CDC Pushes Triple Vaccination of Pregnant Women Despite Lack of Safety Data

The agency has cast science aside to market the new experimental COVID-19 vaccine, influenza shot, and Pfizer’s RSV vaccine during pregnancy.

By Megan Redshaw

The Centers for Disease Control and Prevention (CDC) has released its latest vaccine recommendations for the upcoming flu season and is urging pregnant women to receive three separate vaccines without adequate safety data. 

For the 2024-2025 flu season, the CDC recommends that pregnant women receive an influenza vaccine, the new formulation of Pfizer or Moderna’s mRNA COVID-19 vaccine, and Pfizer’s Abrysvo vaccine for respiratory syncytial virus (RSV)—even though pregnant women were excluded from initial clinical trials, and safety studies on co-administering these vaccines have not been performed.

In an Aug. 23 press conference, CDC director Dr. Mandy Cohen encouraged the public to get vaccinated with all three vaccines once they become available in September. The CDC is teaming up with the U.S. Department of Health and Human Services to launch a national vaccination campaign targeting the most at-risk groups, including pregnant women.

The campaign, Risk Less. Do More., aims to increase vaccination rates for influenza, RSV, and COVID-19 vaccines. However, the government’s push for pregnant women to receive multiple vaccines this upcoming fall could put mothers and their babies at risk.

“I do not recommend that women receive any vaccines in pregnancy due to the fact that vaccines create systemic inflammation, which is unhealthy for the developing placenta and the developing fetus,” Dr. Dan McDyer, an obstetrician and gynecologist with more than 34 years of experience told Reform Pharma. 

COVID-19 Vaccine Not Proven Safe for Pregnancy

The U.S. Food and Drug Administration (FDA) on Aug. 22 approved updated mRNA COVID-19 vaccines from Moderna and Pfizer-BioNTech, claiming they offer “better protection” against circulating variants and combat “waning immunity” from previous doses. 

However, this approval was based only on manufacturing and non-clinical data. Safety studies were not been performed with the new vaccine formula and the targeted variant is already obsolete. 

“With regard to the SARS CoV-2 synthetic modified mRNA injections, I do not recommend these vaccines for numerous reasons, including the fact that pregnant women were excluded from the clinical trials,” McDyer said.

“In any other scenario, that would be sufficient reasoning to prohibit a recommendation for the administration of any medication to a particular group that was not studied. Also, we never administer experimental medications to pregnant women—until now for some inexplicable reason,” he added. 

Dr. James Thorp, an obstetrician-gynecologist, his colleagues, and many others have extensively documented the adverse effects of mRNA COVID-19 injections in pregnant women and unborn fetuses, including the alarming rise in miscarriage rates observed but hidden in Pfizer’s clinical trial, McDyer said.

In Pfizer’s clinical trial of its initial monovalent COVID-19 vaccine, more than 80 percent of women exposed to the vaccine during early pregnancy experienced miscarriages, compared to the expected rate of 5-10 percent—a figure McDyer described as “shocking.” Additionally, evidence suggests that the vaccine’s ingredients can cross the placenta, potentially causing long-term harm to the fetus, he said. 

If the safety concerns with COVID-19 vaccines aren’t enough, research from Cleveland Clinic shows getting vaccinated actually makes one more susceptible to SARS-CoV-2 infection. 

In a recent peer-reviewed study published in Clinical Infectious Diseases, researchers found that the risk of COVID-19 increased as the number of vaccine doses increased and the vaccine became increasingly less effective against variants different from those it was designed to target. This is known as “negative efficacy.”

“There is no evidence that these injections prevent transmission, hospitalization, or death,” McDyer said. “In other words, they are worthless.”

RSV Vaccine Increases Risk of Preterm Birth and Neonatal Deaths 

In addition to COVID-19, the CDC wants all pregnant women to receive Pfizer’s RSV vaccine. According to the CDC, RSV is a common respiratory virus that usually causes mild, cold-like symptoms that resolve within a week. However, it can be severe in some groups of people and is more commonly diagnosed in infants. 

Unlike Pfizer's COVID-19 vaccine, which uses mRNA technology, Pfizer’s Abrysvo is a traditional protein-based vaccine. It uses a protein from the RSV virus to stimulate the immune system but is still not without risk. 

The FDA in August 2023 approved the RSV vaccine for use in pregnant women even though four of its vaccine advisors, including Dr. Paul Offit, said Pfizer’s data was inadequate to support its safety. 

Offit, an infectious disease pediatrician, expressed concerns that Pfizer's clinical trial data was insufficient to ensure the vaccine's safety. His concerns were heightened by the fact that Pfizer's data resembled findings from a similar clinical trial by GlaxoSmithKline (GSK) that was halted due to a safety signal indicating a potential risk of preterm births and neonatal deaths.

GSK at the time said they couldn’t explain the increase in preterm births, but they were no longer going to develop their RSV vaccine. 

During its RSV vaccine clinical trial, Pfizer did not disclose to pregnant participants that GSK had halted its trial over the preterm birth safety signal—a risk Pfizer was actively monitoring as an "adverse event of special interest." 

Despite being aware of these concerns, Pfizer failed to fully inform participants of the potential risks the vaccine could pose to their babies and continued to enroll women for months after the risk was publicized. In some cases, Pfizer provided misleading and contradictory information, according to an investigation by The BMJ.

“If GSK has truly abandoned a program on a similar or almost identical vaccine, that is going to hang over this program,” Offit said during the meeting. He further noted that although it was “death” during the GSK clinical trial that initially “got everyone’s attention,” it was severe premature births that led to those deaths.

