Community Leader MrNA Vaccine Q&A

Community leaders, our hearts go out to you in this season as you navigate a spectrum of strong opinions on politics, disease prevention, conspiracy theories, and more. We can’t help in every area, but we do have a team of doctors who conduct research and work in Public Health (disease prevention), Immunology (immune system), and Virology (viruses). We prepared a resource list for you containing the most common questions we hear about the new COVID mRNA vaccines, because you probably get asked these as well. We hope these are helpful for you as you walk with your community members through these challenging questions so they can make informed decisions.

1. Are there fetal cells in the mRNA vaccines?

No. There are no fetal cells in the mRNA vaccines. We will answer specific vaccine ingredient questions later, but the following question will address the HEK293 cells that were used in the testing of the COVID vaccines earlier in the development process. This cell line was a culture taken in the Netherlands from a single aborted fetus in 1973 (abortion was illegal in the Netherlands until 1984, unless it was absolutely necessary to save the life of the mother). There are no ongoing abortions to keep this cell line alive. The small sample that was taken in 1973 doubles every 34 hours. The cells are immortalized and so far removed from the 1973 sample that they are considered to just be “rounded cells that grow in suspension in cell culture” in the lab.

Research design requires many phases and steps to ensure safety. It’s important to understand key steps and why they happen. Scientists read every possible study related to what they want to research to get an understanding of what has worked, what hasn’t worked, and to obtain a foundation to begin their study. The theoretical foundation moves to the lab, then animal studies, and then sometimes cell lines to make the link between animals and humans to ensure safety. This is where cells grown in the lab often come into play with many modern medications. Meds are often tested on a cell line from a lab before testing on humans, because if the lab cells have an error, imagine if that was a person they were testing the medication on? Clinical trial phases start after that with a small sample of people. Then, if success and expected outcomes continue, they move through larger and larger sample sizes before it can even get to a stage of reaching the general population.

Through the entire process, from the moment researchers step into the lab, they are closely monitored by internal and external ethical committees and review boards (speaking from the perspective of submitting documents and sitting on ethics committees, the paperwork is actually quite daunting and time consuming). The moment participants enter the process of clinical trials and beyond, Informed Consents are used so that people are aware of everything (available in multiple languages, interpretations, and at different readability levels to ensure understanding- we work hard to clearly communicate with our participants and answer questions before any study takes place!).

This is not a complete list, but some of the medications that have been tested with HEK293 cells include Hydroxychloroquine, cancer treatments, Tylenol, Advil, Aspirin, Aleve, Sudafed, Benadryl, Claritin, Robitussin, Mucinex, Pepto Bismol, Lipitor, Prilosec, Albuterol, Azithromycin, Remdesivir, Metformin, and so many more! If someone does not want the COVID vaccine simply because of the safety testing that was done early on with HEK293 cells then they should not take any of the medications listed above (and more), because they went through testing as well.

If a person chooses to get the COVID vaccine it does not mean that they believe in or support abortion. The vaccine development did not require an abortion to take place to be developed, and it is not causing more abortions to happen. One unfortunate abortion took place in 1973, and it is okay to mourn the loss of that life and not agree with what happened. If a person was murdered and you needed an organ transplant, would you turn down the opportunity of that transplant because it was wrong that the person was murdered? We can’t change the abortion that took place in 1973, but what if we mourned the loss of that life and looked at how many lives it is now saving? What if part of the redemption story of that life was to stop the next 3,022,265 people from dying from COVID-19? If there were ongoing abortions to sustain the HEK293 cells then that would be much harder to process morally and ethically, but it was a single death, just like if a single person were murdered and we had to decide to use organs to save others.

These are complex issues that need to be fully understood before jumping to conclusions. We hope this information helps you navigate these grey areas in your communities.

2. Are the vaccine risks worse than the risk of COVID if there is a 99% survival rate?

This question is going to take some unpacking so we can look at correct terms and methods for weighing risks, and then ultimately people and their healthcare providers should determine their risks/benefit analysis together if there are concerns. We need to understand (a) the difference between side effects and allergic reactions, (b) how to interpret the VAERS report, and (c) the terminology used to express disease severity.

