Tag: newborns

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 is Corvelva?

Have you heard of Corvelva?

People are dying of measles in Italy and groups like Corvela are pushing anti-vaccine propaganda to further scare folks away from vaccinating and protecting their bambini.
People are dying of measles in Italy and groups like Corvela are pushing anti-vaccine propaganda to further scare folks away from vaccinating and protecting their bambini.

Probably not, but they are getting some attention in the anti-vaccine world because they think that they have uncovered a Vaccingate!

What is Corvelva?

Specifically, they analyzed the Infranix Hexa vaccine, and instead of finding DTaP-IPV-HepB/Hib antigens, they think that they found “65 signs of chemical contaminants of which only 35% is known” and “7 chemical toxins.”

Should you be worried?

“Coming back to the two basic principles that have been our topic on this analysis path, we reaffirm what we have said in the recent interview on the scientific journal Nature: we are inquiring the vaccines efficacy and safety and we can’t quite understand how it is possible to claim that this vaccine is even able to generate the 6 protective antibodies – reason why it is designed for – and furthermore to understand how this cluster made of 6 neurotoxic antigens bound together can be claimed as not toxic for newborns.”

Corvelva on Vaccingate: Initial results on Infanrix Hexa chemical composition

Although they might not understand it, Infranix Hexa has been proven to be safe and has been proven to work. You can read study after study in well respected peer reviewed journals that say so.

The Corvela Vaccingate “study” wasn’t published in a well respected peer reviewed journal. It wasn’t even published in one of the typical bottom-feeder, pay-to-publish journals that anti-vaccine researchers frequently use.

What Corvela did was more like a very poorly done science fair project by a kid who got too much help from his anti-vaccine parents.

Using the Surface Activated Chemical Ionization-Electrospray-NIST Bayesian model database search (SANIST) platform is pretty cool, to be sure. But why are we supposed to believe that their method would actually deconstruct the Infanrix Hexa vaccine? Because that’s why they were trying to do – separate out all of the combined vaccine ingredients so that they could be detected by SANIST. The combined vaccine ingredients, including one of which is an emulsifier that keeps the ingredients from separating, in a 6-in-1 combination vaccine.

So what’s more likely? That the unnamed ‘scientists’ at Corvela, which is basically an anti-vaccine website in Italy, did the experiment wrong or that the Infanrix Hexa vaccine, which is used in countries all over the world, doesn’t contain any of the antigens that it is supposed to contain?

A previous study on vaccines that they also have posted to their website and to an open peer review site was not approved, getting a lot of criticism.

Have you figured out what Corvela stands for yet?

It’s Italian for covfefe.

More on Corvelva

First Day Deaths and the Hepatitis B Vaccine

Worldwide, one million babies die within 24 hours of their birth?

Why?

“The initial 24 hours of a child’s life are the most dangerous with over one million newborns around the world dying each year on their first and only day of life, according to Ending Newborn Deaths, a new report by Save the Children. The research reveals of another 1.2 million tragic losses: stillbirths where the heart stopped beating during labour. In total, 2.9 million babies die in their first month. Most of these deaths occur because of premature birth and complications during birth – such as, prolonged labour, pre-eclampsia, and infection.”

WHO on One Million Babies Die Within 24 Hours Of Birth

It ain’t vaccines…

First Day Deaths and the Hepatitis B Vaccine

Of course, that doesn’t keep anti-vaccine folks from trying to correlate the two things, especially with the hepatitis B vaccine.

The neonatal mortality rate is actually similar among developed countries…

Korea for example, gives a birth dose of hepatitis B vaccine.

The 2017 Immunization Schedule for South Korea includes all of the US vaccines, plus BCG and Japanese encephalitis vaccines.
The 2017 Immunization Schedule for South Korea includes all of the US vaccines, plus BCG and Japanese encephalitis vaccines. The birth dose of hepatitis B was added to their schedule in 1991.

In general, Korea’s immunization schedule looks a lot like the one used in the United States. And Korea has both a lower infant and neonatal mortality rate than the United States and most European countries.

What about the idea that the United States has 50% more first day deaths than all other developed countries combined?

That’s likely true.

But not because of vaccines.

