Uh, the ACIP can’t request a license for a vaccine…
Dr. Bob and his new podcasting side kick think that the “CDC wants the FDA to approve adult doses of the flu vaccine for babies, because the normal half-doses approved for babies don’t work well enough.”
Did Dr. Bob Uncover a CDC Plot to Give Adult Flu Shots to Babies?
This is likely going to surprise Dr. Bob, but many infants already get the same dose of flu vaccine as adults.
Both FluLaval and Fluarix are given at the same 0.5ml dose, containing 15 µg of HA per vaccine virus, to infants, older children, and adults.
Fluzone, on the other hand, is still given at a 0.25ml dose, containing 7.5 µg of HA per vaccine virus, to children between the ages of 6 months to three years, and a larger 0.5ml dose to older kids and adults.
Why the differences?
“In a randomized trial comparing immunogenicity and safety of 0.5 mL FluLaval Quadrivalent with 0.25 mL Fluzone Quadrivalent, safety and reactogenicity were similar between the two vaccines.”
Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2018–19 Influenza Season
Because they are just as safe at the lower doses and might actually work better.
Then why did we ever use a lower dose for infants?
That recommendation was based on the older, whole-virus version of the flu shot, which did cause more side effects for infants when given at a full dose. We now use split-virus flu shots that don’t have this problem.
And now, the manufacturer of Fluzone has done a study, and not surprisingly, they have also found that “safety profile of a 0.5 ml (full-dose) is similar to 0.25 ml (half-dose) and may be more immunogenic.”
So they are submitting a BLA to the FDA for the use of the 0.5ml dose of their flu vaccine for infants.
What about the idea of an “adult dose of mercury” for infants?
Over 80% of flu vaccines were thimerosal free this year. You almost have to go out of your way to get your kids a flu vaccine with thimerosal, so no, this won’t mean an “adult dose of mercury” for your infant.
Most importantly though, if you understand how vaccines work, you know that the dose of vaccines for kids and adults is not calibrated by weight or age, so none of this really matters. The immune reaction that helps antibodies travel all through your body starts locally, near where the vaccine was given, so a 20-pound infant and a 200-pound adult can get the same dose of flu shot and both can be protected.
More on Dr. Bob’s CDC Plot to Give Adult Flu Shots to Babies
Thimerosal was taken out of most childhood vaccines in 2001, only remaining in muti-dose vials of flu vaccines, which could easily be avoided, as a good supply of thimersosal-free flu vaccine has been available for many years.
“Thimerosal is a mercury-based preservative that has been used for decades in the United States in multi-dose vials (vials containing more than one dose) of medicines and vaccines. There is no evidence of harm caused by the low doses of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site. However, in July 1999, the Public Health Service agencies, the American Academy of Pediatrics, and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure.”
CDC on Thimerosal in Vaccines
For some reason, that hasn’t kept some parents from still being concerned about mercury in vaccines.
Does Pentacel Contain Mercury?
Pentacel is vaccine that combines the diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and Haemophilus b conjugate (tetanus toxoid conjugate) vaccines (DTaP-IPV/Hib) into one shot.
Like most other vaccines on the childhood immunization schedule, Pentacel is mercury free.
It is routinely given to children as a four dose series, when they are 2, 4, 6, and 15 to 18 months old.
Like most other vaccines given to children, Pentacel is thimerosal-free.
After decades with a single type of flu vaccine – the flu shot – there are now many different kinds of flu vaccines that many of us can choose from. And your choices are not just between the nasal spray flu vaccine vs a flu shot. There are also a lot of different kinds of flu shots available now.
Everyone needs a flu shot. When will you get yours? Photo by Gabriel Saldana (CC BY-SA 2.0)
Having choices is nice.
It would be also be nice to have a little more guidance on what to do with these choices.
It is actually easy to start by asking which one you should get for your kids, as many of these flu vaccine options are only available for adults and seniors.
Flu Vaccine Options
Before you start thinking too long and hard about potential options, keep in mind that you might not have as many options as you think.
“Not all products are likely to be uniformly available in any practice setting or locality. Vaccination should not be delayed in order to obtain a specific product when an appropriate one is already available.”
Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2018–19 Influenza Season
Doctors and clinics might not stock multiple brands or types of flu vaccines, so you might have to get whatever flu vaccine that they have available.
