163. COVID19 Vaccine and Pregnancy

NEW covid19 vaccine

I am sure many of you have heard it is the first of its kind. It uses mRNA technology. I am not going to discuss what that means ebcasue so many people already have on other podcasts and publications but the question is should you get the vaccine. I have read many opinons on this from experts for example
Dr. Michal Elovitz, a preterm labor researcher and obstetrician at the University of Pennsylvania.
Said its possible the mRNA and the bubble it travels in, made of lipid nanoparticles, could cross the placenta, and This might, in theory, cause inflammation in utero that could be harmful to the developing fetal brain” she went on to say, “It’s also possible the new vaccines could be totally safe in pregnancy, like the flu shot.”

No pregnant patients were enrolled in the accessible trials, although some people got pregnant during the course of the study. Researchers are monitoring them to see how they do.

We have not even tested this on pregnant animals—we have no idea if this is safe for pregnant women and this is exactly what I am talking about when I say inclusion drift. It was something that big pharm thrives on.

You get your drug approved in one condition or pt population then you market the drug as this great drug and then quickly the providers forget that the benefit found in the trial was only under perfect conditions with mean age of 25 yrs old and no health problems…. The chance you will see the same benefit in your 75 year old HONDA is almost impossible….. BUT as long as you prescribe the drug they don’t care about your individual patient and their lack of benefit because they care about selling more drugs.. in the drug company world this is comparible to a bait and switch seen by car salesman. Show you the fancy benefits with the drug seen in their perfect patients and perfect environment then take your money or your patients money for much less impressive results.

Studying pregnant people requires extra effort in safe study design and recruitment efforts, Anything you do to a pregnant woman also has a chance of affecting the developing offspring


pregnant women are often just excluded altogether.


https://pubmed.ncbi.nlm.nih.gov/21766440/


a paper from 2011
Evolving knowledge of the teratogenicity of medications in human pregnancy

Which looked at all 172 FDA drugs approved from 2000 to 2010 and guess hoa many had known teratogenic risk??? Whatever you said the answer is wrong because they found most had “undetermined” risk -- in fact “The teratogenic risk in human pregnancy was "undetermined" for 168 (97.7%) of drug treatments approved between 2000 and 2010.”

“we have adequate data on the risk of birth defects in less than 10 percent of medications approved by the Food and Drug Administration since 1980. “

If someone on rounds says “med student, tell me the risk of this medication and in pregnancy” you are going to be right 9 out of 10 times if you say “we have no FDA proven data on that”


And speaking of the FDA what did they say about this --
F.D.A. left the choice of whether or not to get the Covid-19 vaccine up to pregnant women,



· The American College of Obstetricians and Gynecologists per usual isn’t worth their weight in feathers as they said- “ACOG recommends that COVID-19 vaccines should not be withheld from pregnant individuals who meet criteria for vaccination based on Advisory Committee on Immunization Practices recommended priority groups.”
I swear the ability to critically think or form your own opinion must occur some place around the second year of OB/gyn residency because their guidelines and opinions are almost always the least imformative or evidence based documents to ever be published. In their released statement they try to state some small crappy observational studies
One which showed if you were preg and had covid you were more likely to go to the ICU—well ist hat cause you are sick or because you are pregnant and have covid and realistically back in April if you were pregnant and had covid and even sneezed you were admitted to the ICU

The other was a morbidity and mortality weekly report which 598 hospitalized pregnant women with COVID-19- now most of these women were hospitalized for labor and delivery and then were asymptomatic and tested positive for covid19
And of those almost 600 women hospitalized lets get to the scary part
16.2% were admitted to an intensive care unit (ICU), and 8.5% required invasive mechanical ventilation.
Which sounds scary but we care about is pregnancy loss
And turns out 2.2% of the women had a pregnancy loss
Which is scary but we know spontaneous abortion is a real thing especially at <20weeks and it is almost impossible to tease out is this a spontaneous abortion in someone who has covid or is this covid causing a spontaneous abortion

Now rates of abortion after 20 weeks is much less.
So in this a morbidity and mortality weekly they estimate that risk of stillbirth was
5 per 458 which is about 1.6 per 160 covid births
And when you look at the CDC data on this they average the risk of stillbirth in the US is
Around 1/160
https://www.cdc.gov/mmwr/volumes/69/wr/mm6938e1.htm
BUT BUT BUT when you break that down by those women who had symptoms at initial presentation and those that did not have symptoms it tells a much different story
Remember the baseline risk of still birth is around 0.6%
If you came in with symptoms of COVID at time of admission your risk of still birth was 2.8%
4x greater risk of still birth if you came in with symptoms of covid19
Now if you didn’t have symptoms what was your rate of stillbirth? And the answer is 0.3%
Yes HALF the rate of still birth from the general if you didn’t come in with symptoms. You could make the hypothesis that those women who have covid but are asymptomatic are protected from having a still birth…
Which begs the questions of why do some have symptoms and why are some are asymptomatic---and what we seem to know from pure observation data is those individuals with co-morbid conditions or said differently those individuals who are already not living a healthy lifestyle are at great risk of getting a virus and dying from a virus. For many the thought that being unhealthy could lead to death or leave you prone to severe infection is a very new and foreign concept!

https://obgyn.onlinelibrary.wiley.com/doi/full/10.1111/aogs.13901
https://www.acog.org/en/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-Pregnant-and-Lactating-Patients-Against-COVID-19

For those of you wondering the CDC has said – “Health care personnel who are pregnant may choose to be vaccinated.”
Which is what they should say because what they are really saying is “we are not going to stop you from doing it but we are certainly not going to promote you getting it”