Annotated Bibliography: Vaccine Safety

Are 35,000 gulf war soldiers dead due to anthrax vaccinations? (n.d.). Snopes. Retrieved on February 2019 from link https://www.snopes.com/fact-check/35000-soldiers-dead-anthrax-vaccinations/

    This article seeks to determine whether or not a claim made in a documentary called Vaccine Syndrome is accurate. The article is careful to mention that it is not trying to make a determination about the subject matter in general, or whether the government acted in a way that is immoral or by any other definition not right. It is strictly an attempt to determine whether the document cited in the documentary, provides the evidence to support the claim made.

    Snopes.com has been called a secret tool of the democratic party and has been accused of liberal bias far more than a conservative bias. While in 2015 its founders, David and Barbara Mikkelson, were alleged to have been arrested on charges of fraud related to their website, it turns out that the story itself was false. What did happen is David and Barbara got divorced. Barbara alleged in court proceedings that David embezzled money from his own company to pay for hookers and legal fees. It’s unclear whether the allegations are true, but there is a strong piece of evidence to support it. David’s new wife also works for Snopes.com, and in the past was an Escort and adult film star.

    The idea that a website such as Snopes can be trusted to hash out the truth of incredibly complex  situations is possibly fallacious. Snopes is at best a weak place to start looking for angles of information, but in the case of my research has assisted in a small and yet meaningful way. It forced me to watch the documentary in question, and read the report in question, and come to my own conclusion on whether or not the claim made is relevant and accurate. 

Attkinson, S. (2008, July). Gardisil HPV vaccine side effects. CBS News. From link https://www.cbsnews.com/news/gardasil-hpv-vaccine-side-effects/

    This article tells the story of a girl named Amanda, who’s life was transformed, from one of an active athlete to one where she must take many pills to control the pain of myofasciitis, after receiving the Gardisil HPV vaccine. Merk, the company that makes the vaccine, is quoted as saying that the Gardisil vaccine is safe and also effective, and that no relationship has been established between the vaccine and serious adverse reactions being reported in the thousands. The CDC has only acknowledged a connection between Gardisil and feinting. The FDA is quoted as saying that true associations between Gardisil and serious adverse reactions may exist, but that many may be coincidental. Overall the FDA finds the information lacking, and yet sticks to their bias that the benefits outweigh the risks. 

    This article is brief and sticks to the main points that are able to be proven. As such I can call it responsible journalism and a quality news item.

    This news article is worthwhile to look at for people who want an informal confirmation that there exists at least one case of serious adverse reaction to the Gardisil vaccine. Beyond that the subject is left open to interpretation.

Clinton, W. (1999, September). Executive order 13139 – Improving health protection of military personnel participating in particular military operations.  Wikisource. From link https://en.wikisource.org/wiki/Executive_Order_13139

    This order allows the Secretary of Defense to use new investigational and experimental drugs as force protection measures with or without informed consent, depending on the situation. It includes stipulations on when a waiver of consent can be given. It asks that the drugs used be thought of as safe and effective according to scientifically based research and development protocols.

    I could not find the executive order in the federal registry, possibly because it may have been reversed by the G. W. Bush Administration afterwards, who replaced it with their own policy that I’m not aware of. Regardless, Wikisource claims to have the full text of the executive order and lists it as public domain, for the reason that it is a work of the United States Federal Government. I have no reason to doubt the validity of the text. Wikisource is a product of Wikimedia, began as a way to chronicle important historical documents, and was enlarged to include general works. Wikisource has in the past been accused of being unreliable, but since then has taken to using an extension to verify the validity of texts. Wikisource only allows verified texts to be hosted.

    This executive order is valuable information for anyone interested in researching the history of governmental use of untested drugs, which are not FDA approved, on soldiers and other DoD personnel.

