Tag: pregnancy

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

Does the CDC Determine Medical Exemptions for Vaccines?

California’s new vaccine law has some folks arguing about medical exemptions again.

Yes, the CDC does not determine medical exemptions for vaccines. That's not news.
Yes, the CDC does not determine medical exemptions for vaccines. That’s not news.

Some want very broad guidelines and are confused about how doctors determine who should get a medical exemption.

Does the CDC Determine Medical Exemptions for Vaccines?

Bob Sears even thinks he has a bombshell revelation that clears everything up.

An email from the CDC!

You can be sure that the "medical provider's prerogative" does not include any reason they think up, even those that have no evidence to back them up.
You can be sure that the “medical provider’s prerogative” does not include any reason they think up, even those that have no evidence to back them up.

The thing is, no one has ever said that ACIP contraindications and precautions to vaccination are the one and only factor that should determine whether or not a child should get a medical exemption.

“If a child has a medical exemption to immunization, a physician licensed to practice medicine in New York State must certify that the immunization is detrimental to the child’s health. The medical exemption should specify which immunization is detrimental to the child’s health, provide information as to why the immunization is contraindicated based on current accepted medical practice, and specify the length of time the immunization is medically contraindicated, if known.”

Dear Colleague letter regarding guidelines for use of immunization exemptions

So no one should really be surprised by an email that says the CDC does not determine medical exemptions.

What Qualifies as a Vaccine Medical Exemption?

What are the other big factors, in addition to ACIP contraindications and precautions?

“A medical exemption is allowed when a child has a medical condition that prevents them from receiving a vaccine.”

What is an Exemption and What Does it Mean?

Medical exemptions for vaccines should be based on AAP and ACIP guidelines, current accepted medical practice, and evidence based medicine.

“Medical exemptions are intended to prevent adverse events in children who are at increased risk of adverse events because of underlying conditions. Many of these underlying conditions also place children at increased risk of complications from infectious diseases. Children with valid medical exemptions need to be protected from exposure to vaccine-preventable diseases by insuring high coverage rates among the rest of the population. Granting medical exemptions for invalid medical contraindications may promote unfounded vaccine safety concerns. Although states may wish to allow parents who make decisions based on poor science or perceptions to withhold vaccines from their children, these exemptions should be distinguished from valid medical exemptions.”

Salmon et al on Keeping the M in Medical Exemptions: Protecting Our Most Vulnerable Children

For example, in addition to kids who may have had a severe allergic reaction to a vaccine, there are often children with immune system problems or who have a moderate or severe illness who can’t get one or more vaccines, at least temporarily.

These are among the common conditions that the AAP says should NOT delay vaccination and which are often mistakenly thought to qualify someone for a medical exemption.
These are among the common conditions that the AAP says should NOT delay vaccination and which are often mistakenly thought to qualify someone for a medical exemption.

Medical exemptions for vaccines should not be based on anecdotes or simply because a vaccine-friendly doctor has scared a parent away from vaccinating and protecting their kids.

There are very few family history issues that would make a child have to skip or delay getting a vaccine.
There are very few family history issues that would make a child have to skip or delay getting a vaccine.

They should rarely be done based on family history of reactions or what some people think are vaccine reactions.

This is what a fake medical exemption will get you - a life-threatening disease.
The child’s medical exemption was for “cytotoxic allergies secondary to immunization,” without any evidence that it was necessary. In addition to a fake medical exemption, he got tetanus.

In general, they should rarely be given, as the AAP states in their policy statement, Medical Versus Nonmedical Immunization Exemptions for Child Care and School Attendance, “only a very small proportion of children have medical conditions prohibiting specific immunizations…”

That’s why rates of medical exemptions should be low.

“Between the 2009-2010 and 2016-2017 school years, the national median prevalence of medical exemptions has remained constant, between 0.2% to 0.3%, with state-level ranges showing little heterogeneity over time, never exceeding the range of 0.1% to 1.6% over this period.”

Bednarczyk et al on Current landscape of nonmedical vaccination exemptions in the United States: impact of policy changes

And why you shouldn’t have schools with high rates of medical exemptions or doctors writing a lot of medical exemptions.

More on Vaccine Medical Exemption Guidelines

Is Measles Dangerous If You Are Pregnant?

While folks often try and make it seem like measles is a common childhood illness, we know that it can be dangerous.

“One of the patients was a 20-year-old pregnant woman who had rash onset on January 5 following exposure to her 12-year-old brother. After delivering a healthy baby on January 6, the mother developed severe pneumonia that was followed by respiratory arrest. She was resuscitated and transferred to an intensive care unit in a larger hospital nearby in Tennessee.”

Epidemiologic Notes and Reports Transmission of Measles Across State Lines — Kentucky, New Hampshire, Tennessee, Virginia

Rarely do people who have really had measles describe it as just a fever and a rash. They remember that it was called a harmless killer for a reason.

Is Measles Dangerous If You Are Pregnant?

And there are some situations in which measles can be especially dangerous, including if you get sick when you are very young, very old, or have immune system problems.

Pregnant women should be screened for measles immunity.
Pregnant women should be screened for measles immunity.

And what if you are pregnant when you get measles?

“The Health Department announced today that the number of measles cases has grown to 390, including two pregnant women diagnosed with the infection, one diagnosed in mid-April.”

The Number of Measles Cases Grows to 390

If you are pregnant and you are exposed to someone with measles, you can get IVIG post-exposure prophylaxis to prevent you from actually getting measles, but this typically only works if given within six days of the exposure.

“To date, studies have not identified an increased risk for birth defects when pregnant women get the measles during pregnancy. However, studies suggest that measles infection is associated with an increased risk for miscarriage, stillbirth, prematurity and the baby being born with a measles infection.”

When Measles Strike, It’s Not The Happiest Place On Earth For Pregnant Women

Unlike a rubella infection during pregnancy, a measles infection is not thought to cause birth defects. Tragically, it can, like rubella, lead to an increased risk for having a miscarriage.

“Infants who develop congenital measles are at increased risk for mortality and for subacute sclerosing panencephalitis, which is more common when measles is diagnosed in infancy. In addition, subacute sclerosing panencephalitis in newborns infected with measles either congenitally or shortly after birth appears to be more severe, with a shorter latency and rapidly progressive course.”

What Obstetric Health Care Providers Need to Know About Measles and Pregnancy

And if the mother gets measles very late in her pregnancy, it can also lead to a case of congenital measles, or a baby being born with an active measles infection.

“In 52% of cases, measles was likely acquired from a relative. Complications included pneumonia in one child; two pregnant women required hospitalization, including one who miscarried.”

Notes from the Field: Measles Outbreak Among Members of a Religious Community — Brooklyn, New York, March–June 2013

Don’t take the risk that you might get measles while you are pregnant.

Make sure you are vaccinated and protected before you ever start thinking about getting pregnant, as pregnancy is a contraindication to getting the MMR vaccine. And you should wait at least 4 weeks after getting vaccinated before getting pregnant.

More on Measles in Pregnancy