Tag: Vaccine Safety Datalink

Why is the Tdap Vaccine in Category C?

The Tdap vaccine is routinely recommended for all pregnant women, so why would it be in the FDA Category C?

The FDA has actually removed the pregnancy categories.

We should start by stating that “risk-benefit decisions regarding use of a drug during pregnancy are more complex than the category designations suggest.”

Why is the Tdap Vaccine in Category C?

Anyway, the category designations are no longer being used on new drugs and vaccines.

“In December of 2014, the FDA published the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR or final rule). The PLLR removes pregnancy letter categories – A, B, C, D and X. Instead, under the final rule, narrative summaries of the risks of a drug during pregnancy and discussions of the data supporting those summaries are required in labeling to provide more meaningful information for clinicians.”

Guidelines for Vaccinating Pregnant Women

So is it still Category C?

Yes, for now. Few vaccines have converted to the new labeling system yet, which still leaves us with:

  • Pregnancy Category B: Tdap (Boostrix) – Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus during the first trimester (and there is no evidence of risk in later trimesters).
  • Pregnancy Category C: Tdap (Adacel) – Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks OR Animal reproduction studies have not been conducted and there are no adequate and well-controlled studies in humans.

Of course, 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.”

And many of these studies are about the Tdap vaccine!

“There are no theoretical or proven concerns about the safety of the Tdap vaccine (or other inactivated vaccines like Tdap) during pregnancy. The shot is safe when given to pregnant women.”

Frequently Asked Questions for Pregnant Women Concerning Tdap Vaccination

This will likely be reflected when we get new labels for these vaccines, with wording that makes it clear that Tdap vaccines are safe in pregnancy.

what to know about the tdap vaccines and their category c designation

Tdap vaccines still have a Category C designation simply because their labels haven’t been updated to reflect the latest safety studies.

More on Tdap Vaccines and Category C

Are Vaccines Causing Long-Term Health Problems?

Did the CDC say that it is impractical to find out of vaccines are causing an epidemic of brain injury and other long-term health problems?

I’m guessing they didn’t…

Are Vaccines Causing Long-Term Health Problems?

Why does anyone think that they did?

The latest anti-vaccine propaganda about vaccines causing long-term health problems.
The latest anti-vaccine propaganda about vaccines causing long-term health problems.

Oh, anti-vaccine folks are sharing a cherry-picked quote from the CDC to scare parents away from vaccinating and protecting their kids.

Would you like to see the full quote?

“Observing vaccinated children for many years to look for long-term health conditions would not be practical, and withholding an effective vaccine from children while long-term studies are being done wouldn’t be ethical. A more practical approach is to look at health conditions themselves and at the factors that cause them. Scientists are already working to identify risk factors that can lead to conditions like cancer, stroke, heart disease, and autoimmune diseases such as lupus or rheumatoid arthritis. Thousands of studies have already been done looking at hundreds of potential risk factors. If immunizations were identified as a risk factor in any of these studies, we would know about it. So far, they have not.

We learn about a vaccine’s safety during clinical trials before it is licensed, and monitor it continually as millions of doses are administered after it is licensed. We also know there is not a plausible biologic reason to believe vaccines would cause any serious long-term effects. Based on more than 50 years of experience with vaccines, we can say that the likelihood that a vaccine will cause unanticipated long-term problems is extremely low.

Parents’ Guide to Childhood Immunizations

So no, the CDC didn’t say that it was impractical to find out of vaccines are causing an epidemic of brain injury.

Instead, they said that it was just impractical to do a study in which you give a child a vaccine and watch him for 20 years to see if he develops a problem, like leukemia, diabetes, or autism, all the while not giving the vaccine to other kids until your study is over. Of course, that’s because a lot of kids would get the potentially life-threatening disease that the vaccine is protecting those kids against while you were waiting to complete those long-term studies.

That’s not to say that we aren’t concerned about these types of long-term health problems occurring after a child is vaccinated.

Plenty of long-term safety studies have been done. It’s just more practical to do the studies on the diseases you are concerned about, sometimes after noticing safety signals, and see if vaccines truly are a risk factor.

Here is one example:

“In this large, population-based, case-control study, we did not find an increased risk of type 1 diabetes associated with any of the routinely recommended childhood vaccines.”

DeStefano et al on Childhood vaccinations, vaccination timing, and risk of type 1 diabetes mellitus.