A. SIDE EFFECTS: Side effects are common with many vaccines. We learned from clinical trials and are continuing to see consistency in what the side effects are with the mRNA vaccines which include pain in the injection site (most people), fatigue (34%), headache (29%), and fever/chills (11%). It is completely normal and expected to feel common side effects for 24-48 hours after receiving the vaccine (more people reported side effects after their second dose compared to their first). Feeling those uncomfortable side effects shows that your body is learning to fight COVID and building an immune response. Unexpected or rare adverse events would include those who have allergic reactions or anaphylaxis (not common). The most recent rate of allergic reactions was documented at 2.5 people out of every 1,000,000,000 doses, so very, very rare. All cases of anaphylaxis and those rare events were treated and no death happened. Your healthcare provider, or the provider giving you the vaccine, will ask you a series of questions about your health history to identify if you are at risk for an allergic reaction. If there is any risk then the providers will talk to you about that, you do not have to get vaccinated, and if you do get vaccinated then they will have you wait for a while after to make sure you are good (most allergic reactions happen within 15 minutes of getting vaccinated).

B. VAERS: We have a wonderful gift available to read, and that is called the Vaccine Adverse Event Reporting System (VAERS). Unfortunately, this gets misinterpreted often. Today, we won’t go into the details about the calculations or in-depth interpretations, but there are a few things to highlight. This system compiles all reports of common side effects to severe adverse events from vaccines. I love the transparency of this data and the follow-through I have seen with colleagues. The purpose of this document is to help us uphold the highest safety standards, and because of that they literally document ANY negative event (especially with the mRNA vaccines) that happens within a few weeks of getting vaccinated. This is where many people get lost in the interpretation, because if they see deaths listed on the report they think that it means that people died from the vaccine. Death is reported in VAERS if it happens within a few weeks of getting a vaccine, because providers and researchers need to follow-up with each case to investigate so if there was ever a connection it would be documented. What this means is that if a 99 year-old man with severe heart disease gets the vaccine and dies 10 days later from a heart attack that would still be reported in VAERS because the death happened within a few weeks of the vaccine. Does it mean the vaccine caused his death? No! It means they will look into his case and investigate to be safe. The report is updated and other reports are created as investigations happen, but that death number will always be listed in VAERS to document this event, even if it was concluded that the vaccine was unrelated and he would have died with or without the vaccine given his age and health history.

Correlation does not equal cause! Our brains like to try to connect the dots between two events happening at the same time, but it is wrong to jump to cause from correlation. Did you know deaths from drowning increase as ice cream sales increase? Do kids eat ice cream and choke while they’re swimming and that’s why drowning rates increase? Not at all. Drownings increase during summer months because it is hot outside, so kids swim, and the more swimming that happens the more drownings will take place. At the same time during summer months it is hot out so people also eat more ice cream, so ice cream sales increase. Both drownings and ice cream sales increase at the same time during summer months so they are highly correlated, but ice cream sales do not cause drownings. We just have to be very careful with jumping to conclusions, because we have things like research design and control groups to account for “noise” and correlations so we can actually look at cause. VAERS does not conduct research for causation, rather it compiles a whole lot of noise to be investigated case by case to see if there are patterns that would require another study. The report also keeps data listed, even if deaths or adverse events were determined to not be related. When you see a death listed, know that there is probably another case study or other reports you need to read to see the follow-up investigations.

C. TERMINOLOGY: Picture a very detailed painted floral picture with lots of colors. That is how we try to understand diseases, as a picture with lots of colors (calculations) to express different sides of the disease so we can understand what the whole picture looks like. We have many calculations we look at all together and not just one to explain how a disease works, the risks, burden, distribution, and more. One calculation isn’t more important than the others, because they all work together to tell the story of a disease.

Throughout the pandemic the term “survival rate” has been thrown around like that is a calculation and the only measurement used to understand COVID-19. That is actually not a term used much, because we like to look at “mortality rate” instead. We paint our disease picture with mortality rate, case fatality rate, risk ratios, prevalence, incidence, burden of disease, and more. Today is not going to be a math lesson on calculating the picture of disease, but I do want you to understand why we don’t use a percentage and say “survival rate” when it comes to new disease. Mortality rate is a more accurate term for this and it looks at the number of people who died from a disease in comparison to the whole population (remember this is only one color in the painting and not usually used alone). This calculation is expressed as a number per 100,000 people. In the US COVID-19 has a mortality rate of 91.5 per 100,000 people. It became the third leading cause of death in the US in 2020 behind heart disease (198.8 per 100,000 people) and cancer (146.2 per 100,000 people). We don’t use percentage with mortality rates because if we did that then every single disease would be seen as a minimal percent (our leading cause of death, heart disease, would be incorrectly represented as 1.9% if we went down that road). When we look at death from disease as a mortality rate per 100,000 it gives us perspective of people being impacted, because if we didn’t then all diseases would look like 1% or less. If Ebola was expressed as a percentage to look at mortality then we’d see it as a fraction of a percent, but there was a time where it horrifically killed 80% of all people who got infected! Would you really want to measure your risk of disease based on one calculation?

