2020 was a tough and trying year for so many people. Within our family, it was a time of change and fear, but also a time of joy and excitement, with so many firsts. I was roughly seven months pregnant when everything changed due to the coronavirus pandemic, and we welcomed our daughter, Carolynn Rose, May 14th, 2020, during what would be toward the beginning of the shutdowns and social distancing time frame of 2020.
I am partnering with the North Dakota Department of Health to provide some data and resources to help you and your family make the best possible healthcare decisions regarding the COVID-19 vaccination. I want to be up-front and clear that I think medical professionals are the experts, and it is my intention to only provide you with straightforward information and encourage you and your family to talk with your healthcare provider about the pros and cons of being vaccinated OR unvaccinated. This blog is sponsored on an informational only basis, and does not attempt to suggest medical advice on behalf of the author.
As a new mom, it was very scary to live through the largest epidemic-turned-pandemic in recent history and I know that a lot of families faced job loss, income reduction, loved ones passing away, depression, and more. For some people, the vaccination route is the easy decision and for others it is not such an easy choice. In western North Dakota, more specifically the Dickinson community area, there are fifteen different locations where you may receive the COVID vaccine, and those can be found here. Of these locations, there are medical professions able to meet with you and discuss making your informed choice at Southwest District Health Unit, West River New England Health Clinic, Richardton Clinic, Three Sanford Health Dickinson Locations—East, West, and Occupational Medicine, as well as CHI St. Alexius Health Center (St. Joseph’s Health Center)—both the hospital and the Dickinson Health Medical Clinic locations.
It is important to have conversations with medical professionals and review the most recent data about the coronavirus and the COVID-19 vaccination which will help you make the best informed decision possible. The North Dakota Department of Health has compiled a list of questions about COVID and the COVID vaccination, and I am going to touch on a few of these topics. Please take some time to thoroughly review my analysis of the information provided, and feel free to reach out to myself, the Department of Health, or your preferred healthcare provider with questions. While I cannot provide you with firsthand answers, I would love to guide you to resources or professionals who are able to provide the answers you may be seeking.
To provide an overview, there are 3 types of vaccines approved for emergency use in the United States at this time, the mRNA vaccines from Pfizer (BioNTech) and Moderna, and the non-replicating viral vector virus Johnson and Johnson/Jansen version. There are currently no fully-FDA approved vaccines using either of these styles on the market. Efficacy rates are higher than the effectiveness rates, which would be expected. Pfizer and Moderna have shown to be the most effective at this time, with little information available on the Johnson and Johnson effectiveness. Presently, 0.22% of cases have been accompanied by an adverse side effect report, and of THOSE 0.22% adverse effects, 3% of them included reports of life-threatening conditions or death. That number translates to roughly .0000658%. This number may seem small, but a kind reminder that all new medicine does run the risk of side effects both small and large, and this is something to consider when making the best decision with your family and health care professionals. Lastly, as we all know, I do feel it is worth noting that we are looking at a population size and data set that has stemmed from a relatively short timeline, particularly in comparison to other data sets on existing vaccinations and vaccination timelines. Data on long-term effects and possible co-morbidities is not yet available or evident.
For those who are interested in more detailed FAQ, here are the ten topics that I felt were most helpful in making informed decisions about whether or not to vaccinate your family:
1. How many approved vaccinations are available?
• While there are additional vaccinations undergoing clinical trials, there are three vaccine options that have been authorized for emergency use by the FDA.
• Pfizer-BioNTech, Moderna, and Johnson & Johnson are all approved for those over the age of 18 years old. Pfizer is authorized for age 12 and older.
2. What types of vaccines are available?
• There are two mRNA vaccines available (Pfizer and Moderna), and one non-replicating viral vector vaccine (Johnson and Johnson).
3. What do the vaccine types mean?
• mRNA stands for messenger ribonucleic acid—this carries the instructions to synthesize specific proteins. In the COVID vaccine, this means that the vaccine carries instructions to create the protein that the body *theoretically* uses to create an immune-response to fight the virus. This means there is not an active or live virus introduced into the body. There are currently no other authorized vaccines that use this approach
• Non-replicating viral vector vaccine—a gene is inserted into a vector virus, which is a virus that does not cause a disease in humans, but the vector virus cannot make the proteins needed to replicate. While the virus cannot replicate, it still contains the COVID-19 spike protein necessary for the body to recognize and synthesize a defense. There are currently no other authorized vaccines that use this approach.
