Woohoo! Hope is finally here! As of 12/12 and 12/17, the FDA has given emergency use authorization (EUA) for the Pfizer and Moderna vaccines to be administered to the public. This is incredible news! While cases are unfortunately skyrocketing and we are breaking records daily for new cases, hospitalizations, and deaths, this is hopefully the beginning of the end as vaccine production/distribution is increased and more and more people are eligible for vaccination. With this incredible news of these vaccines and the skepticism around science which has been bolstered by the federal government, I wanted to bust some more myths, provide all of you with hard facts and science, as well as put all of your minds at ease when it comes to the safety and efficacy of these vaccines. Just to be transparent with my authority on the subject, I have previous experience and degrees in molecular and cellular biology and have actually worked with RNA in a lab/research setting prior to medicine/nursing. So I’m not just “some nurse” who thinks they know what they’re talking about, I’ve lived the nerd life…

So first of all, what are these vaccines and what’s in them? These vaccines are the first of their kind. They are known as mRNA (messenger RNA) vaccines. Messenger RNA is a piece of genetic information which is used in our bodies to make proteins of all kinds. This type of genetic information is different from DNA. DNA contains the genetic instructions that live in the nucleus of the cell and contain all the information of how to make mRNA. Think of DNA as the architect and the RNA as the blueprints they create. The architect has all the knowledge (DNA) necessary on how to build a house and then creates blueprints or instructions (mRNA) on how to actually assemble it. Once DNA creates mRNA, it is then transported to the cytoplasm of the cell where it can then make proteins.

Instead of our own DNA making the mRNA for these vaccines, scientists have created the mRNA which is delivered right into the cells. Scientists have figured out the exact mRNA sequence which creates the spike proteins of SARS-CoV-2 (coronavirus/COVID) which is what is being used in this vaccine. Spike proteins are all the little horns sticking out of the virus on its surface which help it bind to our cells and infect us. They are a unique fingerprint of the virus and the spikes are what our bodies use to identify the virus. Now the reason this is new, is because for many years, scientists have been trying to figure out how to get this mRNA into the cells which was thought to be an impossible feat. This vaccine technology has been studied for decades, more specifically the creation of mRNA and its transport into cells. Now finally after decades of research, mRNA can now successfully be created and then transported into a cell using lipid nano spheres. Our cells are surrounded by a lipid (fatty) membrane and by using a lipid nano sphere, it will bind to the membrane and release the mRNA into the cell. Think of two soap bubbles that are next to each other and when they’re touching for long enough, they became a single, larger bubble. When the lipid nano sphere binds to the cell, it releases the mRNA into the cytoplasm where it starts to make the spike protein. Once it creates enough spike proteins, the mRNA is broken down and disappears after a few hours. The immune system then recognizes these SARS-CoV-2 spike proteins which the vaccine prompted and then creates antibodies so that the next time it sees the same spike protein it can attack and kill it whatever it is attached to, aka the coronavirus.

Now I have read, watched, and seen many claims that this new vaccine will change your DNA and be incorporated into your genetic code making you technically a GMO (genetically modified organism). Insert game show wrong-answer buzzer here *EHHHHHHH*. This could not be further from the truth. In order to do that, we would need to use special technology like gene therapy/CRISPR technology in order to change your DNA. This would require something entering the fortified nucleus of your cell and altering your DNA. Moderna’s and Pfizer’s vaccines only use lipid nano spheres with a small piece of mRNA which is unable to enter the nucleus let alone change your DNA. Also, the mRNA dissolves after a few hours and no longer exists. After all the injected strands of mRNA are used to make the spike proteins, the whole process stops and the cell breaks down the mRNA because it is no longer needed. Poof! And like that, it’s gone. So no, your DNA is not changed and your genes stay the same. That’s not how molecular biology works.

Many people are always touting the dangerous chemicals in vaccines as the cause of so many diseases or reactions which are untrue to the smallest detail. What is in these two vaccines? Well, let’s take a look.

