As a doctor, I never thought much about vaccinations other than what I was told; they’re designed to keep us healthy. Over the past 18 months, we have experienced a world that few thought possible. Nearly every facet of our lives has changed, and in the opinion of many, not for the better. All I learned about the subject of vaccinations 30 years ago in my medical school pediatrics rotation was the childhood vaccine schedule. It is what is called COVID that woke me up.
Let me begin nine months ago, nine months after COVID became a household word. On 12/11/20, the FDA issued an Emergency Use Authorization (EUA) for a product made by Pfizer/BioNTech for prevention against the Coronavirus that causes Coronavirus Disease 2019 (COVID-19), the claimed cause of the worldwide pandemic. The product was marketed as a vaccine, however, the injection’s mechanism of action was unlike any previously used in humans. This vaccine was said to work by the injection of messenger RNA (mRNA) commanding the body to produce a spike protein. The body then makes antibodies against that protein. If the COVID-19 virus is encountered, those antibodies will attack it. What was developed was essentially gene therapy.
On Aug. 23, 2021, the FDA approved an application by BioNTech of Germany for use of a product called Comirnaty “for immunization to prevent COVID-19 in those 16 years or older“, to be distributed by Pfizer. The FDA states that with Comirnaty, “the same formulation…can be used interchangeably. The products are legally distinct with certain differences that do not impact safety or effectiveness” however, the “EUA is maintained for the Pfizer/BioNTech product and authorizes Comirnaty under this EUA.” According to the major media, a fully FDA-approved COVID-19 vaccination now exists called Comirnaty.
However, in their approval, the FDA admits that Comirnaty does not yet exist for clinical use. If you go into a hospital, pharmacy, or physician’s office and ask to be injected with Comirnaty, they will not have it. Currently, and for the foreseeable future, the product injected is the EUA Pfizer/BioNTech product. If Comirnaty has been fully approved, is the product used under EUA since last December its substitution? Or has the brand (Pfizer/BioNTech) gone generic (BioNTech)? However, the generic (BioNTech) is unavailable, or are there two brands (Pfizer/BioNTech) and (BioNTech), with only one being available (Pfizer/BioNTech)?
According to the FDA, Comirnaty is the “same formulation [that] can be used interchangeably. The products are legally distinct with certain differences that do not impact safety or effectiveness.” But what are these specific differences?
What if the products are not identical? Does the Pfizer/BioNTech or the BioNTech product contain propriety ingredients that are not required to be disclosed? Will this be disclosed to the public?
Can either product be claimed to be safe and effective given the submissions to the Vaccine Adverse Event Reporting System (VAERS) to date? How is safe and effective defined, not in the clinical sense but from a layman’s point of view? The government may consider the war of low risk, but to the individual, not so much.
In the FDA’s original EUA for the Pfizer/BioNTech product, it was stated that after the study, “[The] FDA concluded that it is reasonable to believe that the Pfizer/BioNTech COVID-19 vaccine may be effective… known and potential risks outweigh the known and potential risks for prevention of COVID-19.” Notice the significant amount of hedging in that statement.
Presently, all COVID-19 injections are only available through providers enrolled in the CDC COVID-19 vaccination program located in hospitals, pharmacies, physician offices, or health departments. An individual can’t purchase the vaccine by prescription. To most people, that may not be a big deal, but on some level, something seemed off, and it got me thinking about the Influenza (Flu) vaccine.
Flu vaccines are one of the many vaccines that work in the traditional sense by injecting a viral particle to stimulate the immune system directly. Licensure for civilian use was first given in 1945. Like the COVID-19 injection, it’s available for administration in hospitals, pharmacies, physician offices, and the state Department of Health. Curiosity got the better of me, and I wondered if there were other avenues available for procurement.
Like many areas of commerce, the internet has opened up a world of possibilities for purchasing medication. First, I researched the available Flu vaccines and found websites that sell multi-dose vials or individual prefilled syringes. The only problem is that you have to purchase ten doses. Another issue is that you need to provide an NPI number, the equivalent of a Social Security number, but for physicians. Not a problem for me.
Next, I checked out a website called GoodRx. It is a retail cost comparison site for pharmacy pricing and substitutes for your medical insurance coverage. Interestingly, they listed the price for a single syringe of the medication. There was also a notice that there may be a separate administration charge. I was just looking to purchase, so I disregarded that issue.
I am a physician in a state where self-prescribing is not a problem, but that is not true in all states. It is acceptable in my state since I can obtain a special medical license upon retirement, allowing me to prescribe medications for myself and my immediate family. Logically, it should not be a problem to do this under my full medical license.
With the information in hand, I started my quest. Hesitantly. Being in practice for 25 years, I am aware of the pharmacist rulebook. That rulebook is unknowable to physicians. I learned this years ago in confrontations with pharmacists, asking them where they reference the supposed rules that they used to impede my requests made on behalf of my patients. Their rulebook is now out in the open, as noted by some pharmacist’s refusal to fill prescriptions for HCQ and Ivermectin, which physicians are using for COVID-19 treatment.
Historically, any licensed physician can prescribe any FDA-approved drug for any reason if, in their judgment, it is a potentially effective treatment. It’s called off-label use. The FDA allows such usage, accounting for up to 20% of all prescription drug use. What restrains our use is ethics and the potential for malpractice. Nearly all drugs used off-label will never be on-label because it is not worth the time or expense for pharmaceutical companies to formally study what has been demonstrated through observation and in use by physicians sometimes for decades.
With my prescription in hand, the first pharmacy I visited did not let me obtain the Flu vaccine. My encounter went as follows: “Can you fill this prescription? It is for self-administration.” Answer “No.” The reason the pharmacist gave was that it was the policy of the company only to administer, not to dispense vaccines. It was suggested that I try another pharmacy.
I took that advice and went to a large national chain pharmacy. Here I repeated my previous request. The pharmacist repeated that it was the policy not to dispense but only to inject vaccines, but then came the twist; the medicine cannot be dispensed since it requires refrigeration. To that, I asked, “Doesn’t Insulin also require refrigeration?” The pharmacist responded, “You won’t be giving that to yourself.” In disbelief, I repeated, “You won’t be giving Insulin to yourself?” With that, I was told to try the nation’s largest retailer.
On to pharmacy number 3: Here I was met by the pharmacy assistant. The pharmacist was busy giving a “vaccination.” After 10 minutes, the pharmacist appeared, and I made my request and was told that a call would have to be made to the District manager. Twenty minutes later, and double the price because of an incorrect price listing, I was approved to purchase the vaccine. But I was still puzzled why it was so difficult to obtain a medication that could be used in a manner similar to self-administering Insulin for diabetes or Epinephrine for anaphylaxis.
I skipped the drug counseling. Standard questions such as a history of egg allergies or warnings of a rare but serious effect called Guillain Barre were not mentioned. Nor was the need for refrigeration that got me turned away from one pharmacy. The recommendation for storage of Flu vaccine storage is that it be kept between 35 and 46 degrees. Freezing is a no-no. Room temperature until you get home is probably just fine. Remember the initial panic regarding the ultralow temperature that the COVID-19 injection required? Now, it can be kept at room temperature for up to 6 hours. Is something else going on?
As formulated, is it unsafe to purchase and self-administer a Flu vaccine? Many people inject themselves with legal medications daily. I knew a doctor who had brittle diabetes (wide fluctuations in blood sugar) who routinely injected too much Insulin and was visited many a night by EMS. No one in the government seemed concerned by that.
I figured if I could obtain the Flu vaccine, though, with some difficulty, I should be able to prescribe it to a capable patient who could then self-administer it at home, just like Insulin. First, I called the prescription into the same chain that I could obtain mine from, but at a different location. The patient called me and told me the following “the pharmacist wanted to know why I ordered this, and where it would be administered and would have to call corporate.” The pharmacist then called my patient. Corporate’s policy was to only administer at the pharmacy due to “temperature management of the medication.” When prompted about Insulin storage requirements, the pharmacist then added: “Insulin no longer needs refrigeration after it is picked up.” What happens before that or what the patient should do with it at home was not addressed.
The following day I called another national chain in the patient’s area. The pharmacist told me that “due to the company policy, the vaccine could not be dispensed because it had to be authorized by the protocol doctor for on-site administration.” I gave up enquiring what or who the protocol doctor was.
It seems that unless you are a physician and possibly slip through the cracks, you can’t get your hands on the Flu vaccine. Is it really about storage issues, or are we being prepared for something else?
I believe the goal is turning valid vaccination into gene therapy, such as is being used with the COVID-19 injection. Several companies are working on a combined Coronavirus-Influenza injection. Undoubtedly the Flu portion will be formulated like the COVID-19 mRNA injection, transforming it from a traditional vaccine to gene therapy. Once this product is approved, will there remain a standalone traditional Flu vaccine? My guess is no.
Presently there’s a great urgency by those in government, public figures, physicians, businesses, and hospitals to push for mass injection to halt COVID-19 supposedly. There are now even presidential orders mandating it. We know that, at a minimum, the COVID-19 injection requires administration by medical personnel because it is dangerous. Just look at the VAERS data and the number of people who end up on the floor post-administration. There are even instructions given to those administering it to protect the patient/customer’s head from hitting the floor.
Many remain unopposed to the Flu vaccine for those opposed or honestly hesitant to get the COVID-19 injection. Will refusal spread if people learn that the new Flu vaccine will work by the same mRNA action causing the side effects and deaths we see piling up with the COVID-19 injection? Or will people come to realize that Flu vaccines, for most people, were relatively worthless, that fact having flown under the radar since vaccines were always portrayed as a big benefit at low cost?
Some of us knew early on that the action supposedly taken against COVID-19 was never really about a virus but were not certain what it was about. How many more vaccines will be made to alter our genetic code that will be mandated, and with no way to circumvent the system put in place to ensure that they are injected into us? Is it to legislate a reverse version of The Island of Doctor Moreau, not the humanizing of animals but the animalizing of humans for greater control?
Steve Karp is a board-certified radiation oncologist, in practice for 25 years. He is still trying to figure out what he wants to be when he grows up.