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Reproduced from original article:
- Abnormal hormonal exposures in pregnancy can influence fetal brain development, and research published in 2014 warned acetaminophen is in fact a hormone disruptor
- According to that 2014 study, use of acetaminophen during pregnancy was associated with a 37% increased risk of the child being diagnosed with hyperkinetic disorder, a severe form of attention deficit hyperactivity disorder (ADHD)
- A 2019 study found that, compared to children of mothers with the lowest acetaminophen burden, children of mothers with the greatest exposure had a 286% higher risk for ADHD and a 362% higher risk for autism spectrum disorder (ASD) by the time they were about 9 years old
- Findings published in 2016 revealed use of acetaminophen at 18 and 32 weeks of pregnancy were associated with a 42% higher risk of conduct problems and a 31% higher risk of hyperactivity symptoms in the child
- Another 2016 investigation found children of both sexes whose mothers used acetaminophen during pregnancy were 41% more likely to present with ADHD symptoms at age 5. Boys were also more likely to have ASD
Many view over-the-counter (OTC) drugs as safe because they don’t require a prescription. Nothing could be further from the truth. Acetaminophen, for example, (also known as paracetamol and sold under the brand name Tylenol among others) is actually one of the more dangerous drugs you can get your hands on.
Despite statistics showing acetaminophen is the leading cause of acute liver failure in the U.S.,1 most people don’t think twice before downing those pills. Acetaminophen is also found in a wide variety of products designed to treat headache, fever and cold symptoms, as well as in prescription pain medications mixed with codeine or hydrocodone.2 And, most households have more than one of the over-the-counter products, which could easily lead to overdosing.
Although it was initially hailed as a safe drug for pain, by 2013 lawsuits were piling up, citing 50,000 trips to the emergency room every year, all due to Tylenol causing liver and kidney failure.3 The grim truth is that as early as 2005 scientists already knew that “severe acetaminophen hepatotoxicity leads to acute liver failure.”4
Not only that, reports also showed that unintentional overdoses accounted for hundreds of suicide attempts, deaths and liver transplants. Along that line, statistics from national database analyses in 20065 showed that acetaminophen accounted for an estimated 56,000 emergency room visits and 26,000 hospitalizations annually. The average annual death toll from acetaminophen overdose was 458.
A number of studies have also linked acetaminophen use during pregnancy with lifelong repercussions for the child, raising their risk of developing conduct disorders, hyperactivity and autism.
Acetaminophen Use Linked to Hyperactivity in Offspring
In 2014, a study in the journal JAMA Pediatrics6 revealed that “Research data suggest that acetaminophen is a hormone disruptor, and abnormal hormonal exposures in pregnancy may influence fetal brain development.” This is a significant concern, considering many pregnant women are likely to reach for an OTC pain reliever at some point during their pregnancy.
According to that 2014 study, use of acetaminophen during pregnancy was associated with a 37% increased risk of their child being diagnosed with hyperkinetic disorder, a severe form of attention deficit hyperactivity disorder (ADHD).
Their children were also 29% more likely to be prescribed ADHD medication by the time they were 7 years old. The strongest associations were observed in mothers who used acetaminophen in more than a single trimester, and the greater the frequency of use, the more likely their child was to experience behavioral problems. As reported by Forbes at the time:7
“Acetaminophen can cross the placenta, making its way to the fetus and its delicate developing nervous system. The drug is a known endocrine (hormone) disrupter, and has previously been linked to undescended testes in male infants.
Since the maternal hormone environment plays a critical role in the development of the fetus, the authors say that it’s ‘possible that acetaminophen may interrupt brain development by interfering with maternal hormones or via neurotoxicity such as the induction of oxidative stress that can cause neuronal death.’”
Similar findings were published in 2016. This study,8 also published in JAMA Pediatrics, found use of acetaminophen at 18 and 32 weeks of pregnancy was associated with a 42% higher risk of conduct problems and a 31% higher risk of hyperactivity symptoms in the child.
When the mother used acetaminophen at 32 weeks of pregnancy, the child also had a 29% higher risk of having emotional problems and a 46% higher risk of “total difficulties.”
Tylenol in Pregnancy May Double or Triple Risk of Autism
A study9,10,11 published online October 30, 2019, in JAMA Psychiatry further strengthens the link between acetaminophen use and ADHD, while also noting an increased risk for autism spectrum disorder (ASD). According to the authors:12
“Prior studies have raised concern about maternal acetaminophen use during pregnancy and increased risk of attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD) in their children; however, most studies have relied on maternal self-report …
In this cohort study of 996 mother-infant dyads from the Boston Birth Cohort, cord plasma biomarkers of fetal exposure to acetaminophen were associated with significantly increased risk of childhood attention-deficit/hyperactivity disorder and autism spectrum disorder.”
Compared to children of mothers with the lowest acetaminophen burden (first tertile, based on cord plasma biomarkers for acetaminophen), children of those in the second tertile had a 226% higher risk of being diagnosed with ADHD, and a 214% higher risk for an ASD diagnosis by the time they were about 10 years old (average age 9.8 years).
Those with the greatest (third tertile) acetaminophen burden had a 286% higher risk for ADHD and a 362% higher risk for ASD. As noted by the authors,13 their findings “support previous studies regarding the association between prenatal and perinatal acetaminophen exposure and childhood neurodevelopmental risk.”
More Evidence Against Taking Acetaminophen During Pregnancy
In addition to the studies already mentioned, a number of others have also documented this disturbing link between acetaminophen use during pregnancy and neurological problems in the children. Among them:
•A 2013 study14 published in the International Journal of Epidemiology found “children exposed to [acetaminophen] for more than 28 days during pregnancy had poorer gross motor development, communication, externalizing behavior, internalizing behavior and higher activity levels” than unexposed children at age 3. Use of ibuprofen was not associated with these neurodevelopmental effects.
•A 2016 Spanish investigation15,16 published in the International Journal of Epidemiology found children of both sexes whose mothers used acetaminophen during pregnancy were 41% more likely to present with ADHD symptoms at age 5. Boys were also more likely to have ASD. As noted by the authors:
“Prenatal acetaminophen exposure was associated with a greater number of autism spectrum symptoms in males and showed adverse effects on attention-related outcomes for both genders. These associations seem to be dependent on the frequency of exposure.”