• There are other vaccine approaches that have been used in the past that are in trials that include inactivated vaccine (polio, hepatitis A, and rabies), subunit vaccine (a part of the virus is used but not all), weakened, live vaccine (MMR, chicken pox, some rotavirus), replicating viral vector vaccine (ebola virus), and a DNA vaccine (no current vaccines).
4. Does the population size provide adequate representation and quantities to be effective?
• Based on the references provided, “ an article in Human Vaccines and Immunotherapeutics in 2012, phase III clinical trials for vaccines currently being used in the United States included, on average, 29,844.†The NDDOH indicated that Pfizer enrolled 43,000, Moderna 30,000 and Johnson and Johnson enrolled 44,000.
5. Efficacy versus effectiveness
• An important distinction between these two terms when analyzing the data about how well the COVID vaccine works, is that efficacy is ideal conditions such a clinic trial, and it refers to the ability to prevent infections in the vaccinated population.
• Effectiveness describes the rate in which the real-world data is collected, so the number of people who actually contract the virus after being vaccinated.
6. There is no significant data in children under 12, and there is more limited and newer information on pregnant women and children ages 12-18 to indicate efficacy and effectiveness in these populations, but I won’t be touching on this data.
7. Efficacy v Effectiveness Data Available: (again, in ideal conditions versus real application)
I would like to take a pause here to note that when looking on the CDC website, there is concern for those with weakened immune systems: “At this time, there are limited data on vaccine effectiveness in people who are immunocompromised. People with immunocompromising conditions, including those taking immunosuppressive medications, should discuss the need for personal protective measures after vaccination with their healthcare provider†(CDC, Science Briefs; Fully Vaccinated People). Additionally, a likely-unavoidable bias has occurred: “No trials have compared efficacy between any of the authorized vaccines in the same study population at the same time, making comparisons of efficacy difficult. All Phase 3 trials differed by calendar time and geography†(Full Vaccinated People). Lastly, it is of note that through my resources and mild searching within the CDC and through the CDC references listed in articles that Johnson & Johnsons effectiveness data was not readily available.
8. Possible and common symptoms from the COVID vaccine:
• Pain, redness, swelling at injection site
• Tiredness, headache, muscle pain, chills, fever, nausea
9. As of June 28th, 2021 there are approximately 179,615,165 individuals with at least one vaccination reported, and 395,520 adverse effects reported (CDC, VAERS). *important note, VAERS doesn’t not indicate nor differentiate causation of the adverse effects
• Of those adverse effects, 6,603 have been reported to VAERS life threatening effects and 5,218 of the adverse effects are reported as deaths.
• Johnson and Johnson has reported 9 in every million doses has reported an adverse effect
• Symptoms for concern include:
1. Severe/persistent headaches or blurred vision
2. Shortness of breath
3. Chest pain
4. Leg swelling
5. Persistent abdominal pain
6. Easy bruising or tiny blood spots under the skin beyond the injection site.
• Increased cases of both myocarditis and pericarditis have been reported after Pfizer and Moderna mRNA vaccinations
> Most cases responded positively to treatment
• In clinic trials, there were no deaths caused by the vaccination. There were 2 deaths in the vaccination population of the Pfizer trial and 4 deaths in the placebo group (those who did not receive the vaccine). Moderna reported 6 deaths in the vaccinated group and 7 deaths in the unvaccinated, placebo group. Johnson and Johnson noted 5 deaths in the vaccinated group, and 20 in the unvaccinated group. These death rates follow closely with general population rates, and are indicated to not be caused by vaccination.
10. Allergen information:
• There are no eggs, pork, or latex in any of the emergency-use approved vaccines
• Risk for severe allergic reactions for vaccinations runs: 2-5 cases per million doses
Thank you for tagging along through my analysis of the information provided to me by the North Dakota Department of Health and the CDC. I also pulled additional data from the VAERS website. I hope that the information and resources provided lead you to be confident and informed with your medical decision for yourself and your family.
All information can be found at the following websites:
https://www.health.nd.gov/diseases-conditions/coronavirus
https://covid.cdc.gov/covid-data-tracker/#datatracker-home
