by Amy Tuteur, MD
Doctors are often compelled to make quick decisions in life threatening cases with only limited information. Unfortunately, pregnant women are now going to be put in the same situation.
The H1N1 flu has taken an extraordinary toll among pregnant women. A new vaccine is now available. Because of the nature of the emergency, there has not been time to do any long term studies of the vaccine. Yet pregnant women will need to make a decision as soon as possible on whether to be vaccinated.
Many illnesses are more severe during pregnancy, but the H1N1 influenza has had an unexpectedly devastating impact among pregnant women. According to the CDC, there have been approximately 700 reported cases of H1N1 in pregnant women since April. Of these, 100 women have required admission to an intensive care unit and 28 have died. In other words, 1 out of every 25 pregnant women who contracted H1N1 died of it. By any standard, that is an appalling death rate.
There seem to be two reasons for the dramatically increased death toll. The first is the altered immune status of pregnant women making them particularly vulnerable to the virus. The second is that pregnancy compromises lung function. If a pregnant woman gets pneumonia as a complication of the flu, it is particularly difficult to insure that she gets enough oxygen.
We should ensure that pregnant women do not get H1N1 influenza and the best way to do that is by vaccination. The new H1N1 vaccine is similar to other influenza vaccines. We know that other influenza vaccines are not harmful in pregnancy, and there is no reason to believe that the H1N1 vaccine will have any side effects that differ from those normally expected after vaccination. There are no adjuvants added to the vaccine, either, so there will be no danger from adjuvants. However, there has been no time to study the long term effects of the vaccine, so no one can be sure about side effects.
Pregnant women are rigorously counseled to avoid any drugs, diagnostic tests, or treatments that might impact the developing embryo or fetus. Most women reflexively fear the idea of vaccination in pregnancy, although vaccination for many diseases presents no problems in pregnancy. The Centers for Disease Control and physicians are very concerned that pregnant women will refuse vaccination, with potentially lethal results.
How should pregnant women decide what to do? The best place to start is with what we know for sure. We have a great deal of evidence that H1N1 influenza is particularly lethal in pregnant women. To put it in perspective, the chance of a pregnant woman dying from H1N1 is greater than the chance of a heart patient dying during triple bypass surgery. That is not a trivial risk.
We have no evidence that the vaccine will cause any harm to pregnant women or their unborn children beyond the side effects associated with other flu vaccines, such as local irritation at the vaccine site, or the rare complication of Gullain Barre Syndrome. We have no reason to expect that the H1N1 vaccine will be any different.
It would be much easier to make the decision if we knew more, if we had some idea of how extensive the fall outbreak will be, if we had longer experience with the specific vaccine. Unfortunately, that information is not available to us and by the time it becomes available may more pregnant women may sicken and die unnecessarily.
Given the dramatic threat and the fact that we know of no unusual complications of vaccination, the decision seems clear. Every pregnant woman should get vaccinated as soon as possible.
Amy Tuteur is an obstetrician-gynecologist who blogs at The Skeptical OB.
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{ 18 comments… read them below or add one }
Excellent points and let’s also remember that the flu vaccine has been shown to protect newborn infants during the first six months of life. These babies are too young to get the flu vaccine themselves. Mom can do one more thing to help protect her child by getting vaccinated in pregnancy.
Thanks for this. I will post a link to it on my blog and encourage women of childbearing age to read it.
Thanks for putting it in perspective, Dr. Tuteur. “28 deaths” doesn’t mean as much as “one of every 25 pregnant women with H1N1 died.” Their babies, too, I imagine.
-Steve
Minor quibble with the sentence: “In other words, 1 out of every 25 pregnant women who contracted H1N1 died of it.” This is incorrect as the true denominator is not known. A more accurate statement would be “In other words, 1 out of every 25 pregnant women diagnosed with H1N1 influenza infection, died of it.” There are possibly large numbers of pregnant women with H1N1 who were asymptomatic or just not identified as having H1N1.
What you are proposing is insane.
In recent MMWR reports, the CDC wasn’t even checking death certificates or autopsy reports so how do they know H1N1 is the “cause” of death?
Pregnant women shouldn’t consume an abundance of fish, but yet 25mcg of mercury per vaccine is acceptable? Why? 1 shot alone is 250x the recommended EPA safety limit for mercury consumption for a fetus…..
Your statistics are likely skewed as well! Have you considered women that never went to the hospital!? You are assuming anyone who had flu like symptoms went to the emergency room and doesn’t take into account any visits to a doctors office etc!
