Emergency Considerations in COVID-19 Vaccine Administration

Vaccine Considerations
Teresa Hiller, Naval Hospital Pensacolas (NHP) Immunization Program Manager administers one of the first COVID-19 vaccines to Lisa Fournier, a Clinical Pharmacist at NHP on Dec. 16, 2020. (Photo/Marcus Henry)

Abstract

The COVID-19 pandemic and its lethal complications has placed a critical emphasis on vaccine development at a record pace. EMS agencies will be called upon in various locales to play a part in vaccinating a portion of the population, including healthcare workers.

Recent evidence has emerged that some patients may be at a greater risk of developing an adverse medical event associated with vaccine administration.

Related

An international survey was conducted to determine which EMS agencies in the survey group were being called upon to administer the vaccine and what preparations they were making to manage acute adverse reactions immediately following vaccine administration. 

The authors conclude that evidence exists for a potential risk of adverse reactions with vaccine administration, and that EMS agencies administering the vaccine intend to utilize standardized responses to adverse reactions to manage these events.

Introduction

Within a year, the SARS-CoV-2 pandemic has invaded countries around the world. As of December 14, 2020, there have been over 72 million cases and approximately 1.6 million deaths worldwide.1

In the United States, the Center of Disease Control and Prevention (CDC) has reported over 15.9 million cases and exceeding 300,000 deaths to date.2

Aside from social distancing, appropriate masking, and hand washing, little has been available to ameliorate the extent or severity of the infection, though some improvement in critical patient management has emerged.3, 4, 5

Emphasis has been placed on the development of vaccines, which may be distributed on a broad basis to decrease incidence of COVID-19 infection and hence morbidity and mortality. Emerging vaccines with anticipated protection from infection of over 90% have been reported.6,7 

Broad vaccination programs are being established to provide prompt vaccine distribution to the general population, which includes front-line healthcare providers and other at-risk populations.

Distribution plays a key role in any mass vaccination program. The responsibility of vaccine administration generally falls on medical providers. Naturally, emergency medical services (EMS) personnel may be called upon to play a role in vaccination programs,8 depending on authorization permitted for such activities by state regulation. As the administration of any medication raises the issue of potential adverse reactions including anaphylactic events, the presence of EMS on the scene might offer enhanced response to emergencies that may arise in the immediate post-vaccination period.

This study sought to determine which of a large group of EMS agencies were being called upon to administer COVID-19 vaccines and what emergencies they anticipated following vaccine administration.

Methods

The authors conducted a study investigating the role of EMS systems in administering the BNT162b2 vaccine, manufactured by Pfizer and BioNTech, and the mRNA-1273 vaccine, manufactured by Moderna. U.S. metropolitan municipalities EMS medical directors were assessed with a survey. The survey contained two questions for identification (Name and EMS affiliation), and four questions to clarify their EMS system’s role (involvement of EMS systems in vaccine administration, EMS-anticipated adverse side effects in the immediate post-vaccination period, and the EMS systems’ protocols for managing adverse side effects). 

The survey was submitted to 80 members of the Metropolitan EMS Medical Directors Global Alliance (AKA the “Eagles”). 36 medical directors, representing large urban EMS systems around the nation and the world, responded to the survey. Their responses were categorized and statistically analyzed. Their responses were assumed to be their protocols followed by their department system.

Results

Thirty-six EMS medical directors responded to the survey. The results are summarized in Table 1. Responses from the survey are stratified by the four questions asked.

Table 1: EMS involvement in local COVID-19 vaccination distribution

Of the respondents, 66.7% (24 of 36) of EMS systems will be using their paramedics to administer the COVID-19 vaccine, while 19.4% (7 of 36) are still unclear, and 13.9% (5 of 36) will not be utilizing their EMS system for vaccine administration. 

Of those who answered ‘yes’ or ‘unsure’ to the first question, 77.4% (24 of 31) indicated some prior discussion of the spectrum of possible acute patient emergencies that may arise following vaccine administration. 

Twenty-seven respondents indicated that they believed the following adverse events could arise in the immediate post-vaccination period: anaphylactic reaction (20 of 27, 74.1%), acute vasovagal syncope (21 of 27, 77.8%), cardiac arrest (3 of 27, 11.1%). 18.5% (5 of 27) of the respondents also indicated that they anticipated common non-acute reactions, such as headache, fever, fatigue, injection site pain, and mild allergic reactions. 18.5% (5 of 27) of the respondents also indicated ‘other.’ 

