'Are mRNA Vaccines Safe and Effective?'
The question and the answer the CDC Director Nominee gave show serious a lack of scientific understanding.
When asked at a Senate hearing whether she thinks mRNA vaccines are safe and effective, CDC Director-nominee Erica Schwartz replied, “I do believe that mRNA technology is safe and effective.”
Both the question and the answer show a serious lack of scientific understanding.
Here’s the scientifically accurate answer to the question: We don’t know the full safety profile of either of the two types of approved mRNA vaccines or the technology. First, It’s all too new. Second, we’re not even collecting the full data.
Read on for details.
According to FDA scientists and other experts in the field, comprehensive safety data isn’t known until a new drug (including vaccines) has been on the market and in widespread use for 7-12 years.
Even now, we aren’t getting full information on safety profiles because the data isn’t even being collected in the comprehensive manner required for accurate analysis.
The established scientific process requires that all illnesses after vaccination be meticulously recorded regardless of whether a patient or doctor thinks the illness is actually connected to the vaccine.
Most doctors are not following the process. Some misunderstand. Others are willfully ignoring. And no authority is ensuring they do their job.
Doctors typically aren’t even asking their ill patients whether they had an mRNA vaccine (for Covid or RSV), which one(s), and when. So they aren’t collecting that crucial data.
Most people, including physicians, don’t understand that patients being treated for any illness are supposed to be queried. This means, for example, someone who come to the ER with a retinal detachment should be asked if he had Covid vaccine, which, how many, and when, and then the data should be reported to the Vaccine Adverse Event Reporting System (VAERS). Same with someone who becomes sick with a rash, headaches, tendon rupture, stiff neck, depression, or chest congestion. Everything.
Even when patients do tell a physician they think an illness might be vaccine related, the physician frequently, improperly, determines on the front end that he doesn’t need to report the possible adverse event to the established database unless he thinks it’s connected to the vaccine. That’s not how the system works. No doctor is qualified to make that determination about a new medicine. All illnesses are supposed to be recorded so that previously unrecognized adverse events can be unearthed.
Additionally, many doctors and patients don’t understand— and aren’t being told— that adverse events from vaccines and other medicine can arise months or years after the medicine is taken.
Further, they don’t understand that an adverse event can be related to a drug even if the patient did not initially become ill after taking the vaccine or other medicine.
And the blanket question itself, “Are mRNA vaccines safe and effective,” shows a lack of scientific understanding on the part of the questioner. It begs counter-questions: they safe for whom? Under what circumstances? Effective at what? It’s as ridiculous as asking, “Is medicine safe and effective?” Depends on whether or not you’re allergic to it. Depends on whether you have predispositions for things that make you more susceptible to the side effects. Depends on whether its particular mechanisms work in your individual biology. These are individual calculations.
Even in the general picture, there aren’t blanket answers. We know mRNA Covid vaccines failed woefully—proved ineffective—at a sliding scale of supposed goals: They don’t prevent infection. They don’t prevent spread. They don’t prevent illness. There’s a debate over whether they prevent serious illness, which most people don’t get from Covid, and children almost never get.
Until we stop pretending that the blanket questions make sense, and that the answers are connected in any way to science, we will continue to have leaders who misinform or mislead.
So, from diabetes drugs that can cause fatal genital tears to acne medicine that can cause sexual dysfunction that never goes away, here are some notable examples of unexpected adverse events that were eventually linked to vaccines or other medications.
Sildenafil (Viagra) and blindness [non-arteritic anterior ischemic optic neuropathy (NAION)/sudden vision loss].
Viagra treats erectile dysfunction by inhibiting PDE5 to increase blood flow. Early marketing focused on cardiovascular risks but not eye issues. Hundreds of post-approval reports eventually linked it to sudden vision loss from NAION. The adverse event was only recognized when enterprising physicians pressed the issue and published case reports, and I reported on them for CBS News. The FDA added warnings in 2005. Labels now advise stopping use and seeking care for sudden vision changes. Similar risks apply to the PDE5 inhibitor class.Likewise, Viagra was eventually connected to hearing loss.
Reports emerged of sudden hearing decrease/loss (sometimes with tinnitus/dizziness) after use. Initially not linked, post-marketing data led to label updates advising immediate medical attention. Nobody initially guessed an erectile dysfunction drug could cause deafness and blindness!Statins such as atorvastatin and simvastatin, and severe and potentially fatal muscle pain/weakness (myalgia, myopathy, rhabdomyolysis).
Statins are used to lower cholesterol to prevent heart disease/stroke. Early labels noted mild muscle issues, but the drugmakers initially denied severe cases (including rhabdomyolysis, which can cause kidney failure). Independent doctors, lawsuits, and my reporting for CBS News drew attention to this problem. Eventually, the drug makers added warnings, monitoring advice, and dose adjustments.Statins and cognitive effects (memory loss, confusion).
