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Operations

Delivering the COVID Vaccine

The development and delivery of a safe and effective vaccine was one of the highest priorities of the federal response to the COVID-19 pandemic. Operation Warp Speed was designed to facilitate that by streamlining many processes that occur in vaccine development. It allowed some processes that normally occur consecutively to be approached simultaneously. 

Normally, for example, a potential vaccine enters a Phase 3 trial, which is followed by a scientific review of the data and approval by independent bodies and the FDA, and then pharmaceutical companies proceed to manufacturing it. During Operation Warp Speed vaccines could be produced during the Phase 3 trial period. This wasn’t meant to sacrifice safety and efficacy; inoculations still had to go through the review and approval process. But the idea was to reduce the time for initial vaccine delivery to the American people.

In response to CDC and NIH requests for guidance, the National Academies (NAS) developed an overarching framework for vaccine allocation.1 It released these recommendations in October 2020. Using four risk-based criteria, it set general priorities among various population groups based on: 1) risk of acquiring infection; 2) risk of severe morbidity and mortality; 3) risk of negative societal impact; and 4) risk of transmitting infection to others. On December 1, 2020, the CDC included EMS providers for immediate prioritization.

From this framework it defined four distinct allocation phases for vaccine distribution to the public: 

  • Phase 1A—Front-line health workers, first responders, healthcare facility service personnel; 
  • Phase 1B—Those with high-risk comorbid and underlying conditions; 
  • Phase 2—Teachers, school employees, and child-care workers, others in high-risk settings (e.g., food service, transportation);
  • Phase 3—Children, young adults, workers in important industries with moderately high risk; 
  • Phase 4—Others without access in previous phases. 

These allocation phases are recommendations to public health officials—they do not represent policy from the Department of Health and Human Services or proscribe what state and local health departments may do with their vaccine allotments. In the end a myriad of issues will ultimately affect vaccine distribution.

Giving the Shots

The NAS report contained other recommendations as well. One was that the U.S. Department of Health and Human Services should commit to leveraging and expanding the use of existing systems, structures, and partnerships across all levels of government and provide the resources necessary to ensure equitable allocation, distribution, and administration of the vaccine. It also recommended the vaccine be provided with no out-of-pocket costs for recipients.

The NAS identified communication, community engagement, and a program to promote acceptance of the vaccine as keys for success. Its other suggestion was that the CDC and NIH should invest in rapidly building an evidence base of effective strategies for COVID-19 vaccine promotion and acceptance.

What we can expect is that based on a variety of different factors, changes will need to be made over time as best practices are identified. We will not be able to vaccinate the entire public at once, so the ability to make adjustments within the allocation framework is essential.

The next question is, what role will individual EMS organizations play in distribution and administration? If your agency has been identified and equipped as a POD (point of dispensing), you may have some of the paraphernalia you need to set up a vaccine clinic.

If you are in a small jurisdiction without its own public health department and rely on your county health officer, your role may be quite extensive. If you are huge EMS agency in a major city with its own public health department and significant resources, your responsibility may be limited.

If you’re the lead agency for vaccine distribution your state, county, or city, public health officers will be there to assist you. Planning and drills are important. This is a perfect time to do a drill. Plan a seasonal flu vaccine drill utilizing your medication POD materials. Execute it and then analyze where your problems are. It is a great opportunity to get ready for the COVID vaccine event.

Here are some suggestions to help you succeed. First keep in mind the three S’s of success for anything related to a pandemic: stuff, staff, and space. 

Stuff

First, use the tools of the incident command system to help you get organized. Write a plan and complete an after-action report. All these things are crucial for success. Find examples of a plan, after-action report, and some of the ICS forms you should utilize at https://bit.ly/3jvPSff

The various vaccines that have been developed have some logistical challenges. All but one need to be stored at subzero temperatures. And some of those subzero vaccines may need to be administered in two doses.

How will the people who are vaccinated be tracked? The process should be clearly understood even if it is not your responsibility. If there must be two doses delivered to everyone, if your population is 70,000 people, you will need to be prepared to vaccinate 140,000 (assuming everyone is able and wants to be vaccinated).

Who is responsible for vaccine storage? Few organizations can store it at subzero temperatures. Transport, storage on site, how long doses can be kept out a freezer—all of that must be spelled out early on.

Equipment and supplies

The vaccine is supposed to be supplied in prefilled syringes. You will still need PPE (gloves, gowns, face‐ shields, N95 masks, surgical masks), as well as needles, sharps containers, chucks, alcohol preps, 2x2s, and of course some Elmo or Scooby-Doo Band-Aids. Who is responsible for these critical supplies? If it is your responsibility, will you be reimbursed later?

If your EMS agency is in a supporting role, will it provide you PPE, or will you have to use your own? If you are the agency lead, will you have to fit-test your staff members with the masks supplied by the public health department?

What if there is an on-site medical emergency? Is there a plan for medical logistics? These needs may vary depending on the size of the facility.

Do you have vests for volunteers, signage, and food and beverages for everyone working the day of the event? Chairs, tables, and a stretcher for any emergencies that pop up?

Make a list of everything you will need for the vaccine event. Know who will provide what and strategize what you will do if you go short. Update it at the end of every day with things you may have forgotten and who will be responsible for those.

Staff

Begin to think this through: If you have 30,000 people in your town and need to administer two injections 30 days apart, how many people will your organization be able to vaccinate in a day? What staffing ratio will work? You need not only a plan but a work schedule for your vaccinators.

There are many questions regarding your staff. Are vaccinations part of your normal scope of practice for EMS personnel? If not, can a change be accomplished with an executive order from the state medical director or governor? Is it as easy as getting your medical director to agree to a change?