Direct Order (2003, June). Democracy Now!. [Documentary]. From link https://www.democracynow.org/2003/6/4/direct_order_an_award_winning_documentary

    This documentary gives an overview of the subject of the anthrax vaccine, and many studies which have linked it to Gulf War Illness. Many interviews are given to ex-military members who speak about their first-hand experiences. The Pentagon funded their own studies which concluded that the anthrax vaccine was safe and effective, based on unpublished research which was also funded by the Pentagon. Anthrax producer Bioport has repeatedly failed inspection by the FDA, which has at times found contamination of the vaccines to be an issue. In spite of this, Bioport was allowed to distribute 500,000 of those failed vaccines to the military and some postal workers who were the rare ones to not refuse it. Many service members have been court martialed, quit, resigned or transferred rather than having to take the anthrax vaccine.

    Democracy Now! Has received several journalism awards, including the Gracie and George Polk Awards. The show’s producer and anchor, Amy Goodman is an established journalist and has herself received numerous awards. She received the 2008 Right Livelihood Award. She was awarded the first annual Izzy Award. She was inducted into the New York chapter of the Society of Professional Journalists’ Hall of Fame on November 19, 2015. Her work is considered highly credible.

    This documentary is a must see for people who are interested in hearing real life stories of veterans who have suffered Gulf War Illness, and the events which led to the arrival of their symptoms.

Esposito, L. (2018, June). A new shingles vaccine: Prepare for harsher side effects. U.S. News. From link https://health.usnews.com/health-care/patient-advice/articles/2018-06-15/a-new-shingles-vaccine-prepare-for-harsher-side-effects

    This news article explains about the fact that side effects to a new form of shingles vaccine are much worse and more numerous than older and more established shingles vaccines. Some symptoms that have been reported are skin rash, joint pain, flu-like symptoms, arm pain at the injection site, headaches and fatigue. The side effects can last two or three days. The vaccine is said to provide greater protection against shingles. One of every three people in the U.S. will develop shingles, according to the Center for Disease Control. Shingles is caused by varicella zoster virus, which is also responsible for chickenpox. The chickenpox virus becomes inactive for many years and appears later as shingles. Symptoms of shingles include numbness, tingling or burning and touch sensitivity, for the duration of a red rash’s appearance. Some people develop blisters that fill with fluid, burst open and crust over. Fever, headache, fatigue and light sensitivity can occur. Doctor Kathleen Dooling, who is a shingles expert, confirms that clinical trials reported a higher incidence of side effects than previous vaccines used, but maintains that the benefits outweigh the risks, considering the harsh nature of shingles for some people.

    This news article seems to properly weigh the positives and negatives of vaccination, fairly and accurately, so far as at least one expert is concerned.

    This article is a good read for people who are just becoming aware that vaccines do have side effect. It lacks sufficient detail for a thorough analysis, however.

Fell, D., Azziz-Baumgartner, E., Baker, M., Batra, M., Beauté, J., Beutels, P…Ortizab, J. (2017). Influenza epidemiology and immunization during pregnancy: Final report of a World Health Organization working group. Vaccine, 35(43), pp. 5738-5750.
From link https://www.sciencedirect.com/science/article/pii/S0264410X17311258

    The WHO sponsored a working group, and between 2014 and 2017 this group evaluated the impact of influenza programs for pregnant women and their babies. The group concluded that there does seem to be a benefit for immunizing pregnant women with the influenza vaccine, but cited gaps in information, the need for further study, and admitted the debate is not closed on the health impact this may have on health of the babies involved.

    While many of the authors of this study have worked for the WHO, received monies from the WHO and vaccine companies, they treat the subject with the professionalism I would expect from such a group. 

    This source would be useful for anyone seeking a report of the overall affect of influenza vaccine programs for pregnant women in developed countries. As it cites a lack of study or programs in middle to low-income countries, there is no information on such.   

