Saturday, May 26, 2007

Women are Inordinately Harmed by Anthrax Vaccine

There is consensus regarding the fact that women have 2 to 3 times the rate of adverse reactions as men. Every study that has looked into this issue has found the same thing. The following four studies were done by 3 groups of different military researchers, and the last by CDC researchers: because Congress has asked that the role of gender be investigated with respect to adverse effects of the anthrax vaccine. The studies whose abstracts are listed below are all published since 2001, and are peer-reviewed articles in the medical literature. Two authors say this finding needs more study. Two authors say that the acute adverse reactions all resolved. However, if you read the complete studies, you will find that long-term active surveillance (by medical professionals asking questions or performing exams on study subjects) was not conducted in any of the studies, and the evidence that all reactions resolved is tenuous at best. Women also have more autoimmune disorders, in general, than men do.

1. Vaccine. 2001 Dec 12;20(5-6):972-8.
Anthrax vaccine: short-term safety experience in humans.

* Pittman PR,
* Gibbs PH,
* Cannon TL,
* Friedlander AM.

Division of Medicine, US Army Medical Research Institute of Infectious Diseases, 1425 Porter Street, Fort Detrick, Frederick, MD 21702-5011, USA.

Bacillus anthracis is the major terrorist and biological warfare agent of concern to civilian and military medical planners. The licensed anthrax vaccine, adsorbed (AVA) is believed to be an effective prophylactic medical countermeasure against this threat. Our objective in this report was to expand the safety database for this vaccine by assessing data on self-reported, short-term safety of AVA during more than 25 years of use, measured by local and systemic adverse events temporally associated with the administration of AVA. A minority of AVA recipients reported systemic and injection site reactions. Females reported a higher incidence of injection site and systemic adverse events than males. Data show a difference in incidence of local reactions between lots. A prospective, randomized, placebo-controlled study to actively examine reactogenicity is needed to more completely define the extent and nature of reactions associated with receipt of AVA in humans as well as to confirm the gender lot differences in local reaction rates.

2. J Occup Environ Med. 2003 Mar;45(3):222-33.
Analysis of adverse events after anthrax immunization in US Army medical personnel.

* Wasserman GM,
* Grabenstein JD,
* Pittman PR,
* Rubertone MV,
* Gibbs PP,
* Wang LZ,
* Golder LG.

Preventive Medicine Department, Tripler Army Medical Center, Honolulu, Hawaii, USA.

A broad range of health effects in a cohort of 601 health care personnel, immunized with anthrax vaccine adsorbed (AVA) as a military occupational health requirement, were assessed to evaluate adverse events both qualitatively and quantitatively. Active surveillance showed that localized reactions were common and occurred more often in women than men. Five patients were reported to the Vaccine Adverse Event Reporting System, but only one event could be definitively attributed to immunization, a large localized reaction. Two separate cohort studies, one using nested data from a standardized health risk appraisal instrument and the other comparing rates of outpatient visits and hospitalizations, did not reveal significant differences between AVA-immunized and unimmunized individuals. Our findings suggest that AVA is relatively reactogenic but do not indicate serious adverse health effects due to immunization.

3. Vaccine. 2003 Oct 1;21(27-30):4399-409.
Using a structured medical note for determining the safety profile of anthrax vaccine for US soldiers in Korea.

* Hoffman K,
* Costello C,
* Menich M,
* Grabenstein JD,
* Engler RJ.

Military and Veterans Health Coordinating Board, 20420-0002, Washington, DC 20420-0002, USA.

Selected military personnel are immunized with an FDA-licensed anthrax vaccine unless there are clinical contraindications. The objective of this analysis is to capture the experience of soldiers receiving anthrax vaccine to assist in better patient-provider communication and clarify the safety profile of the vaccine in this population as a quality-assurance initiative. Between August 1998 and July 1999, 2824 soldiers immunized against anthrax at one military clinic completed a structured medical note that was reviewed by a clinician. Female gender, prior vaccine-associated adverse events, and medication use were significantly related to higher reports of adverse events. All reported immediate consequences resolved.

4. Pharmacoepidemiol Drug Saf. 2007 Mar;16(3):259-74.
Short-term reactogenicity and gender effect of anthrax vaccine: analysis of a 1967-1972 study and review of the 1955-2005 medical literature.

* McNeil MM,
* Chiang IS,
* Wheeling JT,
* Zhang Y.

Anthrax Vaccine Safety Team, Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.

PURPOSE: In the 1960s, the Centers for Disease Control and Prevention (CDC) held the investigational new drug (IND) application for the anthrax vaccine and collected short-term safety data from approximately 16,000 doses administered to almost 7000 individuals. While some recent anthrax vaccine safety studies have suggested that women experience more injection site reactions (ISRs), to our knowledge the IND safety data were not previously examined for a gender-specific difference. METHODS: We identified and analyzed a subset of the IND study data representing a total of 1749 persons who received 3592 doses from 1967 to 1972. Original data collection forms were located and information extracted, including: vaccine recipient's name, age at vaccination, gender, dose number, date of vaccination, lot number, grading of ISR, presence and type of systemic reactions. Overall and gender-specific rates for adverse reactions to anthrax vaccine were calculated and we performed a multivariable analysis. RESULTS: We found an ISR was associated with 28% of anthrax vaccine doses; however, 87% of these were considered mild. Systemic reactions were uncommon (<1%) and most (70%) accompanied an ISR. Our dose-specific analysis by gender found women had at least twice the risk of having a vaccine reaction compared to men. Our age-adjusted relative risk for ISR in women compared to men was 2.78 (95%CI: 2.29, 3.38). CONCLUSIONS: Our results for both overall and gender-specific reactogenicity are consistent with other anthrax safety studies. To date, possible implications of these gender differences observed for anthrax and other vaccines are unknown and deserve further study.


Anonymous said...

Has there been reputable research done on woman who have received the vaccine and breastfeed or studies on women receiving the vaccine later getting pregnant and possible birth defects?

Meryl Nass, M.D. said...

Ive seen nothing on breastfeeding. One DOD study looked at pregnancy rates before and after vaccination and concluded the rates were the same. It claimed there were no birth defects, but admitted it was insufficiently powered to tell.

A study by Ryan et al was recently published. Earlier reports of this study indicated that if you were vaccinated in the first trimester of pregnancy, the rate of a birth defect increased by 40%. However, recent publication indicated the rate was less, and I have not read the full text, though I have reviewed several presentations of the data.

Meryl Nass, MD

Anonymous said...

Since you've seen nothing on breastfeeding, does it mean it's OK to take the vaccine while breastfeeding? It's interesting that there has not been studies so therefore it's OK. I read that the vaccine is not contraindicated for breastfeeding mothers and yet how do they know?

I have the feeling that studies on the anthrax vaccine word their reports to support the military's requirement that service members must be vaccinated. It seems that any results that do not support the cause, it is not included in the report.

Meryl Nass, M.D. said...

It goes without saying that all Army research that has been published supports the vaccine and military policies, even when the data presented in the papers, when carefully examined, do not. That body of literature is fatally compromised by conflicts of interest. Even the FDA-approved vaccine label disses the Army studies, in nuanced language.

As far as breastfeeding, there really is no data. No one knows. But if you are forced to be vaccinated while breastfeeding, you can at least be relieved that the anti-anthrax antibodies your baby will ingest go through the gut, instead of being injected. The gut has barriers to keep bad stuff out and usually functions well. But an injection bypasses all the body's natural barriers and protections.

Another option is to request the vaccine be delayed during breastfeeding, since there is no data showing it is safe.