Synthetic messenger ribonucleic acid (mRNA) encoding the pre-fusion stabilized spike glycoprotein (S) of SARS-CoV-2 virus. This is the mRNA needed to make the spike protein. SM-102, 1,2-dimyristoyl-rac-glycero3-methoxypolyethylene glycol-2000 [PEG2000-DMG], cholesterol, 1,2-distearoyl-snglycero-3-phosphocholine [DSPC]. These are all lipids/cholesterols for the lipid nano sphere so it can slip inside the cell and deliver the mRNA to do its job. Sucrose. This is sugar found in fruits and vegetables. Sucrose is used to help keep the vaccine stable in refrigerators and freezers and prevents crystallization/vaccines from spoiling. Tromethamine (hydrochloride). This is an anti-inflammatory known as ketorolac which is similar to ibuprofen or naproxen and used as a stabilizing agent that is an inactive ingredient. Sodium acetate and acetic acid. Acetic acid is basically vinegar and sodium acetate is the salt derived from acetic acid; both naturally occurring. These act to help stabilize the vaccine as well and are inactive ingredients. All of the above are found in the Moderna vaccine which is preservative-free. Pfizer’s vaccine contains similar ingredients. It contains the mRNA sequence for the spike protein. Lipids (including ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3- phosphocholine, and cholesterol). These are the lipids and cholesterols for the lipid nano sphere. Potassium chloride, Monobasic potassium phosphate, Sodium chloride, Dibasic sodium phosphate dehydrate. These are all forms of salt which help buffer and stabilize the vaccine. Sucrose. This is a natural sugar to help stabilize the vaccine. Both vaccines are preservative-free and contain only a tiny list of ingredients. No adjuvants needed to boost the immunogenicity or antibody-creating effect because the body is doing the work by using the mRNA and creating the actual protein.

So the vaccine was incepted, studied, and produced at an accelerated rate compared to all the other vaccines. This was all achieved in less than a year! A YEAR!? The fastest vaccine ever to be developed before this was the mumps vaccine in 1963. From inception to FDA approval, it took four years and was finally approved in 1967. So are these new COVID-19 vaccines rushed? Absolutely not. There are a few reasons why these vaccines were created so quickly. One reason is that the entire world basically dropped everything and the top researchers began studying the virus to sequence its genome and find out what protein specifically triggered an immune response as well as the mRNA sequence responsible for that specific protein. Figuring this out is usually what takes 5-7 years for a vaccine to be created. Because of modern technology and revolutionary molecular biology research methods, we were able to decipher this specific protein that creates an immune response (antigen) and the mRNA responsible in making it. So what normally would take many years to discover, researchers did it in a matter of months. Now what about safety and proof of efficacy in such a short period of time? Well, luckily over 76,000 study participants were used (about 45,000 in one and 34,000 in the other). Half in each study received a placebo and the other half received the actual mRNA vaccine. Researchers and participants were blinded, meaning neither knew at the time of the study who received the placebo versus the actual vaccine. Out of the study, only a few people in the actual vaccine group contracted COVID-19 and it was mild/moderate infections while a large number of participants in the placebo group contracted the virus and typically had more severe infections if they did develop symptoms. This came out to a 95% efficacy rate. So not only does this prevent disease, it lessens the severity in the few people it does not completely protect who get the virus despite the vaccine. Now in older adults, that efficacy was lower at about 86% effective. Sadly, a few patients died of COVID-19, however, those were in the placebo group. The final phases of the clinical trials were completed over 60 days, which is 20 days past the usual time frame to collect data and conduct the study (40 days typically for other vaccines). Through decades of evidence and research, we know that if someone were to develop a condition or severe side effect/reaction, it typically occurs within the first 24 hours after vaccination and most long term adverse reactions occur within the first 30 days. During these clinical trials, only a handful of severe reactions occurred and were all in the placebo group. For both vaccines, the first dose injection rarely caused fatigue and soreness of the injection site while the second dose caused small amounts of fever, fatigue, muscle/joint aches, and headache (all occurring at less than 9% occurrence rates). In the UK, two people who received the vaccine after authorization had a severe allergic reaction as did one person here in the US. This occurred in patients who had severe allergies in the past. Overall, based on the data, these are some of the safest vaccines to date based on their mechanism of action and limited, preservative-free ingredients.