Aside from a higher risk of neurodevelopmental problems, studies have also shown:
•Use of acetaminophen during pregnancy may increase your risk of pre-eclampsia and thromboembolic diseases17
•Taking the drug for more than four weeks during pregnancy, especially during the first and second trimester, moderately increases the risk of undescended testicles in boys18
•Using acetaminophen in the third trimester increases your risk of preterm birth19
Acetaminophen After Birth Also Linked to Autism
The use of acetaminophen after birth may also lead to problems. In fact, some argue the increased risk of autism we see following childhood vaccinations may in fact be due to the inappropriate use of acetaminophen after the shots are given — not the vaccines.20
In my view, it seems irrational to give toxic injections a free pass, but acetaminophen administration could certainly make matters worse. A small preliminary study21 published in 2008 concluded “acetaminophen use after measles-mumps-rubella vaccination was associated with autistic disorder.”
Debunkers of the vaccine-autism connection point to statistics showing that, in the early 1980s, when the autism trend began its precipitously steep incline, vaccines were not only being added to the vaccination schedule, but pediatricians were also told to start using acetaminophen instead of aspirin, as aspirin had been linked to Reye’s syndrome.22
A 2017 study23 even claims “The use of acetaminophen in babies and young children may be much more strongly associated with autism than its use during pregnancy, perhaps because of well-known deficiencies in the metabolic breakdown of pharmaceuticals during early development.”
While parents give babies and infants Tylenol for numerous reasons, one instance in which Tylenol is routinely used is after childhood vaccinations, and according to research24 published in the journal Lancet in 2009, acetaminophen might actually render vaccinations less effective when administered together, which is yet another reason to avoid giving acetaminophen to your baby.
Infants who received acetaminophen right after getting a vaccination experienced lowered immune response, developing significantly fewer antibodies against the disease they were vaccinated against.
The vaccines used in the study were for pneumococcal disease, Haemophilus influenzae type b (Hib), diphtheria, tetanus, whooping cough, hepatitis B, polio and rotavirus. The authors concluded that:
“Although febrile reactions significantly decreased, prophylactic administration of antipyretic drugs at the time of vaccination should not be routinely recommended since antibody responses to several vaccine antigens were reduced.”
Understand the Risks Associated With Acetaminophen
Pregnant women are not the only ones that need to be careful in their use of this common pain reliever and fever reducer. Acetaminophen overdose is responsible for nearly half of all acute liver failure cases in the U.S.,25 and its use has also been linked to three serious skin reactions; two of which typically require hospitalization and can be fatal.
These problems can happen to anyone. A major problem is that while acetaminophen is considered safe when taken as recommended, the margin between a safe dose and a potentially lethal one is very small.
Provided you have a healthy liver and do not consume more than three alcoholic beverages a day, the recommended oral dose of acetaminophen is up to 1,000 milligrams (mg) every four to six hours, not to exceed 3 grams (3,000 mg) per day.26 As noted by U.S. San Diego Health:27
“To appreciate how easy it is to exceed the safe limit, consider that one extra strength Tylenol tablet contains 500 mg of acetaminophen. Take two tablets at a single dose three times a day and you are at the maximum recommended dose.
If you then inadvertently consume an acetaminophen-containing allergy medication or cold medication in addition, you risk damaging your liver … The key is to be aware of how much acetaminophen you are consuming.”
What’s more, research28 has shown taking just a little more than the recommended dose over the course of several days or weeks (referred to as “staggered overdosing”) can be riskier than taking one large overdose. So, in summary, please be aware that your risk of severe liver injury and/or death increases if you:
- Take more than one regular strength (325 mg) acetaminophen when combined with a narcotic analgesic like codeine or hydrocodone.
- Take more than the prescribed dose of an acetaminophen-containing product in a 24-hour period.
- Take more than one acetaminophen-containing product at the same time — Make sure to read the list of ingredients on any other over-the-counter (OTC) or prescription drug you take in combination.
- Drink alcohol while taking an acetaminophen product — Research29,30 suggests acetaminophen increases your risk of kidney damage by 123% if taken with alcohol, even if the amount of alcohol is small.
Why You Should Keep NAC in Your Medicine Cabinet
Given their health risks, I generally do not recommend using acetaminophen-containing drugs for minor aches and pains. There are many other ways to address acute and chronic pain that do not involve taking a medication. For a long list of pain-relieving alternatives, please see this previous article.
That said, pain relievers like acetaminophen do have their place. Post-surgical pain, for example, or other severe pain may warrant its temporary use. For those instances, I recommend taking it along with N-acetyl cysteine (NAC), which is the rate-limiting nutrient for the formation of the intracellular antioxidant glutathione.
It is believed that the liver damage acetaminophen causes is largely due to the fact that it can deplete glutathione, an antioxidant compound secreted by your liver in response to toxic exposure. Glutathione also helps protect your cells from free radical damage.
NAC is the standard of care in cases of acetaminophen overdose, approved in 1985 by the FDA as an antidote for acetaminophen toxicity.31 Mortality due to acetaminophen toxicity has been shown to be virtually eliminated when NAC is promptly administered. So, whether you are taking Tylenol in prescription or over-the-counter form, I strongly suggest taking NAC along with it.
Keep in mind, however, that there’s no data showing whether taking NAC would ameliorate the autism or ADHD risk for pregnant women, so if you’re pregnant, I would recommend just avoiding acetaminophen. If you absolutely need an OTC pain reliever, ibuprofen appears to be a safer choice. The same caveat for lack of data goes for infants.
Tips for a More Toxin-Free Pregnancy
I believe it’s imperative to be aware of, and abstain from, as many potential neurotoxins as possible during pregnancy to protect the health of your child. Our environment is saturated with such a wide variety of toxins, and you may not be able to defend yourself against each and every one of them, but you do have a great degree of control within your own immediate household.
The food and drinks you ingest, and the household, personal care and medical products you opt to use during pregnancy can have a distinct impact on your child’s development and long-term health.
ADHD and autism have both skyrocketed in prevalence the past few decades, signaling that something is going terribly wrong. Our environment is becoming overly toxic, and children are paying the price for our chemical-laden lifestyles. OTC drugs like acetaminophen are part of this toxic burden that infants have to contend with.
Avoiding any and all unnecessary drugs is one aspect you have a large degree of control over. Below are several more. Rather than compile an endless list of what you should avoid, it’s far easier to focus on what you should do to lead a healthy lifestyle with as minimal a chemical exposure as possible. This includes:
|As much as you’re able, buy and eat organic produce and grass fed, pastured animal foods to reduce your exposure to agricultural chemicals like glyphosate. Steer clear of processed, prepackaged foods of all kinds. This way you automatically avoid pesticides, artificial food additives, dangerous artificial sweeteners, food coloring, MSG and unlabeled genetically engineered ingredients.
