Tag: pregnancy

Did the FDA Admit That the Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women?

Have you heard?

There is a new bombshell from anti-vaccine folks!

It turns out, they say, that the FDA has admitted that the government is recommending untested, unlicensed vaccines for pregnant women.

Is that true?

Did the FDA Admit That the Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women?

Of course not!

Their evidence?

A response to a Freedom of Information Act request for vaccines that don’t exist. That’s right, neither Tdap nor flu vaccines are currently FDA approved for use by pregnant women.

Of course, that doesn’t mean that Tdap and flu vaccines aren’t recommended for use by pregnant women.

Wait, why the difference?

Why are pregnant women being given a vaccine that isn’t formally FDA approved for their use?

Well, vaccine manufacturers have to seek FDA approval for their products. The FDA doesn’t just up and approve new products or give them new indications. And none have ever sought approval in pregnancy.

But that doesn’t keep health experts from making off-label recommendations, such as getting a flu vaccine when you are pregnant.

“In prelicensure evaluations, the safety of administering a booster dose of Tdap to pregnant women was not studied. Because information on use of Tdap in pregnant women was lacking, both manufacturers of Tdap established pregnancy registries to collect information and pregnancy outcomes from pregnant women vaccinated with Tdap. Data on the safety of administering Tdap to pregnant women are now available.”

Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (Tdap) in Pregnant Women and Persons Who Have or Anticipate Having Close Contact with an Infant Aged <12 Months — Advisory Committee on Immunization Practices (ACIP), 2011

As important as FDA approval is a recommendation from the Advisory Committee on Immunization Practices (ACIP). In fact, even after a vaccine gets approved by the FDA, it still has to get a recommendation from the ACIP before it gets on the immunization schedule and is used routinely!

“Flu shots have been given to millions of pregnant women over many years with a good safety record. There is a large body of scientific studies that supports the safety of flu vaccine in pregnant women and their babies.”

Flu Vaccine Safety and Pregnancy

Getting a flu vaccine during pregnancy is a recommendation that has been evolving since 1983. It was known to be safe then, and we are even more confident that it is safe now.

A Tdap shot has been recommended since 2011, although it was first suggested in 2008 that pregnancy was not a contraindication for receiving Tdap.

How do we know these vaccines are safe during pregnancy?

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.”

Despite what Robert F. Kennedy, Jr and his ironically named Children’s Health Defense organization might think, Tdap and flu shots in pregnancy have been well studied and have been found to be safe.

Ignoring all of the above studies, Kennedy highlights a few that he thinks found problems with flu shots in pregnancy, including one that showed “a suggestion of increased ASD risk among children whose mothers received an influenza vaccination in their first trimester,” a suggestion that was not statistically significant and which was not found in the other trimesters. And another that found an increased risk of spontaneous abortion in women who had also received a flu shot in the previous season, a safety signal that has never been seen before and which continues to be investigated.

Not surprisingly, his latest bombshell is landing with as big of a thud as his HHS lawsuit, as have most of his statements these days…

“CHD’s Chairman Robert F. Kennedy, Jr. notes that most flu shots given to pregnant women still contain a mercury-based preservative thimerosal.”

FDA Admits That Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women

Has Kennedy missed the fact that 80% of flu vaccines are now thimerosal free? It makes you wonder how he defines the word “most?”

“Thimerosal is acknowledged by Proposition 65 in California as a reproductive toxicant and exposure during pregnancy can cause learning and behavioral problems. Tdap contains aluminum, which FDA regulates as a toxin in parenteral nutrition but not in vaccines.”

FDA Admits That Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women

And what is he concerned about in thimerosal-free flu shots which also don’t contain aluminum? Are those okay in his book?

Mostly, after several flu seasons in which so many people have died, you have to wonder what his goal is here. Does Robert F. Kennedy, Jr. expect folks to skip getting a flu shot when they are pregnant and instead risk getting the flu? Should they skip their Tdap shot and risk their baby dying of whooping cough?