“Within these guidelines and approved indications, where more than one type of vaccine is appropriate and available, no preferential recommendation is made for use of any influenza vaccine product over another.”
Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2018–19 Influenza Season
And that’s okay. In most cases, there haven’t been head to head studies showing that one flu vaccine is better than another.
Flu Vaccine Options for Kids
Still, since these options might be available to you, it is good to know about them.
This year, younger kids, between the ages of 6 months and 3 years, can either get:
FluLaval Quadrilvalent
Fluarix Quadrivalent
Fluzone Quadrivalent Pediatric
While you are unlikely to notice a difference, both FluLaval and Fluarix are given at a 0.5ml dose containing 15 µg of HA per vaccine virus, while Fluzone is given at a 0.25ml dose containing 7.5 µg of HA per vaccine virus. Why the difference? “Safety and reactogenicity were similar between the two vaccines,” even at the different doses.
Basically, these are just different brands of the same type of flu shot.
There are even more options as your kids get older though, including Fluzone Quadrivalent (age three and above), Afluria Quadrivalent or Trivalent (age five and above), Flucelvax Quadrivalent (age four and above), FluLaval and Fluarix.
Of these, some folks wonder if Flucelvax, since it isn’t made in chicken eggs, might be more effective than the others. Remember, one of the things that are thought to make the flu vaccine less effective than most other vaccines is that they are made in eggs, leading to mutations. And there is actually some evidence that those flu vaccines that are not made in eggs might be more effective.
“And the University of Pittsburgh Medical Center is taking that a step further, saying it will only be buying the two egg-free vaccines on the market: Flucelvax and FluBlok. That’s because there is some evidence these two formulations may work better than the older vaccines grown in eggs, said Dr. Richard Zimmerman, who advises the UPMC Influenza Committee.”
Guidance on which flu vaccine to get: Shots for kids, maybe go egg-free
Again, remember that the CDC has made “no preferential recommendation” for one flu vaccine over another. Why not? We don’t have enough information to make that kind of recommendation.
Should parents only ask for Flucelvax? That would only work if they made enough doses for every kid to get vaccinated, which they didn’t. Should you hold out until you can find FluceIvax for your kids? No, since doing that might leave them unvaccinated once flu season hits.
What else should you know about your flu vaccine options? While over 80% of flu vaccines are now thimerosal free, most of these flu vaccines are still available in multi-dose vials with thimerosal.
Also thimerosal free, this year, Flumist is back as an option. It is available for healthy kids who are at least two years old. Although the AAP has issued a preference for flu shots this year, the ACIP says that kids can get either Flumist or a flu shot.
What about if your kids are allergic to eggs?
“Persons who report having had reactions to egg involving symptoms other than urticaria (hives), such as angioedema, respiratory distress, lightheadedness, or recurrent emesis; or who required epinephrine or another emergency medical intervention, may similarly receive any licensed, recommended, and age-appropriate influenza vaccine (i.e., any IIV, RIV4, or LAIV4) that is otherwise appropriate for their health status.”
Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2018–19 Influenza Season
Unless they had a severe allergic reaction to a previous flu vaccine, they can get any available flu vaccine, especially if the previous reaction was only hives or they are able to eat eggs.
What if you want a flu vaccine without aluminum? Take your pick. While it would be safe it was, aluminum is not an ingredient in flu vaccines.
Flu Vaccine Options for Adults
In addition to all of the flu vaccines available for older kids, adults have a few more options:
Afluria Quadrivalent or Trivalent can be given by jet injector to those between the ages of 18 and 64 years
Flublok Quadrivalent – a recombinant flu shot that can be given to those who are at least 18 years old
Fluzone High-Dose – a trivalent flu shot with a higher dose of flu virus antigens (4 times the amount of antigen as a regular flu shot) that is available for seniors who are at least 65 years old
Fluad – a trivalent flu shot with an adjuvant that is available for seniors who are at least 65 years old
Why get a flu vaccine with a jet injector instead of a standard needle? High-pressure jet injectors don’t use needles!
Like FluceIvax, Flublok is not made in chicken eggs. The recombinant hemagglutinin(HA) proteins are made in insect cell lines. Does Flublok work better than egg based flu vaccines? That’s the theory, but again, there is no preference for one of these vaccines over another.
Seniors have even more choices.
Should they get Fluzone High-Dose, Fluad, or one of the other flu vaccines? Both have been shown to be more effective than standard flu vaccines in seniors, but they have not been compared against each other.
