FDA is Targeting Pregnant Woman To Receive Vaccines for Preventing Disease in their Infants

FDA is Targeting Pregnant Woman To Receive Vaccines for Preventing Disease in their Infants post image

If sticking children with over 69 strains of vaccines by the time they are 6 is not enough, the FDA (with Big Pharma certainly behind them) is now setting its sights on development of vaccines to be licensed for use in pregnant women with the indication of preventing disease in their infants. That scares the pants off me. What about you?

At first glance, if you are a person who takes the stance that any new medical idea is a good one, it does sound intriguing. Obviously preventing a serious illness in an infant is admirable. However, we know that there is a percentage of folks who do not tolerate all the additives and immune stimulation of vaccines well at all. In fact, some of these folks wind up with autoimmune diseases, autism or other health issues.

The rhetoric of the safety of vaccines sort of follows the rhetoric that Monsanto is producing their genetically modified foods in order to feed the world.

Totally Altruistic.


Or, Monsanto HAS to patent their genetically modified seeds in order to protect the farmers who buy them.


You get my point.

Did you know that there are no vaccines that are currently licensed in the United States for use in pregnant women? But pregnant woman are routinely given inactivated flu vaccines and the Tdap (tetanus, diphtheria, acellular pertussis (Tdap) vaccine).

These two inactivated vaccines are not contraindicated for use during pregnancy (according to the FDA) and are recommended by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices and professional societies for routine off-label use in pregnant women.

But is this a good idea? Injecting the mother with inactivated virus carried along with metal adjuvants like aluminum and even thimerosal (still) that can over-stimulate the immune system?

The two above mentioned vaccines as well as those targeting group B streptococcus, respiratory syncytial virus (RSV), and cytomegalovirus are in the works for licensure specifically to prevent disease in the infants.

Here is yet another open market in which to push more and more vaccines. Big Pharma must be rejoicing!

On November 13, 2015 there was a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, where panel members provided feedback to the FDA on the many technical aspects of how studies need to be conducted to gather the necessary data in order to assess efficacy, safety, and potential interference with infant immunizations.

Take a look at what the panel chair has to say – I added the bold for emphasis.

According to panel chair Robert Daum, MD, professor of pediatrics in the Section of Infectious Diseases at the University of Chicago in Illinois, (via Medscape Medical News).

This is really a game-changer. It’s changing the paradigm of how we do things. We haven’t thought of mothers as immunization targets. We’ve waited until the babies came out and then started to work on them. I don’t think we need to do that. I think we can start on mothers, but we need the data in place before we go forward.

Mothers as immunizations targets? That tells you very clearly what the goal is here.

According to Marion F. Gruber, PhD, director of the FDA’s Office of Vaccines Research and Review, told (via Medscape Medical News).

We have been discussing clinical development of vaccines for use in pregnancy with vaccine manufacturers for a long time. There were many cross-cutting and overlapping issues, and we thought it deserved a public discussion to move the field forward… we can’t really generalize. We have to look at the disease to be prevented…. We can’t just knit together one clinical development program that fits all different vaccines.

GlaxoSmithKline is currently seeking maternal immunization indications for four vaccines: already-licensed influenza and Tdap vaccines and investigational RSV and group B streptococcus vaccines. Novavax, a small biotech company, is also developing an RSV vaccine for which it aims to obtain a maternal immunization indication.

Others will most likely jump on the band wagon of this emerging market.

In 2012 the ACIP began to recommend immunization of all pregnant women with Tdap during every pregnancy, due to the outbreak we had that year. In 2012 there were nearly 42,000 cases reported. Most of the complications and actual deaths were in newborns.

Newborns are most vulnerable to the disease as their immune systems are not developed. The medical viewpoint is that they are most vulnerable because they are too young to be immunized. That is where immunizing the mother in the third trimester comes in. Maternal antibodies may be passed on to the infant and offer protection in those early months.

This preliminary study, Safety and Immunogenicity of Tetanus Diphtheria and Acellular Pertussis (Tdap) Immunization During Pregnancy in Mothers and Infants, published in the JAMA in 2014, evaluated this issue.

The researchers did not find any serious adverse events in the mothers or the infants, but by their own admission, the study group was small and further studies are needed.

The recommendation to immunize every pregnant woman with the Tdap in the third trimester of pregnancy will continue in spite of the absence of any kind of efficacy and safety data.

According to panel chair Robert Daum, MD, (via Medscape Medical News).

The [Tdap] recommendation was made because there were cases of pertussis occurring, not because it was well studied and we had good data. We really don’t know if that’s the right way to use the vaccine. Efficacy and safety have to be studied… When one is making vaccine policy, one has to remember that it’s not just the vaccine safety profile that we need to worry about. It’s also the terrible illnesses we’re trying to prevent. Giving Tdap seems to be a good idea and is a good idea, but we would like more data.

OK. So the recommendation to immunize potentially millions of pregnant women is essentially a huge research project at this point.

What about teaching young people how to eat healthy foods, properly prepared in order to insure a healthy pregnancy, a healthy infant with a robust immune system.

What about encouraging all women to breast feed their infants and thereby pass on maternal antibodies to the newborn?

Find out more about what the Weston Price Foundations says about how to eat traditional healthy real foods to insure healthy children.

Further Reading

Has your doctor or do you know anyone whose doctor has recommended the flu or the Tdap to pregnant women?

Leave a comment and let me know what you think about this!

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