Or should they just stop listening to this type of anti-vaccine propaganda?

More on Did The FDA Admit That The Government Is Recommending Untested, Unlicensed Vaccines For Pregnant Women?

How Often Should You Do Vaccine Titer Testing?

We sometimes hear about folks doing vaccine titer testing.

A vaccine titer is a blood test that can determine whether or not you are immune to a disease after you get a vaccine.

While that sounds good, after all, why not check and be sure, it has downsides. Chief among them is that the results aren’t always accurate.

That’s right. You can sometimes have a negative titer test, but still be immune because of memory B cells and the anamnestic response.

How Often Should You Do Vaccine Titer Testing?

So how often should you do vaccine titer testing?

It depends, but most folks might never have it done!

Why not?

Vaccines work very well, so you would typically not need to routinely check and confirm that you are immune after being vaccinated. And, this is also important, the vaccine titer tests don’t always work that well, titer testing isn’t available for all vaccines (you can’t do titer testing for Hib and pertussis), and the testing can be expensive.

So we usually just do the testing (a quantitative titer) for folks that are in high risk situations, including:

  • pregnancy – rubella titer only (HBsAg is also done, but that’s not a vaccine titer test, but rather to see if you are chronically infected with hepatitis B)
  • healthcare workers – anti-HBs (antibody to the hepatitis B surface antigen to confirm immunity after being vaccinated)
  • students in nursing school and medical school, etc. – anti-HBs
  • children and adults exposed in an outbreakmeasles, chicken pox, mumps, etc., but only if we are unsure if they were previously vaccinated and protected
  • after a needlestick injury, etc. – to confirm immunity to hepatitis B
  • babies born to a mother with hepatitis B – to confirm that their hepatitis B vaccine worked

Vaccine titer testing might also be done for:

  • internationally adopted children – to confirm that they are immune if we unsure about all of the vaccines the child got in other countries
  • children and adults with lost vaccine records – to confirm that they are immune, since we are unsure about all of the vaccines they got
  • evaluation of children and adults with immune system problems – to help identify what immune system problems they might have – typically involves checking pneumococcal titers, giving Prevnar, and then checking pneumococcal titers again
  • people at continuous or frequent risk for rabies – rabies titer testing every 6 months to 2 years
  • patients with inflammatory bowel disease, before starting immunosuppressive therapy – hepatitis A and hepatitis B titers, as they might be at increased risk for hepatitis

While checking titers is easy, it is sometimes harder to know what to do with the results you get.

Of all of these different titers, only one tells you that you are immune due to vaccination.
Of all of these different titers, only one tells you that you are immune due to vaccination.

It is especially important to know that:

  • most people don’t need to have their titers checked routinely if they are not in one of the high-risk groups noted above
  • it isn’t practical to get titers tested as a method of potentially skipping one or more doses of your child’s vaccines, after all, if the titer is negative, then you are still going to have to get vaccinated
  • a healthcare provider with a negative measles titer after two doses of the MMR vaccine does not need another dose of vaccine
  • a healthcare provider who has anti-HBs <10 mIU/mL (negative titer) after three doses of the hepatitis B vaccine should get another dose of vaccine and repeat testing in 1 to 2 months – if still <10 mIU/mL, they should then get two more doses of hepatitis B vaccine (for a total of 6 doses) and repeat testing. If still negative, these documented nonresponders will need HBIG as post-exposure prophylaxis for any future hepatitis B exposures, but no further doses of hepatitis B vaccine.
  • vaccinated women of childbearing age who have received one or two doses of rubella-containing vaccine and have rubella serum IgG levels that is not clearly positive should be administered one additional dose of MMR vaccine, with a maximum of three doses, and should not be tested again
  • postvaccination titer testing is not recommended after the chicken pox vaccine
  • in addition to not being able to test titers for pertussis and Hib immunity, it is becoming difficult to test poliovirus type 2 titers, as the test uses a live virus that isn’t routinely available anymore (type 2 polio has been eradicated)

Still think you need vaccine titer testing?