Also avoid conventional or farm-raised fish, which are often heavily contaminated with PCBs and mercury. Wild caught Alaskan salmon is one of the very few fish I still recommend eating, as well as small fatty fish like anchovies, sardines, mackerel and herring. If you don’t eat these on a regular basis, consider taking a krill oil supplement to optimize your omega-3 level.
|Store your food and beverages in glass rather than plastic, and avoid using plastic wrap and canned foods to avoid exposure to plastic chemicals known to disrupt endocrine function.|
|Install an appropriate water filter on all your faucets (even those in your shower or bath).|
|Only use natural cleaning products in your home.|
|Switch over to natural brands of toiletries such as shampoo, toothpaste, antiperspirants and cosmetics. The Environmental Working Group has a great database32 to help you find safer personal care products. I also offer one of the highest quality organic skin care lines, shampoo and conditioner, and body butter that are completely natural and safe.|
|Avoid using artificial air fresheners, dryer sheets, fabric softeners or other synthetic fragrances. Relinquish the idea that fragrance equals “clean.” It doesn’t. Clean laundry need not smell like anything at all.|
|Replace your nonstick pots and pans with ceramic or glass cookware to avoid toxic PFOA chemicals.|
|When redoing your home and/or shopping for baby items, look for “green” toxin-free alternatives. Avoid plastic toys, especially teething toys, and make sure items like mattresses, car seats and nursing pillows do not contain toxic flame retardant chemicals.|
|Replace your vinyl shower curtain with one made of fabric, or install a glass shower door. Most all flexible plastics, like shower curtains, contain dangerous plasticizers like phthalates.|
|Avoid spraying pesticides around your home or insect repellants that contain DEET on your body. There are safe, effective and natural alternatives.|
- 1 Mayo Clinic, Acute Liver Failure
- 2 DrugWatch.com
- 3 American Council on Science and Health September 11, 2017
- 4 Hepatotology November 29, 2005
- 5 Pharmacoepidemiol Drug Saf. 2006 Jun;15(6):398-405
- 6 JAMA Pediatrics April 2014
- 7 Forbes February 24, 2014
- 8 JAMA Pediatrics 2016;170(10):964-970
- 9 JAMA Psychiatry October 30, 2019 DOI: 10.1001/jamapsychiatry.2019.3259
- 10 Fox5 New York October 31, 2019
- 11 Daily Mail October 30, 2019
- 12 JAMA Psychiatry October 30, 2019 DOI: 10.1001/jamapsychiatry.2019.3259, Abstract and Key Points
- 13 JAMA Psychiatry October 30, 2019 DOI: 10.1001/jamapsychiatry.2019.3259, Conclusions and Relevance
- 14 International Journal Of Epidemiology December 2013; 42(6): 1702-1713
- 15 International Journal of Epidemiology 2016 Dec 1;45(6):1987-1996
- 16 Medical News Today August 19, 2016
- 17 J Matern Fetal Neonatal Med. 2010 May;23(5):371-318
- 18 Epidemiology 2010 Nov;21(6):779-85
- 19 International Journal of Epidemiology 2009; 38: 706-714 (PDF)
- 20, 22 Real Clear Investigations April 13, 2018
- 21 Autism 2008 May;12(3):293-307
- 23 Int Med Res. 2017 Apr;45(2):407-438
- 24 Lancet 2009 Oct 17;374(9698):1339-50
- 25 Hepatology 2004 Jul;40(1):6-9
- 26, 27 US San Diego Health June 29, 2018
- 28 British Journal of Clinical Pharmacology 2012 Feb;73(2):285-94
- 29 Medical News Today November 4, 2013
- 30 141st annual American Public Health Association Meeting, Online Program
- 31 Guidelines for the Management of Acetaminophen Overdose (PDF)
- 32 EWG Skin Deep Database
Reproduced from original article:
- Secondary infections such as pneumonia and other respiratory diseases, as well as sepsis, are included in “influenza death” statistics, and account for a majority of deaths attributed to influenza every year
- U.S. Centers for Disease Control and Prevention data have repeatedly demonstrated that the flu vaccine does not work for seniors. The 2018/2019 flu vaccines against influenza A and B viruses had an adjusted effectiveness rating of just 12% for those over age 50
- Studies have also demonstrated that influenza vaccination has little or no impact on mortality among the elderly
- The flu vaccine is routinely recommended for all pregnant women during any trimester, yet some scientific evidence suggests it could place their pregnancy at risk. Research funded by the CDC found an association between flu vaccination during pregnancy and an eightfold risk of miscarriage
- Injury following influenza vaccination is now the most compensated claim in the federal Vaccine Injury Compensation Program (VICP). Between January 1, 2006, and December 31, 2017, a total of 3,575 injury claims for flu vaccine were filed
Flu season is creeping up on us again and there are widespread calls to get your annual flu shot, despite the fact that, year after year, this strategy turns out to have an abysmal rate of effectiveness across the board. One group that consistently turns out to draw the short end of the stick when it comes to influenza vaccine failures is the elderly. U.S. Centers for Disease Control and Prevention (CDC) data have repeatedly demonstrated that the flu vaccine does not work for seniors.
Pregnant women are another group that should carefully evaluate the risks and failures of influenza vaccine. The CDC recommends routine flu shots for women during any trimester in every pregnancy, but some scientific evidence suggests it could place their pregnancies at risk.
I’ve written many articles questioning the scientific basis for routine influenza vaccination in general. Here, my focus is the elderly and pregnant women, as there is scientific evidence detailing risks of flu vaccination for both groups.
First, though, I want to remind you of a little-known fact about influenza mortality estimates: Secondary infections such as pneumonia and other respiratory diseases, as well as sepsis,1 are included in “flu death” statistics, and account for a majority of deaths attributed to influenza every year.
Beware of Sepsis
As discussed in a Health magazine article2 published 2018, the symptoms of sepsis can actually mimic influenza symptoms — with disastrous results. In this particular case, a strep infection progressed to sepsis, which presented as influenza and, unfortunately, led to the amputation of the woman’s arms and legs. She says:3
“… if you have a fever that doesn’t go away or your body temperature is abnormally low, you have signs of any type of infection (whether it’s a cold or a UTI) that’s not getting better, you feel confused, or are in a lot of pain, go to your doctor and ask about sepsis.”
To learn more about sepsis and its treatment, see “Recognizing the Signs and Symptoms of Sepsis” and “Sepsis Is a Top Cause of Death in Hospitals.” It’s worth finding out about a relatively new sepsis treatment using intravenous vitamin C, hydrocortisone and thiamine, discussed in these articles.