Some users reported “brain fog” or confusion, initially dismissed as unrelated. I reported on this, too, for CBS News. Eventually, FDA added reversible cognitive side effects to labels in 2012 based on reports.Troglitazone (Rezulin) and severe liver failure.
This thiazolidinedione treated type 2 diabetes. Only did post-1997 use among millions reveal dozens of acute liver failure cases (deaths/transplants), originally denied by the drugmaker. Reporting by the Los Angeles Times and then by me at CBS News forced the issue. Eventually, the drug was withdrawn in 2000 after FDA tied it to about 63 deaths. (Scientists say each recognized and reported death implies 1,000 to 100,000 more that are never reported.)SGLT2 inhibitors such as canagliflozin/Invokana, dapagliflozin/Farxiga, empagliflozin and potentially fatal Fournier’s gangrene (necrotizing fasciitis of perineum/genitalia).
These diabetes drugs lower blood sugar via urinary glucose excretion. Believe it own ot, they can cause life-threatening flesh-eating infections in the genital/perineal area. FDA issued a warning in 2018. The labels now carry strong alerts.mRNA Covid-19 vaccines (Pfizer, Moderna) and myocarditis/pericarditis heart issues.
As you know, these vaccines were found to cause heart inflammation, mostly in young men after second dose. This was initially unexpected.Covid-19 vaccines and menstrual irregularities.
Many women reported changes such as heavier bleeding and cycle shifts, but were largely called conspiracy theorists. This adverse event like so many others linked to Covid vaccines, weren’t identified—at least they weren’t reported— after initial studies.Covid-19 vaccines and eye issues. Even without persistent data gathering, there have been enough reports of eye inflammation and retinal problems to raise concern over a possible link.
Thalidomide and severe birth defects.
Once marketed as a sedative and morning sickness aid in the 1950s–60s, it turned out to cause more than 10,000 cases of babies born with shortened or absent limbs and other defects.Isotretinoin (Accutane) for acne and persistent sexual dysfunction.
Recent FDA updates added erectile dysfunction, decreased libido, vaginal dryness, and lubrication issues that may persist even when people stop taking the drug.A similar effect was initially denied by later found with SSRI antidepressants, Selective Serotonin Reuptake Inhibitors. They can cause persistent sexual dysfunction.
Cisapride (Propulsid) for indigestion and cardiac arrhythmias/QT prolongation. It was withdrawn after heart rhythm deaths. I reported for CBS News on the coverup of a baby death in a fraudulent Propulsid study.
Rofecoxib (Vioxx) and cardiovascular events. Nobody guessed a pain medicine and arthritis drug would cause heart attacks and strokes. All concerned initially denied the signals but the medicine was eventually removed from the market for this reason.
Fenfluramine/phentermine (Fen-Phen) weight loss drug and heart damage. This is another drug that caused unpredicted heart problems and was eventually taken off the market after the FDA had approved it as “safe and effective.”
Certain fluoroquinolones and tendon rupture/peripheral neuropathy. Who would have guessed antibiotics could cause a tendon rupture or nerve damage? Eventually, all agreed that fluoroquinolones can do this, and a serious “black box” warning was added to the label.
Antipsychotics and tardive dyskinesia. Drugs meant to control psychotic tendencies can actually cause serious movement disorders, which nobody anticipated initially.
What about when a cancer treatment causes cancer? Tamoxifen for breast cancer can cause and uterine cancer. Nobody predicted that. The warning was later added to the labels.
Ketamine for pain and anesthesia and bladder damage. This side effect only emerged when there was greatly expanded psychiatric use of the medicine.
Lots of medicines turn to to cause unexpected bone loss, including medicine that’s prescribed to protect bones! They include bisphosphonates like Fosamax or alendronate, Actonel, Boniva, and Reclast. They are commonly prescribed to treat and prevent osteoporosis by slowing bone breakdown. However, after lots of use, scientists learned they can actually cause serious bone problems, including thigh bone fractures, osteonecrosis of the jaw (dead jawbone), and delayed bone healing. FDA eventually added warnings and updated the labels. Other drugs eventually linked to bone loss and fracture risk include: corticosteroids like prednisone for inflammation, asthma, autoimmune diseases, and allergies; acid reflux drugs like omeprazole/Prilosec or esomeprazole/Nexium); aromatase inhibitors (like anastrozole/Arimidex) for breast cancer; and the injectable birth control shot Depo-Provera.
Her statement should automatically disqualify her as director of the CDC
Erica Schwartz should not be in any position to make health care decisions.