Of the respondents who have considered the possible emergencies that may arise, 92.9% (26 of 28) indicated that they do not have a specific protocol in place to respond to specific COVID-19 vaccine-related emergencies, and they will continue to use existing standard protocols to address any adverse side effects. 7.1% (2 of 28) respondents indicated that they are developing a specific protocol for this situation.

Discussion

The results from the survey indicate that EMS paramedics will be heavily involved in broad vaccine distribution, and that EMS systems will utilize pre-existing protocolsto address emergencies that may arise immediately following vaccine administration, such as anaphylactic reactions, vasovagal syncope, and cardiac arrest.

Previous EMS sponsored vaccine programs have been effective in increasing immunization rates and vaccine availability in both high risk and marginalized populations. These efforts also acted as opportunities for fostering a positive relationship with the communities being served.8,9 These previous successful vaccination efforts offer a promising outlook as EMS systems are recruited to immunize the public during the COVID-19 pandemic. 

In addition to administering vaccines, EMS systems must also be ready to respond to any emergencies that may arise during the immediate post-vaccination period. While phase 2/3 trials of both the Pfizer and Moderna vaccines demonstrated robust safety profiles,6,7 it is plausible to suspect that the type and incidence of side effects will rise once the vaccine is administered in the broader general population, which has a much wider range of pre-existing conditions.

For example, phase 2/3 trials of the Pfizer vaccine reported that only 1 of 18,801 vaccine recipients developed anaphylactic reaction.6 However, when the UK’s National Health Service began widely administering the vaccine on December 8, 2020, two healthcare workers with significant allergy history suffered symptoms of anaphylactic reaction.10

Thus, it is reasonable to suspect that adverse events in the immediate post vaccination period may be more evident in the general population, and EMS services must have protocols in place to respond to those emergencies as they arise.

Of interest, EMS personnel have not displayed a 100% vaccine compliance rate during the H1N1 pandemic and in past influenza seasons.11,12 Unvaccinated EMS professionals may present a risk to both their EMS department and members of the community through symptomatic or asymptomatic spread. Similarly, COVID-19 illness occurring among EMS personnel may affect departmental vaccination efforts.

As these personnel will be heavily interacting with members of the public, it is imperative for EMS systems to heavily recommend a departmental vaccination policy for EMS personnel to ensure the safety of both EMS professionals and community members. 

There are several obstacles that could impede the success of EMS-sponsored COVID-19 vaccination programs. In a survey of American and Canadian adults, 25% of American respondents and 20% of Canadian respondents indicated that they would decline to receive a COVID-19 vaccine.

Mistrust of vaccine benefit, concern for side effects, concern for commercial profiteering, and preference for natural immunity were most strongly correlated with vaccine rejection.13 Thus, vaccine hesitancy and misinformation remain as obstacles to successful EMS vaccination programs.

Additionally, previous EMS-sponsored influenza vaccine programs have also demonstrated a racial disparity in vaccine recipients.8 It has also been shown that people of color and lower socioeconomic status are disproportionately affected by the pandemic.14,15 Thus, it is crucial to promote culturally sensitive awareness efforts to bridge the gap between racial and socioeconomic health outcomes. 

Furthermore, the need to deliver a second booster vaccine dose6,7 within 21 days for the Pfizer vaccine and 28 days for the Moderna vaccine could be difficult to maneuver logistically and could complicate vaccine compliance. All of these factors have the potential to thwart EMS vaccination efforts for the population at large.

One limitation of our protocol is that survey respondents were self-selected, which could lead to an inaccurate representation of EMS systems broadly. Another weakness of the study is the limited number of survey respondents. Furthermore, not every participant responded to all the questions, and the incompleteness of the data set could cause a skewed analysis of EMS involvement, anticipated adverse events following vaccine administration, and protocols to respond to emergencies. All of these limitations have the potential of misrepresenting the EMS systems’ protocol responses.

Conclusion

The joint response of science and medicine to develop safe and effective COVID-19 vaccines has been brisk and productive. Distribution efforts will now be the next step in limiting the breadth of this pandemic. EMS agencies will play a key role in some areas in the administration of vaccinations for their communities.

