This Post Has 4 Comments

1. 

   pt-109 October 21, 2025 Reply

   For a brief time during my student days, I had to give up my office (and computer) to a visiting professor by the name of Andrew Wakefield. Perhaps the name rings a bell. I ended up with a better office and didn’t have to move back to the old one when Wakefield left after about a week. Anyway, I have my opinions about Siri’s statement, but I ran it through AI just the same because maybe I missed something along the way. Nope. Doesn’t seem so. Rather than type my own report, which would be similar to Gemini’s report pasted below but with more typos, I’ll simply paste in Gemini’s report. But, for what it’s worth, I believe it to reflect my own knowledge from working in public health research. (Not perfect knowledge, of course, but nobody has that, certainly not Siri.)

   RESPONSE:
   Aaron Siri’s Claim: He suggests the FDA admitted via a FOIA request that they have no clinical trials to support the flu shot’s license for pregnant women because it was “never been licensed for pregnant women.”

   FDA/CDC/ACOG Position and Licensing:

   The CDC and the American College of Obstetricians and Gynecologists (ACOG) strongly recommend that all women who are or will be pregnant during flu season get an inactivated flu shot (not the nasal spray).

   The recommendation is based on the fact that flu poses a danger during pregnancy (increased risk of severe illness and complications for the mother and potential harm to the developing baby) and numerous studies that support the vaccine’s safety and effectiveness for this population.

   Many vaccines, including the seasonal flu shot, are initially licensed by the FDA for use in a broader population (e.g., adults and adolescents) based on safety and effectiveness data in non-pregnant individuals.

   Public health bodies like the CDC’s Advisory Committee on Immunization Practices (ACIP) then issue recommendations for use in specific populations, like pregnant women, based on scientific evidence, post-licensure surveillance data (like the Vaccine Adverse Event Reporting System – VAERS), and large-scale safety studies conducted after initial licensure.

   An FDA document confirms that many “vaccines recommended for pregnant women were first licensed and approved for use based on safety and effectiveness data in non-pregnant women,” and were then “recommended by public health policy makers for pregnant women based on their perceived benefit and minimal risk for the mother and infant.” This suggests that the specific indication of “for pregnant women” might not be on the initial FDA license for all flu shots, but rather a public health recommendation based on a significant body of safety and effectiveness evidence.

   Conclusion on Accuracy:

   The literal interpretation of the statement—that the FDA may not hold records of initial clinical trials relied upon to license the flu shot specifically and exclusively for the pregnant women population—may be technically true in a narrow legal sense for certain vaccine products. This is because the FDA license often applies to a broader age group, and the recommendation for pregnant women comes from the CDC/ACIP based on substantial real-world and post-licensure safety data.

   The implication Siri draws from this—that the flu shot is therefore unsafe or should not be given to pregnant women—is widely disputed by the medical and public health communities. Leading health organizations (CDC, ACOG) state the flu shot is safe and highly recommended for pregnant women due to the significant body of evidence from multiple large-scale studies supporting its safety and benefit.

   1. 

      Erich Vieth October 21, 2025

      My query to Grok: “For the past 20 years, what have pregnant women been told by their doctors about safety of the annual flu shot? I don’t care about what public health officials tell each other or hide from us. I want to know about the public facing message.”

      Grok:

      Over the past 20 years (2005–2025), the consistent public-facing message from doctors to pregnant women about the annual flu shot—based on guidelines from organizations like the CDC’s Advisory Committee on Immunization Practices (ACIP) and the American College of Obstetricians and Gynecologists (ACOG)—has been that the inactivated influenza vaccine is safe to receive at any stage of pregnancy, including the first trimester, and is strongly recommended to protect both the mother from severe flu complications and the newborn through transferred antibodies. This messaging emphasizes that the benefits outweigh any theoretical risks, with no evidence from studies linking the vaccine to adverse fetal or maternal outcomes like preterm birth, low birth weight, miscarriage, or congenital abnormalities.

      Doctors have also routinely advised that only the inactivated shot (not the live attenuated nasal spray version) should be used during pregnancy, and it can be given alongside other recommended vaccines like Tdap.

      While the core safety and recommendation message has remained stable, drawing from evidence accumulated since the 1960s and reinforced post-2009 H1N1 pandemic, there have been minor nuances in practice and emphasis over time. For instance, early in the period, some doctors expressed more caution about the first trimester due to limited data or product labeling, but official guidelines always supported administration in any trimester. Uptake among pregnant women was low pre-2009 (around 15%) partly due to these perceptions, but messaging intensified after the pandemic to highlight safety and priority status, leading to higher rates (around 50–60% in recent years).

      Patient education materials, such as CDC fact sheets and ACOG resources, have consistently framed the vaccine as a routine, evidence-based protective measure without contraindications for pregnancy beyond severe allergies to vaccine components.The table below outlines key examples of the public-facing messaging from ACIP annual recommendations (which doctors follow) for sample years within the 20-year span, focusing on safety and timing aspects:

      For more, with citations . . .

   2. 

