The FDA recently gave full approval to the BioNTech COVID-19 vaccine made by Pfizer under the brand name Comirnaty. The Pfizer-BioNTech vaccine that has been available until now remains under an emergency use authorization (EUA). Both vaccines remain under an EUA for children between the ages of 12 and15. These two vaccines are precisely the same, according to the FDA fact sheet. However, with full approval for those 16 and older, a patient should expect to give informed consent before receiving the vaccine.
The vaccine’s frequently asked questions (FAQs) on the FDA website address several aspects of women’s reproductive health. When answering whether the vaccine is safe for pregnant and nursing women, the answer is as follows:
While there have been no specific studies in these groups, there is no contraindication to receipt of the vaccine for pregnant or breastfeeding women. Pregnant or breastfeeding women should discuss potential benefits and risks of vaccination with their healthcare provider.
This discussion will be difficult because the FDA does not even require BioNTech to do these studies. Instead, the vaccine maker has voluntarily committed to doing them:
In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.
Traditionally, the healthcare system takes special care before deploying a treatment in three populations. The first is children because children’s bodies do not react to medications the same way adults do. Often dosages need to be adjusted, and sometimes they have unintended effects on developing bodies. The FDA already states that the highest risk for pericarditis and myocarditis following the Pfizer-BioNTech vaccine is in young men between the ages of 12 and 17.
There is no information about long-term risks associated with a young man suffering from heart disease following vaccination, yet schools and colleges are moving to mandate them. It is a complete inversion of what Western societies have traditionally done. We are subjecting young men to an unknown risk because adults are suffering from media-induced mass hysteria. These young men are at near-zero risk from the virus if they are healthy and not significantly overweight.
Another population that requires special care is pregnant and nursing women. The effects of any medication on the rapidly developing fetus need to be approached carefully. Initial studies demonstrate that the placenta provides a potential barrier to the infant from COVID-19 infection. It also seems that the mother’s SARS-CoV-2 antibodies do not transfer to the infant at high rates compared to influenza. However, the mRNA vaccine wraps the spike proteins in a lipid nanoparticle. There is no data on how that changes the permeability of the placenta.
Budesonide, an inhaled corticosteroid, has been used safely in asthmatic patients in pregnancy. An Oxford study shows it reduces the need for hospitalization by 90% in COVID-19 if given early and outpatient. It also shortened illness duration. A pregnant or nursing mother who opted to use this outpatient if she contracted symptomatic COVID-19 during pregnancy would be able to receive informed consent. Why would the medical community encourage vaccination rather than effective and safe outpatient treatment with the information they don’t know about vaccines in pregnancy?
A final population that is generally carefully considered is men and women of childbearing years. Since the introduction of the mRNA vaccines, complaints about dysmenorrhea, or abnormal menstruation, have been common. The NIH is just now encouraging research into this potential side effect. The NIH suggests menstrual cycle changes could be due to stress. Women, of course, are presumed to be emotionally fragile when it is a convenient excuse to brush aside a medical concern.
Dr. Byram Birdle, Ph.D., requested biodistribution data on the Pfizer mRNA vaccines from the Japanese government. These studies measured the distribution of the lipid nanoparticles that contain the spike proteins in the mRNA vaccine. What these studies found is that the nanoparticles do not remain in the muscle as most vaccines do.
After 24 hours, the study found some of the highest concentrations in the liver, spleen, and ovaries. The ovaries are the only organs where the particle concentration continues to grow, not decline. While many people have tried to minimize Dr. Birdle’s findings, they have primarily focused on his comments about the destructive nature of the spike protein. These “debunkings” do not dispute the biodistribution data.
Women are born with all of the follicle cells they will ever produce. These follicles mature into an ovum capable of being fertilized about once a month during a woman’s reproductive years. The ovaries, which contain these follicles, secrete the estrogen and progesterone that govern the menstrual cycle and prepare the uterus for the egg’s implantation. Lipid nanoparticles used in the Pfizer vaccine accumulate and increase in the ovary for at least 24 hours after vaccination. Women are complaining of menstrual issues post-vaccination.
While that summary is not proof of causation, it is astonishing that the NIH is just looking into it now. It is even more surprising that the FDA did not demand the same biodistribution data from Pfizer and the vaccine manufacturers and investigate it before “full approval.” Millions of women between the ages of 12 and 45 have taken these vaccines. And none of them were able to give full informed consent because the NIH does not know what is causing these issues.
While the CDC and NIH encourage vaccination for everyone, their go-to phrase for people in these groups regarding the vaccine is “there is no evidence that.” What they don’t tell you is that there is no evidence to the contrary either. Not studying something doesn’t prove it is “safe and effective.” And the failure to be especially cautious with deploying these vaccines in the young, the pregnant, and those of childbearing years is just another thing about this pandemic that turns all previous science and medical protocol entirely on its head.