The National Vital Statistics System in 2007 states the Number of births = 4,317,119. Hypothetically speaking if we used a round number of 4,000,000… 28 of these women who gave birth died, supposedly from the h1n1 virus. Assuming these 4,000,000 babies were birthed by women….
28/4,000,000 * 100
In other words 99.9993% of pregnant women have not died from the H1N1 virus. And you are recommending that we vaccinate them with an experimental vaccine? The FDA approved the vaccine even before some safety trials even started! Is this medicine or “medisin” ?
Seriously, I have a hard time believing you are recommending this unless you were somehow threatened or influenced by an ‘authoritative’ agency or entity.
VAERS reports at least 20+ incidents where spontaneous abortion was a result of a flu shot.
Intelligent people have to draw the line somewhere and this vaccine is clearly crossing the line.
“A more accurate statement would be “In other words, 1 out of every 25 pregnant women diagnosed with H1N1 influenza infection, died of it.”
You are absolutely correct. I should have made that clear.
Thanks!
What about the 600 whom were not admitted to the hospital, therefore 28 in 700.
This article began with some good insight: “Doctors are often compelled to make quick decisions in life threatening cases with only limited information. Unfortunately, pregnant women are now going to be put in the same situation.”
Complicating the issues from a publicity standpoint is that physicians are used to these types of decisions, and are better able to make objective decisions. Pregnant women who have not had a long career in medicine will find this much more difficult and are more likely to make a decision based on emotion.
Unfortunately, physicians are trying to counsel women from their objective standpoint, while detractors are using a more effective emotional argument. I guess that’s the negative side of the ‘be you own advocate’ mantra; being forced to make an important decision with little life experience to fall back upon.
And, to Jeffry: The 28 women who died was out of 700 women diagnosed. If all 4,000,000 pregnant women were infected with H1N1 (which they are not, but your example presupposed), that number would be 1/25*4,000,000 = 160,000 deaths. Obviously not every pregnant woman has contracted H1N1 so your underlying assumption was incorrect. Most likely not every pregnant woman will contract it, but that’s the limit of our current statistics.
Just thought I would clear up that math a little.
Actually, his argument was perfectly sound. There are 4,000,000 births, and 28 died from H1N1. He said nothing about all of them being exposed to it and it doesn’t matter. The simple fact is that 28/4,000,000 died from H1N1 making the chance of dying while pregnant from H1N1 0.0007% (that is, the chance of contracting and dying from it).
I’d tend to agree, 0.0007% wouldn’t be enough for me to try an untested drug.
Obviously once that death toll starts climbing it will be a far more important statistic… but it would have to climb at least 100x its current value before the risk would be anything BUT trivial.
Keep in mind, that there is a chance you wont get the flu, so you’re looking at a chance within a chance, if there is a 1 in 1 billion chance that I will die 100% of the time it’s still a ridiculously small chance..
I see your point, and I think we can both agree that it is a statistic of the moment. While it is .0007% as of now at the beginning of the flu season, not every person has been exposed to the virus. We also have no way of measuring that every person who is exposed actually develops a significantly high enough viral load to become symptomatic.
The CDC reports that between 5% and 20% of people every year are infected with the seasonal flu. Assuming that H1N1 is equally contagious, then between 200,000 and 800,000 pregnant women will be infected this fall, agreed? .05*4,000,000 = 200,000 and .20*4,000,000 = 800,000. And holding the same mortality rate, which should remain constant assuming no additional mutations in the virus, of 1/25, we would have between 8,000 and 32,000 deaths in this population.
That would bring us to a 0.2-0.8% (8000/4 million and 32,000/4 million) expected mortality rate at the end of the flu season. To me, that is a large number, especially for a largely preventable infection. Are there potential complications to the vaccine? Of course. Nothing that works is free of side effects; everything has unintended consequences. I would also never force it upon a pregnant woman, but I would certainly recommend it.
“Actually, his argument was perfectly sound. There are 4,000,000
births, and 28 died from H1N1. He said nothing about all of them being
exposed to it and it doesn’t matter. The simple fact is that
28/4,000,000 died from H1N1 making the chance of dying while pregnant
from H1N1 0.0007% (that is, the chance of contracting and dying from
it).
I’d tend to agree, 0.0007% wouldn’t be enough for me to try an untested
drug.”
In addition, I have searched and can not find any new updated
information on the number of deaths in pregnant women from confirmed
H1N1 since this last report of 28 deaths from April till the end of
August.
What about the last 8 weeks?
I would think since all deaths and reported sickness has increased that
that same percentage should be the same?
They have reported the number of child deaths, ages of deaths, etc. but
no new info on pregnant woman ( in the US at least )
Maybe I just can not find it, but I do find it very odd.
