Debunking myths about vaccine testing and safety

vaccine testing

The goal of this article is to respond to a number of recurring myths raised by anti-vaccine activists regarding vaccine testing and safety – a common trope used against vaccines.

The bottom line is that vaccines are extensively and carefully tested for safety, and that vaccine safety is shown by many, many studies from a variety of sources, reinforcing each other and all pointing to the same result – serious problems from vaccines are possible, but extremely rare. And those small, rare risks are far outweighed by the benefits vaccines provide by protecting us against much larger risks.

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Bacteremia risk lower in children after pneumococcal vaccine – why we vaccinate


Sometimes, it’s important to remember that there are solid answers to the question “why do we vaccinate our children?” Frequently, we focus on what vaccines don’t do, like they don’t cause autism, and forget to forcefully remind the public of the benefits of vaccines – preventing diseases. Recent research, published in Pediatrics, provides valuable evidence that bacteremia risk drops significantly after receiving the 7-valent (this vaccine contains 7 different pneumococcal antigens)  and 13-valent pneumococcal conjugate vaccines. (See Note 1)

Bacteremia, the presence of bacteria in what should be sterile blood, is a common complication of pneumococcal pneumonia. And about 1 out of 100 children die from it, so it is considered a very dangerous condition for children (and older adults). Preventing pneumonia, along with the subsequent bacteremia, with the pneumococcal conjugate vaccine is one of the best reasons to vaccinate your children.

Bacteremia frequently evokes an immune system response called sepsis, which consists of serious symptoms such as fever, chills, and low blood pressure. Bacteremia may induce severe immune responses which can lead to potentially fatal conditions such as septic shock and multiple organ dysfunction syndrome. In the most severe cases, the bacteremia infection can travel through the blood stream and cause infections in distant locations, such as endocarditis (infections of the heart), meningitis (infections of structures around the brain), and osteomyelitis (bone infections).

Greenhow et al., from Kaiser Permanente Northern California, a vertically integrated health management system, examined the incidence of bacteremia in children 3-36 months old. They looked at the data in three time periods between 1 September 1998 through 31 August 2014. The first period, pre-PCV7 (7-valent pneumococcal conjugate vaccine) , was before the pneumococcal conjugate vaccine was available. The second period, post-PCV7/pre-PCV13 (13-valent pneumococcal conjugate vaccine), was after PCV7 was introduced but before PCV13. And finally, the third period, post-PCV13, included the period when Kaiser switched all of its pneumococcal vaccines to the PCV13 version.

The researchers designed a retrospective case control study which reviewed the blood culture results collected from children 3 to 36 months old, between 1 September 1998 through 31 August 2014, who were seen in Kaiser Northern California outpatient clinics, emergency departments, and within the first 24 hours of hospitalization. The researchers collected results from 57,733 blood cultures during that period to see what changes in bacteremia were observed after implementation of the vaccine.

The researchers found that the incidence of Streptococcus pneumoniae bacteremia dropped from 74.5 per 100,000 children in the pre-PCV7 period, to 10 in the post-PCV7/pre-PCV13 period, all the way to 3.5 by the post-PCV13 period. That represents a 95.3% reduction in Streptococcus pneumoniae bacteremia after introduction of the pneumococcus vaccine, an impressive number that directly reduces serious complications for children.

Interestingly, the researchers also found that Streptococcus pneumoniae makes up a smaller percentage of bacteremia cases. After introduction of the vaccine, which caused the precipitous drop in Streptococcus pneumoniae bacteremia incidence, other bacteria, especially Escherichia coli, Salmonella, and Staphylococcus aureus, are now responsible for 77% of bacteremia cases. New vaccines may become available in the future to prevent

What can we conclude from this study? Routine immunizations against pneumococcal bacteria have made bacteremia in healthy toddlers an extremely rare event. And given that bacteremia can have very dangerous complication for children, this is an important reason why we vaccinate.



  1. There is a 23-valent pneumococcal polysaccharide vaccine, called Pneumovax 23 (PPV-23), which is not in the vaccine schedule for children. It is mostly given to older adults, although children who are at risk to pneumococcus because of a pre-existing condition can be safely given PPV-23 if necessary.




Adult vaccines – the CDC wants to save adult lives too

adult vaccines

Generally, when I write about vaccines, it’s about protecting children’s lives from vaccine preventable diseases. That itself is a noble goal for vaccines. But in case you didn’t know, there is also a CDC schedule for adult vaccines, which is as important to adults as they are to children.

Vaccines have one purpose – to protect us and those whom we love from potentially deadly and debilitating diseases. Many of us in the blogosphere have talked about the children’s schedule a lot, often to debunk claims of people who are ignorant of science, and think that the children’s vaccine schedule is causing undue harm. Yeah our intellectually deficient president, Donald Trump, thinks he knows more than the CDC, but that’s a problem shared by many vaccine deniers.

