COVID‑19 Vaccine Q&A

Demystifying the New Vaccines

It's okay to have questions about the COVID‑19 vaccines! There is so much information being thrown from every direction, it can be difficult to make sense of it all, much of it seems contradictory, and it can be flat-out overwhelming. On this page, I intend to bring some of that data together and try to make it a little more transparent and understandable.

Question: Why should I consider getting vaccinated?

Answer: Vaccination greatly reduces the chances of becoming infected or needing to be hospitalized if an infection happens. Vaccines can save lives and widespread vaccination can eradicate disease. Every time someone becomes infected with the virus that causes COVID‑19 (SARS‑CoV‑2), even if that person's case is asymptomatic, the virus has the opportunity to mutate. Mutations such as these are the reason that influenza vaccines must be reformulated every year. SARS‑CoV‑2 has already proven itself to be far more contagious than other coronaviruses such as the viruses that caused SARS and MERS, giving it significantly more opportunities to mutate. Rapid worldwide vaccination has the potential to eradicate this virus, including its current variants. But every time a new variant emerges, the risk of the virus becoming resistant to currently available vaccinations increases and the possibility of total eradication diminishes.

Question: What is the difference between FDA approval and an Emergency Use Authorization?

Answer: When new medications or medical devices are being introduced, they need to undergo clinical trials to determine their safety and efficacy; if trials show that the medication or device is safe and effective, a panel of specialists at the FDA will review the data, assess the risks, and decide whether or not to grant approval for its use in the general population.

There is a significant amount of "red tape" for a manufacturer to go through when seeking approval; this means that there is a minimum of six to ten months before the FDA comes to a determination following an application. As I explained in my previous post, "Addressing Common COVID‑19 Misconceptions," trials for countermeasures during a pandemic are naturally accelerated because of the inherently large size of the control group, which is essentially the entire population instead of just a couple thousand people. During public health crises, the FDA has the power to issue "Emergency Use Authorizations" to permit the use of unapproved countermeasures, allowing the "red tape" of getting full approval to be temporarily skipped. When seeking an Emergency Use Authorization rather than full approval, manufacturers are permitted to let trial phases overlap rather than having one trial at a time, and they are allowed to begin mass manufacture of the product before being granted approval. The FDA still requires clinical trials and rigorous evidence of a treatment's safety and efficacy before it will grant an Emergency Use Authorization, but the trial data review can "skip the line" ahead of any other pending approvals and required minimum times can be bypassed if doing so is deemed appropriate.

Another key difference has to do with marketing. Following full FDA approval, manufacturers are allowed to engage in direct-to-consumer marketing, such as television ads and billboards, as well as marketing of their products to care providers. This type of marketing is not permitted for preventatives or therapeutics that have only been granted an Emergency Use Authorization; the research must be strong enough that the product can speak for itself.

Question: What is VAERS?

Answer: The Vaccine Adverse Event Reporting System (VAERS) is a tracking tool that the U.S. Department of Health & Human Services uses that allows self-reporting of vaccine complications. VAERS is a very useful tool for the CDC, FDA, vaccine developers, and epidemiologists for tracking adverse reactions to vaccines, but all submissions must be carefully reviewed to make sure that reports are actually relevant to vaccination. Many reports are coincidental rather than related to vaccination and a majority of reports are completely expected reactions such as a sore arm. Looking purely at report numbers does not provide an accurate picture of actual adverse events, and the individual reports must be reviewed for a full understanding. Despite the complexity of reviewing the data, VAERS is an extremely important tool, exemplified by the discovery of the extremely rare blood clots associated with the Johnson & Johnson/Janssen vaccine.

You may have heard about the anesthesiologist who filed a VAERS report claiming that a vaccine turned him into the Incredible Hulk. Out of curiosity, I ran a query in the VAERS database and quickly found these three claims that exemplify how discretion is a necessity when reviewing reports.