More on Vaccine Titer Testing

Who Is Judy Mikovits?

Dr. Judy Mikovits has a PhD in Biochemistry and Molecular Biology, doing her thesis on Negative Regulation of HIV Expression in Monocytes.

She had several papers published with Dr. Frank Ruscetti, with whom she continues to work.

Instead of research, it seems that they now do:

  • Advocacy for vaccine injury legal cases worldwide. 
  • Research and documentation on medical exemptions for vaccinations.

What happened?

Who Is Judy Mikovits?

After working at the National Cancer Institute, it seems that Judy Mikovits became research director of the Whittemore Peterson Institute (WPI).

A paper by Mikovits and Ruscetti was retracted because no one else could replicate the work.

She was eventually fired after a paper she was lead author on, which found xenotropic murine leukemia virus-related virus (XMRV) in patients with CFS, was retracted and the institute accused her of stealing notebooks and manipulating data.

“But the leader of the team that authored the 2009 paper, researcher Judy Mikovits, apparently presented the same figure — carrying different labels and supporting a different point — in a talk given at a conference on Sept. 23 in Ottawa.”

Manipulation alleged in paper linking virus, chronic fatigue syndrome

An even larger study found no evidence of XMRV infections in patients with chronic fatigue syndrome, even as she had claimed the virus could cause CFS, Parkinson’s disease, autism and multiple sclerosis.

The source of XMRV in her patients?

“Well-controlled experiments showed that detection of XMRV was due to contaminated samples and was not a marker of or a causal factor in prostate cancer or CFS.”

Johnson et al on Xenotropic Murine Leukemia Virus-Related Virus (XMRV) and the Safety of the Blood Supply

The virus was in a contaminated cell line in which she and others were doing research. The virus wasn’t in the actual patients themselves.

Judy Mikovits on Vaccines

Before her paper was retracted and she was fired from her lab, Judy Mikovits did actually do research on viruses and she is a scientist. She didn’t do research on vaccines though.

Judy Mikovits is still finding retroviruses wherever she looks for them...
Judy Mikovits is still finding retroviruses wherever she looks for them…

That seems to be something she talks about a lot now though:

  • at anti-vaccine rallies
  • at anti-vaccine conferences
  • in anti-vaccine videos

Her claim to fame seems to be talking about contaminated vaccines and bashing Gardasil. And deep state conspiracy theories about why she was arrested and lost her job.

To be clear, a rotavirus vaccine was found to be contaminated with DNA of porcine circovirus type 1.  While that might sound a little scary, it is important to keep in mind that the PCV1 virus doesn’t actually cause disease in people and these weren’t even “biologically active virus particles.”

PCV1 isn’t a retrovirus though and Judy Mikovits wasn’t even the researcher who discovered the contamination, which has since been resolved. 

“These findings do not indicate the presence of either ALV or EAV infection in MMR vaccine recipients and provide support for current immunization policies.”

Hussain et al on Lack of Evidence of Endogenous Avian Leukosis Virus and Endogenous Avian Retrovirus Transmission to Measles Mumps Rubella Vaccine Recipients

Studies have looked at retrovirus contamination of vaccines, but they were  done over 17 years ago. And not by Mikovits. Studies that confirmed that vaccines are safe.

None of this has kept Judy Mikovits from scaring people about vaccines, especially the HPV vaccine.

“Cervical cancer is not a public health threat. It’s not an infectious disease. Why is it in the Department of Public Health? Why are we mandating every child over 9 years old, and I heard soon to be pregnant women, to get this vaccine? It makes no sense.”

Judy Mikovits

It is really hard to understand how someone who worked at the National Cancer Institute could make these statements. Cervical cancer is one of the most common cancers in women.