The treatment has been shown to be extremely effective — far more so than conventional treatments — but many hospitals have yet to make it routinely available, which means it can be difficult to convince them to use it. It’s worth a try, though.
Why Is the Flu Vaccine so Ineffective?
It’s important to remember that the influenza vaccine contains only three or four type A or B vaccine strain influenza viruses, of which there are hundreds. So, even if those vaccine strain viruses are a perfect match for influenza viruses that are circulating in a given flu season, the vaccine does not prevent the majority of other respiratory infections that make people sick and often mistake for influenza unless lab testing is done.4
Twice a year, the World Health Organization issues recommendations on the composition of the upcoming season’s flu vaccines. For the 2019/2020 season, trivalent vaccines distributed in the U.S. will contain:5,6,7
- A/Brisbane/02/2018 (H1N1)pdm09-like virus
- A/Kansas/14/2017 (H3N2)-like virus
- B/Colorado/06/2017-like (Victoria lineage) virus
Quadrivalent vaccines will contain the three above, plus B/Phuket/3073/2013-like (Yamagata lineage) virus. The selected strains for this year are anticipated to improve coverage. In Australia, where the flu season got an early start in the Southern Hemisphere, health officials told people to get vaccinated because it could be an unusually severe season.8 The predominant influenza viruses circulating in Australia this year have been H3N2 influenza A virus followed by influenza B virus.9
In the U.S., health officials have said that the selection of influenza viruses for inclusion in the vaccine this year occurred later than usual. There are reports that flu vaccine production and shipments have been delayed and there will a shorter window of opportunity to get vaccinated.10
A study11 published in 2018 sheds some much-needed light on unvaccinated individuals at risk for influenza and how as many as half of unvaccinated people infected with influenza do not know they have it. Researchers found that “approximately 1 in 5 unvaccinated children and 1 in 10 unvaccinated adults were estimated to be infected by seasonal influenza annually, with rates of symptomatic influenza roughly half of these estimates.”
Flu Vaccine Effectiveness Has Always Been Low
Historically, regardless of how well-matched the vaccine is to circulating strains, your chances of getting influenza after vaccination are still greater than 50/50 in any given year. According to CDC data updated September 10, 2019,12 the 2018/2019 flu vaccine (all vaccine types) against influenza A or B viruses had an adjusted effectiveness rating of:
|29% for all ages|
|49% for children aged 6 months through 8 years|
|6% for children ages 9 through 17|
|25% for adults between the ages of 18 and 49|
|12% for those over 50|
|12% for those over 65|
Ironically, despite offering no protection for more than two-thirds of the population, health officials in February touted higher numbers, calling them a great success, as the numbers they had at that time outperformed the 2017/2018 vaccine. Obviously, as the Southern Hemisphere’s season wore on, the numbers wore down, and they’re just as abysmal, if not more so, than other years.13
The 2017/2018 seasonal influenza vaccine’s adjusted overall effectiveness for the U.S. was just 36% against influenza A and influenza B virus infection.14,15 To put this into context, gargling with tea has been shown to lower your relative risk of the flu by 30%.16
Between 2005 and 2015, the flu vaccine’s adjusted overall effectiveness was less than 50% more than half the time — with a low of only 10% in the 2004/2005 season.17,18
Vaccinated Individuals Pose a Hidden Threat to Public Health
It’s also important to realize that you can get vaccinated, show few or no symptoms of infection, and still shed and transmit influenza to other people.19,20 This scientific fact flies in the face of statements claiming that vaccination is a “social responsibility” that “protects others around you, including family, friends, co-workers and neighbors.”21
In reality, after vaccination, you may actually become a contagious silent carrier of disease. A person with influenza who fully expresses symptoms of fever, body aches, cough and other signs of respiratory illness would likely stay at home. However, a vaccinated individual, who is silently contagious, would go to work and into stores and other public places and be unaware they are spreading infection.
This is an especially important fact for vaccinated health care workers, who move freely among patients in hospitals and other medical facilities because everyone assumes vaccinated medical personnel are “immune” to influenza if they get a flu shot every year.
A study22 published in the journal PNAS January 18, 2018, showed that people who receive the seasonal flu shot and then contract influenza excrete infectious influenza viruses through their breath.
What’s more, those vaccinated two seasons in a row have a greater viral load of shedding influenza A viruses. According to the authors, “We observed 6.3 times more aerosol shedding among cases with vaccination in the current and previous season compared with having no vaccination in those two seasons.”
They also note that other studies suggest annual flu vaccination leads to reduced protection against influenza, which means each vaccination is likely to make you progressively more prone to getting sick.
A 2014 paper23 also reveals how priming your immune system with influenza vaccine can make you more susceptible to infection from other viral and bacterial pathogens. This phenomenon is an effect inherent in what’s known as “heterologous immunity.”
Year After Year, Flu Vaccine Proves Useless for Seniors
As mentioned, the 2018/2019 flu vaccine had an adjusted effectiveness rating of just 12% for those ages 50 and above,24 but the full range was between a negative 12% to a positive 31% for ages 50 to 64 and a negative 29 to 41 in those over age 65. That means that for some people, vaccination actually made them more susceptible to infection. Unfortunately, the 9- to 17-year-old group also had a negative confidence interval.
For infections caused by the A(H3N12) virus, the statistics were even more worrisome, with a mere overall adjusted effectiveness of 9% for all ages. For A(H1N1) the numbers were better at 44% — but it’s worth noting that the CDC chose to lump all ages together in that report, rather than breaking them down by age (something they had done earlier in the year, and which they had done for all past years). For example:
- In 2017/2018,25,26 the adjusted influenza vaccine effectiveness for all vaccine types against influenza A viruses for people aged 50 through 64 was 20% (range: -5% to 39%); for those over the age of 65 it was 11% (range: -8% to 38%)
- In 2016/2017,27 the adjusted effectiveness for all vaccine types against influenza A or B viruses for those aged 50 through 64 was 40% (range: 24% to 53%), and those over 65 was 20% (range: -11% to 43%). This despite the fact that the vaccine for the 2016/2017 season was well-matched to the viruses in circulation28
Studies29,30 have also demonstrated that influenza vaccination has no impact on mortality among the elderly. As noted in one such study,31 “Because fewer than 10 percent of all winter deaths were attributable to influenza in any season, we conclude that observational studies substantially overestimate vaccination benefit.”
