An Update and Your Questions Answered
By: Adrianna Munoz, MSN RN CNL and Taryn Ketels, AGAC-NP, MSN
Hello fellow RNs! Thank you for taking the time to read ENA’s Government Affairs Blog. This post will touch on the COVID-19 vaccine: the federal distribution of vaccines*, Colorado’s distribution of vaccines*, and a special contribution by Taryn Ketels, AGAC-NP, MSN. Hyperlinks are included in the first portion of the blog. Taryn explains common COVID-19 vaccine questions, concerns, and differences between Pfizer and Moderna vaccines. Let’s dive right in.
*Information is time sensitive, article written on 2/15/2021.
Federal COVID-19 Vaccine Response
As of 2/15/2021, the United States has administered a total of 52,884,356 vaccines. 79,057,800 doses have been delivered to different states, and 14,077,440 people have received two doses of the COVID-19 vaccine. If you would like to look more into this information please visit the CDC’s website. If you are more of a visual person, you may like this map, which displays each state’s percentage of vaccinated population.
The CDC recommends administering COVID vaccines through these phases. This PDF outlines ethical considerations and supporting data to answer one question: which groups should be offered COVID-19 vaccinations in Phases 1b & 1c? Many healthcare personnel and long term care facility (LTCF) residents have already received vaccines, these individuals are in group 1a. Another important question often arises when people ask when they are eligible for the vaccine: do I have to pay for the COVID-19 vaccine? The federal government is providing the vaccine for free, but the administering provider may charge an individual’s insurance a vaccine administration fee. However, no individual may be denied a vaccine if they are unable to pay the vaccine administration fee.
Would you like to learn more about COVID-19 vaccine distribution? Visit this HHS website! It details authorization of the Pfizer-BioNTech and Moderna COVID-19 vaccines, prioritizing who receives vaccines first, allocating vaccines, and distributing vaccines. If you would like to contribute to federal data after you’ve received the COVID-19 vaccine, you can participate in V-Safe. V-Safe is a personal phone-based tool that uses text messaging to send vaccinated people a symptom survey after they receive the first and second vaccines.
Colorado COVID-19 Vaccine Response
At this time, Colorado is in phases 1a and 1b of COVID-19 vaccine distribution. Phases 1a and 1b started in winter. Colorado residents in Phase 1b.2 are eligible for the vaccine beginning February 8, that’s happening now! Look up where you can get vaccinated here.
Colorado has administered 666,698 people with one dose of the COVID-19 vaccine, and 302,414 people with two doses of the COVID-19 vaccine. When will Colorado get more vaccines? The federal government determines how many vaccines Colorado receives, this is based on Colorado’s percentage of the US population. Colorado has received approximately 76,000 vaccines per week for the past 6 weeks. If you would like Colorado’s COVID-19 vaccination updates, you can visit this webpage. Here you will find a list of COVID-19 vaccine providers and data trends for each of Colorado’s 64 counties.
COVID Vaccine Q&A
Taryn Ketels, AGAC-NP, MSN
- What is the difference between the two mRNA vaccines with current EUA (emergency use authorization) from the FDA (U.S. Food and Drug Administration)?
- Pfizer and Moderna are the manufacturers who have received EUA for their vaccines. Both are mRNA vaccines (explained in more detail below), require extremely cold temperatures for storage and transport, and require two doses.
- Pfizer needs to be kept even colder than Moderna and requires reconstitution prior to administration.
- Pfizer was approved for 16 years of age and older, Moderna for 18 years of age and older.
- Pfizer 2nd dose is 21 days after the 1st, Moderna’s 2nd dose is 28 days after the 1st
- Can an mRNA vaccine alter our DNA?
- The vaccines do not have reverse transcriptase and, therefore, cannot alter DNA. Additionally, mRNA is translated in the cytoplasm (doesn’t get into the nucleus where our DNA is stored).
- Can I get the virus from the mRNA vaccines?
- No, they are not made from a live virus and, therefore, cannot cause infection
- Why do I need 2 vaccines?
- The first vaccine primes your cells and the second is a booster. As far as we know, it is necessary to receive the second vaccine to achieve greater than 94% effectiveness rate and to create more lasting immunity.
- Do we know how long the immunity will last?
- The first round of patients from July are still being followed. Moderna showed 4 months or persistent neutralizing antibodies (U.S. Food and Drug Administration, 2020).
