Swine flu: the facts about pregnancy and vaccination

A week which involved conversations with an immunologist, a paediatrician, an expert in respiratory infection and a variety of public health specialists, and one recurring theme emerged: why are so many expectant mothers still not persuaded by the benefits of vaccination against swine flu? Online forums are flooded with concerns. Many of them are entirely valid - the idea of taking any medication in pregnancy requires that much extra thought.

But many are also borne of misinformation, all too easily spread when the terms and topics - such as adjuvants, thiomersal, licensing processes - are ones that the majority of people will have had very little previous contact or context. It has left public health experts exasperated, and though the Government will not suggest as much, must be a reason why a further set of guidance is being issued on the topic (to all GP surgeries next week), even though it is three weeks since the start date of the national vaccination campaign. It is, by rough count, about the sixth guidance sent either to doctors, health workers, general public or all of the above in recent months. The message is not getting across, as my colleague, the Times GP Mark Porter observes from his encounters with pregnant women in his community.

The vaccine is not mandatory, nor should it be. But for those wanting clarification about the whys and wherefores, the hearsay and speculation, here are a few Q&A points (I have compiled from a range of sources including WHO, DH, CDC and independent experts). They cannot be made often enough...

I am pregnant. Should I be considering having the vaccine?

Yes. Pregnant women are one of the high-risk groups identified by the Government for priority vaccination. Vaccination is not compulsory but it is strongly recommended for the country’s 500,000 pregnant women, and to help protect their babies. People under the age of 45 have been most affected by the pandemic — an age group that includes most pregnancies. Evidence of the impact of swine flu infection shows that within this group, pregnant women are at a higher risk of severe disease and flu-related hospital admissions.

But isn’t flu likely to be little more than a nasty cold? What are the risks?

To date most people have a full recovery within a week, even without medical treatment. The most commonly reported symptoms include cough, fever, sore throat, muscle aches and headache. However, flu is a serious viral infection, and a minority of patients develop severe illness, principally severe progressive pneumonia and heart and lung problems. The World Health Organisation (WHO) states that pregnant women may be four to five times more likely to develop severe disease, and ten times more likely to need care in an intensive care unit compared with the general population. The risks increase with gestational age, with women in the third trimester particularly at risk. The WHO states that between 7 and 10 per cent of all hospital patients are pregnant women in their second or third trimester. The Department of Health has not released figures for the number of pregnant women now in hospital with a swine flu infection. (As of this week there were about 700 people in English hospitals, with about one in five in critical care.) As of November 12, there had been 182 deaths in Britain have been directly linked to swine flu. Of these, at least 10 (5.5 per cent) have been pregnant women or women who have recently given birth — six in England, two in Scotland, and one each in Wales and Northern Ireland.

So what should I be doing?

From this week (if not before), GPs should have begun vaccinating pregnant women as well as other priority groups with the community distribution of the vaccine. Roll-out has been steady but slow, with many practices so far receiving only one box of 500 doses when serving thousands of patients. Recent postal strikes have also delayed notification letters sent to patients. If you have not yet heard from your doctor, it is worth ringing the surgery.

What vaccine is being offered?

The vaccine recommended for pregnant women by the Joint Committee on Vaccination and Immunisation is Pandemrix, manufactured by GlaxoSmithKline. The vaccine can be administered in a single dose, which appears to give adequate levels of antibodies against the H1N1 virus. A second vaccine, Celvapan, manufactured by Baxter, has also been ordered by the Government. However, it requires two doses, given three weeks apart, so does not confer protection as rapidly. Both vaccines have been licensed for use in pregnant women, and at any stage of pregnancy, by the European Medicines Agency (EMEA), which considered evidence from trials involving thousands of people. All licensed vaccines have a high standard of safety.

So have the vaccines been trialled on pregnant women?