This has been another post, and could have even more to it, but I just want to mention Long-COVID. This is a piece of our disease picture, because disease isn’t simply black and white, live or die. Diseases like COVID-19 have lasting impacts for up to 30% of people infected! That means that almost one third of people who get COVID will have lasting symptoms or damage from the disease (heart damage, neurological damage, lung damage, etc.) that goes far beyond their initial onset of symptoms. We are part of Long-COVID support groups to listen, support, and encourage those who “survived” COVID but are still suffering from the impacts from the disease.

SUMMARY: Community leaders, when you are helping others look at risks remind them that even though we don’t like it, disease is complicated and has many perspectives to look at the big picture. Also remind people that it is normal to have side effects from vaccines, and that it is even a good sign that their bodies are learning to fight (we’ll explain the ingredients and how they work in other questions). Be encouraged and empowered as you navigate this season!

4. Do the mRNA vaccines contain mercury or harmful metals in the ingredients?

The ingredient list is actually quite short for the mRNA vaccines. There are four categories of ingredients found in Pfizer and Moderna:

Fats: Fats, or you might see these listed as lipids, are used to protect the mRNA. They coat the mRNA to protect it and allow easy entry.

Sugars: Sugars are used to help maintain the structure and stability of the mRNA. They really help the molecules keep their shape when frozen.

Salts: Salts are used to help to stabilize and maintain the pH balance.

mRNA: Messenger ribonucleic acid (mRNA) is the ONLY active ingredient. This is what teaches your immune system how to recognize SARS-CoV-2 (COVID-19) and fight it.

*Acid stabilizers: This is the one additional ingredient Moderna has that Pfizer does not. Note that the Moderna vaccine doesn’t have to be kept quite as cold as Pfizer and is easier to transport.

**Please also note that there is no virus (dead or alive) in either of the vaccines, so you will not test positive for COVID-19 from vaccination.

The list of ingredients is not long because mRNA is so precise. The inactive ingredients just have jobs to protect and stabilize the mRNA because it is a very fragile molecule. One of the reasons there are so few allergic reactions could be because there are so few ingredients and they are found in our daily lives like fat, salt, and sugar (see our post with question 3 to read more about allergic reaction rates). We’ll explain how the vaccines actually work in another question.

5. Will the mRNA vaccines change my DNA?

No. The vaccines do not change your DNA. In a non-science analogy, you can think of DNA like the CEO of a company and the mRNA like the factory workers. The CEO is in charge of the structure or blueprint of the company and sets the values. The factory workers are told what to do by the CEO and make whatever products they’re told to make. DNA and mRNA have a similar relationship where DNA holds the genetic material and blueprint, and the mRNA converts the instructions into proteins. The mRNA does not dictate what to do to the DNA, just like factory workers wouldn’t tell a CEO how to run a company.

6. How do the mRNA vaccines work?

We learned yesterday that the vaccines only have mRNA, fats, salts, and sugars in them (all ingredients our bodies are very familiar with). Another key piece of information to note is that viruses need a special way to enter our cells to replicate and cause disease. When SARS-CoV-2 (COVID) enters bodies it has a special “doorknob to our cells” which is the spike protein (see the second picture).

The vaccines were brilliantly designed to teach our bodies to recognize SARS-CoV-2 (COVID) without actually injecting the virus (or parts of the virus) into our bodies. The mRNA enters our bodies and has detailed instructions to make a protein. That specific protein mimics the spike protein (entry way to our cells) that we see with SARS-CoV-2 (COVID).

Our immune systems get alerted when something new is noticed. Then our immune systems start to build a defense and fight against this foreign protein. As our bodies learn to fight what looks like COVID, we may feel like we are sick for 24-48 hours (fatigue, headache, body aches, fever/chills), because our immune systems are literally in training.