- Do I still need to get it if I have had COVID?
- Yes. While we don’t know how long the immunity from vaccine will last, it is believed to be longer than natural infection.
- How effective are they?
- Moderna: 94.1%, Pfizer: 95%
- Is the vaccine effective against the new variants?
- As far as we know, yes. While the variants have different epitopes, they have the same spike, which is where this vaccine works. Both Pfizer and Moderna have begun work creating boosters, should the need arise in the future.
- Will getting vaccinated prevent transmission to others?
- We do not have enough data yet, but this is being studied. In the Moderna Trial(U.S. Food and Drug Administration, 2020), the participants were swabbed at visits one and two (day 1 and day 28), they measured how many participants in the placebo group and how many in the vaccinated group had asymptomatic PCR+. There were 14 in the vaccine group and 38 placebo group. While this is small data, it does suggest a 2/3 reduction after the first vaccine. Also, many other vaccines, that are not technically “sterilizing,” prevent transmission (think Rubella, yellow fever, influenza).
- The CDC’s new guidelines recommend that those who are fully vaccinated (between 2 weeks and 3 months after the second vaccine) and exposed to COVID do not have to quarantine. That would suggest that experts do not think vaccinated people wearing masks can transmit to others.
- Other vaccines(WHO, 2021):
- Johnson and Johnson is close, they will probably apply for EUA February 26. So far, this vaccine appears to have 90% effectiveness. This is a single dose vaccine and is not the new mRNA technology. Instead, this is an adenovirus based vaccine, with some genetic material changed out to create COVID-19 response. Like the mRNA vaccines, there are none currently approved, however, there are several in clinical and pre-clinical trials. It requires normal refrigeration.
- AstraZeneca + University of Oxford: Viral vector (non-replicating) vaccine. This one has been approved for emergency use in the UK but has not been submitted for review in the US. It is about 70% effective. Also 2 doses. Normal refrigeration.
- What if I am pregnant or want to become pregnant?
- There is no evidence that would suggest that the vaccines can cause infertility. There were women in both trials who became pregnant (U.S. Food and Drug Administration, 2020).
- Developmental and Reproductive Toxicology (DART) animal data for both Pfizer and Moderna showed no adverse events on female reproduction(AGOG, 2020).
- American College of Obstetricians and Gynecologists (ACOG) mentions the increased risk of complications in pregnancy when COVID positive and recommends a discussion regarding levels of risk of exposure and joint decision making with patient and provider. They do not recommend withholding the vaccine on the basis of pregnancy.
- As mentioned by ACOG, there is evidence that COVID carries increased risks for pregnant women, including spontaneous abortions, preterm labor, increase need for cesarian section, and increased oxygen demand during labor (NIH, 2021)
- Basic mechanisms of action:
- mRNA (messenger RNA) is a molecule in our body that makes protein. It is just the messenger, so it sends its message (meaning it makes a protein) and then it is recycled by the body. The mRNA does not stick around. The mRNA in the vaccine will make the spike protein of the virus, which will display on some cells. This is enough to create an immune reaction.
- Common side effects:
- Reactogenicity is an expected reaction after a vaccine, it’s the patient’s immune system working! Expected reactogenicity include: pain, redness, swelling, fever, myalgias, headache, or rash (Haerve, et, al. 2019).
- Common reactions post vaccination were published by Pfizer(U.S. Food and Drug Administration, 2020) and Moderna(U.S. Food and Drug Administration, 2020) in their briefing. I am sure that there will be more data as people continue to get vaccinated and we have a bigger n. See this infographic.
- Adverse reactions include anaphylactic reactions and autoimmune events.
- Vaccine safety:
- Pfizer and Moderna have been studying RNA vaccines for a long time. They had already created a platform (with the intent to treat Zika, HIV, or other viruses) for these vaccines. Genome technology has advanced so much recently that we had the RNA sequence of the virus that causes COVID-19 in January 2020. By May, Pfizer and Moderna were starting Phase I/II trials (Mulligan, et al., 2020). Phase I and II are purely safety trials(Jackson, et al., 2020) (Walsh, et al., 2020). There are people who have had the vaccines since May and they are still being monitored. For the Pfizer vaccine, 40,000 people received the vaccine, for the Moderna, 30,000+ (Pardi, et al., 2018).
- Why did it get through so fast?