Now why did they get EUA and not formal approval? Well that’s because in order to approve a vaccine before it is administered to the public, longer term data on efficacy and lasting immunity needs to be reached which we have yet to collect, however, because the pandemic is so lethal and infecting millions with impacts on so many aspects of human existence, it was determined that the significant efficacy and safety greatly outweighed the side effects compared to the morbidity and mortality of COVID-19 itself.

Who can and can’t get the new mRNA vaccines? Well currently there aren’t any hard contraindications for the vaccine however if you have a known severe allergic reaction to vaccines in the past, you should talk with your primary care provider or allergist/immunologist regarding whether or not you have any risk. This is also helped by the 15-30 minute waiting period after getting the vaccination because if anyone is going to have a severe allergic reaction to any vaccine, it almost always occurs within the first 15 minutes after vaccination and can be responded to/treated immediately. For those who are under 16, the risk of COVID-19 morbidity/mortality is extremely low and there is no pediatric data yet, so it is not recommended for these children. In women who are pregnant. breastfeeding, or trying to conceive, the American College of Obstetrics and Gynecology (ACOG) as well as the Society for Maternal Fetal Medicine, suggest that COVID-19 is a much greater risk to the mother and fetus than the vaccine which is considered low risk and safe by current data and scientific theory. While it is not a recommendation, they are not recommending against its use in these women therefore it is acceptable for any of those who are pregnant, planning to get pregnant, or are breastfeeding to choose to have the vaccine. For those with immunocompromised conditions, chronic disease, or advanced age, it is safe and recommended as they are at high risk of morbidity and mortality from COVID-19 infection. So, overall, the vaccine is safe and anyone over the age of 16 should talk to their PCP about getting the vaccine once widely available as this is the only way the pandemic will end in conjunction with wearing a mask and other prevention measures.

So when can you get the vaccine? Well, as of right now, the federal government bungled acquiring enough doses for the country so the ACIP (Advisory Committee on Immunization Practices) released distribution criteria for those who should be prioritized for the vaccine. First is healthcare workers, nursing home staff/residents, and first responders. Then it will slowly build into a more broad distribution. I don’t want to be too specific as each state can set their own priorities. Vaccines are already being administered and with the recent news of Moderna getting EUA this past week, more will be available. I can say for certain that I am jealous all of my friends and colleagues on social media who are posting their post-vaccine selfies and I am grateful for them listening to science and leading by example. You should NOT be afraid of this vaccine because the science and data exists to support its efficacy and safety. Getting COVID-19 is still a significant threat to your health, whether or not you are healthy or older. So when the time arrives to get your vaccine, be proud and confident that medicine and science is on your side and you are taking a step forward to returning to “normal.” I am chomping at the bit, waiting to be able to get my vaccine. I can understand why some have reservations about this vaccine, but I can assure you with all my clinical knowledge and experience, it is safe and certainly a step in the right direction. We may not know how long the immunity lasts and if this virus will change enough to evade the immunization, however by everyone taking the vaccine and practicing good public health measures, we can all get back to our “normal.”

If you have a friend or loved one who is questioning this vaccine, does not believe in it, or is reading lies and myths about it, please forward this to them and have them reach out to me on my contact page. I would be more than happy to explain anything to them to help them better understand the science. In learning and educating ourselves, we can better inform the decisions we make in life. I am not here to force someone to believe in something but to educate and teach so that they can live their best life.

Stay safe and be well!