Just over 160 million doses of flu vaccine will be distributed in the United States this season.
Since 2006, over 1.6 trillion doses of flu vaccine have been distributed in the United States, which equals about the combined total of all the other vaccines we use, including DTaP, rotavirus, hepatitis B, MMR, Tdap, and HPV, etc.
Overall, since we give so many more flu vaccines than any other vaccine, we can expect to get more reports of side effects from those flu vaccines.
That’s simple math.
On the other hand though, after getting a flu vaccine, you should not expect to have any extra side effects as compared to getting any other vaccine.
The urine is dark because of myoglobinuria secondary to muscle break down. Hemoglobinuria, from blood, is the other thing that makes urine dark. Photo Kumar et al (CC BY-NC-SA 3.0 US).
Children with rhabdomyolysis have severe muscle pain, muscle weakness, and dark urine.
It is classically caused by exercising too much (really overdoing it or exercising a lot more or a lot longer than you typically do) and damaging your muscles, leading to a breakdown of muscle cells and the release of creatine kinase, which in addition to muscle symptoms, can lead to kidney failure.
In addition to exercise, rhabdomyolysis can be caused by seizures, drugs, toxins, insect stings, snake bites, metabolic disorders, infections (viral myositis), and trauma.
“The most common causes of pediatric rhabdomyolysis were viral myositis (38%), trauma (26%), and connective tissue disease (5%).”
Mannix et al on Acute Pediatric Rhabdomyolysis: Causes and Rates of Renal Failure
Keep in mind that rhabdomyolysis is rare. You won’t confuse the aches and pains that most kids get, and which often get blamed on growing pains, with rhabdomyolysis. Although younger kids don’t always have dark urine when they have rhabdo, the pain and weakness is severe. Seek immediate medical attention if you think that your child might have rhabdomyolysis.
Can Vaccines Cause Rhabdomyolysis?
It is well known that rhabdomyolysis can be caused by infections.
“Rhabdomyolysis has been reported to be associated with a variety of viral infections, including influenza, [15,16] Coxsackie virus, human immunodeficiency virus (HIV), echovirus and cytomegalovirus [17]. In our series, the definite viral infection was identified in 5 patients (influenza type B in 4, Coxsackie A10 in 1)”
Chen et al on Clinical spectrum of rhabdomyolysis presented to pediatric emergency department
So if a natural influenza virus infection can cause rhabdomyolysis, does that mean that the flu vaccine can too? What about other vaccines?
Not necessarily, but there are a few case reports that associate vaccines with rhabdomyolysis.
“Influenza A infection has been described as a major viral cause of infection-induced rhabdomyolysis, but to date, only one reported case was described as having been induced by influenza vaccine.”
Callado et al on Rhabdomyolysis secondary to influenza A H1N1 vaccine resulting in acute kidney injury.
In several of the reports, patients already had chronic medical problems for which they were being treated. Still, no signal was found to suggest that the flu vaccine is a problem for these patients.
It is important to note that reports of post-vaccination rhabdomyolysis in healthy people are even rarer.
So while it is could be possible that vaccines are rarely associated with rhabdomyolysis, we know that many infections, including many vaccine-preventable diseases, are a more common cause.
Don’t skip or delay a vaccine because you might have heard that vaccines cause rhabdomyolysis.
It turns out, they say, that the FDA has admitted that the government is recommending untested, unlicensed vaccines for pregnant women.
Is that true?
Did the FDA Admit That the Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women?
Of course not!
Their evidence?
A response to a Freedom of Information Act request for vaccines that don’t exist. That’s right, neither Tdap nor flu vaccines are currently FDA approved for use by pregnant women.
Of course, that doesn’t mean that Tdap and flu vaccines aren’t recommended for use by pregnant women.
Wait, why the difference?
Why are pregnant women being given a vaccine that isn’t formally FDA approved for their use?
Well, vaccine manufacturers have to seek FDA approval for their products. The FDA doesn’t just up and approve new products or give them new indications. And none have ever sought approval in pregnancy.
But that doesn’t keep health experts from making off-label recommendations, such as getting a flu vaccine when you are pregnant.
“In prelicensure evaluations, the safety of administering a booster dose of Tdap to pregnant women was not studied. Because information on use of Tdap in pregnant women was lacking, both manufacturers of Tdap established pregnancy registries to collect information and pregnancy outcomes from pregnant women vaccinated with Tdap. Data on the safety of administering Tdap to pregnant women are now available.”
Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (Tdap) in Pregnant Women and Persons Who Have or Anticipate Having Close Contact with an Infant Aged <12 Months — Advisory Committee on Immunization Practices (ACIP), 2011
As important as FDA approval is a recommendation from the Advisory Committee on Immunization Practices (ACIP). In fact, even after a vaccine gets approved by the FDA, it still has to get a recommendation from the ACIP before it gets on the immunization schedule and is used routinely!
“Flu shots have been given to millions of pregnant women over many years with a good safety record. There is a large body of scientific studies that supports the safety of flu vaccine in pregnant women and their babies.”
Flu Vaccine Safety and Pregnancy
Getting a flu vaccine during pregnancy is a recommendation that has been evolving since 1983. It was known to be safe then, and we are even more confident that it is safe now.
A Tdap shot has been recommended since 2011, although it was first suggested in 2008 that pregnancy was not a contraindication for receiving Tdap.
How do we know these vaccines are safe during pregnancy?
The Vaccine Safety Datalink has published more than 14 studies “related to pregnancy and vaccination during pregnancy” and has used “data to study the health of children born to women who were vaccinated during pregnancy.”
Despite what Robert F. Kennedy, Jr and his ironically named Children’s Health Defense organization might think, Tdap and flu shots in pregnancy have been well studied and have been found to be safe.
Ignoring all of the above studies, Kennedy highlights a few that he thinks found problems with flu shots in pregnancy, including one that showed “a suggestion of increased ASD risk among children whose mothers received an influenza vaccination in their first trimester,” a suggestion that was not statistically significant and which was not found in the other trimesters. And another that found an increased risk of spontaneous abortion in women who had also received a flu shot in the previous season, a safety signal that has never been seen before and which continues to be investigated.
Not surprisingly, his latest bombshell is landing with as big of a thud as his HHS lawsuit, as have most of his statements these days…
“CHD’s Chairman Robert F. Kennedy, Jr. notes that most flu shots given to pregnant women still contain a mercury-based preservative thimerosal.”
FDA Admits That Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women
Has Kennedy missed the fact that 80% of flu vaccines are now thimerosal free? It makes you wonder how he defines the word “most?”
“Thimerosal is acknowledged by Proposition 65 in California as a reproductive toxicant and exposure during pregnancy can cause learning and behavioral problems. Tdap contains aluminum, which FDA regulates as a toxin in parenteral nutrition but not in vaccines.”
FDA Admits That Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women
And what is he concerned about in thimerosal-free flu shots which also don’t contain aluminum? Are those okay in his book?
Mostly, after several flu seasons in which so many people have died, you have to wonder what his goal is here. Does Robert F. Kennedy, Jr. expect folks to skip getting a flu shot when they are pregnant and instead risk getting the flu? Should they skip their Tdap shot and risk their baby dying of whooping cough?
While H1N1 seems to be the most frequently identified influenza virus type this year, in reality, since causing the “swine flu” pandemic in 2009, this strain of flu virus never really went away.
It instead became a seasonal flu virus strains.
So it is back again this year, but just like it was back during the 2013-14 and 2015-16 flu seasons.
Is that good news or bad news?
In general, it’s good news, as “flu vaccines provide better protection against influenza B or influenza A (H1N1) viruses than against influenza A (H3N2) viruses.”
“The 2009 H1N1 influenza virus (referred to as “swine flu” early on) was first detected in people in the United States in April 2009. This virus was originally referred to as “swine flu” because laboratory testing showed that its gene segments were similar to influenza viruses that were most recently identified in and known to circulate among pigs. CDC believes that this virus resulted from reassortment, a process through which two or more influenza viruses can swap genetic information by infecting a single human or animal host. When reassortment does occur, the virus that emerges will have some gene segments from each of the infecting parent viruses and may have different characteristics than either of the parental viruses, just as children may exhibit unique characteristics that are like both of their parents. In this case, the reassortment appears most likely to have occurred between influenza viruses circulating in North American pig herds and among Eurasian pig herds. Reassortment of influenza viruses can result in abrupt, major changes in influenza viruses, also known as “antigenic shift.” When shift happens, most people have little or no protection against the new influenza virus that results.”
Origin of 2009 H1N1 Flu (Swine Flu): Questions and Answers
The only reason we were so concerned about this strain of H1N1 in 2009 was because it was new.
Still, even in a good year, it is important to remember that a lot of people die with the flu, including a lot of kids. And most of them are unvaccinated.
So while it might be interesting to talk about which flu virus strain is going around, just remember that your best protection against that strain is a yearly flu vaccine.