Research32 published in 2006 analyzed influenza-related mortality among the elderly population over age 65 in Italy, where flu vaccination coverage between 1970 and 2001 had significantly increased. Here too, investigators found no corresponding decline in deaths. According to the authors:
“These findings suggest that either the vaccine failed to protect the elderly against mortality (possibly due to immune senescence), and/or the vaccination efforts did not adequately target the frailest elderly. As in the U.S., our study challenges current strategies to best protect the elderly against mortality, warranting the need for better controlled trials with alternative vaccination strategies.“
Another 2006 study,33 which followed 72,527 seniors for eight years, showed that, even though seniors vaccinated against influenza had a 44% reduced risk of dying during flu season compared to unvaccinated seniors, those who were vaccinated were also 61% less like to die before the flu season ever started — a finding attributed to the “healthy user” effect.
According to the authors, “the magnitude of the bias demonstrated by the associations before the influenza season was sufficient to account entirely for the associations observed during influenza season.” In other words, the vaccine played no role whatsoever in reducing the risk of death during flu season.
Research trying to ascertain whether flu vaccination has any impact on hospitalization rates among the elderly has found it difficult to draw any conclusions due to rampant bias. As noted in a 2019 study34 in the journal Vaccine:
“… 22 studies were included in the systematic review. Overall, two studies (9%) were deemed at moderate risk of bias, thirteen (59%) at serious risk of bias and seven (32%) at critical risk of bias.
For outpatient visits, we found modest evidence of protection by the influenza vaccine. For all-cause hospitalization outcomes, we found a wide range of results, mostly deemed at serious risk of bias.
The included studies suggested that the vaccine may protect older adults against influenza hospitalizations and cardiovascular events. No article meeting our inclusion criteria explored the use of antibiotics and ILI hospitalizations. The high heterogeneity between studies hindered the aggregation of data into a meta-analysis.”
Cell-Based Flu Vaccine No Better Than Egg-Based
The “new and improved” flu shot, Flucelvax — a cell-based35 rather than egg-based vaccine — introduced during the 2017-2018 flu season, has also demonstrated disappointing results. Research by the U.S. Food and Drug Administration found it protected just 26.5% of those over the age of 65.36
A study37 published September 2019, “Comparison of Vaccine Effectiveness Against Influenza Hospitalization of Cell-Based and Egg-Based Influenza Vaccines, 2017-2018” also concluded that:
“For any influenza, the adjusted relative VE [vaccine effectiveness] of cell-based vaccine versus egg-based vaccines was 43% for patients ages < 65 years and 6% for patients ages ≥ 65 years.
For influenza A(H3N2), the adjusted relative VE was 61% for patients ages < 65 years and −4% for patients ages ≥ 65 years. Statistically significant protection against influenza hospitalization of cell-based vaccine compared to egg-based vaccines was not observed …”
Is Flu Vaccine Safe for Pregnant Women?
Historically, pregnant women have been discouraged from taking drugs and vaccines because there’s very little scientific data evaluating risks for the pregnant woman or the growing fetus. Including pregnant women in clinical trials has been considered unethical because there are unknown risks for both mother and child.
For better or worse, that is changing. In 2018, the FDA issued nonbinding recommendations38 for industry detailing when and how pregnant women can be enrolled in clinical trials for drugs and therapies.
Coincidentally, the increased push for women to get flu shots during any trimester in every pregnancy seems to coincide with an amendment to the 1986 National Childhood Vaccine Injury Act that was included in the 21st Century Cures Act passed by Congress at the end of 2016.
The amendment gives a liability shield to drug companies producing CDC-recommended vaccines for pregnant women so they can’t be sued if a pregnant woman or her child developing in the womb born alive suffers injury from maternal vaccinations.39
As noted by Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center in a public statement given at a hearing September 17, 2018:40
“This is a stunning expansion of vaccine product liability protection for the pharmaceutical industry in a 1986 tort reform Act that created a federal compensation program option for children injured by government recommended and mandated vaccines that was never intended to cover adults or be an exclusive remedy.”
Despite the lack of safety data when it comes to maternal vaccination,41 the CDC now urges all pregnant women to get vaccinated against the flu. In a 2018 article,42 CNN quotes Dr. Laura E. Riley, professor and chair of the department of obstetrics and gynecology at Weill Cornell Medicine, saying “The flu vaccine is safe and effective for both pregnant women and their fetuses” and can be given during any trimester.
A definitive statement like that deserves strong supporting evidence, but not only is safety data for pregnant women sorely lacking, some of the data published in the medical literature suggests maternal vaccination may actually be deeply problematic.
Flu Vaccination Linked to Eightfold Risk of Miscarriage
Importantly, research43,44 funded by the CDC itself linked flu vaccination during early pregnancy to an eightfold risk of miscarriage. In all, 485 pregnant women aged 18 to 44 who had a miscarriage during the flu seasons of 2010/2011 and 2011/2012 were compared to 485 pregnant women who carried to term.
Women who had received an inactivated 2009 pandemic H1N1-containing flu shot the previous year were more likely to suffer miscarriage (spontaneous abortion) within 28 days of receiving another pH1N1-containing flu shot during pregnancy.
While most of the miscarriages occurred during the first trimester, several also took place in the second trimester.45,46,47 The median fetal term at the time of miscarriage was seven weeks.
Of the 485 women who miscarried, 17 had been vaccinated twice in a row — once in the 28 days prior to miscarriage and once in the previous year. For comparison, of the 485 women who had normal pregnancies, only four had been vaccinated two years in a row. CDC adviser for vaccines Amanda Cohn told The Washington Post:48
“I think it’s really important for women to understand that this is a possible link, and it is a possible link that needs to be studied and needs to be looked at over more [flu] seasons. We need to understand if it’s the flu vaccine, or is this a group of women [who received flu vaccines] who were also more likely to have miscarriages.”
Contradictory Findings Proclaimed ‘Unequivocal’ Evidence
The same researchers have now completed a second study and, this time, they found no link between flu vaccination and miscarriage. A quote by Dr. Edward Belongia, head of the Center for Clinical Epidemiology and Population Health at Wisconsin’s Marshfield Clinic, in STAT news reads:49 “For women right now who are wondering if it’s safe to get a vaccine in early pregnancy, we can say unequivocally, ‘Yes, it is safe.'”
The data, presented at a February 2019 Advisory Committee on Immunization Practice meeting, has yet to be published so I cannot give any details on the findings as of yet. I’d like to point out the obvious, though.
When the 2017 study came out, detractors were quick to point out that you can’t draw conclusions based on a single study. Yet now, they’re claiming to have “unequivocally” proven safety — based on a single study. In my view, the issue is still wide open for discussion and contemplation. Far more research needs to be done before a claim of safety can be made for women receiving influenza vaccine during pregnancy.
Categorical claims of safety cannot be made for vaccinating infants younger than 6 months against influenza, either.