Fulton, T., Narayanan, D., Bonhoeffer, J., Ortiz, J., Lambach, P., Omer, S. (2015). A systematic review of adverse events following immunization during pregnancy and the newborn period. Vaccine, 33(47), pp. 6453-6465.
From link: https://www.sciencedirect.com/science/article/pii/S0264410X15011706

    This study is focused on research needed to push the goal of implementing vaccination of pregnant women, in order to reach a goal of reduced infant mortality rates compared to 1990 rates. The study admits that there are limitations to safety data regarding pregnant women. Also, the absence of global standard definitions for maternal immunization adverse events hinders comparisons of safety data and therefore proper analysis. Of 5488 studies, 121 were selected as relevant and 47 were excluded for various reasons. 10 of those remaining 74 studies were previously published reviews. Half of the studies used focused on influenza vaccines, followed by yellow fever, tetanus, diphtheria and Tdap, and rubella vaccines, and others. The studies reviewed identified adverse events including congenital malformations and abnormalities, 10 of which were most frequently reported. Those 10 included miscarriage, preterm birth, stillbirth, fever of mother, pre-eclampsia, site pain, low birth weight, elective abortion, respiratory distress and small-for-gestation age. Authors admit that very few studies are done in middle to low income countries. They admit that their review has limitations, including a lack of hand-searched individual journals or gray literature. 

    This study was funded by the World Health Organization. The authors admit no conflict of interest. 

    This study is useful for an overview of reported adverse events following immunization during pregnancy.

Historical vaccine safety concerns (n.d.). Center for Disease Control. Link retrieved February 2019 from https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html

    The Center for Disease Control lists a meager number of examples of historically proven vaccine blunders. In 1955 Cutter Laboratories sent out a vaccine with live polio in them, even though they were safety tested. Over 250 cases of polio-related paralysis was reported, in what became known as The Cutter Incident. Between 1955 and 1963 an estimated 10-30% of polio vaccines were contaminated with simian virus 40, which came from monkey kidney cells. Concerns were noted that the virus could cause cancer in humans. Testing for the virus became mandatory in polio vaccines after the incident was discovered. In 1976 a significant uptick in the number of Guillain-Barre Syndrome (GBS) was reported as related to the swine flu vaccine. Federal health officials decided to stop the use of the vaccine until the issue could be explored. The Institute of Medicine did a thorough review in 2003 and concluded that there was in fact an increased risk for GBS related to the vaccine but could not determine causality. In 1998 some research caused concern that there may be a relation between the Hepatitis B vaccine and multiple sclerosis. A 2002 Institute of Medicine study could not validate this claim and declared that there was in fact no link. 6 other historical events are listed including the 2013 recall of the HPV vaccine.
The Center for Disease Control is responsible for justifying governmental policies concerning the control of disease.

    The CDC came under fire two decades ago for funding research which was biased regarding gun control. In 1996 the U.S. Congress defunded $2.6 million to the CDC’s anti-gun research and alleged their research was driven by anti-gun bias. The parent organization to the CDC is  the U.S. Public Health Service, which has an officially stated goal, “to reduce the number of guns in private ownership.” Obama signed an executive order re-allowing the CDC to influence governmental policy on gun control legislation. For this reason, it is clear that the CDC has the ability to be a biased organization. Vaccines are a multi-billion-dollar industry, and the government makes billions of dollars per year off of lobbying, patents and FDA applications for vaccines and other drugs. The government has a massive incentive to err on the side of money, and so I take what they say with a skeptical ear and eye. They are, however, a reputable source of information on the subject of vaccines, whether or not they use slanted language in their conclusions or ignore significant data.

    This page is especially helpful for anyone researching verifiable vaccine debacles in history.