One adult vaccine I push regularly is the flu vaccine. It protects adults, pregnant women, the elderly, children, and healthy young adults from a severe infection that hospitalizes and kills more people every year than you’d think. Because flu is not really a serious disease, in some people’s minds, a lot of people decide that they don’t need the vaccine. They’d be wrong.

Just in case you were wondering, there is more to adult vaccines than just flu vaccines. There are several other vaccines indicated for adult use, including those adults with underlying health issues like diabetes, HIV and heart disease – unfortunately, the uptake for adult vaccines is depressingly low. Let’s take at the low uptake and the recommended adult vaccines schedule.

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A failed vaccine clinical trial – it happens

There is a trope that Big Pharma has an open door to push whatever drug they want onto the unwitting public, whenever they want, irrespective of any safety and effectiveness data. For those who actually work in Big Pharma, this causes more nervous laughter than any other trope, because they know how hard and complicated it is to actually do so.

I’ve written previously that less than 10% of hyped pre-clinical data ever makes it through clinical trials so that it might be considered valuable evidence for clinical decisions. And less than 10% of drugs, such as cancer treatments, ever make it from the first step through the last step (often called pivotal studies) of clinical trials to gain regulatory approval (pdf).

So if Big Pharma is lying to the public about the quality of their drugs (and by extension, vaccines), and then bribing the FDA to cover up these lies, they are laughably incompetent. I guess if they really were that inept, it’s a good thing.

But now we come to a failed vaccine clinical trial – what does that tell us about vaccine development. Continue reading “A failed vaccine clinical trial – it happens”

Vaccines save lives–30K US adults die annually of preventable diseases

President Obama getting his flu shot.
President Barack Obama receiving his flu shot.

One of the consistent tropes of the antivaccination cult is that vaccine preventable diseases are not that dangerous, so why take the risk (mostly minor, although not in the cult’s mind) for little benefit. Except for one tiny issue–vaccine preventable diseases kill. Recent studies have shown that an average of approximately 30,000 adults die of these diseases every year, about 95% of the total deaths from vaccine preventable diseases.

Researchers at the University of Colorado at Denver surveyed USA physicians regarding adult vaccine delivery. The results and analysis were recently published in the Annals of Internal Medicine. The researchers found that rates for adult vaccination remain quite low.

Some of the more interesting results from the study were:

  • Only 62% of adults above the age of 65 received the pneumococcal vaccine.
  • Only 65% of adults in the same age group received the flu vaccine
  • This group is at high risk of death from pneumonia and flu, and in fact, deaths from these diseases in this age group, makes up a significant portion of vaccine preventable deaths in this group.
  • Physicians also reported significant barriers to providing vaccines to adults including stocking vaccines (pediatric offices are better equipped for vaccine storage) and reimbursement from insurance companies. In addition, some patients cannot afford the cost of the vaccines if they are not reimbursed by a third party payer. According to the study authors, “Physicians in smaller, private practice often assume more risks from stocking expensive vaccine inventories and may be particularly affected by these financial barriers.”
  • The authors noted the Affordable Care Act addresses the cost barrier to vaccination for privately insured patients by requiring insurers to cover recommended vaccines with no co-pay when delivered by in-network providers. 

Setting aside the embarrassment that the USA doesn’t make vaccines easier to get for those who cannot afford them, it is clear that the low rates of adult vaccination has lead to higher rates of vaccine-preventable illnesses and death. Saving 30,000 lives through proper vaccination and following the new adult vaccine schedule (see figure below) will help reduce that number quickly.

©Centers for Disease Control and Prevention, 2014. Current adult vaccination schedule.
©Centers for Disease Control and Prevention, 2014. Current adult vaccination schedule.

The authors concluded that,

Vaccines provide an important but underutilized opportunity to reduce the burden of vaccine-preventable disease among adults. Although primary care physicians appear motivated to ensure that patients are up to date on vaccinations, many barriers exist. Implementation of system changes, including adopting practices that improve communication between primary care physicians and alternate vaccinators, more widespread use of effective tools (IISs and clinic decision support systems), and removing policy-related barriers, could improve adult vaccination in the United States.

Vaccines really do save lives.

 Visit the Science-based Vaccine Search Engine.

Key citations:

Vaccination coverage in US children,19-35 months–uptake still high

The United States Centers for Disease Control and Prevention (CDC) has reported in the 2012 National Immunization Survey (NIS) that the majority of children, age 19-35 months, remained extremely high from 2008 through 2012, although there was a small, but statistically significant drop in uptake of some vaccines from 2011 to 2012. In addition, the CDC specified a substantial concern about clusters of unvaccinated children in widespread communities that are at risk from vaccine preventable diseases, and may pose a health risk to the community at large.

The study results were based upon a survey (cell and land-line phone calls with follow-up details from the health care provider) of about 16,000 children (an extremely large sampling for a survey). The data was then adjusted for racial/ethnic, income, and other population factors. Even though the CDC provided data from 2008-2012, the current method of polling was started in 2011, and only results from 2011 and 2012 are mathematically comparable.