      Erich Vieth October 21, 2025

      That message from public health officials that you discuss was not being effectively sent to pregnant women:

      Influenza vaccination coverage among pregnant women in the United States has shown a gradual upward trend over the past 20 years, starting from low levels around 20% in the mid-2000s, surging during the 2009 H1N1 pandemic, stabilizing around 50% in the mid-2010s, and declining somewhat in recent years (post-2020) to below 50%. These estimates are primarily derived from CDC surveillance systems, including the Pregnancy Risk Assessment Monitoring System (PRAMS) for self-reported data, the Vaccine Safety Datalink (VSD) for electronic health records, and Internet panel surveys conducted annually in April following each flu season. Coverage is defined as the percentage of women aged 18–49 who were pregnant at any point during the influenza season (typically August–May) and received ≥1 dose of inactivated influenza vaccine before or during pregnancy.

      More . . .

2. 

   pt-109 October 21, 2025 Reply

   Is the point you’re making that Grok is reporting FALSE guidance from health officials? And that Grok knows, but wasn’t asked, what the truth is? Of course, that would be the biggest conspiracy since… forever. As somewhat of an insider, I would say with confidence that such a conspiracy would be unsustainable for more than a few days at most. Or, is the point that public health officials are getting it wrong, not on purpose, but due to their ongoing competence? Or, is the point that they are getting it right, but like all science, including medical science, they need to tweak things based on continuing investigations? Here is Grok’s response to my two questions:
   1) General Epidemiological Reasons for Pregnant Women to Avoid the Flu Vaccine
   Assuming no allergies to components or history of adverse reactions (as you specified), there are no general epidemiological reasons why pregnant women shouldn’t receive the flu vaccine. In fact, the evidence strongly supports vaccination for this group. Pregnancy increases the risk of severe influenza complications due to physiological changes like immune system alterations, increased heart rate, and reduced lung capacity, which can lead to higher rates of hospitalization, pneumonia, preterm birth, and even maternal or fetal death during flu outbreaks. Studies show that unvaccinated pregnant women are up to 5-7 times more likely to be hospitalized for flu-related issues compared to non-pregnant women of similar age.
   The flu vaccine (inactivated or recombinant versions; not the live attenuated nasal spray) is recommended for pregnant women in any trimester by major health authorities. It not only protects the mother but also provides passive immunity to the newborn for the first few months of life, reducing infant flu hospitalizations by about 40-60%. Safety data from millions of doses administered worldwide, including large-scale surveillance systems like the Vaccine Safety Datalink, show no increased risk of miscarriage, birth defects, or other adverse outcomes attributable to the vaccine. For the 2025-2026 flu season, recommendations emphasize getting vaccinated in September or October, or anytime during flu season if not earlier. If anything, the epidemiological rationale is firmly in favor of vaccination to mitigate these heightened risks.

   2) Conceivability or Sustainability of an Attempt to Hide or Distort Evidence
   A large-scale conspiracy among public health agencies, pharmaceutical companies, and researchers to systematically hide or distort evidence of harm from flu vaccines in pregnant women is neither conceivable nor sustainable in practice. Here’s why, based on the structure of scientific research and oversight:
   Scale and Diversity of Involved Parties: Flu vaccine safety data comes from thousands of independent studies across dozens of countries, involving universities, government agencies (e.g., CDC, FDA, WHO), nonprofits, and private researchers. For example, post-marketing surveillance includes global systems like VAERS (U.S.), EudraVigilance (EU), and independent cohorts from places like Denmark’s national registries, which track millions of pregnancies. A conspiracy would require coordinated deception among all these entities, including whistleblower suppression on a massive scale—improbable given the incentives for researchers to publish contradictory findings (e.g., career advancement via novel discoveries).
   Transparency and Peer Review: Data is publicly accessible through peer-reviewed journals (e.g., The Lancet, NEJM), clinical trial registries like ClinicalTrials.gov, and open databases. Any distortion would be detectable through meta-analyses and replications by unaffiliated groups. Historical examples of pharma misconduct (e.g., Vioxx in 2004) were uncovered precisely because of this transparency, leading to recalls and lawsuits—not sustained cover-ups.
   Regulatory and Ethical Safeguards: Vaccines undergo rigorous pre- and post-approval monitoring by independent bodies like ACIP (Advisory Committee on Immunization Practices) and EMA. Pregnant women are a protected population, so trials and surveillance are designed with extra scrutiny. If harm were evident, it would trigger immediate warnings, as seen with the 1976 swine flu vaccine and Guillain-Barré syndrome.
   Economic and Practical Realities: Flu vaccines are low-margin products compared to other drugs, and “Big Pharma” isn’t monolithic—multiple manufacturers compete. Public health agencies aren’t profit-driven; their mandates prioritize population health. Sustaining a conspiracy over decades (flu vaccines have been recommended in pregnancy since the 1960s) would collapse under leaks, litigation, or shifting administrations.
   While isolated biases or data gaps can occur (e.g., underreporting in surveillance systems), these are addressed through ongoing research, not hidden. Claims of conspiracy often stem from misinformation or distrust but lack substantiation when examined. If specific evidence of distortion emerges, it would be front-page news and lead to reforms, not perpetuation.