“In a Canadian observational study of 282 people aged 65 years and older conducted during the 2011-12 season, Fluad was 63% more effective than regular-dose unadjuvanted flu shots.”
CDC on People 65 Years and Older & Influenza
But neither Fluzone High-Dose nor Fluad are quadrivalent, so only protect against three flu virus strains.
Is there a quadrivalent flu shot for older adults that might work better than standard flu shots?
Yes. FluceIvax and Flublok are non-egg based quadrivalent flu shots that might be more effective than standard flu vaccines.
So are you more confused now that you know you have so many options? Just remember that for most people, the mistake isn’t about choosing the right flu vaccine, it is about not getting vaccinated.
What to Know About Your Flu Vaccine Options
While it might seem like you have a lot more options in a flu vaccine this year and that some might be more effective than others, keep in mind that availability will likely greatly limit these “options.”
And the best flu vaccine is the one that you actually get, as it will be the one that reduces your risk of getting the flu. Missing your chance to get vaccinated and protected because you are waiting for a specific brand or type of flu vaccine isn’t going to help keep the flu away.
Most folks will remember that on February 12, 2017, at a meeting of the Advisory Committee on Immunization Practices (ACIP), members voted to once again recommended FluMist Quadrivalent to prevent the flu. So it will be available for this year’s flu season.
Many parents and pediatricians welcomed the news, as it meant that many kids could avoid getting a shot and could get the nasal spray flu vaccine instead.
Why did flu vaccine rates drop in younger school age kids when Flumist wasn’t available?
It was especially good news for those kids who skipped getting a flu vaccine because they didn’t want to get a shot when Flumist wasn’t available.
Flumist as a Last Resort?
So what’s the problem?
“The Academy recommends pediatricians give children inactivated influenza vaccine in the upcoming season and use live attenuated vaccine only as a last resort.”
American Academy of Pediatrics
Members of the AAP Committee on Infectious Diseases (COID) are concerned that FluMist, even after it has been changed to address previous issues, may not work as well as a standard flu shot.
“Influenza is unpredictable from year to year, so we really want to immunize as many kids as we can against the flu with what we think will be the most effective product. That’s why we’re recommending the flu shot this coming season.”
Henry H. Bernstein, D.O., M.H.C.M., FAAP
While many of us were surprised by the “last resort” phrasing from the AAP, maybe we shouldn’t have been.
In addition to being an ex officio member of the AAP Committee on Infectious Diseases (COID), Henry H. Bernstein was one of only two members of the ACIP who voted against bringing FluMist back, going against the opinion of twelve other members who voted in favor of FluMist.
Dr. Henry H. Bernstein is also the “leading voice on AAP’s annual policy statement on preventing flu in children with flu vaccines.”
“The data reviewed showed that receiving the nasal spray vaccine is better than not getting any vaccine at all,” said Flor Munoz, MD, FAAP, member of the AAP Committee on Infectious Diseases. “If you get the nasal spray vaccine, just be aware that, depending on the performance of the new vaccine formulation, there might be a chance you will not be fully protected against H1N1 strains of flu. The efficacy of this new formulation has not yet been determined.”
It is important to note that the AAP is not saying that Flumist won’t work though.
“The effectiveness of this new formulation of LAIV4 has not been confirmed, since A/H1N1 virus has not widely circulated recently.”
AAP influenza immunization recommendations revised for 2018-’19 season
They are basically saying that if the reformulated version of Flumist doesn’t work as it is predicted to work, then your kids might not be protected. They are concerned that we haven’t seen the new version of Flumist work in real world studies against the H1N1 strain of the flu.
Flumist Is Not Just a Last Resort
Fortunately, the AAP has somewhat rephrased their message about Flumist (LAIV4). While they still recommend that the inactivated influenza vaccine (flu shots) be the primary choice for children, they now say that:
“LAIV4 may be offered for children who would not otherwise receive an influenza vaccine (and for whom it is appropriate by age and health status).”
AAP influenza immunization recommendations revised for 2018-’19 season
Importantly though, parents and pediatricians should note that the recommendations of the Advisory Committee on Immunization Practices (ACIP) for the 2018–19 flu season very clearly make no preferential recommendation for the use of any influenza vaccine product over another.