Leary, W. (1994, May). Experimental drugs linked to gulf war veterans’ illness. New York Times. From link https://www.nytimes.com/1994/05/07/us/experimental-drugs-linked-to-gulf-war-veterans-ills.html

    This article reveals that a Senate Committee investigation concluded that unexplained illnesses suffered by veterans of the Persian Gulf War may have been caused by experimental drugs. Senator John D. Rockafeller the 4th was Chairman of the Senate Veteran’s Affairs Committee and spoke to the Times about the subject. He explained that the committee had found a link between the symptoms suffered by veterans and the experimental drugs given, including pyridostigmine bromide, a rarely used anthrax vaccine and a botulism vaccine. In 1990 the military was given a waiver by the FDA to give experimental drugs to soldiers without providing them with informed consent, even though many of the drugs had not been tested adequately. Some of the symptoms suffered by veterans include vomiting, speech disorders, muscle weakness and fatigue, and short-term memory loss. Neil R. Tetzlaff never recovered from symptoms he expressed after receiving pyridostigmine bromide. A panel of experts convened by the National Institute of Health concluded that the symptoms expressed could not be concisely defined, and yet represented a real condition.

    This article is an example of solid journalism, covers many angles effectively and is concise. It names relevant people, committees, scientists, victims and the government.

    This article is a must read for people discovering the relevancy of vaccine adverse reactions in our modern times.

Leite, A., Andrews, N., Thomas, S. (2016). Near real-time vaccine safety surveillance using electronic health records- A systematic review of the application of statistical methods. Pharmacoepidemiology and Drug Safety, 25(3).
From link: https://onlinelibrary.wiley.com/doi/full/10.1002/pds.3966

    The study is a systematic review of almost 2800 other studies, ranging from 2005 to 2015, with respect to the statistical methods used for each study. Only 31 were used and considered to be worthwhile, due to their methodology. The study focused mainly on the influenza vaccine, especially the 2009 H1N1 vaccine. The most studied adverse reactions were listed as Guillain-Barre syndrome, meningitis/encephalitis/myelitis, and seizures. The authors note that pre-licensure studies are not useful for determining safety related to adverse events, and that more proper post-licensure studies are needed, and are needed to be timely and accurate. The authors conclude that certain methods are more reliable than others, and that future access to electronic health records will be very useful, but that they are not currently used widely. It is noted that infrastructure is often an issue in the acquisition of data. 

    The authors cite no bias or conflict of interest. In general this study is quite dry and arduous to read, but is a worthwhile overview of the various methods for statistical analysis, giving insight into the ways methodology of vaccine studies can be improved. The specific conclusions are interesting. The general conclusion of requiring electronic health records is stating the obvious. 

    The study is useful for the specific conclusions it addresses, for those that understand complex methodology of statistical analysis.

Li-Kim-Moy, J., Yin, J., Rashid, H., Khandaker, G., Kind, C., Wood, N…Booy, R. (2015). Systematic review of fever, febrile convulsions and serious adverse events following administration of inactivated trivalent influenza vaccines in children. Euro Surveillance, 20(24).
From link https://www.eurosurveillance.org/content/10.2807/1560-7917.ES2015.20.24.21159

    The authors of this study conduct a systematic review of records, trials, and studies. They identify fever rates of 5-7% of children 6-35 months in various trials, but rates as high as 37.1% in studies of bioCSL vaccines. Fibril convulsions were identified at a rate of 1.1 out of 1000 vaccinated children. One study identified febrile convulsions in 2.59 per 1000 vaccinated children aged 6 to 71 months. The authors admit that standardized methodology and individual-level data would be more helpful in making conclusions. They admit that further study of adjuvanted vaccines is warranted to investigate safety related to fever and febrile convulsions. 

    3 of the 9 authors of this study have received money from Sanofi Pasteur, bioCSL, Roche, Sanofi, GlaxoSmithKline, Novartis and Pfizer for various research in the past. The original publication did not include a statement of conflict of interest, but it was added over a year later, and table 4 was updated at that time with a new line of data.

    Overall this study is useful for anyone interested in reviewing the rates of fever and febrile seizures related to trivalent influenza vaccines in children.