The 2019 scientific review,50 “Influenza Vaccination: Effectiveness, Indications, and Limits in the Pediatric Population,” published in the journal Frontiers in Pediatrics, points out that “questions and limits about influenza vaccine in pediatric population remain open,” and that “vaccine effectiveness in children is variable and suboptimal, with reported differences according to vaccine types, seasons, and child age.” It also states that “there is no influenza vaccine that directly protects infants <6 months of age.”
Questions Abound About Vaccine Safety for Pregnant Women
In the 2013 article, “Vaccination During Pregnancy: Is it Safe?”51 Loe Fisher lists 10 vaccine facts pertaining to the lack of evidence of safety in pregnant women, including the following:
- Drug companies did not test the safety and effectiveness of giving influenza vaccine to pregnant women before the vaccines were licensed in the U.S.52,53
- Data on inflammatory and other biological responses to vaccination during pregnancy that could affect pregnancy and birth outcomes are still lacking.54 For example, it’s still unknown whether the influenza vaccine can cause fetal harm or affect your reproductive capacity,55 which is why the vaccine manufacturer product inserts state that the influenza vaccine should be given to a pregnant woman only if it’s “clearly needed.”
- The biological mechanisms of how maternal vaccination affects the immune and neurological systems of mother and child are not known. Loe Fisher points out, “There are no published biological mechanism studies that assess pre-vaccination health status and measure changes in brain and immune function and chromosomal integrity after vaccination of pregnant women or their babies developing in the womb.”
- There are very few studies comparing health outcomes between pregnant women and their children who receive the flu vaccine and those who do not.
Flu Vaccine Has Thousands of Vaccine Injury Filings
Importantly, injury following influenza vaccination is the most compensated claim in the federal Vaccine Injury Compensation Program (VICP). Between January 1, 2006, and December 31, 2017, a total of 3,575 injury claims for flu vaccine were filed, 3,057 of which were compensated.56 Being one of the riskiest vaccines, based on VICP injury filings and awards, is it really wise to proclaim the flu vaccine is safe for all pregnant women at all times?
Influenza vaccine package inserts57,58,59 will also inform you that flu vaccine safety and effectiveness have not been established in pregnant or breastfeeding women. This means there is a lack of scientific evidence demonstrating conclusively that pregnant women will benefit from flu vaccination or that getting vaccinated during pregnancy is, in fact, safe.
If safety and effectiveness have not been scientifically established through methodologically sound and rigorously controlled, replicated studies, the issue is still open for debate, and that’s certainly true when it comes to vaccinating pregnant women.
Sanofi Pasteur’s patient information sheet60 for Fluzone quadrivalent vaccine states that “Sanofi Pasteur Inc. is collecting information on pregnancy outcomes and the health of newborns following vaccination with Fluzone Quadrivalent during pregnancy.”
The American College of Obstetricians and Gynecologists also tracks vaccine safety for pregnant women after the fact, while claiming it’s perfectly safe to receive the flu vaccine during pregnancy.61 The sad reality is that pregnant women who are given influenza vaccinations during any trimester during every pregnancy are basically participating in an uncontrolled experiment. They just don’t know it.
Vaccinating During Pregnancy Is a Risky Proposition
Aside from the 2017 study linking flu vaccination to miscarriage, research has shown that stimulating a woman’s immune system — which is what vaccination does and must do to stimulate production of antibodies and artificial immunity — during midterm and later-term pregnancy significantly increases the risk that her baby will develop autism62 during childhood, and/or schizophrenia during the teenage years or early adulthood.63
Strong inflammatory responses during pregnancy may also increase the risk of seizures in the baby, and later, as an adult.64 In fact, a number of neurodevelopmental and behavioral problems can occur in babies born to women immunologically stimulated during pregnancy.65,66,67
Overall, given the uncertainty about how flu vaccination affects health in the short and long term, and the absolute unknowns about how it may affect the future health of the baby, it seems as reasonable to avoid vaccination during pregnancy as it is to avoid alcohol, smoking and exposure to other toxins.
As noted by Jeremy R. Hammond in his May 14, 2019, article, “The CDC’s Criminal Recommendation for a Flu Shot During Pregnancy,”68 the CDC relies on retrospective observational studies for its recommendation. The problem with that is that retrospective observational studies are designed to test a hypothesis. They’re not designed to prove or disprove causation and, in fact, cannot do that.
So, a finding of “no association” in an observational study does not mean that a causal relationship is nonexistent. Observational studies also make it difficult for researchers to detect unexpected harms. If they’re not specifically looking for an outcome, it likely will not show in the data.
It’s a rather long and detailed article, but well worth reading. In it, Hammond points out the hypocrisy of relying on observational data for vaccine safety, saying:69
“[W]hen Aaron E. Carroll in the New York Times advocated the CDC’s flu shot recommendations, he was telling pregnant women, too, to get vaccinated.
He was, in other words, parroting the CDC’s implicit message that we can trust that observational studies are methodologically robust enough to rule out the possibility, with a high degree of confidence, that vaccination could cause harm to the expectant mother or her child.
Yet just a few months earlier, Carroll had reassured the public that observational studies finding a link between alcohol consumption and cancer aren’t determinative and suggested that more randomized controlled trials are needed to establish what harms and benefits are associated with drinking!
As he advised Times readers in that case, ‘Don’t give too much weight to observational data’ … Why should we forego our skepticism when it comes to the lives and health of entire future generations of children? …
Carroll’s credulous acceptance of the observational studies that the CDC relies upon to support its claims is another good example of the kind of institutionalized cognitive dissonance that exists when it comes to the practice of vaccination. It has become a religion, and we are supposed to believe in the safety and effectiveness of vaccines as a matter of faith …
When it comes to vaccines, we are not supposed to concern ourselves with the methodological weaknesses of the kinds of studies the CDC relies on to support its flu shot recommendation for pregnant women.
We are not supposed to notice that the CDC’s statement that ‘there’s a lot of evidence’ that it’s safe to vaccinate pregnant women also implies that there’s at least some evidence that it is not …
[I]f pharmaceutical companies made the same claims that the CDC makes about the safety of vaccinating pregnant women, they could be sued for fraud.”