• VAERS ID# 0904970: "it caused my head to explode in 18 parts"
• VAERS ID# 0937696: "PAIN BEHIND EYES, HEAD TO EXPLODE DOWN BAck OF HEAD"
• VAERS ID# 0985991: "all of a sudden, the right breast implant just popped"

Question: Are the new COVID‑19 vaccines really vaccines if it's still possible to get infected after being inoculated?

Answer: Yes, they most certainly are real vaccines. Vaccination is a way to give the immune system a chance to learn how to fight a pathogen or disease without the danger of exposing someone to the actual infectious substance. mRNA and viral vector vaccines are simply the latest versions of vaccination (and they're actually decades-old platforms at this point). In the past, vaccines have used a weakened form or small fragment of an actual contagion. The new platforms still result in exposure and immunity, just with more safety and efficiency than ever before. Following vaccination, your body is exposed to COVID‑19 spike proteins to give your immune system the opportunity to develop antibodies with zero risk of the vaccine causing the actual disease. By definition, these undeniably are vaccines.

"Vaccines aren't forcefields." That's my somewhat silly response that I like to use to simplify the explanation. Vaccines have never been 100% effective; there has always been a chance that you could still get a disease that you have been vaccinated against, no matter what platform the vaccine uses. While vaccines aren't forcefields, they do boost your immune system's response time and dramatically reduce infection rates.

Question: What kind of nanotechnology is in the vaccines?

Answer: The short answer is that it's fat, not robots or computer chips. The term "nano" only means that something is extremely small (measured in nanometers) and in no way implies that anything must be digital. The strands of mRNA in some of the COVID‑19 vaccines (including the Pfizer-BioNTech and Moderna vaccines) are extremely fragile and would be destroyed before being effective without some form of protection. The manufacturers of these vaccines coat the strands of mRNA with lipid nanoparticles, a fancy term for microscopic balls of cholesterol and other fats, in order to achieve the protection necessary to keep the vaccines effective. It's like how making an herb butter keeps the herbs fresher longer than if they were left out bare!

Question: Do the vaccines contain aborted fetal cells?

Answer: The vaccines themselves do not contain any fetal cells. A human fetal cell line that was obtained in 1985 is utilized in the process of growing the viral particles used within the Johnson & Johnson/Janssen COVID‑19 vaccine, but the vaccine itself does not contain any of those cells. When the Pfizer-BioNTech and Moderna COVID‑19 vaccines were being developed they were tested on a human fetal cell line that was obtained in 1972, but the vaccines contain absolutely no fetal cells of any sort. Neither of the cell lines used for these vaccines require ongoing abortions; the cell lines are based on tissue obtained from two fetuses that were aborted decades ago.

The cell line that is utilized when growing viral particles used for the Johnson & Johnson/Janssen COVID‑19 vaccine is known as PER.C6. This cell line is based upon fetal tissue obtained in 1985 by Dr. Alex van der Eb in the Netherlands.

The cell line that was utilized as part of the initial trials for the Pfizer-BioNTech and Moderna COVID‑19 vaccines is known as HEK-293. This cell line is based upon fetal tissue obtained in 1972, also by Dr. van der Eb in the Netherlands. While patient-specific records are not available, it is worth noting that elective abortions were illegal in the Netherlands during that time and that they were only performed when absolutely necessary in order to save the life of the mother.

PER.C6 and HEK-293 are among the most frequently utilized human fetal cell lines used in medical research. It is by no means my place to attempt to influence the opinions of anyone other than myself when it comes to controversial matters such as the use of fetal tissue in medical research, but I am using this site to help make information available to anyone who wants it. I appreciate the fact that scientific advancements have been made possible in the face of unfortunate events and I thank those who have sacrificed and the families who have experienced loss.

Question: How long will the components of the vaccine stay in my body?

Answer: Exact numbers are not known, but it is a very short period of time. What we do know is that the currently authorized COVID‑19 vaccines begin to degrade after 6-12 hours of storage at room temperature. It is within that time period that COVID‑19 spike proteins are produced. A typical immune system should eliminate those spike proteins and vaccine remnants within a few days.