No. This has been seized upon by some to question their safety, and has spurred controversy. However, no vaccines are routinely tested on pregnant women. Vaccines are given to pregnant women when it is clinically necessary — such as polio, tetanus and seasonal flu vaccines. The safety of giving a particular vaccine is instead assessed from what is already known about its ingredients and the results of toxicity studies. Some non-pregnant women enrolled in trials do fall pregnant shortly after — these cases are followed up, with all information added to the assessment of possible risks. Any medication given to pregnant women is subject to extremely careful consideration on both clinical and ethical levels. The decision is made on a balance of benefit and risk. The Department of Health states that it has "no reason to believe there is a risk of harm from giving the swine flu vaccines in pregnancy".

So why have concerns been raised?

There is a large body of evidence from seasonal flu vaccination programmes that immunisations similar to Celvapan are safe. The Pandemrix vaccine has been the subject of more discussion, and unfounded speculation, because it contains an adjuvant. An adjuvant is a chemical that enhances the immune response following vaccination, meaning that a lower dose of the vaccine is needed to produce the same level of protection. The adjuvant in Pandemrix is called squalene, which is extracted from fish oil. There is less evidence on the use of adjuvanted vaccines in pregnant women. However, both vaccine and adjuvant have been the subject of thorough evaluation by the EMEA and the Department of Health, taking into account the severity of swine flu illness in pregnant women. In early June, the WHO reviewed the safety of adjuvants and found no significant safety concerns.

What is thiomersal and does it pose a risk?

Thiomersal is a preservative used in Pandemrix. It is added to prevent bacterial contamination occurring. Thiomersal contains a small amount of mercury, which has been the cause of further doubts on its safety. The evidence does not support this. Again WHO, Department of Health and other organisations state that there is no evidence of risk from thiomersal in vaccines, including for children, pregnant women and their offspring.

Are there any side-effects from the vaccines?

The most common side-effects reported from the trials are minor: headaches, joint pain, muscle pain, fever and fatigue. It cannot cause swine flu as it does not contain a live virus. All vaccines can also cause redness, soreness and swelling at the site of the injection.

If you deliver your baby before getting your flu jab, should you still receive it? Can a woman who is breast-feeding receive the vaccine?

Yes and yes. In addition to protecting women from infection, the vaccine may also help protect the infant. Breast-feeding is fully compatible with flu vaccination, and preventing maternal infection provides obvious secondary protection to the child.

Comments

[Sara]

the two concerns i and i know many others would like addressed and which i have not seen addressed anywhere are 1) GSK admit in their leaflet that pregnant rats injected with the vaccine had offspring with developmental delay and birth defects - why has it been decided that that will not happen in pregnant women and 2) squalene is known to cause automimmume disorders in rats - what then is the rationale for believing it will not have the same effect in humans? I would like to take the vaccine but i and lots of other pregnant women (and i suspect other people considering the vaccine) would be more inclined to take the vaccine if they had proper answers to their concerns rather than reminders of the risk of catching swine flu (which we all aware of and paranoid about). By the way, in relation to 2 i am not convinced by the argument that lots of elderly people have been getting a flu jab with squalene for years. i have never heard of a 80 year old developing lupus or MS and if they were to get arthritis would anyone link it to the vaccine...?

[RSM]

http://www.who.int/vaccine_safety/topics/adjuvants/squalene/questions_and_answers/en/

[cadalyst]

Proper clinical trials have never been done to determine the long term safety (for both mom and child) of injecting foreign species DNA, mercury, and formaldehyde directly into the bloodstream. Do the clinical trials and then there might be some science behind it. Until then, there is no reason to trust that toxic poisons are safe for you.

[Jon]

Re: Sara's concerns about squalene, which is a naturally occuring substance found in plants, animals and humans:

•Twenty two million doses of Chiron's influenza vaccine (FLUAD) have been administered safely since 1997. This vaccine contains about 10mg of squalene per dose. No severe adverse events have been associated with the vaccine. Some mild local reactogenicity has been observed.
•Clinical studies on squalene-containing vaccines have been done in infants and neonates without evidence of safety concerns.

