from Childrens Health Defense:
The FDA, meanwhile, has been busy handing out “Breakthrough Therapy” designations to Pfizer as if they were papal dispensations, signaling a regulatory willingness to speed up approval not only for Pfizer’s RSV vaccine but also for a maternal Group B Streptococcus (GBS) vaccine the company is developing.
To this expedient end, the FDA allowed Pfizer to “stop the [RSV] study short,” halting enrollment at about 7,400 participants — though the trial was supposed to involve 10,000 pregnant women.
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Researchers devoted to vaccine orthodoxy pay lip service to the need for an extra-high evidentiary bar for pregnancy vaccines — stating that such vaccines should not only prove they reduce illness, with minimal reactogenicity in the woman, the fetus and the neonate, but should also “demonstrate safety or lack of evidence of harm.”
However, those turn out to be empty words.
In fact, the influenza and Tdap (tetanus-diphtheria-acellular pertussis) vaccines that public health agencies have long recommended for pregnant women never underwent any clinical trial safety testing in that population, and the FDA never licensed those vaccines specifically for pregnant women.
Moreover, flu shots and Tdap shots have never even resulted in any statistically significant reduction in the outcomes they are supposed to address.
With the advent of Emergency Use Authorization COVID-19 vaccines, the FDA, Pfizer and other manufacturers barely made any pretense of assessing maternal safety, and likely “colluded together to conceal damaging data” about high rates of fetal death.
Other researchers, however — and even vaccine insiders — began to speak out in 2021.
For example, Canadian researchers writing in late 2021 worried that many of the systemic reactions commonly reported after COVID-19 vaccination might be “sufficient to affect fetal/neonatal development.”
Those authors included vaccinologist Byram Bridle, Ph.D., who earlier in 2021 characterized the COVID-19 vaccines’ disturbing biodistribution and accumulation in vital organs as “a big mistake,” and neurology professor Dr. Steven Pelech, who expressed repeated concerns about myocarditis and the vaccines’ risks to young people.
Now, as horrified pregnant women who took the COVID-19 jabs experience skyrocketing miscarriages, stillbirths and fetal malformations, they are wondering why regulators issued no warnings.
But as Pfizer’s exuberant RSV press release and the FDA’s complacent endorsement of clinical trial shortcuts suggest, vaccine makers and regulators not only intend to ignore or bulldoze even the most outsized safety signals but are clearly positioning themselves to go after pregnant women in an even bigger way.
Read More @ ChildrensHealthDefense.org