“Following two seasons (2016–17 and 2017–18) during which ACIP recommended that LAIV4 not be used, for the 2018–19 season, vaccination providers may choose to administer any licensed, age-appropriate influenza vaccine (IIV, RIV4, or LAIV4). LAIV4 is an option for those for whom it is appropriate.”
Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2018–19 Influenza Season
And the ACIP and CDC aren’t the only ones who disagree with the AAP’s decision.
“So I think the AAP was wrong, frankly, to say that FluMist should only be used as a last-resort vaccine for influenza. Rather, they should have gone along with what the ACIP said, which was that these vaccines can now be used interchangeably for persons aged 2-49 years.”
Paul Offit, MD on FluMist: Reasonable Vaccine Option or ‘Last Resort’ for the Upcoming Flu Season?
So what should you do?
If it is going to be a battle getting your kids a flu shot and you might you might have even skipped it the last few years because Flumist wasn’t available, then your choice is very clear.
Get vaccinated with Flumist, as long as your child is at least two years old and otherwise meets the requirements.
And don’t feel bad or worried that your decision is leaving your child unprotected. Remember that Flumist is recommended by the ACIP and CDC and has been used continuously in most other countries (under the name Fluenz).
Your next battle might simply be finding Flumist. Because of the AAP’s “last resort” comment, some pediatricians didn’t even bother ordering any doses.
Multi-dose vials of flu vaccine clearly still contain the preservative thimerosal.
Believe it or not, your kids aren’t going to be exposed to any heavy metals when they get their routine vaccines.
The closest that they might come would be getting a flu vaccine with thimerosal, as mercury is indeed a heavy metal and thimerosal breaks down to ethylmercury. But then, the great majority of flu vaccines are now thimerosal-free, so they probably won’t.
Even if they did, it is important to note that thimerosal was removed from vaccines as a precaution, not because it was toxic.
It is no secret that many vaccines contain aluminum.
“Aluminum is a heavy metal with known neurotoxic effects on human and animal nervous systems. It can be found in the following childhood vaccines – DTaP, Pediarix (DTaP-Hepatitis B-Polio combination), Pentacel (DTaP-HIB-Polio combination), Hepatitis A, Hepatitis B, Haemophilus influenzae B (HIB), Human Papilloma Virus (HPV), and Pneumococcal vaccines.”
NVIC on Aluminum and Vaccine Ingredients: What Do We Know? What Don’t We Know?
Heavy metals include copper, gold, iron, lead, mercury, platinum, plutonium, silver, tin, and zinc.
Aluminum is classified as a light metal. Other light metals are calcium, magnesium, potassium, and sodium.
I guess that it makes aluminum sound scarier if you say it is a heavy metal though…
It also make it sound scary if you imply that the aluminum salts in vaccines are neurotoxic. They aren’t.
But what about the idea that vaccines are contaminated with heavy metals?
“Metals including toxic lead contaminate virtually all aluminum adjuvants, a widely-used ingredient of human and animal vaccines, according to a recent study published in the leading journal of the vaccine industry.”
CMSRI on Lead, Iron, Chromium and Other Metals Routinely Contaminate Vaccine Adjuvants, Industry Study Reports
While that was the CMSRI takeaway from the study, Influence of elemental impurities in aluminum hydroxide adjuvant on the stability of inactivated Japanese Encephalitis vaccine, IXIARO, if you actually read it, you find that they found that “all aluminum hydroxide lots examined in this study met” safety guidelines from European agencies (Ph. Eur. 2.4.8) and the United States Pharmacopoeia (USP 231).
And many folks think that a study ‘finding’ contamination by a few Italian scientists, New Quality-Control Investigations on Vaccines: Micro- and Nanocontamination, actually found “that vaccines are incredibly pure.”
Over the years, especially since thimerosal was removed from most vaccines, the myths about thimerosal have surprising been increasing.
“Currently, the actions taken by the vaccine manufacturers, the FDA and the CDC have increased the possible maximum childhood exposure to mercury from vaccines to twice the level that triggered the 1999 call to remove mercury from all vaccines as soon as possible!”
Rev. Lisa K. Sykes on “Ten Lies” Told About Mercury in Vaccines
Of course, none of them are true.
Myths About Thimerosal in Vaccines
To begin with, there was no “call to remove mercury from all vaccines as soon as possible.”
Instead, as a “precautionary measure,” the AAP asked vaccine manufacturers “for a clear commitment and a plan to eliminate or reduce as expeditiously as possible the mercury content of their vaccines.”