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Vaccines save lives–even more evidence

Vaccines-save-lives;-fear-endangers-them.-It's-a-simple-message-parents-need-to-keep-hearing.One of my favorite tropes (of so many) of the vaccine denier gang is that vaccines are not effective, thereby implying that the limited usefulness is not worth the risks of vaccines, real or imagined. But the fact is vaccines do save lives in measurable and sometimes fascinating ways. Two peer reviewed papers, recently published, provided clear evidence of some of the ways vaccines directly save lives.

The first article analyzed the relationship between flu vaccines and reduction of cardiovascular events; while the second one examined how vaccines might reduce morbidity and mortality from pneumococcal meningitis.

Let’s start with the flu vaccine, which has a high safety profile and most people receive for the obvious reasons–flu prevention. However, we are aware of other benefits of the flu shot, including providing somewhat better outcomes during pregnancy. In an article published on 21 August 2013 examined a previously suspected, but not firmly established, benefit of the flu vaccine was examined. This study found that the risk of getting a heart attack was about 50% less amongst patients who were vaccinated against the flu compared to a group that was not.

Now, the study does not show that the flu vaccine has some miraculous anti-heart attack component, it might reduce the risk of catching the flu, or possibly reducing the severity of the infection, which reduces the risk of having a heart attack. In fact, the study’s original hypothesis was that catching the flu might actually increase the risk of a cardiovascular event, specifically a heart attack.

Furthermore, the researchers observed that the flu vaccine reduced heart attack risk even when the vaccine’s effectiveness was shown to be not very high. This conclusion itself debunks one of the huge myths of the antivaccination crowd (which is essentially that if it’s not 100% effective then we must conclude that it’s 0% effective, an application of the Nirvana logical fallacy); sometimes even when a vaccine isn’t completely effective, it still has some net positive effects. Continue reading “Vaccines save lives–even more evidence”

The benefits of immunization: reducing pneumonia hospitalizations

pneumonia_355pxIn this blog, I have spent an inordinate amount of time refuting claims from vaccine deniers about the effectiveness of vaccines (along with debunking claims about safety). Even if the safety claims were legitimate, and they are not, in general,  even close to being legitimate, the antivaccinationists give disproportionate weight to the adverse events over the actual benefits of the vaccination. For example, I just reviewed an article about non-medical exemptions to vaccinations, in which the authors concluded that, “the past several decades have seen a shift in parental concerns from disease prevention to vaccination risks, largely and paradoxically because of the success of large scale immunization.” 

But it’s much more than just ignoring the successes of vaccinations, sometimes the vaccine denier community will actually misrepresent and revise history, to make facetious, and easily discredited,  claims such as diseases were disappearing before vaccines. Sometimes, the vaccine refusers confuse mortality and morbidity, failing to understand how vaccines have reduced both. Or they just invent stories to show that the decline in infectious diseases was caused by anything but vaccines. Continue reading “The benefits of immunization: reducing pneumonia hospitalizations”

New 13-valent pneumococcal vaccine is safe

pneumonia_355pxA recent study, published in the journal Vaccine, provided evidence that the new 13-valent pneumococcal conjugate vaccine (PCV13) is as safe as the previous version, the 7-valent pneumococcal conjugate vaccine (PCV7). The newer version of the vaccine, introduced in 2010 after clinical trials, protects against a broader range of pneumococcus (Streptococcus pneumoniaea significant human pathogenic bacterium) subtypes. These studies show that the new version did not increase  the risk for any serious adverse events related to the vaccine.

Pneumococcal disease is a serious health care issue, especially for children and adults with certain risk factors. Pneumococcal disease can lead to various serious diseases like pneumonia and bacterial meningitis, or less serious ones like otitis media. Unfortunately, pneumococcal disease can be fatal. In some cases, it can result in long-term problems, like brain damage, hearing loss, and limb loss. Continue reading “New 13-valent pneumococcal vaccine is safe”

Consequences of not vaccinating–Report 4, meningitis and education

college_meningitisThis is the fourth in a series of reports about actual consequences from not vaccinating against infectious diseases. The reports are all based on verifiable reports from health agencies and/or articles published in high impact peer-reviewed journals. 

Bacterial meningitis is a usually severe inflammation of the protective membranes covering the brain and spinal cord, known collectively as the meninges. While most people with meningitis recover, it can cause serious complications, such as brain damage, hearing loss, or learning disabilities. For example, in the United States, about 4,100 cases of bacterial meningitis, including 500 deaths, occurred each year between 2003–2007.

There are several pathogens that can cause bacterial meningitis including Haemophilus influenzae (most often caused by type b, often called Hib), Streptococcus pneumoniae, group B StreptococcusListeria monocytogenes, and Neisseria meningitides. Depending on the pathogen, bacterial meningitis is highly contagious, especially among groups that are in enclosed areas such as schools, college dormitories and other such situations. There are other types of meningitis, viral, fungal, parasitic and non-infectious, but they are significantly different than bacterial meningitis, about which is the focus of this article. Continue reading “Consequences of not vaccinating–Report 4, meningitis and education”