In addition to our higher population, this reflects “significant gaps between babies born to wealthy, well-educated urban mothers and those born to poor, less-educated mothers,” among other factors.

“In the United States, many suspect increases are due to more high-risk pregnancies caused by the rising prevalence of obesity, diabetes, hypertension and cardiovascular disease, more older women having children, advancements in fertility treatments that result in multiple births, and the high rate of cesarean sections – all of which increase the risk a mother faces during pregnancy and childbirth. Recent studies in the U.S. also suggest that poor quality care and better counting of maternal deaths may play a role.”

State of the World’s Mothers 2014

First day deaths are a serious issue.

It shouldn’t become yet another talking point anti-vaccine folks use to scare parents away from vaccinating and protecting their kids.

More on Myths About Newborn Deaths

What Shots Do You Need to Be Around a Newborn?

We often focus on what vaccines a baby will need once they are born, but it is also important that folks around your new baby get vaccinated too.

What Shots Do You Need to Be Around a Newborn?

To protect their new baby, many parents institute a no visit policy for friends and family members who don't get vaccinated.
To protect their new baby, many parents institute a no visit policy for friends and family members who don’t get vaccinated.

Of course, all of your vaccines should be up-to-date, especially if you plan to be around young kids. That’s how we maintain herd immunity levels of protection for those who can’t be vaccinated and protected, including newborns who are too young to be vaccinated.

In addition to routine vaccines, it is especially important that teens and adults who are going to be around a newborn or younger infant have:

  • a dose of Tdap – now routinely given to kids when they are 11 to 12 years old and to women during each pregnancy (to protect newborns against pertussis), others should get a dose if they have never had one. There are currently no recommendations for a booster dose.
  • a flu shot – is it flu season? Then anyone who is going to be around your baby should have had a flu shot. And for the purposes of keeping a newborn safe from the flu, you can assume that flu season extends from September through May, or anytime that flu shots are still available.

That’s it?

Only two shots?

Yes, only two shots assuming you are either immune or are up-to-date on your other vaccines. If you have been delaying or skipping any vaccines, then you might need an MMR, the chicken pox vaccine, and whatever else you are missing.

Other Precautions Around a New Baby

Unfortunately, there are many risks to a new baby that aren’t vaccine preventable.

Just because everyone is vaccinated and protected, that doesn’t mean that you should have a party welcoming your baby home and invite everyone in the neighborhood. Besides the flu, we get concerned about other cold and flu-like viruses, especially RSV.

That means to protect them, you should keep your baby away from:

  • large crowds, or even small crowds for that matter – in general, the more people that your baby is exposed to, the higher the chance that they will catch something
  • people who are sick
  • cigarette smoke – second hand smoke increases the risk of infections, like RSV

And make sure everyone, even if they don’t seem sick, washes their hands well before handling your baby.

“Parents or relatives with cold sores should be especially careful not to kiss babies—their immune systems are not well developed until after about 6 months old.”

AAP on Cold Sores in Children: About the Herpes Simplex Virus

Because you can sometimes be contagious even if you don’t have an active cold sore (fever blister), some parents don’t let anyone kiss their baby. Most of this fear comes after news reports of babies getting severe or life-threatening herpes infections after a probable kiss from a family member or friend.

When Can I Take My Newborn Out in Public?

When can you take your baby out in public? Most people try to wait until they are at least two months old.

Is that because that’s when they are protected with their two month shots?

Not really, as your baby won’t really be protected until they complete the primary series of infant vaccinations at six months.

Two months is a good general rule though, because by that age, if your baby gets a cold virus and a fever, it won’t necessarily mean a big work-up and a lot of testing. Before about six weeks, babies routinely get a lot of testing to figure out why they have a fever (the septic workup), even if it might be caused by a virus. That’s because younger infants are at risk for sepsis, UTI’s, and meningitis and they often have few signs when they are sick.

Keep in mind that going out in public is much different from going out. You can go for a walk with your baby at almost any time, as long as they are protected from the sun, bugs, and wind, etc., as long as there aren’t people around.

What to Know About Protecting Newborn Babies

Protect your baby by making sure everyone around them is vaccinated and protected, especially with a dose of Tdap and the flu vaccine.

More on Protecting Newborn Babies