When asked at a U.S. Senate hearing whether she believes mRNA vaccines are safe and effective, CDC director nominee Dr. Erica Schwartz replied, “I do believe that mRNA technology is safe and effective.” Both the question and the answer reveal a serious lack of scientific understanding.
Here is the scientifically accurate response: We do not know the full safety profile of the two approved mRNA vaccines or of the underlying technology. First, the technology is still too new. Second, we are not even collecting the comprehensive data required for a reliable assessment.
According to FDA scientists and other experts, comprehensive safety data for a new drug—including vaccines—typically does not emerge until the product has been on the market and in widespread use for 7 to 12 years. Even now, full information on safety profiles remains unavailable because the necessary data are not being gathered systematically.
The established scientific process requires that all illnesses following vaccination be meticulously recorded, regardless of whether a patient or physician believes the illness is related to the vaccine. Most doctors are not following this process. Some misunderstand the requirement; others appear to ignore it. No authority is ensuring compliance.
Physicians typically do not ask ill patients whether they received an mRNA vaccine (for COVID-19 or RSV), which product(s), how many doses, or when. As a result, crucial data go uncollected. Most people—including many physicians—do not realize that patients being treated for any illness are supposed to be queried on this point.
This means, for example, that a patient arriving at an emergency room with a retinal detachment should be asked about COVID-19 vaccination history, the specific product(s), number of doses, and timing, and the information should be reported to the Vaccine Adverse Event Reporting System (VAERS). The same applies to patients presenting with a rash, headaches, tendon rupture, stiff neck, depression, chest congestion, or any other condition. Everything.
Even when patients volunteer that they suspect a vaccine connection, physicians frequently—and improperly—decide on their own that reporting is unnecessary unless they personally believe a causal link exists. That is not how the system is designed. No doctor is qualified to make that determination for a relatively new medicine. All post-vaccination illnesses are supposed to be recorded so that previously unrecognized adverse events can be identified.
In addition, many doctors and patients do not understand—and are not being told—that adverse events from vaccines and other medicines can appear months or years after administration. An adverse event can also be related to a drug even if the patient experienced no immediate illness after taking it.
The blanket question itself—“Are mRNA vaccines safe and effective?”—betrays a lack of scientific understanding on the part of the questioner. It invites necessary follow-up questions: Safe for whom? Under what circumstances? Effective against what endpoint?
It is as meaningless as asking, “Is medicine safe and effective?” The answer depends on individual factors: allergies, predispositions that increase susceptibility to side effects, and whether the drug’s mechanisms work in a particular person’s biology. These are individual calculations. Even at the population level, blanket answers do not exist.
We already know that the mRNA COVID-19 vaccines failed to meet a sliding scale of claimed goals. They do not prevent infection. They do not prevent transmission. They do not prevent illness. There remains debate over whether they meaningfully prevent serious illness—an outcome most people, and almost never children, experience from COVID-19 itself.
Until we stop pretending that these blanket questions make scientific sense and that the answers are grounded in rigorous evidence, we will continue to have leaders who misinform or mislead the public.
History is filled with examples of unexpected adverse events that only became clear after drugs and vaccines entered widespread use. Here are some notable cases:
- Sildenafil (Viagra) and sudden vision loss (non-arteritic anterior ischemic optic neuropathy, or NAION). Viagra increases blood flow by inhibiting PDE5. Early marketing emphasized cardiovascular risks but overlooked eye problems. Hundreds of post-approval reports eventually linked the drug to sudden vision loss. Enterprising physicians published case reports; the FDA added warnings in 2005. Labels now advise patients to stop the drug and seek care for sudden vision changes. Similar risks apply across the PDE5 inhibitor class.
- Viagra and sudden hearing loss. Reports of sudden hearing decrease or loss (sometimes accompanied by tinnitus or dizziness) emerged after approval. Post-marketing data prompted label updates advising immediate medical attention. Few initially expected an erectile dysfunction drug to cause deafness or blindness.
- Statins (atorvastatin, simvastatin, and others) and severe muscle injury. These cholesterol-lowering drugs were known to cause mild muscle symptoms, but manufacturers initially denied severe cases, including rhabdomyolysis that can lead to kidney failure. Independent physicians, lawsuits, and investigative reporting forced recognition. Warnings, monitoring recommendations, and dose adjustments were eventually added.