Maglione, M., Das, L., Raaen, L., Smith, A., Chari, R., Newberry, S…Gidengil, C. (2014). Safety of vaccines used for routine immunizations of US children: A systematic review. Pediatrics, 134(2).
From link: http://pediatrics.aappublications.org/content/134/2/325.short

    This study reviewed various sources to determine the safety and efficacy of various vaccines used in the USA, in children. Of 20478 studies, only 67 were included. The authors admit that adverse events do happen, though they reported them as rare. In particular, there is strong evidence cited connecting the MMR vaccine and febrile seizures. The conclusion drawn is that protective benefits of vaccines outweigh the risk of adverse events. The omission of thousands of studies seems to indicate a limitation of what could be considered a systematic review. The authors have not disclosed any conflict of interest. The major contributor to this study, Margaret Maglione, is an associate of the RAND Corporation, which is a think tank which offers research and analysis for the US Armed Forces. 

    This study seems less thorough than others, and Doctors were mainly used as advisors. Other Doctors helped with the design of the study, revision of the manuscript and one helped with interpreting the results. This study has not been endorsed by the Agency for Healthcare Research and Quality or the US Department of Health and Human Services.

    This study is not very useful for use as an accurate or reliable systematic review of the safety of vaccines used on children in the USA.

Martins, R., Leal, M., Homma, A. (2015). Serious adverse events associated with yellow fever vaccine. Human Vaccines & Immunotherapeutics, 11(9). From link https://www.tandfonline.com/doi/full/10.1080/21645515.2015.1022700?scroll=top&needAccess=true

    Study overviews the history of the use of Yellow Fever vaccine, adverse events that have been reported, and the ways in which vaccine policy has been altered over time, and ways which the vaccine was changed, to fix for issues that resulted in adverse events. The authors admit that more study is needed, and that causal factors related to various adverse events are not well understood, though some are. They report that efforts are being made to develop a new, safer yellow fever vaccine, and suggest a possible candidate- using inactivated YF 17D virus. Overall since yellow fever is so lethal, “risk-benefit analysis” suggests that use of the vaccine is the best way to remain free of yellow fever and is considered worthwhile.

    All of the authors of this study work for Bio-Manguinhos/Fiocruz, which is a non-profit, government producer of vaccines, including the yellow fever vaccine. They do seem to appear to lack bias, admitting to a history of adverse events. They admit that a new safer vaccine is needed. This promotes their own job security. 

    Overall, this study is a worthwhile review for anyone interested in understanding the history of the yellow fever vaccine, causal factors related to adverse events, how the vaccine has changed over time and the current status of its safety. 

National Childhood Vaccine Injury Act (1986). US Congress.
From link https://www.congress.gov/bill/99th-congress/house-bill/5546

    This bill was passed in 1986 and relates to Congressional action to mandate a national vaccine program which both encourages the availability of vaccines and administers research priorities to the National Vaccine Advisory Committee. It establishes the National Vaccine Injury Compensation Program as an alternative to judicial action for vaccine-related injuries. It sets limits on the amount of compensation a person can receive and limits the types of injuries a person may claim injury from, to those recommended by an appointee. This act also stipulates that there will be no liability by a vaccine manufacturer in cases of injury or death resulting from inadequate warning, or “unavoidable side effects”. The vaccine manufacturer may be held liable in specific and limited circumstances. This bill requires an appointee to study certain vaccines’ safety, to review warnings, instructions of vaccines listed in the Vaccine Injury Table, and empowers that appointee to force manufacturers to revise and reissue any warning, instruction or information found to be inadequate. The appointee is also given recall authority and is required to make annual reports to specified congressional committees on the impact the act has on the supply of vaccines.

    I find this act to be of particular interest, related to the history of vaccine policy in America. It represents an admission by congress that there have been issues with vaccines, supplies manufacturers with legal immunity from adverse events which may occur, It sets a priority on the availability of vaccines and not on the safety of those vaccines.

    This bill is essential to understand for anyone interested in the history of vaccine policy in America.