Without that information and without really knowing how many people
have actually gotten this virus ( it is assumed millions already ), we
can not say what the “percentages “are.
We can only say what the percentages are of pregnant women verses “other
people” who have died, which is not the same thing.
Also we talk of the risks of getting this flu verses benefit/risk of
vaccine, but no one is considering that there is also a benefit to
GETTING the flu.
If you do get the flu your child will also get your antibodies to
protect it, and it seems like you will also get some good immunity in
the future as being demonstrated by older people that were exposed
many years ago.
There may well be benefits we are not aware of.
And frankly we really do NOT know the Benefits or risks for the
vaccine.
Even the regular flu vaccine is not very effective is it is usually
less so in the very people it looks to protect.
And even in all these years there has never been any long term studies
on the safety in pregnancy and infants and children ” down the road”.
The head of the CDC and other ’s keep saying it is safe and effect
Please read the Cochrane reviews on this subject.
http://www.cochrane.org/influenza/index.html
http://www.cochrane.org/influenza/reviews.html
In a nutshell :
Some public-health officials have described flu vaccines as “highly effective,”
but the internationally recognized Cochrane Collaboration (which accepts no
money from the pharmaceutical industry)
did a systematic review of all high-quality randomized trials
(25 in all) studying influenza vaccination.
They concluded that “the evidence does not support universal
immunization of healthy adults
And remember that anyone can read those reports which are very convincing.
I am not against the vaccine per say but I am against giving out poor
information.
In addition, the fact that this vaccine is protected from lawsuits to
the Pharm companies gives less credibility to the CDC saying that this
vaccine is no different than the “normal flu vaccine”.
If so, why no liability?
I believe that is more of a political reason, but it still creates a
credibility issue if if there is no liability for either MD’s , the
health care workers giving the vaccine or the drug company.
In fact, there would be more liability
if they were to advise against it.
Do you see what I mean?
People really do need to have good information to make informed choices
and I believe so much of the confusion is being caused by people that
think we have to DO SOMETHING.
here are the links to the actual inserts of the H1N1 vaccines. both versions of the vaccine say it has not been tested for pregnant women and is not recommended (they are unaware on harm to the fetus and also future reproductivity). why are doctors and the government pushing it then? i am pregnant and there is no way i will be injecting and untested substance into my body.
http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm182404.pdf
http://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm182406.pdf
I thought the article addressed the reason why the vaccine has not been tested in pregnant women yet: It is too new. However, the article went on to say that the emergency is great because of the risk of death for pregnant women. The point of the whole article is that women are being asked to make a decision with few facts and make one relatively quickly. To do so, they (you) need information and the author was pointing the direction of the information. The decision and the responsibility for the decision lies with the patient. No one is trying to take that decision away from anybody, women have the right to make the decision for themselves and their baby. However, it seems to me that with the public’s scrutinizing focus on adjuvants and their potential complications, people are forgetting that infections do actually harm people.
Addressing a comment in Marcy R.N.s, I don’t believe there are any benefits to a woman getting the flu while pregnant. She will gain immunity that will passed to the baby prenatally and through breast milk, but that immunity is passive through antibodies, not through the child’s own cellular memory. Meaning the baby can’t produce it’s own antibodies to the virus, and has no immunity. After the baby stops nursing, he/she is on its own. So, I don’t think there will be that benefit. Also, an active seasonal flu infection (vs. an inactivated flu vaccine) has been shown to be a risk factor for schizophrenia and autism in the child. I don’t believe that any potential benefit from the flu infection would offset the risks from the vaccine.
“Addressing a comment in Marcy R.N.s, I don’t believe there are any benefits to a woman getting the flu while pregnant. She will gain immunity that will passed to the baby prenatally and through breast milk, but that immunity is passive through antibodies, not through the child’s own cellular memory. Meaning the baby can’t produce it’s own antibodies to the virus, and has no immunity. After the baby stops nursing, he/she is on its own”
Yes, and babies younger than 6 months can not get the vaccine and would have no “protection”
We really do not know the efficacy of flu vaccine in pregnancy but we do know that there is less efficacy in
patients that have compromised immunity.
That is including older people, who’s “compromised immunity” is nature ( a function of aging )
just like pregnancy is a “natural ” state of decreased immunity.
When the chickenpox vaccine was introduced it was to prevent 50 deaths a year . Considering virtually every child got chicken pox that’s 50 deaths verses 3 to 4 million cases
a year.
It was already well known that adults were much more likely to have serious complications from chickenpox than children and it was not known how long immunity would last from the vaccine.