Dr. Hana El Sahly, the chairwoman of the FDA’s advisory panel, said the signal showing an increased risk of preterm births associated with Pfizer’s RSV vaccine was “significant” in phases two and three of its clinical trial and “in a very similar product” that was administered in another study, referring to GSK’s clinical trial.

“So, having said that, is it reason enough to pause? Probably so,” Sahly said. “I mean, increasing the risk of or having pregnant women have 20% increased risk of premature delivery is not trivial, even if it is late preterm delivery. The fact that we’re putting them into preterm delivery while we’re sitting here debating the matter intellectually is not trivial.”

McDyer has substantial concerns about the safety and efficacy of Pfizer’s RSV vaccine for pregnant women based on his own analysis of the company’s clinical trial data.

McDyer said he does not recommend the RSV vaccine for pregnant women because the clinical trial that included pregnant women was not appropriately conducted.

“The trial group of pregnant women received the RSV vaccine, but the control group did not receive a placebo,” said McDyer. “They received all of the chemicals in the RSV vaccine but without the small amount of RSV antigens to which the immune response is desired. This trial design eliminates the possibility to assess for side effects.”

This isn’t a new phenomenon. As lawyer Aaron Siri has pointed out, “not a single routine childhood vaccine was licensed based on a long-term placebo-controlled trial.” Pfizer’s RSV vaccine is no exception. 

Expert Finds RSV Vaccine Causes 642 Preterm Births to Prevent One RSV Death

Aside from the lack of a placebo in the trial, McDyer’s analysis offers a grim assessment of the true impact of vaccinating pregnant women against RSV. Using U.S. birth and RSV death data, over 64,210 pregnant women would need to be vaccinated to prevent a single RSV-related death in infants under six months.

If all pregnant women were vaccinated, there would be 57 fewer RSV-related deaths in infants aged six months and under each year but 642 more preterm births to prevent each RSV-related death. Moreover, thousands of women will also experience side effects—but the side effect rate cannot be calculated because the control group didn’t receive a placebo. 

This calculation calls into question the overall benefit-risk profile of the vaccine, especially considering the potential rise in preterm births and other unmeasured side effects, McDyer added.

In Pfizer’s clinical trial, there was a one percent increase in preterm births among those vaccinated with the company’s RSV vaccine—one percent multiplied by 3,660,000 births (U.S. annual births in 2021) equates to 36,600 more preterm births if all pregnant women are vaccinated, according to McDyer’s analysis. 

Another point of concern for McDyer was that Pfizer’s clinical trial, raw data of which was not made available to health professionals for evaluation, used relative risk reduction to make its vaccine look more effective and excluded high-risk pregnancies. 

Absolute risk reduction is a measure that indicates the actual decrease in risk of a particular outcome—here, hospitalization—between those who received the vaccine and those who did not. 

“The absolute risk reduction (ARR) for the study endpoint of hospitalization for RSV for children six months of age or younger is 0.72 percent. This does not sound quite as appealing as the 57 - 85 percent relative risk reductions that the manufacturer touts in its marketing materials, does it?” McDyer said.

Yet U.S. health agencies and the American College of Obstetricians and Gynecologists are recommending the RSV vaccine to all pregnant women across the board between 32 and 36 weeks of gestation. 

No Safety Studies to Support Flu Shots During Pregnancy

In addition to new COVID-19 vaccines and the RSV vaccine, the CDC also recommends pregnant women receive a trivalent influenza vaccine. A trivalent vaccine contains strains designed to target three different flu viruses.

For the 2024-2025 influenza season, pregnant women were not included in any specific clinical trials for the recommended influenza vaccines. Instead, the recommendations for influenza vaccination during pregnancy are based on previous studies.

The CDC funds and performs its own studies to determine how well influenza vaccines protect against the flu and uses those and previous studies with different strains to support its statements about influenza vaccine effectiveness.

For instance, the CDC’s safety data on flu vaccines during pregnancy consists of a handful of studies carried out by the agency between 2011 and 2014. The CDC lists two studies on its webpage that assessed the risks of influenza vaccines in newborns, with the most recent 2020 study using data gathered between 2007 and 2015.

“The influenza vaccine typically has seasonal efficacy rates that are far less than 50 percent,” McDyer told Reform Pharma. “That should disqualify any vaccine from recommended use.”

Influenza vaccines also contain aluminum adjuvants, and some formulations approved for pregnant women contain thimerosal. 

“Aluminum is a neurotoxin. No developing fetus should be intentionally exposed to a toxic substance,” McDyer said. 

Thimerosal is a mercury-based preservative used in vaccines and is associated with severe neurological disorders—even in trace amounts. Peer-reviewed scientific publications demonstrate broad consensus among independent research scientists that thimerosal is harmful.

Although the CDC says that thimerosal is safe and most influenza vaccines are now thimerosal-free, some recommended flu vaccines still contain this controversial ingredient. For instance, up to 25 micrograms of thimerosal remained in last season’s influenza vaccines, including those administered to pregnant women and infants.

The CDC's aggressive push for pregnant women to receive three vaccines this flu season—without sufficient safety data—reveals a troubling disregard for the well-being of mothers and their unborn children. By promoting the new COVID-19 vaccine, influenza shot, and Pfizer's RSV vaccine, the agency is prioritizing pharmaceutical interests over the cautious, evidence-based approach that should be the hallmark of public health recommendations.