- Statins and cognitive effects. Some users reported memory loss, confusion, or “brain fog,” initially dismissed as unrelated. The FDA added reversible cognitive side effects to labels in 2012 based on accumulating reports.
- Troglitazone (Rezulin) and severe liver failure. This Type 2 diabetes drug appeared safe in trials. Only after millions of patients used it did dozens of cases of acute liver failure (including deaths and transplants) become evident. Investigative reporting forced the issue; the drug was withdrawn in 2000 after being linked to roughly 63 deaths. Experts note that each recognized death may imply thousands of unreported cases.
- SGLT2 inhibitors (canagliflozin/Invokana, dapagliflozin/Farxiga, empagliflozin) and Fournier’s gangrene. These diabetes drugs lower blood sugar by increasing urinary glucose excretion. They can also cause life-threatening necrotizing infections of the genital and perineal area. The FDA issued a warning in 2018; labels now carry strong alerts.
- mRNA COVID-19 vaccines (Pfizer and Moderna) and myocarditis/pericarditis. These vaccines were found to cause heart inflammation, predominantly in young men after the second dose—an outcome that was not anticipated in the initial trials.
- COVID-19 vaccines and menstrual irregularities. Many women reported heavier bleeding and cycle changes. These reports were initially dismissed; the signal was not identified or systematically reported in the early studies.
- COVID-19 vaccines and eye problems. Even without comprehensive data collection, enough reports of eye inflammation and retinal issues have accumulated to raise concern about a possible association.
- Thalidomide and severe birth defects. Marketed in the 1950s and 1960s as a sedative and treatment for morning sickness, it caused more than 10,000 cases of babies born with shortened or missing limbs and other defects.
- Isotretinoin (Accutane) and persistent sexual dysfunction. Recent FDA updates added warnings for erectile dysfunction, decreased libido, and vaginal dryness that may continue after the drug is stopped.
- SSRI antidepressants and persistent sexual dysfunction. Similar effects, initially denied, were later recognized.
- Cisapride (Propulsid) and cardiac arrhythmias. The indigestion drug was withdrawn after it was linked to fatal heart-rhythm problems, including cover-ups of deaths in clinical studies.
- Rofecoxib (Vioxx) and cardiovascular events. A pain and arthritis medication that no one expected to increase heart attacks and strokes. Signals were initially denied; the drug was eventually removed from the market.
- Fenfluramine/phentermine (Fen-Phen) and heart valve damage. Another drug approved as “safe and effective” that later caused unexpected cardiac harm and was withdrawn.
- Certain fluoroquinolone antibiotics and tendon rupture / peripheral neuropathy. Few anticipated that antibiotics could cause tendon ruptures or nerve damage. Black-box warnings were eventually added.
- Antipsychotics and tardive dyskinesia. Drugs intended to control psychosis can themselves cause serious, sometimes irreversible movement disorders—an outcome not initially anticipated.
- Tamoxifen and uterine cancer. A breast-cancer treatment later found to increase the risk of uterine cancer. Warnings were added after the association became clear.
- Ketamine and bladder damage. This side effect emerged primarily after the drug’s use expanded into psychiatric applications.
- Medicines that cause bone loss—including some prescribed to protect bones. Bisphosphonates (Fosamax/alendronate, Actonel, Boniva, Reclast) can lead to atypical thigh fractures, osteonecrosis of the jaw, and delayed healing. Other drugs later linked to increased fracture risk include long-term corticosteroids, certain acid-reflux medications (omeprazole, esomeprazole), aromatase inhibitors, and the injectable contraceptive Depo-Provera.
These examples illustrate a consistent pattern: unexpected harms often become apparent only after large-scale, real-world use and only when clinicians and regulators actually look for them. Claiming that any new medical technology is simply “safe and effective” short-circuits that essential process.
Your new CDC Director just said “I do believe that mRNA technology is safe and effective.”
Erica Schwartz also MANDATED almost every major vaccine on our military — forcing smallpox, anthrax, and flu shots into U.S. Forces with threats and discipline for those who refused…. pic.twitter.com/w4CsrujpG3
— Nicolas Hulscher, MPH (@NicHulscher) July 15, 2026