It would have made sense to just vaccinate children after a certain age if they never got chickenpox rather than universal vaccination at 1 year of age.
A few years later we need to give a booster dose and we still do not know how long immunity lasts but we do know more adults are getting chickenpox and more adults and children are getting shingles which is a much more serious problem.
I am not saying this is the same as influenza, I am saying that there can be benefits to individuals and populations from some large scale infections.
The lay public was not aware that chicken pox in adults was a problem or could become one, nor were they aware of the association with shingles, but people in health care DID know and this information was not provided to the public.
They did not know there was a benefit of having chicken pox. Well, maybe some did when they tried to have “chicken pox” parties, and when they did they were casts as people that were putting their children in danger and as “miss educated ” parents .
The very point of this article, I agree, is that sometime choices have to be made with limited information.
My point is that there is more information that is not being provided and some information that is being provided incorrectly.
This makes the situation very confusing for people and also creates mistrust.
The author states that
” 1 out of every 25 pregnant women who contracted H1N1 died of it. By any standard, that is an appalling death rate.”
This is may have been a mistake in wording on her part but it is a big mistake and changes the entire message.
We do NOT KNOW how many people have gotten this flu, but best guess is many millions.
We DO know there are about 3 to 4 million pregnant women in the USA and so far 28 have died, which really changes the perception.
We alo know that research for flu vaccine has not been done on pregnant women or their babies, and that there is a study not yet completed being done of a few pregnant woman and this is basically to try to test to see how large a dose they may need if it it will require more than one dose.
We DO know:
Neither Fluzone vaccine nor Influenza A (H1N1) 2009 Monovalent Vaccine have been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or Fluzone vaccine. It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed.
So the question is What IS Clearly Needed?
We also know flu vaccine, in general , does not
reduced the number of cases, deaths, complications
This is an excellent article for “lay people” back by very good science ,
http://medicalconsumers.org/2009/09/24/why-the-h1n1-virus-is-not-a-major-threat/
http://medicalconsumers.org/2009/09/24/why-the-h1n1-virus-is-not-a-major-threat/
For the record, I am an RN that worked for many years in
a high risk labor and delivery setting at a major University
Hospital in New York.
People may need to make quick choices but rather than trying to coerce them with selective information , let’s give them all the information we do have and let them make informed choices.
I am currently 32 weeks pregnant. The first week of Sept ‘09 I had flu like symptoms. I went to the doctor’s and it was assumed I had H1N1. The doctor said they can’t test everyone and at that time over 95% of the cases were H1N1. I did not feel great, but after a week I was up and about and 2.5 weeks later I could breath regularly and my sore throat was gone. (Oh by the way I also have asthma and was often on a breathing machine the first 6 years of my life during the flu season). I live in a small town (30K) and 12 women at my OBGYN’s office were assumed to have H1N1 (during Sept 09) yet none were reported. My point is that there are “lies, more lies, and statistics.” It is important to see how people use statistics to prove their point and to realize there are many people who have gotten sick yet are not being reported causing the stats to be unbelievable.
This is a great thread, thanks to everyone who has posted and to the author for initiating this discussion. I have read and read and read, and as a pregnant woman 33 weeks along I’ve decided against the unknown risks of the vaccine. I was sick in the late spring after a trip abroad with flu symptoms and a fever. Since there is no way to know if the flu I contracted on the plant was or wasnt H1N1 I’m sticking to the old handwashing, salt water gargling and avoiding dirty and crowded places and in particular avoiding groups of children who seem to be sick every year regardless of H1N1. I searched for information about pregnant women who had H1N1 and didn’t die, but there is nothing out there to indicate that this has happened at all. Of course it has – but as in many medical statistics only the bad is being reported.
What I find extra frustrating is the hysteria in the media and all around me about this – my doctors were insistent that I get it and when I refused they tried to gang up on me and pressure me into it by telling me i was being irresponsible and risking my childs life! I have since switched doctors.
The quote is “700 reported cases of H1N1 in pregnant women since April. Of these, 100 women have required admission to an intensive care unit and 28 have died.” So, technically, that’s 28 out of 700, not 28 out of 100. You could say, “OF the women who required hospitilization, 1 in 4 died.” Your chances of being hospitalized are 1 in 7. Your chances of NOT being hospitalized with H1N1 are 6 out of 7. If you ARE hospitalized, your chances of living are 3 out of 4.
Has anyone been able to find any updated information on
hospitilizations and deaths of pregnant women for the US and worldwide?
I can not seem to find any current information.
Current information would be VERY helpful for people.
I see updates on these states for children adults , but not pregnant women.
The numbers and stats may have changed alot, or not, but how would we know?