“In addition, today most tetanus shots and the multi-dose Sanofi Menomune vaccine that are approved by the US Food and Drug Administration (FDA) still contain 25-micrograms-a-dose mercury.”
Rev. Lisa K. Sykes on “Ten Lies” Told About Mercury in Vaccines
After “realizing” the amount of mercury in the childhood vaccination schedule recommended by the CDC exceeded all national and global maximum safety limits, the American Academy of Pediatrics and the United States Public Health Service called for the immediate removal of Thimerosal from all vaccines on July 7, 1999. – the amount of thimerosal in the childhood immunization schedule actually only exceeded EPA guidelines and was well below the guidelines of the Agency for Toxic Substances Disease Registry (ATSDR) or the FDA. Also, since thimerosal-free versions of DTaP and Hib have always been available, only “a minority of infants could receive as much as 187.5 mg of ethylmercury during the first 6 months of life.”
children are getting even more mercury from vaccines today than when mercury was removed from vaccines, because pregnant women and kids get flu shots now – this theory doesn’t take into account that thimerosal-free flu vaccines have been available since 2003 and until recently, many kids didn’t get flu shots. For example, during the 2008-09 flu season, only 25% infants and toddlers were fully vaccinated against flu and even fewer pregnant women got flu shots (about 15%). The only way this myth could possibly be true would be if these folks all got a flu vaccine with thimerosal each and every year.
even as thimerosal was removed from the DTaP, Hib, and hepatitis B vaccines, kids still got exposed to thimerosal from other vaccines, like Menomume, the meningococcal vaccine – Although Menomume contained thimerosal, it had only been recommended for high risk kids since it was approved in 1981. It was later replaced by Menactra and Menveo, both of which are thimerosal-free, and which were recommended to all kids as they provided better coverage. Menomume was discontinued in 2017 and it is unlikely that many kids got it once Menactra and Menveo became available.
kids still get a tetanus shot with thimerosal – yes, they did, at least until the Tdap vaccines were approved in 2006. Tdap is thimerosal-free.
Thimerosal has never undergone even one modern safety test. – although mercury can be toxic, the thimerosal in vaccines has been shown to be safe. That’s not surprising – remember, “the dose makes the poison.”
Published studies have shown that Thimerosal and its mercury breakdown product contribute to: Alzheimer’s, Cancer, Autism Spectrum Disorders, Attention Deficit Disorders, Bipolar Disorder, Asthma, Sudden Infant Death Syndrome, Arthritis, Food Allergies, Premature Puberty, and Infertility. – thimerosal in vaccines doesn’t cause any of these things, but you can probably find a published study somewhere saying that thimerosal causes Alzheimer’s, cancer, or food allergies, etc., but that just points to how important it is to look to trusted sources of information, as almost anyone can publish a bad study
Contrary to sound bites you hear on the nightly news, to be “anti-mercury” is not to be “anti-vaccine.” – if this is true, then why did Robert F. Kennedy, Jr write an editorial against University of Colorado students who passed a resolution for meningococcal B vaccines, which are thimerosal-free? And why push so much propaganda about thimerosal?
Corresponding to the sharply increasing level of mercury in the immunization schedule globally, which started in the late 1980’s, there has been an increasing rate of autism among children. This also explains why autism among 40-, 50-, 60-, 70- and 80-year-olds is not epidemic, but rather rare. – this is one of the main problems of the anti-vaccine movement… if you believe that autism is an epidemic, then there must be a cause and it becomes easy to blame vaccines. You also have to ignore the fact that there are plenty of autistic adults.
Among the Amish who do not vaccinate, the rate of autism is strikingly low. – there are autistic Amish
Unused vaccines with a preservative level of Thimerosal, however, are considered hazardous waste because of their high mercury content. If not injected into patients, discarded vials of these mercury-preserved vaccines, therefore, must be disposed of in steel drums, by law. – this is not true – at all… you also don’t have to call a Hazmat team if you break an unused vaccine vial with thimerosal…
…instead of requiring immediate removal, the CDC allowed the pharmaceutical companies to save money by using up their inventories of mercury-containing vaccines. By 2003, the industry had finally used up stocks of thimerosal-containing vaccines and Thimerosal is no longer used in these three vaccines. – the only basis for this statement is that the last thimerosal containing DTaP, Hib, and hepatitis B vaccines expired in 2003, but it is important to keep in mind that most vaccines are used well before their expiration date. In fact, many doctors order vaccines every month, so as to not keep large supplies of vaccines in their office, and since thimerosal-free versions were already available, those likely would have been ordered.