In that study, they found all of the kids with diabetes born during 1988 through 1997 in the 4 health maintenance organizations (HMOs) that participate in the Vaccine Safety Datalink project of the Centers for Disease Control and Prevention, compared them to matched controls, and did not find an increased risk of type 1 diabetes associated with any of the routinely recommended childhood vaccines.

There are many more…

And that’s how we know vaccines aren’t causing long-term health problems.

Well at least those of us who did our research, looked for the original quote, and saw through this anti-vaccine propaganda.

More on Vaccines and Long-Term Health Problems

More Vaccinated vs Unvaccinated Studies

Anti-vaccine folks continue to call for vaccinated vs unvaccinated studies.

A vaccinated vs unvaccinated study that anti-vaccine folks don't talk about...
A vaccinated vs unvaccinated study that anti-vaccine folks don’t talk about…

Not surprisingly, they ignore all of the studies that have already been done.

More Vaccinated vs Unvaccinated Studies

Listening to these anti-vaccine folks, you would actually think that the only vaccinated vs unvaccinated “study” that has ever been done is the survey about homeschoolers that they always talk about

That leaves out a lot of other vaccinated vs unvaccinated studies, including:

Do we need even more studies on vaccinated vs unvaccinated children?

We already know that unvaccinated kids get sick more and they have more severe disease. Who is going to approve of or want to do a study that only puts kids at risk to get a vaccine-preventable disease?

Vaccines are safe, with few risks, and they are obviously necessary.

More on Vaccinated vs Unvaccinated Studies

Anaphylaxis After Vaccines

Anaphylaxis after vaccines is a well known side effect, but just how common is it?

Anaphylaxis After Vaccines

Since it is listed as a possible reaction to nearly all vaccines and it can be life-threatening, anaphylaxis must be fairly common, right?

“Vaccine providers should be familiar with identifying immediate-type allergic reactions, including anaphylaxis, and be competent in treating these events at the time of vaccine administration. Providers should also have a plan in place to contact emergency medical services immediately in the event of a severe acute vaccine reaction.”

Preventing and Managing Adverse Reactions

After all, pediatricians even get warned to have a plan in place and to be prepared to treat children just in case they develop anaphylaxis after getting their vaccines.

Your pediatrician will likely have an EpiPen in the office in case your child has an anaplylactic reaction after his vaccines.
Epi Is Readily Available to Treat Most Kids with Anaphylaxis After Vaccines

Still, most probably have never had to.

“Any medication can cause a severe allergic reaction. Such reactions to a vaccine are estimated at about 1 in a million doses, and would happen within a few minutes to a few hours after the vaccination.”

Possible Side-effects from Vaccines

And that’s because anaphylaxis after vaccines is very rare.

Anaphylaxis After Vaccines is Rarely Fatal

And suprisingly, it is even more rare for these cases to be fatal!

“All 30 patients with anaphylaxis survived (9 reports specified anaphylaxis, and we classified another 21 as probable cases, based on compatible clinical features, including respiratory and skin symptoms within 4 hours after vaccination). In half of 22 detailed reports, symptoms developed within 15 minutes after vaccination.”

Wise et al on Postlicensure Safety Surveillance for Varicella Vaccine

But that study just looked at the chicken pox vaccine and used VAERS, so we have to be concerned about under-reporting, right? Well, not necessarily. Under-reporting likely isn’t a big problem for serious reactions.

Anyway, that’s not the only study…

“We identified 33 confirmed vaccine-triggered anaphylaxis cases that occurred after 25,173,965 vaccine doses. The rate of anaphylaxis was 1.31 (95% CI, 0.90-1.84) per million vaccine doses.”

McNeill et al on Risk of anaphylaxis after vaccination in children and adults

The McNeill study used the Vaccine Safety Datalink, which unlike VAERS, is not a passive reporting system. So there is no concern about underreporting.

And like the Wise study, there were no deaths among these vaccine-triggered anaphylaxis cases.

“Fatalities from vaccine-induced anaphylaxis are exceedingly rare.”

Adverse reactions to vaccines practice parameter 2012 update

Similarly, a study in the UK found rare reports of anaphylaxis after vaccines in children and all those children made a full recovery.

Parents should understand that while anaphylaxis is a known side effect to getting a vaccine, it is extremely rare, and can usually be treated. This once again reinforces that vaccines are safe!

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