- Billions of dollars and thousands of man hours have been invested. All of the brilliant scientists who have been working on a Zika vaccine, a universal flu vaccine, an Ebola vaccine, an HIV vaccine, and every other vaccine you can think of, were told to focus on THIS disease.
- They have gone through the expected phases; they just did them simultaneously.
- Genome technology allowed us to sequence the virus super-fast, so we knew the vaccine target very quickly (Krammer, 2020).
- The phase III trial required a certain number of people to become sick to be able to unveil the results. Because this is a highly contagious disease and is continuing to experience surges, those numbers were reached very quickly. When that happened, Pfizer and Moderna put tremendous effort into crunching the data. For example, if 5 people would normally be assigned from the company to work for 3 months to analyze data, instead, the companies assigned 30 people to do it in 2 weeks. The same number of person hours, just less time to finish. 30 people doing the work of 5. The assessments can be completed quicker without cutting any corners.
- How can I check that the vaccine worked?
- Unfortunately, the recommendation is to trust the process. At this time, the CDC does not recommend antibody testing post vaccination to assess for immunity to COVID-19 (CDC, 2021).
- There are two main types of antibodies (IgG) that are tested: nucleocapsid and spike. Vaccination effects the spike protein and most IgG antibody tests on the market evaluate nucleacapsid. So, before you run out to get an antibody test at your hospital, check the type of test that they are running.
- The Abbott test at UCH tests for nucleacapsid (won’t be effective to check post vaccination IgG). I don’t know which tests are being utilized at other hospitals.
Stay safe, wash your hands, wear masks, there is a light at the end of the tunnel!
Thanks for reading.
American College of Obstetricians and Gynecologists (ACOG). COVID-19 Vaccines and pregnancy: conversation guide for clinicians. Retrieved from: https://www.acog.org/covid-19/covid-19-vaccines-and-pregnancy-conversation-guide-for-clinicians
Centers for Disease Control and Prevention (CDC). (2021). Interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States. U.S. Department of Health and Human Services. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
Haerve, C., Laupeze, B., Giudice, G., Didierlaurent, A., & Tavares Da Silva, F. (2019). The how’s and what’s of vaccine reactogenicity. NPJ Vaccines, 4(39). Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6760227/
Jackson, L., Anderson, N., Rouphael, P., Roberts, M., Makhene, R., Coler, M., … Beigel, J. (2020). An mRNA Vaccine against SARS-CoV-2 – preliminary report. New England Journal of Medicine, 383, 1920-31. retrieved from: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483
Krammer, F. (2020). SARS-CoV-2 vaccines in development. Nature, 586, 516-527. Retrieved from: https://www.nature.com/articles/s41586-020-2798-3#Fig1
Mulligan, M., Lyke, K., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., …Jansen, K. (2020). Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature, 586, 589-593. Retrieved from: https://www.nature.com/articles/s41586-020-2639-4
National Institutes of Health (NIH). (2021). Severe COVID-19 in pregnancy associated with preterm birth, other complications. Retrieved from: https://www.nih.gov/news-events/news-releases/severe-covid-19-pregnancy-associated-preterm-birth-other-complications#:~:text=Compared%20to%20COVID%2D19%20patients,%2C%20and%20Rebecca%20Clifton%2C%20Ph.
Pardi, N., Hogan, M., Porter, F., & Weissman, D. (2018). mRNA vaccines- a new era in vaccinology. Nature Reviews Drug Discovery, 17, 261-279. Retrieved from: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2022483
U.S. Food and Drug Administration (FDA). (2020). FDA Briefing Document, Moderna COVID-19 Vaccine. Retrieved from: https://www.fda.gov/media/144434/download
U.S. Food and Drug Administration (FDA). (2020). FDA Briefing Document, Pfizer COVID-19 Vaccine. Retrieved from: https://www.fda.gov/media/144246/download
Walsh, E., French, R., Falsey, A., Kitchin, N., Absalon, J., Gurtman, A., … Li, P. (2020). Safety and imunogenicitiy of two RNA-based COVID-19 vaccine candidates. New England Journal of Medicine 383, 2439-2450. Retrieved from: https://www.nejm.org/doi/full/10.1056/NEJMoa2027906
World Health Organization (WHO). COVID-19 Landscape of novel coronavirus candidate vaccine development worldwide. Retrieved from: https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines