Tag: baby

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

What Are the Recommended and Minimum Ages and Intervals Between Doses of Vaccines?

Most parents likely don’t think about the minimum age or minimum intervals between vaccines, as they just get their kids vaccinated according to the routine immunization schedule.

Things don’t always go according to schedule though…

Recommended and Minimum Ages for Vaccines

After their birth dose of the hepatitis B vaccine, your baby’s next vaccines are usually at two months.

Can you get them earlier?

When necessary, many vaccines can be given earlier and faster than the standard schedule.
When necessary, many vaccines can be given earlier and faster than the standard schedule.

Yes. The minimum age for the first dose of rotavirus, DTaP, IPV, Hib, Prevnar, is 6 weeks.

Some other vaccines can be given earlier than their recommended age too, including:

  • the first MMR vaccine, which can be given as early as age 6 months in certain high risk situations, like traveling out of the country or in an outbreak situation, although this dose will have to be repeated once the child is 12 months old
  • the 4th dose of DTaP, which can be given as early as age 12 to 15 months, as long as at least 4 to 6 months have passed since the third dose
  • the 2nd dose of Varivax, which may be given as early as 1 to 3 months after the first dose
  • the Tdap vaccine, which can be given as early as age 7 years, instead of the more typical 11 to 12 years
  • the HPV vaccine, which can be given as early as age 9 years, instead of the more typical 11 to 12 years

Why would you get a vaccine early?

What if you are going to be traveling just before you infant is going to be 2 months old? Or your 9 year old stepped on a rusty nail, and it had been just over 5 years since his last tetanus (DTaP) shot?

Recommended and Minimum Intervals for Vaccines

In addition to earlier ages, you can sometimes get vaccines more quickly, on an accelerated schedule.

For example:

  • the minimum interval between the 1st and 2nd dose of rotavirus, DTaP, IPV, Hib, Prevnar is 4 weeks, instead of the standard 2 months
  • the minimum interval between the 2nd and 3rd dose of rotavirus, DTaP, IPV, Hib, Prevnar is 4 weeks, instead of the standard 2 months
  • the minimum interval between the 1st and 2nd dose of HPV is either 4 weeks (3 dose schedule) or 5 months (2 dose schedule)
  • the minimum interval between the 2nd and 3rd dose of HPV is 12 weeks
  • the minimum interval between the 1st and 3rd dose of HPV is 5 months, instead of the standard 6 months

Why give these vaccines more quickly than usual?

The usual reason is that a child is a little behind and is working to get caught up.

Absolute Minimum Ages for Vaccines

It is important to remember that in some cases, there are some hard and fast rules about minimum ages. That means that if you get these vaccines any earlier, they won’t count and you will likely have to repeat them, including getting :

  • the 3rd dose of hepatitis B before 6 months (24 weeks) or sooner than 8 weeks after 2nd dose and  16 weeks after 1st dose
  • the first dose of MMR, Varivax or hepatitis A before 12 months
  • the 4th dose of Hib before 12 months
  • the 4th dose of Prevnar before 12 months
  • the 4th dose of DTaP before 12 months
  • the 5th dose of DTaP before 4 years
  • the 4th dose of IPV before 4 years

Sticking to the routine schedule helps to avoid vaccine errors, like giving a vaccine too early. In some situations, the 4 day grace period helps if a vaccine is given a little early.

More on Recommended and Minimum Ages and Intervals Between Doses of Vaccines

What to Do If Your Child Is Exposed to Pertussis

Although things are much better than they were in the pre-vaccine era, we still have pertussis outbreaks in the United States.

How does that work?

Waning immunity and folks who are unvaccinated.

How Contagious is Pertussis?

Pertussis is very contagious, but not quite as contagious as other vaccine-preventable diseases, such as measles.

That’s why the focus on controlling pertussis outbreaks is usually looking at close contacts – those who were within about 3 feet for at least 10 hours a week or who had direct face-to-face contact with the person when they were contagious.

Have you gotten a letter from your child's school about pertussis yet?
Have you gotten a letter from your child’s school about pertussis yet?

So when you get a letter about a possible case of pertussis in your child’s school, it may be a a general warning and not that your child is at risk.

How do you get pertussis?

“Persons with pertussis are infectious from the beginning of the catarrhal stage through the third week after the onset of paroxysms or until 5 days after the start of effective antimicrobial treatment.”

Manual for the Surveillance of Vaccine-Preventable Diseases

Spread by respiratory droplets (coughing and sneezing), pertussis symptoms usually start about 5 to 10 days after being exposed to someone else who is in the early stage of their pertussis infection.

While pertussis symptoms can linger for up to 10 weeks, someone who has pertussis is most contagious during the first 2 or 3 weeks of symptoms.

Is Your Child Protected Against Pertussis?

Two pertussis vaccines, DTaP and Tdap, help protect us against pertussis.

In the Unites States, they are routinely given as a primary series (DTaP) at 2, 4, and 6, and 15 to 18 months, with a booster dose at age 4 years. And then a booster of Tdap at age 11 to 12 years. Later, Tdap is given again during each pregnancy, between 27 and 36 weeks gestation. Adults who have never had a dose of Tdap should get caught up, especially if they will be around a baby.

Protection from the pertussis vaccines wanes or wears off, so even fully vaccinated children and adults can still get pertussis. Of course, you are much more likely to get pertussis if you are unvaccinated and you will likely have more severe illness if you are unvaccinated.

Postexposure Antimicrobial Prophylaxis for Pertussis

Fortunately, as with meningitis was caused by Neisseria meningitidis and Haemophilus influenzae type b (Hib), taking antibiotics after being exposed to someone with pertussis can help prevent you from getting sick.

There are only specific situations for which this type of postexposure antimicrobial prophylaxis is recommended though, so for example, you wouldn’t usually give everyone in a school antibiotics because a few kids had pertussis.

Why not give antibiotics to everyone who might have been exposed to someone with pertussis?

“…there are no data to indicate that widespread use of PEP among contacts effectively controls or limits the scope of pertussis outbreaks.”

Postexposure Antimicrobial Prophylaxis

In addition to the fact that it likely wouldn’t stop our pertussis outbreaks, overuse of antibiotics can have consequences.

Situations in which postexposure antibiotics (azithromycin, clarithromycin, and erythromycin, or Bactrim) likely would be a good idea include:

  • household contacts of a known pertussis case
  • to help control an outbreak in a limited closed setting, like a daycare
  • contacts of a pertussis cases who are at high risk for severe pertussis, including pregnant women, infants, especially infants less than 4 months old, and people with chronic medical problems
  • contacts of a pertussis cases who are also contacts of someone who is at high risk for severe pertussis

What if you were exposed to someone with pertussis and have already gotten sick?

If your child was exposed to pertussis and is now coughing, then in addition to antibiotics, pertussis PCR testing and/or culture will also likely be done to confirm that they have pertussis. And remember that their contacts might need postexposure antibiotics.

Kids who have been exposed to pertussis and who have been coughing for more than 3 weeks won’t need antibiotics or testing, as it is too late for the antibiotics to be helpful and likely too late for testing to be accurate. Fortunately, after 3 weeks, they should no longer be contagious.

What to Do If Your Unvaccinated Child Is Exposed to Pertussis

Unvaccinated kids who are exposed to pertussis should follow the postexposure antimicrobial prophylaxis guidelines.

They should also get caught up on their immunizations, including DTaP if they are between 2 months and 6 years, or Tdap if they are older.

What to Do If Your Vaccinated Child Is Exposed to Pertussis

Since protection from the pertussis vaccines wanes, even kids who are fully vaccinated should follow the postexposure antimicrobial prophylaxis guidelines if they are exposed to pertussis.

Then why get vaccinated?

Again, being vaccinated, your child will be much less likely to get pertussis than someone who is unvaccinated. Even though the pertussis vaccine isn’t perfect, it has been shown that children who had never received any doses of DTaP (unvaccinated children) faced odds of having pertussis at least eight times higher than children who received all five doses.

What to Know About Getting Exposed to Pertussis

Talk to your pediatrician if your child gets exposed to pertussis to make sure he doesn’t need post-exposure prophylaxis to keep him from getting sick, even if you think he is up-to-date on his vaccines.

More on Getting Exposed to Pertussis

How Can the Unvaccinated Spread Diseases They Don’t Have?

Folks who are intentionally unvaccinated often have a hard time understanding why the rest of us might be a little leery of being around them.

That’s especially true if we have a new baby in the house, younger kids who aren’t fully vaccinated and protected, or anyone with a chronic medical condition who can’t be vaccinated.

Why? Of course, it is because we don’t want them to catch measles, pertussis, or other vaccine-preventable diseases.

“How can you spread a disease that you don’t even have?”

It’s true, you can’t spread a disease that you don’t have.

But infectious diseases don’t magically appear inside our bodies – we catch them from other people. And if you have skipped or delayed a vaccine, then you have a much higher chance of getting a vaccine-preventable disease than someone who is vaccinated and protected.

So, just avoid other people when you are sick, right?

“…the increased risk of disease in the pediatric population, in part because of increasing rates of vaccine refusal and in some circumstances more rapid loss of immunity, increases potential exposure of immunodeficient children.”

Medical Advisory Committee of the Immune Deficiency Foundation

That works great in theory, but since you are often contagious before you show signs and symptoms and know that you are sick, you can very easily spread a disease that you don’t even know that you have.

An infant hospitalized during a measles outbreak in the Philippines in which 110 people died.
Children with measles are contagious 4 days before through 4 days after their rash appears, but you often don’t recognize that it is measles until they get the rash! Photo by Jim Goodson, M.P.H.

There’s the trouble:

  1. being unvaccinated, you or your child are at higher risk to get sick
  2. when you get sick, you can be contagious several days before you have obvious symptoms
  3. you can spread the disease to others before you ever know that you are sick, or at least before you know that you have a vaccine preventable disease

This makes intentionally unvaccinated folks a risk to those who are too young to be vaccinated, are too young to be fully vaccinated, have a true medical exemption to getting vaccinated, or when their vaccine simply didn’t work.

measles-santa-clara-county
Folks with measles often expose a lot of other people because they don’t yet know that they have measles and aren’t showing signs and symptoms yet.

In fact, this is how most outbreaks start. Tragically, kids too young to be vaccinated get caught up in these outbreaks.

Keep in mind that these parents didn’t have a choice about getting them protected yet. Someone who decided to skip their own vaccines made that choice for them.

And remember that while you can’t spread a disease that you don’t even have, you can certainly spread a disease that you don’t realize that you have.

What to Know About The Unvaccinated Spreading Disease

If you aren’t going to get vaccinated or vaccinate your kids, understand the risks and responsibilities, so that you don’t spread a vaccine-preventable diseases to others that you might not even know that you have yet.

More on the Unvaccinated Spreading Disease