Source: The World Health Organisation
http://www.who.int/vaccine_safety/topics/adjuvants/squalene/questions_and_answers/en/

[cherrie]

I completely agree with above post. Really worried about getting swine flu. But there is no data available for the use of adjuvanted vaccines in pregnant women. I would like to have the choice of the unadjuvanted vaccine I know the immunity takes longer and two injections but surely being vaccinated is better than not being vacccinated at all.

[Clive Burghard]

Before considering any kind of injection for anything, watch David Icke's latest video on the subject, and then decide.
You owe it to yourself, and future generations.
Just remember. we were promised a Referendum, British Jobs for British Workers etc.

[Clive Burghard]

First, watch David Icke's video, then decide!

[James Herd]

Sara
There is a flu vaccine called Fluad. It has an adjuvant that contains squalene. It has been in use with seasonal flu virus strains since 1997 in Europe. To that end, it has been administered to millions of patients in it's 12 year licensure. To that end, there is no "argument" to be convinced by, these are facts and thus indisputable. I hope that this helps.

Also, i'm amazed at people's selfishness when it comes to protecting themselves. Vaccines stop diseases locking onto a host, and thus an individual cannot pass a disease onto a loved one. To not protect yourself is not not protect those close to you.

Dr Andrew Wakefield's hollow assessment of MMR have a lot to answer for. The fact remains, that after clean drinking water, vaccinations are the most important health intervention across the world. A case example is our own national childhood immunisation programme that over a 9 year period has prevented deaths from Meninigits C for the first time on record. Men C killed 200+ of our children prior to the availability of the vaccine, in 2008, it killed none and helped prevent many of the disabilities that survivors suffer.

Vaccines work, they save lives, get your seasonal and H1N1 vaccine.

[novaccine4me]

Please read the study done on primates by Thoughtful House at www.thoughtfulhouse.org which explicitly demonstrates how just thimerosal containing vaccine can damage the brain of a neonatal primate, much less 2 thimerosal containing vaccines being recommended by OB's and our national health organizations. Recommending these vaccines without long term safety studies having been performed on primates first is a national and scientific disgrace, and anyone who is involved in this poisoning of our next generation, be it the media, doctors, public health "experts" and our government, especially President Obama who should know better bears responsibility for the damage that will be incurred, the increased helathcare costs, the increased educational costs, and the loss of human potential via these poisons administered during critical stages of brain development. Please take the time to watch these two informative videos about flu vaccines and vaccines in general. it is worth the investment of time to become educated becasue you will bear the ultimate costs of brain and immune system damage in your children and elderly adults.

http://articles.mercola.com/sites/articles/archive/2009/11/14/Expert-Pediatrician-Exposes-Vaccine-Myths.aspx

http://www.youtube.com/profile?user=1ALISH&annotation_id=annotation_405898&f

To read about how flu vaccines may be causing increased hospitalizations in asthmatics, read this study by the Mayo Clinic:

http://www.sciencedaily.com/releases/2009/05/090519172045.htm

[ken]

James Herd the study you suggest has a big problem they used 13, 4 and 3 monkeys so the results are not clinical they should have used 13, 13, 13 to really see.

[Kathleen christie]

as a pregnant woman myself i will not be having the vaccine...whenever i ask the midwife what her opinion on it is she says "government recommend it" i dont care what the recommend...i want the opinion of my trusted health care professional....i also found out that one of the other midwives in out group chose to NOT have the vaccine...why is this? who would be to blame if anything happend to our babies for taking this vaccine? sure the government wouldnt take the blame for recommending it now would they?! this is a situation where your damned if u do...and your damned if you dont!!...if u do and the vaccine has an affect on u or baby ull wish u never had it and if u dont and u or baby catch swine flu u'll wish u had it...they have left us in a sticky position....

[Mike]

There is a lot of data to suggest keeping your vitamin D levels up will protect you from flu. On the front page of www.vitaminD3world.com there is a link to a report on this data. Also if you are pregnant you need vitamin D anyway for the developing baby