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Covid-19 (mRNA) Vaccine for Pregnant/Lactating Women??

The Problem

Pregnancy changes how the body functions including the heart, lungs and immune system

YET

No pregnant/lactating women (or children under 16) were included in vaccine trials to date

AND

Medical  societies and the CDC are recommending that pregnant and lactating women who are at high risk be offered vaccination

WITH NO DATA AVAILABLE

Pregnant and lactating women are ‘free to make their own decision” according to experts

Facts to Consider 

Vaccine Facts

  • Both available mRNA vaccines are >90% effective
  • Vaccine administration lead to few short term risks in trials
  • No known contraindications to offering vaccine to pregnant women
  • Vaccine contains no live virus
  • mRNA causes your own cells to make a virus protein and stimulate an immune response
  • mRNA does not enter the nucleus of your cells or affect your DNA
  • mRNA breaks down quickly

Known Risks

An estimated 330,000 pregnant or lactating women are  health care workers many with risk of Covid 19 exposure 

 Studies show pregnant women are more likely than their non-pregnant counterparts to develop severe illness

  • increased risk of intensive care admission
  • needing mechanical ventilation
  • increased risk of preterm delivery

Unknown questions????

  • Is the effectiveness of the vaccine different in pregnant women (immune system and metabolism are changed by pregnancy)
  • Does the vaccine cross the placenta?
  • What is the effect of the mRNA on developing fetal cells?
  • Could vaccine cause maternal immune system to attack fetal cells?
  • Is the vaccine found in breast milk?
  • What is the effect of the vaccine on the developing newborn (the newborn immune system is not fully developed)?

Decision Making

Talk to your doctor about your individual risk of 

  • disease exposure and likelihood of becoming infected
  • baseline health (more health conditions pose higher risk of disease complications)
  • history of allergies to medications or vaccines
  • ability to avoid infection without vaccination

Concerning Issues

  • The purpose of clinical trials is to give the public the assurance that therapies offered are safe and effective. Yet in 2020, pregnant women are now in the position of making a decision without any such data.
  • While recruiting pregnant/lactating women can be challenging, these studies could/should  have been carried out concurrently.
  •  It would have been unconscionable to carry out trials entirely left out an ethnic group or women as a whole, yet pregnant/lactating women were entirely excluded from these trials.
  •  In Britain, regulators have advised against offering the Pfizer-BioNTech vaccine to pregnant people or those who are breastfeeding. They also warn that “women of childbearing age should be advised to avoid pregnancy for at least 2 months after their second dose.”
  • History has shown us that biology can be surprising

–Thalidomide in the 1950-60s was  thought to be safe by the standards of the time and used to alleviate nausea in pregnancy. The drug interfered in fetal limb development. 

–From the 1930s-197os, DES (Diethylsilbestrol) was prescribed to prevent miscarriage, it had no effect on the women who took it but affected the female fetuses carried by those women causing an increased risk of vaginal cancer.

Studies that include pregnant women and those under age 16 are said to be planned to start in the first quarter of 2021

 

 

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