“Trust the science” is the mantra repeated to pregnant women, but Pfizer’s deliberate omission of preterm birth risks in RSV trials shows Big Pharma values profits over ethics.

Key findings from BMJ Open study:

• Pregnant women who received Pfizer’s RSV vaccine (Abrysvo) faced higher rates of preterm births, with most occurring within a week of injection.
• GSK previously halted its identical RSV vaccine trial due to preterm birth risks—information Pfizer intentionally withheld from participants.
• FDA approved Pfizer’s shot despite internal objections, exposing women and infants to potential harm.
• Post-marketing surveillance confirms what trial data suggested: this vaccine disrupts fetal development and threatens maternal health.

The unethical concealment of preterm birth risks

For decades, pregnant women have been warned against consuming caffeine, alcohol, sushi, and even certain herbal teas—yet Pfizer injected them with an experimental biologic without disclosing known dangers. How did we get here?

When GlaxoSmithKline (GSK) discovered in 2022 that its RSV vaccine was causing preterm births—1 in 54 vaccinated mothers delivered early—it suspended trials. Pfizer, aware of this red flag, plowed ahead with its own RSV trials, never informing pregnant participants of the risk.

“Any failure to provide new and potentially important safety information to trial participants is ethically problematic,” said Dr. Charles Weijer, a bioethicist who condemned Pfizer’s actions. Yet this omission wasn’t an oversight—it was policy.

Pfizer’s consent forms falsely claimed the vaccine was “risk-free for the baby,” a deception experts call “misleading and irresponsible.” Worse, researchers found over 80 investigators across 18 countries failed to warn pregnant women of the dangers.

VAERS found preterm ruptured membranes and hemorrhages

This study provides the first post-approval safety assessment of Pfizer’s respiratory syncytial virus prefusion F (RSVpreF) vaccine in pregnant individuals using data from the Vaccine Adverse Event Reporting System (VAERS) from September 2023 to February 2024. Among 77 reported adverse events (AEs), 54.55% were classified as serious, with preterm birth being the most prevalent pregnancy-related complication (12.8%). Other pregnancy-associated AEs included preterm rupture of membranes, cesarean sections, cervical dilation, and hemorrhages (each ?3.3%). Non-pregnancy-related side effects included headache and injection site reactions.

A disproportionality analysis identified a statistically significant signal for preterm birth, suggesting it was reported more frequently than expected. Most preterm births occurred between 32 and 37 weeks of gestation, with a median onset of three days post-vaccination (two-thirds occurring within a week). While the safety profile generally matched prelicensure trial findings, the study underscores the need for further investigation into the observed preterm birth signal. The authors recommend active surveillance to evaluate maternal and perinatal outcomes, emphasizing the importance of robust post-marketing monitoring to inform clinical guidelines on RSV vaccination during pregnancy.

Science confirms what Pfizer denied: RSV shots trigger early labor

The new peer-reviewed analysis in BMJ Open examined VAERS reports and found:

• Most preterm births occurred within 3 days of vaccination.
• No co-administration with other vaccines (ruling out confounding factors).
• Statistical safety signals strongly linked the shot to premature rupture of membranes and preterm labor.

The FDA ignored these risks, approving Abrysvo in 2023 despite 4 advisory members voting “no.” Their compromise? A narrow 32-36 week window for vaccination—a flimsy attempt to dodge liability for the most dangerous preterm births (before 32 weeks).

But premature birth at any stage carries risks:

• Lifelong chronic illness (heart disease, diabetes, kidney failure).
• Cognitive impairments, developmental delays.
• Higher infant mortality rates.

Dr. Peter Selley, a U.K. physician, slammed regulators: “How many more trials are needed [to prove this is dangerous]?”

Global regulators disagree—while pregnant women pay the price

The FDA’s restricted window (32-36 weeks) contradicts other agencies:

• Europe (EMA): 24-36 weeks.
• France (HAS): 32-36 weeks.
• Germany (STIKO): No recommendation—citing insufficient safety data.

French scientist Hélène Banoun asked, “How can we justify that EMA, FDA, and STIKO disagree on a vaccine for vulnerable pregnant women?” The answer: Corporate influence. Pfizer’s $95 billion COVID windfall bought it political leverage, and the FDA’s approval—despite known risks—proves regulators serve Pharma, not patients.

When GSK’s RSV vaccine caused harm, it halted trials. Pfizer hid the data and pushed forward. The result? Another case of profits over people—where pregnant women and newborns bear the consequences. Karl Jablonowski of Children’s Health Defense nailed it: “A vaccine that increases prematurity is self-defeating—preterm babies are most vulnerable to RSV.”

Will lawsuits finally hold Pfizer accountable? Or will we keep sacrificing mothers and children at the altar of “trust the science”—while corporations laugh their way to the bank?

Sources include:

ChildrensHealthDefense.org

BMJOpen.com

ChildrenHealthDefense.org