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