FDA, CDC advisers say lost pregnancies higher than expected following early mRNA vaccination

President Trump's second-term agenda has been careful not to cast doubt on his signature first-term achievement, the development of COVID-19 vaccines through Operation Warp Speed, which congressional Republicans continue to laud and even claim was sabotaged by Pfizer to deny Trump a consecutive term despite his base souring on the therapeutics.

A new preprint study on mRNA COVID vaccines in early pregnancy, coauthored by top advisers to Trump's Food and Drug Administration and Centers for Disease Control and Prevention, may fuel the splintering of the Make America Healthy Again movement as the jabs' opponents ramp up pressure on Health and Human Services Secretary Robert F. Kennedy Jr. to ban them.

Not yet peer-reviewed, the study analyzed hundreds of thousands of Israeli medical records on pregnant women in the three years before and after SARS-CoV-2 emerged in China, finding 43% more "observed-to-expected" fetal losses per 100 pregnancies — 13 instead of nine — when the first mRNA dose is taken between 8-13 weeks' pregnancy.

Pregnant women who took a booster between 8-13 weeks lost an additional two pregnancies per 100, a "potential dose-response relationship," the study said.

By using pregnant women who got flu vaccines between 8-27 weeks and women who received either vaccine before their pregnancy as "comparative controls," the authors said they were able to show the association is unique to COVID vaccines. 

The former had a "consistently lower-than-expected observed number of fetal losses, likely the result of healthy vaccinee bias" – in which people with overall better health tend to have higher vaccination rates – while the latter had "according-to-expected or lower-than-expected numbers of fetal losses," the study found.

It said "almost all" mRNA doses were made by Pfizer, whose own 2021 report to the FDA – which the agency hid for 16 months until a court made it public – shows 44% of women in Pfizer's clinical trial lost their pregnancies.

'You will pay a political price' without mRNA ban

Kennedy's HHS, through the Justice Department, similarly seeks to halt vaccine-related Freedom of Information Act litigation by the Informed Consent Action Network for 18 months, ICAN lawyer Aaron Siri claimed last week. 

Pertinent to COVID, two of the suits seek the final reports for three safety and effectiveness studies of Pfizer's COVID vaccine, "including incidence of sub-clinical myocarditis [heart inflammation] in teens," and records on how the "FDA developed the contents" of its 2020 COVID vaccine industry guidance, Siri said.

Opponents of the mRNA platform are showing increasing hostility to the Trump administration's public health decisions, particularly Kennedy's middle path on COVID vaccines given his legacy as a vaccine skeptic.

HHS yanked recommendations for "healthy" pregnant women and children, and Kennedy dumped the CDC's 17-member Advisory Committee on Immunization Practice for alleged "persistent conflicts of interest," but authorized Moderna's new therapeutic for older and sicker people despite the vaccine maker allegedly hiding a child's death in its booster trial.

Americans for Health Freedom, led by Texas physician and victorious FDA lawsuit plaintiff Mary Talley Bowden, published an open letter to Kennedy and Makary titled "Not for Sale" that accuses them of betraying the MAHA movement by leaving "dangerous mRNA injections" on the market and ignoring them entirely in Kennedy's MAHA report.

Through a "set of distractions, linguistic misdirections, and watered-down policy announcements," agency leaders have ignored mRNA data showing "catastrophic levels of deaths and serious damage … including high miscarriage rates," the letter says, citing Siri-secured Pfizer documents, federal databases and foreign government data.

The removal of the healthy-pregnancy recommendation looks like "wordplay" because "pregnancy remains listed as a 'high risk' health category in the revised FDA policy for mRNA vaccines," the letter says, warning "you will pay a political price" in state and federal races and legislation, "for the midterms and even for 2028," without drastic changes.

It's not clear whether the changes would drastically alter Americans' attitudes on the shots, however. The CDC's dashboard on COVID vaccine uptake for adults shows it hovering around 20% for the past two seasons, based on the National Immunization Survey.

The open letter's original signatories include Bowden, feminist contrarian Naomi Wolf – who led the FOIA project to get the Pfizer clinical trial report and identify pregnancy losses – and  Oregon naturopath Henry Ealy, who with Beaver State lawmakers sought a federal grand jury investigation into COVID statistical manipulation.

HHS didn't answer Just the News queries for its response to the preprint coauthored by FDA and CDC advisers and the "Not for Sale" letter, and why it allegedly wants an 18-month pause on FOIA litigation — another continuation of Biden administration policy.

Agencies try to 'retrospectively justify' their 'gross negligence'

Led by Hebrew University of Jerusalem sociologist Josh Guetzkow, the new pregnancy study's coauthors include FDA senior adviser for clinical sciences Tracy Beth Hoeg and Kennedy-appointed ACIP member Retsef Levi, an MIT professor.

Hoeg served on the Florida Public Health Integrity Committee created by GOP Gov. Ron DeSantis and overseen by state Surgeon General Joseph Ladapo – whose department urged Floridians to avoid mRNA vaccines – with another coauthor, emergency room doctor Joseph Fraiman at Thibodaux Regional Medical Center.

Fraiman coauthored a 2022 peer-reviewed paper in the Elsevier journal Vaccine that found a 1-in-800 rate of serious adverse events in adults following mRNA vaccination, and he has challenged "fact checkers claiming it’s a fact the covid vaccine saved more lives than it cost" – which is also the implication of the GOP-led Coronavirus Subcommittee's final report.

The Danish-American Hoeg, an MIT vaccine-safety researcher when FDA Commissioner Marty Makary tapped her in March to be his special assistant, transitioned to her current role last month. She's a vocal critic of the quality of federal COVID research and the number of vaccines on the U.S. childhood vaccine schedule compared to other countries.

Levi's 2022 peer-reviewed study found COVID vaccination "significantly associated" with a spike in emergency heart problems in 16-39 year-olds in Israel, consistent with the Israeli government's own assessed heart-inflammation risk of 1 in 3,000 to 1 in 6,000 in 16-24 year-old males, though the Nature journal Scientific Reports quickly slapped it with a scarlet letter.

"The fact that pregnant women were recommended and even pushed to vaccinate during pregnancy without appropriate clinical trials was gross negligence,” Levi told medical scientist-turned-journalist Maryanne Demasi. 

He accused public health agencies of trying to "retrospectively justify this negligence with observational studies that are known to have fundamental biases."

"Pregnant women were excluded from the pivotal randomized clinical trials used for the initial regulatory approvals of the COVID-19 vaccines," with only one subsequent RCT in pregnant women by Pfizer, limited to 173 women "vaccinated in relatively advanced stages of pregnancy," the study opens.

Observational studies that largely found no statistically significant "adverse pregnancy outcomes" associated with the jabs suffer from poor methodology, such as comparing vaccinated and unvaccinated women "during active vaccination campaigns," and others use the problematic case-control method, the study said.

The authors reviewed more than 226,000 pregnancies in Israel from weeks 8-27, using "anonymized data from Maccabi Healthcare Services (MHS), the second-largest health fund in Israel." Three coauthors are affiliated with Maccabi.

They excluded the first seven weeks of pregnancy "because identification and follow-up of pregnancies during these weeks is partial and inconsistent, raising concerns about reporting biases" that might make women more likely to "report early fetal loss."

The findings illustrate "the importance of developing robust pharmacovigilance methods, including prospective ones, to detect weak safety signals in sub-groups of the population" such as women who are vaccinated at various stages of pregnancy, since any harm to this group is "not easily detectable by traditional pharmacovigilance mechanisms," they said.