Tag: safety

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

Understanding the Vaccine Injury Table

The Vaccine Injury Table was created by the National Childhood Vaccine Injury Act of 1986.

“The Table makes it easier for some people to get compensation. The Table lists and explains injuries/conditions that are presumed to be caused by vaccines. It also lists time periods in which the first symptom of these injuries/conditions must occur after receiving the vaccine. If the first symptom of these injuries/conditions occurs within the listed time periods, it is presumed that the vaccine was the cause of the injury or condition unless another cause is found.”

What You Need to Know about the National Vaccine Injury Compensation Program

A table injury is an illness, disability, injury or condition covered by the National Vaccine Injury Compensation Program.

“For example, if you received the tetanus vaccine and had a severe allergic reaction (anaphylaxis) within 4 hours after receiving the vaccine, then it is presumed that the tetanus vaccine caused the injury if no other cause is found.”

What You Need to Know about the National Vaccine Injury Compensation Program

To quality as a table injury, the illness, disability, injury or condition has to occur within a specific “time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration.”

Understanding the Vaccine Injury Table

So if there is a Vaccine Injury Table, then that proves that vaccine injuries are real, right?

The Vaccine Injury Table is easier to understand if you actually look at the table.
The Vaccine Injury Table is easier to understand if you actually look at the table.

Wait, does anyone dispute that vaccine injuries are real?

No one says that vaccines are 100% safe, so yes, of course, it is known that they have risks and cause adverse effects. While most of these adverse effects are usually mild, they can rarely be severe or even life threatening.

The idea the vaccine injuries are common is what is misunderstood and misrepresented by anti-vaccine folks.

It's no joke, studies have shown fewer side effects after the second dose of MMR!
It’s no joke, studies have shown fewer side effects after the second dose of MMR!

Consider the above post by Bob Sears

Yes chronic arthritis after a rubella containing vaccine is a table injury, but it is very rare. Arthritis after the rubella vaccine is typically mild and temporary, lasting just a few days.

While rubella containing vaccines can cause arthritis, they do not cause lifelong rheumatoid arthritis. So even if you were to be one of the very rare people who developed chronic arthritis after a rubella containing vaccine, a table injury, it would still not be the same thing as rheumatoid arthritis.

“The association between rubella vaccination and chronic arthritis is less clear. Most recently published research, has shown no increased risk of chronic arthropathies among women receiving RA27/3 rubella vaccine and do not support the conclusion of the IOM (Slater et al., 1995; Frenkel et al., 1996; Ray et al., 1997). These studies have included a large retrospective cohort analysis which showed no evidence of any increased risk of new onset chronic arthropathies and a double-blind historical cohort study. One randomised placebo-controlled, double-blind study of rubella vaccination in sero-negative women demonstrated that the frequency of chronic (recurrent) arthralgia or arthritis was marginally increased (1.58 [1.01-2.45], p = 0.042) (Tingle et al., 1997). In 2011, the United States Institute of Medicine (IOM) reviewed available research and concluded that the evidence is inadequate to accept or reject a causal relationship between MMR vaccine and chronic arthralgia in women.”

Information Sheet Observed Rate of Vaccine Reactions Measles, Mumps and Rubella Vaccines

And it wouldn’t even be clear if your chronic arthritis was caused by the vaccine!

“The Table lists and explains injuries and/or conditions that are presumed to be caused by vaccines unless another cause is proven.”

What You Need to Know about the National Vaccine Injury Compensation Program

To be added to the Vaccine Injury Table, there only has to be scientific evidence that a condition could be caused by a vaccine.

“Where there is credible scientific and medical evidence both to support and to reject a proposed change (addition or deletion) to the Table, the change should, whenever possible, be made to the benefit of petitioners.”

Guiding Principles for Recommending Changes to the Vaccine Injury Table

That makes sense, as the NVICP is a “is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions” for VICP-covered vaccines.

Vaccines Covered by the Vaccine Injury Table

Most routinely used vaccines are covered by the Vaccine Injury Table, including vaccines that protect against:

  • diphtheria, tetanus, and pertussis – DTaP, Tdap, Td
  • measles, mumps, and rubella – MMR, ProQuad
  • chickenpox – Varivax, ProQuad
  • polio – IPV, OPV
  • hepatitis B
  • hepatitis A
  • Hib
  • rotavirus
  • pneumococcal disease – Prevnar
  • influenza – seasonal flu vaccines
  • meningococcal disease – MCV4, MenB
  • human papillomavirus – HPV4, HPV9

In fact, “any new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children, after publication by the Secretary of a notice of coverage” is automatically included, at least for Shoulder Injury Related to Vaccine Administration and vasovagal syncope.

New vaccines are also covered if they are already “under a category of vaccines covered by the VICP.”

Immunizations given to pregnant women are also covered.

A few others, including vaccines that protect against pandemic flu, smallpox, and anthrax are covered by the Countermeasures Injury Compensation Program (CICP).

Vaccines Not Covered by the Vaccine Injury Table

What about vaccines that aren’t routine?

Other vaccines that are used in special situations, including vaccines that protect against rabies, yellow fever, Japanese encephalitis, cholera, and typhoid aren’t listed in the Vaccine Injury Table and aren’t covered by the National Vaccine Injury Compensation Program.

Have you seen any TV ads for lawsuits against the shingles vaccine, which isn't in the vaccine injury table.
Have you seen any TV ads for lawsuits against the first shingles vaccine?

Shingles vaccines and the older pneumococcal vaccine, Pneumovax, aren’t covered either.

And since they are not covered by the National Vaccine Injury Compensation Program, there are no restrictions on lawsuits against the manufacturers of these vaccines or the health providers who administer them.

