Tag: thimerosal-free

What Level of Mercury Is Considered Toxic?

Why would an Arizona State Representative be posting about mercury and flu shots?

It’s easy to figure out once you look at the rest of her posts…

What Level of Mercury Is Considered Toxic?

We should start off by correcting a few things in Representative Kelly Townsend’s post.

The mercury in a thimerosal containing flu vaccine is ethylmercury, not methylmercury, the type that we might be exposed to in a can of tuna.

And mercury is only considered to be toxic if you are exposed in specific ways, at specific levels, and depending on the length of exposure.

“In case reports of accidental high-dose exposures in humans to thimerosal or ethylmercury toxicity was demonstrated only at exposures that were 100 or 1000 times that found in vaccines.”

FDA on Thimerosal in Vaccines Questions and Answers

Not only is the ethylmercury in vaccines not toxic, since only a small percentage of flu vaccines now contain thimerosal and you almost have to go out of your way to get a vaccine with thimerosal, you have to wonder why Representative Kelly Townsend is posting about it?!?

If she is really concerned about mercury toxicity, she should be sure that the EPA is truly doing everything they can to reduce mercury pollution and our exposure to mercury. She shouldn’t be scaring folks away from vacinating and protecting their kids.

Still, I guess it is much better than some of her other recent anti-vaccine posts, like the one that is said to have compared mandatory vaccinations to forced number tattoos

More on Toxic Levels of Mercury

Did the FDA Admit That the Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women?

Have you heard?

There is a new bombshell from anti-vaccine folks!

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?

Or should they just stop listening to this type of anti-vaccine propaganda?

More on Did The FDA Admit That The Government Is Recommending Untested, Unlicensed Vaccines For Pregnant Women?

Did Dr. Bob Uncover a CDC Plot to Give Adult Flu Shots to Babies?

Have you heard the news?

Uh, the ACIP can't request a license for a vaccine...
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

Does Pentacel Contain Mercury?

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.

Pentacel is mercury free.
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.

It does not contain mercury.

More on Mercury in Vaccines

Which Flu Vaccine Should You Get?

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?
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.

Are any of the flu vaccines better than others?

Which Flu Vaccine Should You Get?

This year, we will have:

  • quadrivalent flu shots – Afluria, Fluarix, FluLaval, Fluzone, Fluzone Pediatric Dose
  • quadrivalent flu shots that are cell-culture based – Flucelvax
  • quadrivalent flu shots that can be given intradermally – Fluzone Intradermal
  • trivalent flu shots – Afluria
  • trivalent flu shots that are adjuvanted – Fluad
  • high dose trivalent flu shots – Fluzone High-Dose
  • quadrivalent flu shots that are made with recombinant technology – Flublok
  • nasal spray flu vaccine – Flumist

Which one should you get?

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 three 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.

More on Your Flu Vaccine Options

Flumist Is Not Just a Last Resort

The return of FluMist has hit a slight snag.

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?
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.

More on the Latest Flumist Recommendations

Which Vaccines Contain Heavy Metals?

Are you worried about heavy metals in vaccines?

Which Vaccines Contain Heavy Metals?

Multi-dose vials of flu vaccine clearly still contain the preservative thimerosal.
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.

What about aluminum?

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?

Do you know what we know about aluminum?

It isn’t a heavy metal.

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.”

Vaccines are safe and necessary.

Don’t let folks scare you from vaccinating and protecting your kids by making you think they contain heavy metals or anything other “toxin.”

What to Know About Heavy Metals in Vaccines

Vaccines do not contain any toxic heavy metals.

More on Heavy Metals in Vaccines