Public readiness and emergency preparedness act (2005). U.S. Federal Registry. From link http://www.hrsa.gov/gethealthcare/conditions/countermeasurescomp/covered_countermeasures_and_prep_act.pdf

    The PREP Act (Public Readiness and Emergency Preparedness Act) was an addition to the PHS (Public Health Service Act) to provide liability immunity to companies who respond to declarations of emergency. In particular it included stipulations relative to the manufacture, testing, development, distribution, administration and use of medical countermeasures against biological, chemical, nuclear, and radiological agents of terrorism, epidemics, and pandemics. It first stripped injured persons from the legal ability to receive compensation for any harm caused by such medical countermeasures but added established a program to compensate eligible individuals who suffer from the use or administration of covered products. There are currently nine declarations active under this act. They are:
– Ebola Disease Vaccines (effective December 1, 2018)
– Ebola Disease Therapeutics (effective December 1, 2018)
– Nerve Agents and Certain Insecticides (Organophosphorus and/or Carbamate)
– Countermeasures (effective April 11, 2017)
– Zika Virus Vaccines (effective August 1, 2016)
– Pandemic Influenza Medical Countermeasures (effective January 1, 2016)
– Anthrax Medical Countermeasures (effective January 1, 2016)
– Acute Radiation Syndrome Medical Countermeasures (effective January 1, 2016)
– Botulinum Toxin Medical Countermeasures (effective January 1, 2016)
– Smallpox Medical Countermeasures (effective January 1, 2016)

    The PREP Act is a legitimate U.S. Law, and is found in the Federal Registry. It’s validity is undeniable and evidenced.

    This law is a major boon to the research of anyone interested in the progress of government laws concerning the legality of biological countermeasures such as vaccines.

Rondy, M., El Omeiri, N., Thompson, M.,  Leveque, A., Moren, A., Sullivan, S. (2017). Effectiveness of influenza vaccines in preventing severe influenza illness among adults: A systematic review and meta-analysis of test-negative design case-control studies. Journal of Infection 75(5), pp. 381-394.
From link https://www.sciencedirect.com/science/article/abs/pii/S0163445317302992

    This study assessed the effectiveness of influenza vaccines in preventing severe influenza illness among adults. Of 3411 publications only 30 met their inclusion criteria, for test-negative design case-control studies. The authors found that the effectiveness of the influenza vaccine for people aged 18-64 was 51% or below for various years and various vaccines. Some vaccines were as low as 14 percent effective. They conclude that influenza vaccines provide only moderate to low protection.

    The authors researched the PubMed database from January 2009 to November 2016 to find studies that  used test-negative design to enroll patients who were hospitalized with influenza-associated conditions. They pooled data and stratified it by age groups. It appears as if they made a scientifically valid effort to conclude accurately.

    This study is generally useful for a quick glance at the efficacy rates of various influenza vaccines for certain years. I am unsure if this study relates to US rates or UK rates of efficacy.

Vaccines distributed in Kentucky, Ohio and Indiana causing infections (2019, February). WKRC.
From link https://wpta21.com/news/indiana-news-from-the-associated-press/2019/02/02/health-agency-investigating-vaccine-associated-infections/

    This news article reports on a failure of certain vaccines administered recently in Mount Sterling, to be effective. Also, as the Kentucky Department of Public Health has admitted, the vaccines have caused adverse reactions including redness, pain, swelling and hard lumps at the injection site. Dr. Jeff Howard, the public health commissioner, claims that the negative side effects are “likely” linked to improper storage and handling and not the vaccine supply. In spite of this failure of vaccines to protect and safeguard the health of those who receive it, Dr. Jeff Howard suggests that people affected get another dose to ensure immunization. 

    The words of the public health commissioner are an admission of uncertainty, and his response could be pencil whipped by a grade school student. To merely suggest a causal factor without any scientific study is at best negligence on the part of the public health authority. This happenstance should stand as a reminder to people that there are times vaccines are not safe, and that public health officials responsible for policy are not scientists. Officials rely on carefully worded statements which minimize responsibility and reduce panic amongst citizens, rather than caring for the truth of the matter. 

    This news is important for anyone worried about the safety of vaccines and interested in exercising their right to refuse injections.

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