent of an asthmatic whose GP practice doesn't know when they are getting the vaccine, this is rather alarming. So my question is, is the initial vaccine delivery to GP surgeries for patients 'at risk' on schedule, and is the above information surprising or expected?
DavidSalisbury: ohyoubadbadkitten and others ask about vaccine delivery schedules. Starting last week we have been shipping vaccines out to GPs as fast as we get it in from the manufacturers.
We are sending one box of 500 doses to every practice in the country and as soon as we have completed that first wave of distribution, we will then allow practices to order more as they need it. A week before practices will get their delivery the information is posted onto a website so that PCTs and practices can see the date of their delivery.
We do depend on the practices actually registering onto the website but we have told them what they need to do.
EldonAve: Is Pandemrix significantly cheaper than Celvapan?
DavidSalisbury: The prices we have paid are commercially confidential but can I reassure you that the recommendation for Pandemrix has nothing to do with the price.
lumpasmelly: Is there any truth in the rumour that pushing the jab is a cost decision - ie it's more cost-effective for the government to cut down the number of people requiring hospitalisation from swine flu than it is for the government to deal with the potential impact of babies being born with damage that could be attributed to the vaccine. If this is the case, then perhaps it will save more lives, but I would prefer that we were honest about it.
DavidSalisbury: The argument that lumpasmelly makes is that it is more cost effective for the Government to cut down the number of people requiring hospitalisation from swine flu than it is for the Government to deal with the potential impact of babies being born with damage attributed to the vaccine; this is bonkers.
Of course there is an economic consideration. It is far better value to purchase vaccines, to prevent people becoming ill and even dying than letting unnecessary illness and death occur. In our economic analyses we use the cost of gaining extra years of healthy life as our measurement - and we all want healthy and long lives.
Arnica: Czech Republic cancelled its orders with Baxters (company who makes the swine flu vaccine) when Baxters made serious errors in the avian glu vaccines. What assurances do we have in the UK that Baxters vaccines are not contaminated?
DavidSalisbury: Arnica asks about contamination of flu vaccines. All of our vaccines have to be tested both by the manufacturers and by an independent expert agency before they can be released for human use.
HappySeven: I am being offered both seasonal and swine flu jabs together as an NHS worker. When our children have their innoculations we are advised to wait until they are well, should I do the same and should I avoid having both jabs together? Sorry, I should clarify, I'm in my second trimester.
RTKangaMummy: Both myself and my son have asthma and so have the regular flu vaccine. How long should be between regular flu vaccine and swine flu vaccine should there be? Is there any problem with having both vaccines at same time?
DavidSalisbury: HappySeven and RTKanga ask about having seasonal and swine flu vaccines together. These are both inactivated vaccines and can be given at the same time or separately with no particular interval between them. Obviously they should be given into different sites or different limbs.
HappySeven: Just wanted to say thanks to Professor Salisbury for taking the time to answer some of these questions. Many of us just want the facts and sadly our midwives aren't always the best informed. I shall definitely be having the innoculations after reading his replies.
LeninGhoul: Is it true that 25% of the swine flu cases in critical care are children? If so, this is significantly disproportionate. Will all children be next on the list to be vaccinated? I'd rather my kids were vaccinated than me (I'll probably be called due to asthma) as I can judge if I'm worsening or developing a complication better for myself than I can for them.
DavidSalisbury: Our priority right now is to vaccinate people with risk factors that would mean that they would be most severely affected if they caught swine flu. Once we have got that part of the programme out of the way, we will be looking very carefully at what the next steps in the programme should be.
This will be driven by what is happening with the disease in different age groups, including children and newborns. The best way to protect newborns is for the mother to be vaccinated.
lumpasmelly: Why are GPs, midwives and consultants giving such mixed messages regarding the vaccine? How can we feel safe to take it as pregnant women when we are being told "off the record" not to touch it with a barge pole?
DavidSalisbury: Lumpasmelly says that pregnant women are being told "off the record" not to touch it with a barge pole. I can say that anyone who is giving that advice does not know the facts. The evidence that pregnant women are at risk of complications, admission to intensive care or dying is unfortunately strong. The other side of that coin is to be vaccinated and for you and your baby to be protected.
Serennos: You say: "The best way to protect newborns is for the mother to be vaccinated." So, bearing in mind the lack of clinical evidence regarding safety of this particular vaccincation to unborn children, you consider that the risk to the unborn child would be greater if the mother does not have the jab than if she does? If so, you disagree with my midwife!
DavidSalisbury: Yes, the best way to protect newborns is for the mother to be vaccinated. I do disagree with your midwife - she needs to get the facts. And we have sent out more material on immunisation and pregnancy for health professionals - there is a new leaflet for pregnant mothers going out now and these can be downloaded from the DH website.
DavidSalisbury: Thank you so much for the time you have spent asking so many pertinent questions. MNHQ will pass on any other queries and I promise to get back as soon as possible. I can't believe nobody asked this, but my favourite biscuit is a good milk chocolate digestive and can kill a few chocolate finger biscuits. I do try to avoid them but have been known to fail.