After our bodies fight the protein that looks like SARS-CoV-2 (COVID) two key things happen:

1. Your immune system has learned something amazing and begins to build memory and antibodies to fight. (The second shot, or booster, reminds your immune systems so it can build a stronger memory to know how to fight longer.)

2. After using the small amount of instructions injected (mRNA), the body metabolizes and gets rid of it. The body not only breaks down and gets rid of that waste, but the immune system attacks the spike protein made from the mRNA and gets rid of that as well. The supportive ingredients (fat, sugar, and salt) are metabolized and removed from the body as usual. Nothing remains in your body other than antibodies and the memory from the training on how to fight SARS-CoV-2 (COVID)!

Additional thoughts on the past, present, and future of mRNA:

It was incredible to see so many unique pieces align in making these vaccines with a culmination of mRNA being studied for the last 50 years, the knowledge gained from SARS/MERS, and the world paused (researchers given time and funding). Before the pandemic mRNA was often studied for cancer treatments and targeted therapy. I hope that this historic moment has not only given us tools and hope to fight this virus, but I dream about the progress we will see in cancer treatments after this. I hope we see mRNA therapy continue to make leaps and bounds so we have ways to treat cancer by killing the cancer cells and not hurting the whole body with chemo. I have remarkable colleagues researching this and am excited about what is to come!

7. Are the mRNA vaccines experimental?

This question is similar to an earlier question that was answered. We learned that the term “99% survival rate” is not a correct term, and “experimental” is another term being widely misused. The term experimental is appropriate to use with research, but it is used back in the beginning of the process. In question 2 of this series we mentioned the research process (reading→[experimental design development]→ lab→ testing→ trials→ then released for the population). Experimental refers to the type of design a researcher is using to conduct their study, and this is determined right after the reading stage before the lab. There are many different types of experimental designs and they each have their own purpose to control “noise” and look for cause.

Let’s not get lost in research design and terminology. The vaccines were considered experimental in the lab stages, with animals, and through clinical trials. After the regular and rigorous clinical trial process, they were determined to be safe as ethical measures were upheld (by internal and external safety and ethics committees). Then the vaccines were rolled out to the general public according to risk. Vaccines and meds are no longer under experimental design after clinical trials and when they are released to the public. So in short, no, the vaccines are no longer experimental as they have moved beyond the lab and clinical trial phases.

8. Why are the vaccines approved through the EUA and not FDA?

The term EUA (emergency use authorization) has caused many people to fear the vaccines and question approval. The EUA falls under the FDA, as they work hand-in-hand on emergency situations. The EUA was created for the exact scenario we are seeing right now. Let’s be honest for a moment and think about many processes in the government. A lot of government programs and systems take a long time to be processed! That is the reality of working within complex systems, especially when every detail needs to be documented. The government actually recognized that the FDA application process, site visits, and more took a really long time. Thankfully, they also thought about emergency situations where we may need life-saving vaccines or medications and people may not have the luxury of waiting. They created the EUA as a sub-category of the FDA for the purpose of allowing access to life-saving diagnostics, medications and vaccines under emergency conditions.

The easiest way to picture the relationship between the FDA and EUA is like a hospital and ambulance. We have hospitals and doctors appointments that provide care when you have the privilege of driving there or the time to schedule an appointment. When you get to the hospital or doctors office, you often fill out a lot of papers and sit in a waiting room until you can be seen. The process can take a while. If you have an emergency then an ambulance quickly goes directly to you to provide life-saving care immediately. The ambulance is a service of the hospital, but the purpose is to respond quickly to emergencies. The FDA is like the hospital or doctors office where the process takes a little longer, and the EUA is like the ambulance where it works with the hospital but focuses on the emergency at hand. The hospital and ambulance work together for the same system, just like the FDA and EUA.

When an emergency happens and a product is needed immediately to either diagnose, treat, or prevent a life-threatening illness an EUA request is sent to the FDA. There are still safety protocols and criteria that need to be met in order for a product to become available. The rigor, ethics, and safety of the clinical trials do not differ between the EUA and FDA. The FDA is currently conducting site visits for vaccine manufacturers (one of the steps that differs between the two and takes longer), and mRNA vaccines are expected to be FDA approved within the coming months. There have been no flags or warnings that would appear to hinder formal approval from the FDA.

Imagine if our government did not recognize the lengthy process of the FDA and didn’t have emergency systems like the EUA in place? The pandemic has highlighted many weaknesses in many countries, but I am grateful that we have the EUA and that it is functioning as it should.