It’s the time of the year commonly referred to as “cold and flu season.” Signs are up in pharmacies and doctor’s offices across the nation to advertise the flu vaccine. But have you ever read the sign close enough to see who is actually endorsing the shot? The catchy headline urges people that it is necessary, that it is “safe and effective.” Let’s take a closer look at those signs.
Do you ever see the name of the company that manufactured the vaccine on the sign? Often not, especially when the marketing is targeted to pregnant women. Why? Every company with a vested interest advertises their own product, right?
The Flu Shot and Pregnant Women
The images range from heart-warming to fear-inducing as you walk past a pharmacy advertising the annual flu shot. Looking at the bottom of the poster, you’ll see that it is the CDC touting these vaccines, not the manufacturer that is advertising the message. Why?
The product insert for all vaccines are available on the FDA site. In the Influenza section, all approved vaccines are available with links to each, including the product inserts. In the insert, all populations that have been reviewed in trials and the observable outcomes are listed, as well as ingredients, risks, etc. In nearly all, if not all, inserts, it is clearly stated trials have not been done on pregnant women.
With no clinical trials done, nor data submitted to analyze, the FDA can’t approve the vaccine for pregnant women. Therefore, the use of the vaccine is considered “off-label” which can be recommended by the CDC, but not advertised by the manufacturer. That would be illegal. Sound confusing? Aaron Siri, Esq, an attorney representing many vaccine cases weighs in. You can watch his explanation starting at 18:00.
Small and Concerning Study for the Flu Shot
We did find one small study that included 100 pregnant women. The study was quite small and not well established. For instance, there wasn’t a control group. Both groups of women were given a flu shot, just one of two variations.
In reviewing the study data, Table 2 showing the Number of Maternal Complications of Pregnancy, Labor, and Delivery indicates a high incidence of concerning events for such a small sample. Table 3 showing the Number of Participants Reporting of Neonatal Complications is also of significant concern.
Table 4 indicates the Number of Participants Reporting Serious Adverse Events (SAE). This table reflects that 8 of 46 mothers receiving the Fluzone® vaccine and 13 of 56 mothers receiving the Fluarix® vaccine reported an SAE. These rates are rather concerning indicating that 17.4% and 23.2% experienced an adverse event respectively. An SAE is defined as:
Serious adverse events included any untoward medical occurrence that resulted in death of the mother, fetus or infant; was life threatening to mother, fetus or infant; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; was a congenital anomaly/birth defect in fetus or infant; or may have jeopardized the mother, fetus or infant, or required intervention to prevent one of the outcomes.1
COVID Vaccine and Pregnant Women
Women were not included in the original trials of the COVID vaccines. At the questionable approval of the Pfizer-BioNTech vaccine, Comirnaty, it was indicated that registries were to be established to follow pregnant women. Studies are also to be established in post-marketing according to the approval letter. These studies are set to be completed with final reports due to the FDA on December 31, 2025.
According to the package insert:
Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.2
Researchers Call for a Pause on COVID vaccines in Pregnant Women
In April, The New England Journal of Medicine published an article which referenced a study believed to support vaccinating pregnant women against COVID. Many researchers have indicated that the data was used to incorrectly support a positive outcome. The fine print in the footnotes of table four indicate:
Data on pregnancy loss are based on 827 participants in the v-safe pregnancy registry who received an mRNA Covid-19 vaccine (BNT162b2 [Pfizer–BioNTech] or mRNA-1273 [Moderna]) from December 14, 2020, to February 28, 2021, and who reported a completed pregnancy. A total of 700 participants (84.6%) received their first eligible dose in the third trimester. Data on neonatal outcomes are based on 724 live-born infants, including 12 sets of multiples.3
If the study was published in April, we know that many of these live births were vaccinated during their third trimester, or near the very end of the second. This is indicated by the 700 participants listed above. The Table we are referring to is below:
A spontaneous abortion is also known as a miscarriage before 20 weeks. If there are 700 participants who were vaccinated in the third trimester, they wouldn’t qualify to be considered in the number with the possibility to experience a spontaneous abortion; they are post 20 weeks gestation at the time of vaccination. That leaves 127 participants eligible to be considered at the most. The table indicates 104 spontaneous abortions before 20 weeks. 104/127 is 81.8%. That is well outside of the number of anticipated miscarriages of any health agency.
This week, researchers Dr. Aleisha R. Brock and Dr. Simon Thornley commented on this article by publishing their review of the study which raised not just this concern with data manipulation, but others as well. As a result, the New England Journal of Medicine published a correction, however significantly diluted from the robust analysis provided by Brock and Thornley.
Brock and Thornley “question the conclusion of the study”:
“The assumption that exposure in the third trimester cohort is representative of the effect of exposure throughout pregnancy is questionable and ignores past experience with drugs such as thalidomide. Evidence of safety of the product when used in the first and second trimesters cannot be established until these cohorts have been followed to at least the perinatal period or long-term safety determined for any of the babies born to mothers inoculated during pregnancy.”
Dr Thornley continues:
“Since the risk of fatality or severe outcome following COVID-19 infection is generally extremely low for younger people, including those who are pregnant, we caution against the use of the vaccine, given the substantial uncertainty that exists.”