The term “trace amounts” means less than 1 microgram (mcg). Thimerosal-containing flu shots contain what in biochemical terms is actually a massive dose of mercury: 25 mcg. – vaccines labeled as having a trace amount of thimerosal have less than or equal to 1mcg, while others are clearly labeled as having up to 25mcg.
Why do I call that massive? Because the Environmental Protection Agency’s maximum exposure limits for methyl mercury is .1 microgram per 1 kilogram of bodyweight, which means a baby would have to weigh 550 pounds to safely absorb 25 micrograms of mercury. At these levels, a growing fetus in a mother receiving the flu shot could get up to a million times the EPA’s safe levels. – wait, what? First, that is the maximum recommended daily exposure limit based on the assumption that the exposure to mercury will continue for long periods of time. That’s not the case when a pregnant woman gets a one time flu shot. And it is the pregnant mother who is getting the flu shot, not the baby. Although some thimerosal will cross the placenta, it is still not in levels that will cause harm, so calling the dose massive ends up just being an obvious propaganda tool to scare folks.
The review, Thimerosal and Autism?, explains why autism and mercury poison really don’t share the same symptoms.
Autism and mercury poisoning have the same symptoms. – they don’t… In fact, there are many reports of epidemics of mercury poisoning throughout history that weren’t associated with autism, including in Minamata and Niigata, Japan, exposures from mercury in teething powders and worm medicines (pink disease), and food contamination in many countries.
“Yet mercury had long been the every-day treatment of infants at the time of teething in the form of teething powders.”
Ann Dally on The Rise and Fall of Pink Disease
Although it is hard to believe now, mercury wasn’t taken out of teething powders until 1957, after which time pink disease quickly disappeared. Why was mercury in teething powders in the first place? Unlike thimerosal in vaccines, I don’t think it was acting as a preservative, as it sounds like it was present in very high doses. So there was a lot of risk with no benefit.
Sounds like the opposite of what we had with thimerosal in vaccines – lots of benefit (vaccines didn’t get contaminated) with no risk.
But taking thimerosal out of vaccines was risk-free too, wasn’t it?
Nope. That’s another myth.
“Unfortunately, the precautions taken by the AAP and CDC calling for thimerosal removal from vaccines appears to have led to unintended risks. In particular, inappropriate recommendations by autism advocacy groups regarding treatment of autism (e.g., use of chelation) and avoidance of vaccines (e.g., influenza vaccine) may mislead parents to place children at unnecessary risks.”
Hurley et al on Thimerosal-Containing Vaccines and Autism: A Review of Recent Epidemiologic Studies
You know the story about vaccines and thimerosal, right?
Unfortunately for the movie Trace Amounts, simple calling something a fact doesn’t make it a fact. In addition to mischaracterizing how the process started, they seem to think that kids have been getting exposed to even more mercury in vaccines today…
Are you sure?
Thimerosal Timeline
Although it was never actually linked to any significant side effects, as a “precautionary measure,” the AAP recommended that thimerosal (mercury) be removed from childhood vaccines in 1999.
That’s not when the hype over thimerosal started though.
A few years before that, in 1997, an amendment to the Food and Drug Administration (FDA) Modernization Act called on the FDA to compile a list of foods and drugs with added mercury.
“At the time the FDA Modernization Act was passed, it was recommended that infants receive 3 different vaccines that contained thimerosal: diphtheria-tetanus-acellular pertussis (DTaP), hepatitis B, and Haemophilus influenzae type B (Hib). Infants who received all of these vaccines could have been exposed to a cumulative dose of mercury as high as 187.5 μg by 6 months of age. This value exceeded guidelines recommended by the Environmental Protection Agency (EPA) but did not exceed those recommended by the Agency for Toxic Substances Disease Registry (ATSDR) or the FDA.”
Offit et al on Addressing Parents’ Concerns: Do Vaccines Contain Harmful Preservatives, Adjuvants, Additives, or Residuals?
And it was found that in some circumstances, infants could get 187.5 μg of mercury from vaccines by 6 months of age, which exceeded some, but not all regulatory guidelines.
Which regulatory guidelines?