There is, of course, no mandate for 9-year-olds to get the HPV vaccine. In the United States, HPV vaccination is recommended, beginning at age 11 to 12 years. The HPV vaccine is not recommended for pregnant women and while several vaccines are recommended, no vaccines are actually mandated in pregnancy.

“It was never developed to prevent cancer. It was developed and approved to prevent warts. Warts are not a public health threat. It’s beyond… When scientists like myself, and I work in cancer and AIDS hear this, we are just…”

Judy Mikovits

Gardasil and Cervarix were developed to prevent HPV infections, which cause cervical cancer. HPV can also cause genital warts.

“I think we need to ban… Japan and India have, all HPV vaccinations now, until the appropriate studies are done, until the patients are tested…”

Judy Mikovits

Neither Japan nor India have banned HPV vaccinations.

Why should we? The HPV vaccines are safe, effective, and necessary.

And why would anyone listen to Judy Mikovits? 

More on Judy Mikovits

How Does a Mother’s Flu Shot Protect a Newborn Baby?

We know that pregnant women are supposed to get a flu vaccine.

Although recommendations on exactly when to get it have changed over the years, it has been a universal recommendation since at least the 1994-95 flu season.

But why?

How Does a Mother’s Flu Shot Protect a Newborn Baby?

One obvious way that a flu shot provides protection during pregnancy is that it reduces your risk of getting the flu while you are pregnant.

A flu shot during your pregnancy protects both you and your baby.
A flu shot during your pregnancy protects both you and your baby.

That’s good, as having the flu while you are pregnant can lead to preterm labor, a premature birth, birth defects, or a miscarriage. And of course, the flu can be life-threatening for pregnant women.

Getting a flu shot while you are pregnant can also help to make sure that you don’t get the flu after your baby is born, which not only keeps you healthy, but decreases the chance that your baby will be exposed to the flu. After all, if you get the flu, no matter how much you try to cover your cough and wash your hands, there is a good chance that you will give it to your baby.

And since babies can’t get flu shots of their own until they are at least six months old, a flu shot during pregnancy helps to make sure that your baby gets some of antibodies to protect them from the flu.

“When you get a flu shot, your body makes antibodies that also pass to your fetus. This means your baby has protection against the flu after birth. This is important because infants less than 6 months of age are too young to get the flu shot.”

Frequently Asked Questions for Patients Concerning Influenza (Flu) Vaccination During Pregnancy

Do you have to wait until late in your pregnancy to make sure that the most antibodies get passed to your baby?

While that might seem like a good idea, especially since that’s what we do for the Tdap vaccine and protection against pertussis, there are several reasons that we don’t do that with the flu vaccine, including that:

  1. pregnant mothers need the protection before flu season hits, so waiting would not be safe and could mean that you get sick with the flu before getting your shot
  2. protection from the flu vaccine shouldn’t wane or wear off so quickly that you need to get it later, after all, the earliest that you can get vaccinated is when flu vaccines first become available in August or September and that should provide good protection past the peak of flu season

When you get your flu shot while pregnant is going to have more to do with when you got pregnant in relation to the start of flu season more than anything else.

“The flu shot can be safely given during any trimester. Pregnant women can get the flu shot at any point during the flu season (typically October through May). Pregnant women should get the shot as soon as possible when it becomes available. If you are pregnant, talk with your obstetrician–gynecologist (ob-gyn) or other health care provider about getting the flu shot.”

Frequently Asked Questions for Patients Concerning Influenza (Flu) Vaccination During Pregnancy

Most importantly, remember that flu shots are considered an “essential component of prenatal care.”

While everyone should get a flu vaccine each year, since pregnant women are in a high risk group for flu complications, you should especially make sure that you get vaccinated and protected if you are pregnant. Everyone around you should get vaccinated too!

More on Flu Shot Protection During Pregnancy