1 Virulence January 1, 2014; 5(1): 137–142
2 Health October 2, 2018 https://www.health.com/cold-flu-sinus/sepsis-left-me-an-amputee
3 Health October 2, 2018 https://www.health.com/cold-flu-sinus/sepsis-left-me-an-amputee
4 Cochrane.org http://www.cochrane.org/CD001269/ARI_vaccines-prevent-influenza-healthy-adults
5 Precisionvaccinations.com 2019-2020 Recommendations
6 CDC.gov Upcoming 2019/2020 Flu Season https://www.cdc.gov/flu/season/flu-season-2019-2020.htm
7 Pharmacy Times May 2, 2019 https://www.pharmacytimes.com/contributor/marilyn-bulloch-pharmd-bcps/2019/05/changes-in-influenza-vaccine-may-improve-coverage
8 7 News May 27, 2019 https://7news.com.au/news/health/flu-deaths-2019-australia-three-influenza-strains-causing-deadly-flu-season-c-135163
9 VaxBeforeTravel. Aug. 12, 2019. https://www.vaxbeforetravel.com/australianpharmacists-may-have-reduced-influenza-season-impact-2019
10 WFLA.com July 23, 2019 https://www.wfla.com/video/doctors-warn-of-delayed-vaccine-shipments-ahead-of-flu-season/
11 Vaccine May 311, 2018; 36(23): 3199-3207
12 CDC.gov 2018-2019 Vaccine Effectiveness https://www.cdc.gov/flu/vaccines-work/2018-2019.html
13 US News February 14, 2019 https://www.usnews.com/news/healthnews/articles/2019-02-14/flu-shot-much-more-effective-this-year-cdc-says
14 CDC.gov MMWR February 16, 2018; 67(6): 180-185
15 The Lancet April 6, 2016
16 BMC Public Health. 2016; 16: 396, Results
17 CDC, December 21, 2015 Influenza Vaccine Effectiveness: How Well Does the Flu Vaccine Work?
18 CDC, February 14, 2019
19 Clinical Infectious Diseases December 22, 2016; 64(6): 736-742
20 PLOS One December 11, 2012, DOI: 10.1371/journal.pone.0051653
21 CNN September 27, 2018 https://www.cnn.com/2018/09/26/health/flu-deaths-2017-2018-cdc-bn/index.html
22 PNAS January 18, 2018; 115(5): 1081-108
23 Journal of Leukocyte Biology 2014 Mar; 95(3): 405–416 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3923083/
24 CDC.gov 2018-2019 Vaccine Effectiveness https://www.cdc.gov/flu/vaccines-work/2018-2019.html
25 CDC.gov Influenza VE Tables for 2017-2018 https://www.cdc.gov/flu/vaccines-work/2017-2018.html
26 MD Edge February 15, 2018
27 CDC.gov, Influenza VE Tables for 2016/2017
28 Medicalxpress June 21, 2017 https://medicalxpress.com/news/2017-06-fluvaccine-ineffective-people-older.html
29 Jama Internal Medicine 2005;165(3):265-272
30 Vaccine 2006 Oct 30;24(42-43):6468-75 https://www.ncbi.nlm.nih.gov/pubmed/16876293
31 Jama Internal Medicine 2005;165(3):265-272
32 Vaccine 2006 Oct 30;24(42-43):6468-75 https://www.ncbi.nlm.nih.gov/pubmed/16876293
33 International Journal of Epidemiology April 1, 2006; 35(2): 337-344
34 Vaccine May 27, 2019; 37(24): 3179-3189
35 CDC.gov Cell-Based Flu Vaccine https://www.cdc.gov/flu/prevent/cell-based.htm
36 U.S. News & World Report, June 20, 2018
37 Vaccine September 16, 2019; 37(39): 5807-5811
38 FDA.gov, Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials, Guidance for Industry (DRAFT April 2018) (PDF)
39 National Vaccine Information Center September 18, 2018
40 National Vaccine Information Center September 18, 2018
41 Vaccine 2003; 21(24): 3487-3491
42 CNN September 27, 2018 https://www.cnn.com/2018/09/26/health/flu-deaths-2017–2018-cdc-bn/index.html
43 Vaccine September 25, 2017; 35(40): 5314-5322
44 Fortune September 13, 2017 http://fortune.com/2017/09/13/flu-vaccine-miscarriage-link-study/
45 Vaccine September 25, 2017; 35(40): 5314-5322
46 AAFP September 20, 2017 https://www.aafp.org/news/health-of-thepublic/20170920flumiscarry.html
47 CDC.gov September 13, 2017
48 Washington Post September 13, 2017
49 STAT News February 27, 2019 https://www.statnews.com/2019/02/27/new-study-finds-no-link-between-flu-shots-and-miscarriages-allaying-fears/
50 Frontiers in Pediatrics 2019; 7: 317 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6682587/
51 NVIC.org November 9, 2013 http://www.nvic.org/NVIC-VaccineNews/November-2013/Vaccination-During-Pregnancy–Is-It-Safe-.aspx
52 Vaccine 2003; 21(24): 3487-3491
53 CDC. MMWR 2011; 60(41): 1424-1426
54 Vaccine 2011; 29(48): 8982-8987
55 NVIC.org. Influenza Vaccine Package Inserts: Important Information from Manufacturers http://www.nvic.org/vaccines-and-diseases/Influenza/Influenza-Vaccine-Package-Inserts.aspx
56 HRSA.gov, VICP Adjudication Statistics, Updated September 1, 2019 (PDF)
57 Fluzone Package Insert https://www.fda.gov/media/99172/download
58 Fluarix Package Insert https://www.fda.gov/media/84804/download
59 Afluria Package Insert http://labeling.seqirus.com/PI/US/Afluria/EN/Afluria-Prescribing-Information-TIV.pdf
60 Sanofi Pasteur Patient Information Sheet Fluzone Quadrivalent Vaccine (PDF)
61 American College of Obstetricians and Gynecologists September 13, 2017
62 Excessive Vaccination and Autism, Russel Blaylock MD (PDF)
63 Journal of Neuroscience 2007; 27: 10695-10702
64 Journal of Neuroscience 2008; 28: 6904-6913
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66 Biological Psychiatry 2006; 59: 546-554
67 Brain Behavior and Immunology 2006; 20: 378-388
68 Jeremyhammond.com May 14, 2019
The above list at:
Flu Shots During Pregnancy Failed to Lower the Risk of Fetal Death, Preterm Birth and Low Birth Weight
… and For Some Outcomes Infants of Unvaccinated Moms Fared Better
© 6th August 2019 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc.
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By the Children’s Health Defense Team
Public health officials and doctors, ever more insistent that pregnant women get flu shots, are frustrated that fewer than four in ten American moms-to-be avail themselves of the recommendation. Policy-makers’ disappointment stems not just from their zeal to achieve the Healthy People 2020 goal of 80% coverage of pregnant women but also from their recognition that women who go along with vaccine recommendations during pregnancy are more acquiescent about vaccinating their newborn infants as well.
