#22 Can Vs Should

Throughout the five boroughs of New York City, you can find this sign posted inside buildings. The title reads,

“Who Can Receive a COVID-19 Vaccine?”

The NYC Health Department provides the answer to its own question—Everybody, 12 years or older, except those who are severely allergic to the vaccine itself, can receive the vaccine. Just in case there are any doubts, a reassuring checklist is provided. Notice the last item on the checklist:

“…pregnant, breastfeeding or planning to become pregnant.”

Let’s be clear. We are talking about an experimental gene therapy technology that has never before been used on large numbers of human beings. It programs our own cells to produce a protein that is part of the COVID-19 virus. No vaccine we have ever received in our lives has programed our cells to produce proteins. That is why many people insist that it shouldn’t even be called a vaccine. It should be called gene therapy. Harvard Scientists take the middle road and call it the Gene Vaccine. https://hms.harvard.edu/news/gene-vaccine

Can or Should? A pregnant woman can sniff cocaine, inject heroine, practice skydiving during her ninth month, but she probably shouldn’t. We humans unconsciously make hundreds, if not thousands, of automatic decisions every day based on risk vs benefit. However, some decisions are more difficult than others and must be made consciously using all available information. To Vax or not to Vax is one of these decisions. How can a woman who is “pregnant, breastfeeding, or planning to become pregnant” decide if she should or should not receive a COVID-19 vaccine? It might help to take a look at the available scientific data. Unfortunately, there is little or no scientific data available. Yes, a woman can receive the vaccine, but there is little or no data that proves that it is safe for herself and for her unborn child.

What about Pfizer’s Covid-19 Vaccine clinical trials? Don’t they provide proof? After all, they are the basis for the FDA approval of the Pfizer vaccine.

The answer is no. The Pfizer Covid-19 Vaccine clinical trials provide no data whatsoever about vaccine safety for pregnant women and their unborn children.

Between March and November of 2020 Pfizer experimented on animals and human beings. None of the animals were pregnant. Human female subjects were placed on contraceptives to prevent pregnancy. They were given pregnancy tests before receiving each dose and excluded from the clinical trial if they tested positive for pregnancy. Twenty-three women got pregnant at some point in the trials. Pfizer has provided no data on these women.

6.3.3.2.8. Pregnancies
At the time of the data cutoff in Study C4591001 (14 November 2020), a total of 23 participants
had reported pregnancies in the safety database, including 9 participants who withdrew from the
study due to pregnancies. These participants continue to be followed for pregnancy outcomes. (page 53)

https://www.fda.gov/media/144246/download

What about pregnant women who have already taken the vaccine?

V-Safe Surveillance System—Limited, Incomplete, Short-Term Data
December 14, 2020 through February 28, 2021.

Despite the fact that Pfizer offered zero safety data for pregnant women, the v-safe COVID-19 Vaccine Pregnancy Registery Team was able to find 35,691 women who had already taken either the Pfizer or the Moderna vaccine during the eleven-week period between December 14 and February 28. There was data on the immediate reaction to the vaccine, but none on the long-term effects. On March 30, 2021 follow-up calls were made. In the end, only 3958 pregnant women out of the original 35,691 provided short-term follow-up data—which leads one to wonder, what happened to the other 31,733?
https://www.nejm.org/doi/full/10.1056/NEJMoa2104983

Are there any long-term studies in progress?

Pfizer COVID-19 Long-Term Study—In progress—Zero Data

“Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS CoV-2 RNA Vaccine Candidate (BNT162b2) Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older “ This study was begun in February, 2021 and will be complete in February, 2023. No data is available yet. https://clinicaltrials.gov/ct2/show/NCT04754594

So where does this leave the woman who is pregnant, breastfeeding, or planning to get pregnant? She must now weigh the threat of the virus against the unknown threat of the vaccine (zero data). You may have seen reports that COVID-19 is very dangerous–especially for pregnant women and their unborn children. HOWEVER, those are just words. What does the data say?

The following study shows that out of 1,219 mothers who tested positive for COVID-19, almost HALF (47%) were asymptomatic (not sick). The 12% who were classified as severe or critical also had the medical conditions that are dangerous for everyone in these COVID times–not just pregnant women: “older mean age, higher median body mass index, and higher frequency of medical comorbidities (asthma/COPD, diabetes, hypertension, liver disease, seizure disorder)”. As we might expect, the more severe the illness, the worse the effects on mother and child. In other words, the virus is dangerous or not depending on your age and your general health. Here’s the study:

Maternal and neonatal outcomes of pregnant patients with coronavirus disease 2019 (COVID-19): A multistate cohort

Objective: To describe COVID-19 disease course in a multistate cohort of pregnant patients and evaluate whether more severe disease is associated with worse maternal and neonatal outcomes.

Study Design: Cohort of all pregnant patients with a singleton gestation and positive SARS-CoV-2 nucleic acid or antigen test (either in- or out-patient), who delivered at one of 33 U.S. hospitals from March 1 to July 31, 2020. Disease severity was classified by NIH criteria. Perinatal outcomes included death, cesarean delivery (CD), postpartum hemorrhage (PPH), hypertensive disorders of pregnancy (HDP), and preterm birth < 37 weeks’ (PTB). Centrally-trained perinatal research staff abstracted data from medical records. We evaluated trends in maternal characteristics and outcomes across COVID-19 severity classes and associations between severity and outcomes by multivariable modeling.

Results: 1,219 patients were included: 47% asymptomatic, 27% mild, 14% moderate, 8% severe and 4% critical. Those with more severe illness had an older mean age, higher median body mass index, and higher frequency of medical comorbidities (asthma/COPD, diabetes, hypertension, liver disease, seizure disorder). The majority of included patients were Hispanic ethnicity; however, there was no trend in race-ethnicity distribution by severity (Table 1).
The most common symptoms were cough (34%), dyspnea (19%), and myalgias (19%). Four maternal deaths (0.3%) were attributed to COVID-19. Adverse perinatal outcomes became more frequent with increasing severity of COVID-19, including a 6% (95% CI 2.5-10.9%) VTE rate with severe/critical (Table 2). In adjusted analyses, severe/critical COVID-19 was associated with CD, PPH, HDP, and PTB compared with asymptomatic patients. Approximately 1% (95% CI 0.5-1.8%) of neonates tested positive for SARS-CoV-2 before discharge.

Conclusion: Medical comorbidities were present more often in patients with more severe disease. Compared with asymptomatic patients, those with severe/critical COVID-19, but not those with mild/moderate COVID-19, were at increased risk of perinatal complications. Perinatal transmission was rare.

• Torri D. Metz, MD, MSCR for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network
  Bethesda, MD

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7848486/

ASK QUESTIONS, DEMAND ANSWERS

BASE YOUR DECISIONS ON LOGIC, NOT FEAR