So much for the idea that you can’t sue a vaccine manufacturer or that vaccine manufacturers have no liability for vaccines…

Why weren’t these vaccines covered?

Remember, the NVICP and Vaccine Injury Table were created by the National Childhood Vaccine Injury Act of 1986. The vaccines that aren’t covered are not on the routine childhood immunization schedule.

“There are no age restrictions on who may receive compensation in the VICP. Petitions may be filed on behalf of infants, children and adolescents, or by adults receiving VICP-covered vaccines.”

National Vaccine Injury Compensation Program Frequently Asked Questions

Still, since many of the covered vaccines can be given to adults, they are included, even if some of the vaccines adults routinely get aren’t covered.

Will they ever be covered?

“They found a low liability burden for these vaccines, that serious adverse events were rare, and that no consensus existed among stakeholders. After considering the staff report, NVAC chose, in 1996, not to advise the Department of Health and Human Services to include adult vaccines in VICP.”

Loyd-Puryear et al on Should the vaccine injury compensation program be expanded to cover adults?

Adding more adult vaccines to the Vaccine Injury Compensation Program (VICP) is something that has been looked at in the past, but it wasn’t thought to be necessary.

What to Know About the Vaccine Injury Table

The Vaccine Injury Table is a list of conditions set up to make it easier for people to get compensated from the National Vaccine Injury Compensation Program.

More on Understanding the Vaccine Injury Table

How is the Immunization Schedule Developed?

For some reason, there still seems to be a lot of confusion out there about just how the immunization schedule is developed.

Jay Gordon wonders about the research used to set the current immunization schedule...
ICYMI – Jay Gordon was Jenny McCarthy‘s pediatrician.

Who decides which vaccines we give and get?

How do they make that decision?

History of Immunization Schedule Development

While the current immunization schedule is developed by the CDC based on recommendations of the Advisory Committee on Immunization Practices (ACIP), that’s not how it was always done.

It has just been since 1995 that we have had this single, simple vaccine schedule and format.

The first unified immunization schedule was developed in 1995.
The first unified immunization schedule was developed in 1995.

Before that, we had separate vaccine schedules from the:

Even earlier, we had recommendations and schedules from

  • WHO Expanded Programme on Immunization (EPI)
  • AAP’s Special Committee on Prophylactic Procedures Against Communicable Diseases – from its start in the early 1930s, it evolved into today’s Committee on Control of Infectious Diseases
  • American Public Health Association Subcommittee on Communicable Disease Control

Differences in those schedules, which could lead to confusion, lead experts to create a simpler, unified schedule.

Well, at least in the United States. Of course, other countries still set their own schedules…

The Science Behind Setting the Immunization Schedule

Now that you know who sets the immunization, you are probably wondering how they set the immunization schedule.

To truly understand how the immunization schedule gets set up, it is best to go to an ACIP meeting when they make those decisions.

Can’t make it to Atlanta for one of the ACIP meetings?

You can watch them online!

Thoughtful discussions on setting the immunization schedule at ACIP.
Thoughtful discussions on setting the immunization schedule at ACIP.

Past ACIP meetings, agendas, minutes, slides, and videos, are archived online too.

Reading the minutes from the third meeting of the Advisory Committee on Immunization Practices on November 19-20, 1964 shows how they work, looking at data to make decisions about our vaccines and set the immunization schedule.
Reading the minutes from the third meeting of the Advisory Committee on Immunization Practices on November 19-20, 1964 shows how they work, looking at data to make decisions about our vaccines and set the immunization schedule.

Review them and you will get a very good idea of how the immunization schedule gets set up.

The first flu vaccine was developed in 1945.

ACIP basically told folks to go back to the drawing board and make a better flu vaccine at this 1966 meeting.
ACIP basically told folks to go back to the drawing board and make a better flu vaccine at this 1966 meeting.

Did you ever wonder why it took so long to get it on the immunization schedule?

Why was the primary series of polio vaccines made up of three doses?

At the Advisory Committee on Immunization Practices meeting on May 24-26, 1967 they discussed polio vaccine scheduling.
At the Advisory Committee on Immunization Practices meeting on May 24-26, 1967 they discussed polio vaccine scheduling.

Hopefully you are starting to understand how this works…

And no, all of this work doesn’t get done over a couple of days a few times a year. ACIP members belong to workgroups which focus on specific vaccines and they gather, analyze, and prepare information and research about those vaccines throughout the year.

It is at the ACIP meetings where the workgroup findings are presented.

“Development of vaccine schedules is based on a large body of basic sciences and epidemiologic research. There is constant review of evidence, adverse events, and epidemiology by a panel of experts.”

Shetty et al on Rationale for the Immunization Schedule: Why Is It the Way It Is?

And yes, among that body of research are studies of vaccines tested together, vaccines tested with placebos, vaccines tested vs unvaccinated kids, vaccines tested for long periods of time, and studies looking at risk factors to make sure vaccines don’t cause long-term health problems.

It’s a very thorough process!

And that’s why the great majority of folks understand that following the immunization schedule is the best way to keep their kids protected from vaccine-preventable diseases.

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

What’s not safe? What hasn’t been well studied?

Following a non-standard, parent-selected, delayed protection vaccine schedule.

Thinking that an individualized approach is better doesn't trump the 55 years of ACIP meetings that went into setting the current immunization schedule...
Thinking that an individualized approach is better doesn’t trump the 55 years of ACIP meetings that went into setting the current immunization schedule…

Studies have actually shown that delaying or skipping vaccines offers no benefits and actually puts kids at extra risk.

It puts the rest of us at risk too.

More on Setting the Immunization Schedule

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