There is no doubt a great deal of information being thrown at us every day in regards to the Swine flu. Just deciding what is important to focus on takes a great deal of time and effort. For this update I am going to focus on the news widely reported in the media that results from a clinical trial indicates that the vaccine is safe in pregnant women. As soon as this came out the media were all over it and public health officials were once again making a mockery out of those women who were choosing not to vaccinate themselves out of concern for the untested vaccine.

Let’s walk slowly through the data as reported by the National Institutes for Allergy and Infectious Disease.  

1. This clinical trial is studying only 120 women
2. There are two groups with only 60 subjects in each group
3. They are getting two doses of the vaccine with one group getting a larger dose than the other.
4. They are 18 to 39 years of age
5. They are in their second or third trimester (14 to 34 weeks) of pregnancy
6. The vaccine is a candidate 2009 H1N1 influenza vaccine manufactured by Sanofi Pasteur.

In order to be in this study these women must be in good health. They determine good health as follows:

By vital signs (heart rate 100 beats per minute; blood pressure: systolic 140 mm Hg; diastolic less than or equal to 90 mm Hg; oral temperature 100 degrees Fahrenheit), medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant, and targeted physical examination based on medical history. A stable medical condition is defined as health outcomes of the specific disease are considered to be within acceptable limits in the last 3 months.

• Has a known allergy to eggs or other components in the vaccines (these may include, but are not limited to: gelatin, formaldehyde, octoxinol and chicken protein).
• Has a history of severe reactions following previous immunization with influenza virus vaccines.
• Has participated in a novel influenza H1N1 2009 vaccine study in the past 2 years or has history of novel influenza H1N1 2009 infection prior to enrollment.
• Has received any other live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study prior to vaccination or plan receipt of such vaccines within 21 days following the last vaccination (except for seasonal inactivated influenza vaccine which may be received 2 weeks post either vaccination). Measles, mumps, and rubella vaccine and tetanus, diphtheria, and acellular pertussis vaccine are permitted post-partum.
• Has received an experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within one month prior to vaccination in this study, or expects to receive another experimental/investigational agent during the study period (prior to the Day 201 follow-up call - 180 days after the second vaccination).
• Has an acute illness and/or an oral temperature greater than or equal to 100.0 degrees Fahrenheit, within 72 hours of vaccination (This may result in a temporary delay of vaccination).
• Has immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months.
• Has an active neoplastic disease (excluding non-melanoma skin cancer), a history of any hematologic malignancy, current bleeding disorder, or taking anticoagulants.
• Long term use of glucocorticoids, including oral or parenteral, or high-dose inhaled steroids (>800 micrograms/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed) or has received betamethasone or dexamethasone to accelerate fetal lung maturity.
• Has a history of receiving immunoglobulin or other blood product (with exception of Rhogam) within the 3 months prior to enrollment in this study.
• Has a diagnosis of a current and uncontrolled major psychiatric disorder.
• Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
• The subject is receiving any of the following psychiatric drugs: aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, trifluopromazine, chlorprothixene, chlorpromazine, perphenazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate. Subjects who are receiving an antidepressant drug (not listed above) and are stable for at least 3 months prior to enrollment without decompensating are allowed enrollment into the study.
• Known active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection.
• History of alcohol or drug abuse in the last 5 years.
• Has a seizure disorder or is on an anti-seizure medication.
• Has a history of Guillain-Barré Syndrome.
• Plan to travel outside of North America in the time between the first vaccination and 42 days following the first vaccination.
• Has an acute or chronic medical condition that, in the opinion of the investigator would render vaccination unsafe, or would interfere with the evaluation of responses (this includes, but is not limited to, known cardiac disease, chronic liver disease, significant renal disease, unstable or progressive neurological disorder, transplant recipients or uncontrolled diabetes, juvenile diabetes (Type I) or advanced diabetes with renal disease or eye disease, diabetes controlled by diet or insulin is acceptable.)
• Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

In terms of adverse outcomes they are looking at:

• The occurrence of solicited local and systemic adverse events within 8 days post vaccination.
• The incidence of maternal and neonatal complications at the time of delivery. (Emphasis added)

So what does the data from the study show so far?

• In 25 women who received a single 15-microgram dose of the vaccine, the H1N1 flu vaccine elicited an immune response likely to be protective in 92 percent, or 23 of 25, of these women. 
• In 25 women who received a single 30-microgram dose of the vaccine, the H1N1 flu vaccine elicited an immune response likely to be protective in 96 percent, or 24 of 25, of these women.

So in 8 and 4 percent of women an immune response likely to be protected was not illicited - extrapolate that to the millions who might get the vaccine. They also note that the vaccine appears (emphasis added) to be well-tolerated, and no safety concerns related to the vaccine have arisen.

So what do we really know at this point? We know that in a small group of 50 healthy, pregnant women in their 2nd or third trimester an immune response to the vaccine was illicited in the majority of these women - some did not.

The report did not reveal whether or not there were local or systemic adverse events within the 8 days following vaccination – they just said no safety concerns had arisen.  And they either have no data on maternal or neonatal complications yet or they just didn’t report on them, or they lump these into their “no safety concerns” statement. Note that they are not going to follow these women and children after delivery to see what if any long term effects occur months or years afterwards.   
 
Interestingly the NIAID quotes Anthony Fauci MD stating: “For pregnant women, who are among the most vulnerable to serious health problems from 2009 H1N1 infection, these initial results are very reassuring,”

What Fauci leaves out is that the best data we have on how H1N1 effects preganant women is from studies just published based on data from the United States, New Zealand and Australia.

These data show that 30% of the pregnant women who died from H1N1 were either obese or morbidly obese and 60% had underlying medical conditions that put them at greater risk of overwhelming viral and bacterial infections.

So how can Facui make a blanket statement that all pregnant women are the most vulnerable when the data says otherwise?  And then to recommend the vaccine to every single pregnant woman in the country based on the response in a healthy cohort of an incomplete study? Science at its best – or perhaps worst.

The best advice I can give at this point is: In God we trust – everyone else has to bring data.

As always I look forward to your feedback, comments and suggestions.

Matthew McCoy DC, MPH
matthewmccoy@comcast.net
Editor – Journal of Pediatric, Maternal & Family Health – Chiropractic
http://www.chiropracticpediatricresearch.net

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