EPA – 89 µg
ATSDR – 266 µg
FDA – 354 µg
That led to the recommendation from the AAP, in July 1999, to remove thimerosal from vaccines, including the hepatitis B, DTaP, and Hib vaccines, the only routinely used, non-flu vaccines that had ever had thimerosal. Specifically, the AAP asked vaccine manufacturers “for a clear commitment and a plan to eliminate or reduce as expeditiously as possible the mercury content of their vaccines.”
“There is a significant safety margin incorporated into all the acceptable mercury exposure limits. Furthermore, there are no data or evidence of any harm caused by the level of exposure that some children may have encountered in following the existing immunization schedule. Infants and children who have received thimerosal-containing vaccines do not need to be tested for mercury exposure.”
Notice to Readers: Thimerosal in Vaccines: A Joint Statement of the American Academy of Pediatrics and the Public Health Service
It is important to note that thimerosal-free versions of the DTaP and Hib were already available at the time though.
So we had:
DTP vaccines – contained 25μg thimerosal, but had largely been replaced by DTaP vaccines at this point
Infanrix – a DTaP vaccine that never contained thimerosal since it was first approved in 1997 (most folks incorrectly state that Infanrix first contained trace amounts of thimerosal)
Tripedia – a DTaP vaccine that was first approved in 1992 and did contain 25μg thimerosal, a thimerosal-free formulation became available in March 2001 – it was discontinued in 2011
Acel-Imune – a DTaP vaccine that was approved in 1991 and did contain 25μg thimerosal, it was discontinued in 2001
Certiva – a DTaP vaccine that was approved in 1998 and did contain 25μg thimerosal, it was discontinued in 2000
TriHIBit – a DTaP/Hib combination vaccine that was approved in 1997 and did contain 25μg thimerosal, it was discontinued in 2011
Tetramune – a DTP/Hib combination vaccine that was approved in 19 and did contain 25μg thimerosal, it was later discontinued
OmniHib – a Hib vaccine that never contained thimerosal since it was approved in 1993
ActHIB – a Hib vaccine that never contained thimerosal since it was approved in 1993
ProHIBIT – the first Hib conjugate vaccine licensed in 1987, it contained 25μg thimerosal
PedvaxHIB – a Hib vaccine that never contained thimerosal since it was approved in 1989
HibTITER – a Hib vaccine that never contained thimerosal since it was approved in 1988, except in multidose vials (25μg thimerosal)
Comvax – a Hib/hepatitis B combination vaccine that never contained thimerosal
Recombivax HB – a hepatitis B vaccine with 12.5μg thimerosal that was approved in September 1983, but a thimerosal-free formulation became available in September 1999
Engerix B – a hepatitis B vaccine with 12.5μg thimerosal that was approved in 1989, but a form with only a trace amount of thimerosal became available in March 2000, followed by a thimerosal-free formulation in January 2007
And of course, the other vaccines that younger kids got at the time never contained thimerosal, including hepatitis A, MMR, Varivax, polio, and Prevnar.
By January 2003, remaining stocks of vaccines with thimerosal expired.
It wasn’t that infants were getting exposed to thimerosal in vaccines, but rather that they might get exposed to too much thimerosal.
Looking back at the available vaccines at the time, it is fairly obvious that most infants didn’t get that much thimerosal though, as there were already plenty of thimerosal-free versions of all routinely used vaccines. To get to the higher doses that some folks were concerned about, they would have to get the hepatitis B vaccine, plus thimerosal containing versions of both DTaP and Hib, and a flu shot.
Because young, otherwise healthy children are at increased risk for influenza-related hospitalization, influenza vaccination of healthy children aged 6-23 months is recommended.
Also, keep in mind that it wasn’t until 1991 that hepatitis B and Hib vaccines were added to the immunization schedule to be given to all infants.
And many kids didn’t get flu shots yet.
Remember, it was until the 2004-05 flu season that we started to see strong recommendations to give flu shots to anyone who wasn’t at high risk for complications from the flu. And by that time, thimerosal free flu shots were beginning to appear.
Still, the most important takeaway from all of this is that even though thimerosal was removed from vaccines, it was done as a precautionary measure and not because these kids were harmed. In fact, some kids were harmed in the process, especially as some infants didn’t get their newborn hepatitis B vaccine and at least one went on to get a fatal hepatitis B infection.
What to Know About Vaccines and Thimerosal
Even at the height of the thimerosal scare, most vaccines didn’t contain thimerosal.