Yet maternal worries about vaccine-related harm to the fetus are widespread and operate as a principal barrier to higher pregnancy vaccine uptake. Envisioning a day when “even more vaccines” will be added to the maternal vaccine schedule, researchers are studying how to improve uptake and design more persuasive “communication interventions.” Their messaging generally emphasizes a twofold rationale for prenatal flu shots. The first and primary stated aim is to prevent influenza in mothers and babies—but researchers also assert that by preventing such infections, they may be able to prevent unwanted fetal outcomes thought to be linked to influenza infection during pregnancy.
A research team out of South Africa has just published a paper examining the second rationale, comparing four outcomes—fetal death, low birth weight, small for gestational age birth and preterm birth—for infants whose mothers received flu shots or a placebo. In their surprisingly frank conclusions, not only do the researchers report that influenza vaccination during pregnancy was ineffective in lowering risk for the four outcomes, but—ever so cautiously—they also note that the vaccinated infants fared worse.
The 2011–2012 South Africa study was one of three large double-blind, randomized, placebo-controlled trials of influenza vaccination during pregnancy funded by the Bill & Melinda Gates Foundation (BMGF). As originally described in 2014 in the New England Journal of Medicine, over 2,000 mothers received either trivalent inactivated influenza vaccines or placebo between 20 and 36 weeks of pregnancy—in other words, in their second or third (but not first) trimester of pregnancy. (In the U.S., which encourages flu shots during any trimester of pregnancy, studies have identified a heightened risk of autism in the children of women vaccinated during the first trimester.) The researchers followed up on fetal outcomes when the infants reached 24 weeks of age.
Of note, the study used an inert saline placebo. This is unusual in the context of vaccine clinical trials, which nearly always compare one group that receives the vaccine of interest against another group that receives a different vaccine (called an “active comparator”). The use of active comparators can “increase the occurrence of harms in the comparator groups and thereby [mask] harms caused by the…vaccines” being studied. In contrast, an inert placebo enhances the likelihood of detecting differences between groups, if any are present.
Overall, the investigators found “no significant vaccine efficacy” with respect to any of the fetal outcomes. Unexpectedly (to the researchers), they also found that the average gestational age at birth was lower in the vaccinated versus placebo group—a statistically significant result indicative of a greater risk of preterm birth. Although most of the study’s other findings did not attain statistical significance, the pattern of results showed, in another writer’s words, tendencies that were “not reassuring.” Across all analyses, the percentages and rates of fetal death, preterm birth, low birth weight and small for gestational age birth were higher in the vaccine group than in the placebo group. Couching their conclusions with caveats, the authors explain:
[W]e found a slight, though non-significant decrease in the birth weight of infants in the vaccinated group…as well as a non-significant increase in fetal deaths among [influenza]-vaccinated mothers. […] We point this out only as a cautionary word and suggest this observation be explored carefully in larger studies of vaccine safety data bases.
Weak, inconsistent and biased evidence
In 2017, researchers who carried out a systematic review found that “comparative studies of adverse birth outcomes following maternal influenza disease are limited in quantity and have produced inconsistent findings.” In a 2019 paper, an Italian researcher agrees, arguing that it is inappropriate to recommend across-the-board influenza vaccination of all pregnant women in the absence of “strong and consistent” randomized clinical trial evidence—particularly if one also acknowledges that current evidence often exhibits bias. Making specific reference to the South Africa clinical trial, the author notes that the trial “was funded by BMGF and by public sponsors, with the principal investigator in financial relationships with the vaccine producer, and two authors with other influenza vaccine producers.”
The author describes other results from the South Africa trial that, while again not attaining statistical significance, “were not in the expected/hoped direction.” For example, maternal hospitalizations for infections were “numerically higher” in the vaccinated group, as were severe neonatal infections. Overall, the trial produced only “18 less influenza illnesses in vaccinated mothers and their children, to be weighted…against 9 more maternal hospitalization for any infection and 6 more neonatal hospitalization due to sepsis within 28 days of birth.”
In addition to the South Africa trial, the Italian author mentions several other randomized controlled trials (RCTs) in low-income countries that compared influenza vaccination during pregnancy against meningococcal or pneumococcal vaccination; even with an active comparator, the author suggests that these trials [hyperlinks added] do not support influenza vaccination during pregnancy:
The first and larger trial substantially disregarded an alarming excess of infant deaths and serious “presumed/neonatal infections” in the influenza vaccine group. Even in the other small RCT the fetal plus infant deaths were nonsignificantly higher in the influenza vaccine group. In a last large trial the tendency for miscarriage, stillbirth, congenital defects, and infant deaths at 0-6 months were not in favour of the vaccine group. These countries are not comparable to high-income ones, but one could expect that their poverty and demographic conditions would magnify the benefits of influenza vaccination, not the opposite.
A 2013 study that evaluated adverse pregnancy outcomes following influenza vaccination of pregnant women found that “low-risk” women (that is, women without medical complications or co-morbidity) who received the vaccine during the 2009–2011 influenza seasons had an increase in a composite measure of adverse outcomes (miscarriage, fetal demise, preterm birth and neonatal demise) compared to unvaccinated pregnant women—“even after adjusting for confounding factors.” Reluctant to accept the implications of their findings, the authors stated, “We do not believe that influenza vaccination causes adverse pregnancy outcomes in low-risk women; instead our findings likely represent the result of selection bias and residual confounding.”
The same kind of avoidance was apparent in a study that investigated risks for preterm delivery and birth defects following influenza vaccination in three consecutive seasons beginning in 2011. Although the researchers found that women in the vaccinated group had a shorter gestational duration and their infants had an elevated risk of a rare abdominal wall defect called omphalocele, the investigators concluded that their results were “generally reassuring” and that “[t]he few risks that were observed are compatible with chance.”
A questionable policy
Researchers have speculated that influenza infection during pregnancy could be associated with adverse birth outcomes due to “mechanisms such as maternal fever and inflammation,” and they note that “[i]mmunological responses, such as elevated pro-inflammatory cytokine levels…are recognised as an important pathway to preterm birth.” What they generally do not acknowledge is that prenatal vaccination also introduces immune activation risks—and these risks remain scandalously understudied. Instead of bemoaning pregnant women’s “suboptimal” flu shot uptake—or dismissing the risks to a developing fetus from vaccinating the mother during pregnancy as “theoretical”—researchers and policy-makers should be putting their poorly supported pregnancy vaccination recommendations on hold. And members of the public should remember that no vaccines have ever been approved by the Food and Drug Administration (FDA) “specifically for use during pregnancy to protect the infant.”