Severely Flawed and Limited Trial Data Used to Disingenuously Claim Covid-19 Vaccine Safety for Pregnant Women. The CDC & Media are acting against public health.
-media uses preliminary 2 1/2 Month study of self reported data monitoring majority third trimester outcomes post mRNA covid-19 vaccination to declare the vaccines 'safe in pregnancy'
-experts fear mRNA antibody reaction might lead to possible interference with proper placental formation in early pregnancy, study lacked enough substantive data to inform any determinations on early pregnancy outcomes, time frame placental formation problems would occur
-Vaccine Trials too short to inform any conclusion on safety - 2 1/2 months of data is not long enough duration to properly assess safety for use in this population - additionally, trial design demonstrated significant flaws to impede accuracy of study findings
-mRNA drugs are not traditional vaccinations utilizing never before approved gene line editing technology, some experts argue the Pfizer & Moderna products are not vaccinations at all, but medical devices. Risks to fetus extend beyond adverse pregnancy outcomes of stillbirth, gene line editing mRNA may have effects on immune system development which can not be determined through this type of study. There is NO DATA on the effect of utilizing gene line editing medications in post natal outcomes.
-(update, CDC walked back comments from CDC director stating agency advised pregnant women to get the vaccinatio) Vulnerable population groups such as pregnant women are typically the LAST to receive any approval or recommendation for new drugs, with studies conducted to determine safety after extensive research has been done in general population. mRNA vaccinations are emergency use only approved and the current trial methods of utilizing pregnant women to ascert trial data by individuals not enrolled directly in study with informed consent (VAERS trial data reports) may constitute Nuremberg Code violations
On April 21, the New England Journal of Medicine, released a preliminary finding paper entitled:
The news agencies immediately ran with bold headlines declaring the vaccines safe for pregnant women such as:
CBS News:
NPR:
Fort Wayne, NBC:
'Study Says Covid 19 Vaccine Safe for Pregnant Women'
Only the preliminary trial study does not provide substantive evidence mRNA Covid-19 vaccinations are safe in pregnancy. Not at ALL.
The trial measures two and a half month preliminary trial data (coming from self reported data from pregnant women who met study guidelines for inclusion) and only reflects 2 /1s months of incredible preliminary data AND majority of data reflected third trimester outcomes:
Additionally, the study utilized survey data from highly limited adverse event monitoring systems. VAERS CDC data was included in the study findings, however, the system is notorious for capturing only a tiny percentage of post vaccination adverse events, with a Harvard Study finding only 1% of vaccine adverse events are ever reported to the system. The FDA failed to set up a proper monitoring system before emergency use mass vaccinations began in December, according to a February story in the New York Times.
Only 3,958 women were enrolled in the actual trial study with the rest of the data compiled from analysis of adverse events to reporting systems.
Trial design flaws include failure to account for VAERS low event capture rate, no control group, failure to account for Covid-19 trial design flaws for Covid-19 infection outcomes in pregnant women due to use of severely flawed PCR testing employed to measure and diagnosis end point outcomes, and limited study participation rate.
These flaws severely undermine credibility for accurate determination of safety for pregnant women.
This report does not meet the minimum standard of evidence based research to inform public health policy decisions
Additionally, the study has extensive limitations flagging reliability of data with three extensive paragraphs listing caveats to why the study can not truly determine any safety for mRNA Covid-19 vaccinations for pregnancy at this time (partial quote, please read FULL study for entire discussion):
"limitations should also be noted. As with all participant-reported surveillance systems, mistakes in completion of v-safe health surveys can result in misclassification of participants as pregnant; as a result, data for local and systemic reactions that participants reported to the v-safe platform may include some reports from nonpregnant persons. Participants are not required to complete surveys at the same time every day, and our ability to assess onset or duration of adverse events, such as fever, is limited. The registry data are preliminary, are from a small sample, and describe mostly neonatal outcomes from third-trimester vaccination; the findings may change as additional pregnancy outcomes are reported and the sample size increases, which may facilitate detection of rare outcomes. We were unable to evaluate adverse outcomes that might occur in association with exposures earlier in pregnancy, such as congenital anomalies, because no pregnant persons who were vaccinated early in pregnancy have had live births captured in the v-safe pregnancy registry to date; follow-up is ongoing. In addition, the proportion of pregnant persons who reported spontaneous abortion may not reflect true postvaccination proportions because participants might have been vaccinated after the period of greatest risk in the first trimester, and very early pregnancy losses might not be recognized. Whereas some pregnancies with vaccination in the first and early second trimester have been completed, the majority are ongoing, and a direct comparison of outcomes on the basis of timing of vaccination is needed to define the proportion of spontaneous abortions in this cohort. Because of sample-size constraints, both pregnancy and neonatal outcomes were calculated as a proportion instead of a rate"
The study lacks substantive data on pregnancy outcomes in the first and second trimesters.
This is important because one of the main concerns experts have around the use of mRNA vaccinations in pregnant women is a potential antibody response which could impede proper placenta formation and attachment in early pregnancy.
Dr Michael Yeadon, former VP of Pfizer UK Division and Dr Wolfgang Wodarg, a lead investigator into the 2009 Swine Flue pandemic filed a Emergency Stay in the European union, partially based on this concern:
"Several vaccine candidate sare expected to induce the formation of humoral antibodies against spike proteins of SARS-CoV-2.Syncytin-1 (see Gallaher, B., “Response to nCoV2019 Against Backdrop of Endogenous Retroviruses” -http://virological.org/t/response-to-ncov2019-against-backdrop-of-endogenous-retroviruses/396),which is derived from human endogenous retroviruses (HERV) and is responsible for the development of a placenta in mammals and humans and is therefore an essential prerequisite for a successful pregnancy, is also found in homologous form in the spike proteins of SARS viruses.There is no indication whether antibodies against spike proteins of SARSviruses would also act like anti-Syncytin-1 antibodies. However, if this were to be the case this would then also prevent the formation of a placentawhich would result in vaccinated womenessentially becominginfertile.To my knowledge, Pfizer/BioNTech has yet to release any samples of written materials provided to patients, so it is unclear what, if any,informationregarding (potential) fertility-specific risks caused by antibodiesis included.According to section 10.4.2 of the Pfizer/BioNTech trial protocol, a woman of childbearing potential (WOCBP) is eligible to participate if she is not pregnant or breastfeeding, and is using an acceptable contraceptive method as described in the trial protocol during the intervention period (for a minimum of 28 days after the last dose of study intervention). This means that it could take a relatively longtime before a noticeable number of cases of post-vaccination infertility could be observed'.
The CDC approval comes at the same time research investigations are being launched do to women reporting severe menstrual anomalies and heavy bleeding post Covid-19 vaccination, an indicator the vaccines may effect women's hormonal balance which might effect pregnancy outcomes:
Thread/Story Documenting Anecdotal Evidence Triggering Research Studies Into the Issue of Menstrual Irregularities, Viral Shedding Concerns Due to Symptoms Occurring in Women Who Have Not Received Vaccine
It is the height of irresponsibility for the CDC to utilize compromised and highly limited trials to assert ANY safety claim around mRNA Covid-19 vaccination use in pregnant women. And, the media is now imperiling public health in failing to perform the most basic due diligence to review evidence to ensure public official claims match the evidence.
Many health Care professionals have serious concerns aroundCovid 19 vaccination safety Please refer to Section 6 of the petition for full documentation and evidence regarding this issue:
Part 6 Petition: Sars CoV2 Covid-19 Emergency Approved Vaccines: Unnecessary, Serious Safety Concerns