The authors suggest that to better clarify the side effects of the COVID-19 vaccines, EMS systems must maintain a log of the type and incidence of adverse events following vaccine administration, EMS responses to the adverse events, as well as those patients’ outcomes from this management. Careful inclusion of these data points will help to bolster the vaccine’s safety profile and public confidence in the vaccine. 

References

  1. COVID-19 Coronavirus Pandemic. (2020, December 13). Retrieved from https://www.worldometers.info/coronavirus/.
  2. Center for Disease Control and Prevention COVID-19 Data Tracker. (2020, December 13). Retrieved from https://COVID-19.cdc.gov/COVID-19-data-tracker/#cases_casesper100klast7days.
  3. WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group, Sterne, J., Murthy, S., Diaz, J. V., et al. (2020). Association Between Administration of Systemic Corticosteroids and Mortality Among Critically Ill Patients With COVID-19: A Meta-analysis. JAMA, 324(13), 1330–1341. https://doi.org/10.1001/jama.2020.17023
  4. Tomazini, B. M., Maia, I. S., Cavalcanti, A. B., et al., COALITION COVID-19 Brazil III Investigators (2020). Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19: The CoDEX Randomized Clinical Trial. JAMA, 324(13), 1307–1316. https://doi.org/10.1001/jama.2020.17021
  5. Beigel, J. H., Tomashek, K. M., Dodd, L. E., et al. ACTT-1 Study Group Members (2020). Remdesivir for the Treatment of COVID-19 – Final Report. The New England journal of medicine, 383(19), 1813–1826. https://doi.org/10.1056/NEJMoa2007764
  6. Polack, F. P., Thomas, S. J., Kitchin, N., et al. (2020). Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine. New England Journal of Medicine. doi:10.1056/nejmoa2034577
  7. Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study. (2020, November 16). Retrieved from https://investors.modernatx.com/news-releases/news-release-details/modernas-COVID-19- vaccine-candidate-meets-its-primary-efficacy
  8. Mosesso, V. N., Jr, Packer, C. R., McMahon, J., Auble, T. E., & Paris, P. M. (2003). Influenza immunizations provided by EMS agencies: the MEDICVAX Project. Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors, 7(1), 74–78. https://doi.org/10.1080/10903120390937139
  9. Shaddock, D., Henry, B., Varia, M., & Schwartz, B. (2004). Vaccine delivery by paramedics for an urban Influenza immunization program: A public health-EMS partnership. Prehospital Emergency Care, 8(1), 102. https://doi:10.1080/31270300337X
  10. Reynolds, E., Braithwaite, S., & Cassidy, A. (2020, December 10). Allergy warning for Pfizer/BioNTech vaccine after UK health workers with allergy history suffer reaction. Retrieved from https://www.cnn.com/2020/12/09/health/COVID-19-vaccine-allergies-health-workers-uk-intl-gbr/index.html
  11. Hubble, M. W., Zontek, T. L., & Richards, M. E. (2011). Predictors of influenza vaccination among emergency medical services personnel. Prehospital emergency care : official journal of the National Association of EMS Physicians and the National Association of State EMS Directors, 15(2), 175–183. https://doi.org/10.3109/10903127.2010.541982
  12. Rebmann, T., Wright, K. S., Anthony, J., Knaup, R. C., & Peters, E. B. (2012). Seasonal and H1N1 influenza vaccine compliance and intent to be vaccinated among emergency medical services personnel. American journal of infection control, 40(7), 632–636. https://doi.org/10.1016/j.ajic.2011.12.016
  13. Taylor, S., Landry, C. A., Paluszek, M. M., Groenewoud, R., Rachor, G. S., & Asmundson, G. (2020). A Proactive Approach for Managing COVID-19: The Importance of Understanding the Motivational Roots of Vaccination Hesitancy for SARS-CoV2. Frontiers in psychology, 11, 575950. https://doi.org/10.3389/fpsyg.2020.575950
  14. Kim, S. J., & Bostwick, W. (2020). Social Vulnerability and Racial Inequality in COVID-19 Deaths in Chicago. Health education & behavior : the official publication of the Society for Public Health Education, 47(4), 509–513. https://doi.org/10.1177/1090198120929677.
  15. Abedi, V., Olulana, O., Avula, V., et al. (2020). Racial, Economic, and Health Inequality and COVID-19 Infection in the United States. Journal of racial and ethnic health disparities, 1–11. Advance online publication. https://doi.org/10.1007/s40615-020-00833-4
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