Question: Are there people who shouldn't get a COVID‑19 vaccine?

Answer: Yes, but it's a very small group of people. The main reason someone should not get the vaccine is if they are allergic to any of the vaccine's ingredients. The mRNA vaccines contain no live virus, making them safe for most immunocompromised individuals. As a matter of fact, vaccination is recommended for individuals with compromised immune systems because they are at higher risk for serious complications if they were to become infected. Of course, if you have any concerns regarding the safety of being vaccinated, discuss it with your care team first.

Question: What is going on with the blood clots associated with the COVID‑19 vaccines?

Answer: After reviewing VAERS data, a small number of rare blood clots were detected following vaccination with the Johnson & Johnson/Janssen COVID‑19 vaccine. The type of clot detected is called a cerebral venous sinus thrombosis with thrombocytopenia. In the general population, this type of clot occurs in approximately 5 out of every one million people. Following a report released May 7, 2021, there have been 28 cases detected out of 8.7 million people vaccinated with the Johnson & Johnson/Janssen vaccine, which comes out to approximately 3 cases per one million people, which is less than the 5 cases per million seen in the general public. While this finding is concerning and deserves thorough investigation, the current assessment finds the risk to be acceptable since the occurrence is less common within the vaccinated population than what is seen within the general population.

Question: Can the vaccine cause infertility?

Answer: There is no evidence supporting the claims that the COVID‑19 vaccines can cause infertility, and vaccination follow-up studies are showing an expected number of pregnancies. The theory that vaccination could cause infertility proposed that the vaccine could train the immune system to attack a protein involved in placenta formation called syncytin‑1 (pronounced sin-sis-shin won), claiming that syncytin‑1 is structurally similar to the COVID‑19 spike protein. The fact of the matter is, however, that these two proteins have very little in common and the human immune system is smart enough to not mistake one for the other.

Proteins are complex arrangements of amino acids, and 20 different types of amino acids exist that can be combined to form proteins. For example, syncytin‑1 is a chain that is 538 amino acids long. Syncytin‑1 and the COVID‑19 spike protein share two sequences of two amino acids, that's it. It's like claiming that "escalator" and "infinitesimal" are the same word because they both have "es" and "al" in them (but pretend those words are 500+ letters long and still only had those two commonalities).

Question: Is it safe to get vaccinated while pregnant?

Answer: The general consensus is that it is safe, but definitely discuss it with your obstetrician or midwife first. Pharmaceutical companies commonly exclude pregnant women from their initial clinical trials as a matter of safety; most of the COVID‑19 vaccine trials have followed this pattern, meaning there initially wasn't much data available regarding the vaccines' safety during pregnancy. Thus far, follow-up studies are suggesting that vaccination is safe while pregnant and the American College of Obstetrics and Gynecology recommends offering the vaccine to expectant mothers. A recent study out of Harvard and MIT found that COVID‑19 spike protein antibodies crossed the placenta following vaccination, providing protection to the baby.

Question: Is it safe to get vaccinated while breastfeeding?

Answer: The general consensus is that it is safe, but definitely discuss it with your obstetrician, midwife, pediatrician, and/or primary care provider first. Both the American College of Obstetrics and Gynecology as well as the American Academy of Pediatrics recommend offering the vaccine to breastfeeding mothers. A recent study out of Harvard and MIT found that COVID‑19 spike protein antibodies passed through breastmilk following vaccination, providing protection to the baby.

Question: Why should children be vaccinated if severe cases and deaths are nearly unheard of?

Answer: While it is true that the prognosis of COVID‑19 among children is very good, there is still a great deal of concern over long hauler syndrome leading to ongoing health complications. Beyond that, infected children can become vectors, transferring infection to higher-risk individuals. Vaccine response trials in children show extremely impressive results with impressively few complications or risks. It simply makes sense to vaccinate as many people as possible when trying to control a global pandemic.