You will need a medical logistics plan, first to screen all the people working at the clinic and then to screen everyone who shows up to be vaccinated. Another part of your planning and communications will be to advise the community not to show up if they are ill.

If EMS participates as vaccinators, will it be covered under the National Vaccine Injury Compensation Program? Will there be an emergency use authorization that indemnifies the EMS agency and personnel for the expanded scope of practice? 

How will you compensate your staff? Will you need to resort to overtime to fill roles as vaccinators and then backfill positions to maintain normal service levels?

The reality is that you may not have enough staff. If you have a CERT team in your community, you can utilize it to assist with handing out and collecting forms, crowd/traffic control, and setting up your clinic and breaking it down. 

Do you have a Medical Reserve Corps (MRC) in your community? It could be instrumental in performing vaccinations. Do you have a state version of a DMAT? Activating it may be an option.

What can you request from the Red Cross? Does it have vaccinators who can assist? Can it provide support for administrative operations? 

The other issue has to do with provider wellness. You will have staff members in full PPE all day. They will get tired and dehydrated. You will need to schedule breaks every hour, and it probably makes sense not to work them more than four hours in a row. They will require meals, water, snacks, and, most important, a place where they can take a break and be socially distant. Consider groups like the Salvation Army to assist with meals and rest areas for staff.

Vaccine training

The California Department of Public Health’s EZIZ program has a one-stop shop for vaccine training resources. California provides resources in areas like online training for vaccinators and program managers, routes of administration, vaccine administration worksheets, comfort measures, skills checklists, etc. That’s all free at https://eziz.org

If you’re a vaccine program administrator, you should take the complete program. If you need to train paramedics on vaccine administration, the sections covering vaccine preparation and administration will suffice. If you need to, you can add a lab/practical component to the training.

Finally there’s the matter of security for your vaccine program. COVID-19 and the very vaccine itself have resulted in an extremely polarized populace. The safety of your personnel, the safety of those being vaccinated, and the security of the site are paramount. Spell the rules out ahead of time. Have adequate security for the event and be prepared for protesters.

Space 

If you’d asked me two years ago to set up a seasonal flu clinic for the general public, I honestly would not have thought about social distancing or masks. I would have advertised the clinic as first come, first served—let people line up and sign up the same day. When we operationalized our H1N1 clinic in 2009, we had roughly 1,900 in line at the high school.

If I utilized that same scenario today, I would risk creating a superspreader event. 

Consider using multiple locations in different neighborhoods. Schedule times and appointments through a website if you can. Utilize multiple entrances so people aren’t in a long queue. Mark out your six-foot spacers on the ground. Use a strike team format where you can send vaccines and vaccinators out to businesses, schools, long-term care facilities, and assisted-living locations. 

Space cannot be underestimated. Even though everyone will be wearing masks, you will need to maintain 6–10 feet between people and vaccination stations. Not many places can accommodate that space and the number of people required to staff it. 

High school gyms and sports arenas are options, but being outside will be better. Pop-up tents outside at fairgrounds or a high school football field may be better. Look at the possibility of using a supermarket’s, shopping mall’s, or big box store’s parking lot.

If you need to use an enclosed facility, think about ways to improve air flow and circulation. If it has an air conditioning system, do not recirculate the air inside. Open all the windows and doors.

Think about where you can set up a respite station for your staff. You will need to provide someplace they can rest, grab a snack and drink, and safely doff their PPE. What will social distancing look like for them? What protocols will you need to develop?

With whom else can you partner? For example, food insecurity is a huge issue, with one of every five children going to bed hungry every night. Is this an opportunity to work with a food pantry or food bank to provide meals?

Do you have at-risk populations that could benefit from outreach from community groups in your area? Domestic violence outreach, shelter services, mental health assistance, addiction specialists—who else could partner with you to reach people at risk during your COVID vaccinations? So many people have been impacted by COVID-19, but this is a huge opportunity beyond vaccinations to help those in need.

Summary

Training, planning, and preparation are all key. Think about how they apply to the three S’s: stuff, staff, and space. Make a list, check it twice, and find out who is responsible for what. If you can run a one-day seasonal flu clinic before actual COVID vaccine administrations, do it. The COVID clinic may bring logistical challenges and manpower issues, all while dealing with a pandemic that’s not abating. Organization is the key to success. 

Reference

1. National Academies of Sciences, Engineering, and Medicine. Framework for Equitable Allocation of COVID-19 Vaccine. Washington, DC: National Academies Press, 2020.

Daniel R. Gerard, MS, RN, is EMS coordinator for Alameda, Calif. He is a recognized expert in EMS system delivery and design, EMS/health-service integration, and service delivery models for out-of-hospital care. 

 

Sidebar: #GetVaccinated

On Dec. 14, 2020, EMS World Senior Editorial and Program Director Hilary Gates published an online editorial commemorating the first day of administration of the COVID vaccine to the American public and urging her EMS colleagues to lead the charge in lining up to get vaccinated.

“Let us lead the charge and bare our deltoids,” Gates wrote. “Let us honor the memories of our fallen brothers and sisters by helping stem the tide of suffering and death. Let us contribute to a healthier population by helping change the course of this disease.”

The editorial precipitated a outpouring of support and stories of EMS providers getting vaccinated and administering the vaccine to their departments. Just a few examples from Twitter:

I will get a COVID-19 vaccine. I hope you do the same. Stay safe.

—Michael Dailey, MD, EMS World medical director

48 hours later: no fever, no fatigue, no malaise. I’ve felt fine since I got my vax. My arm is still a bit sore at the injection site, but nothing compared to the heartache I have every time I go to work in the COVID ICU. 

—Blair Bigham, MD, EMS World editorial advisory board member

Do your part! I got #COVID19 #vaccinated today for my family, my team, and my community. Proud that our hospital valued #ems & #CCT as 1A healthcare professionals! 

—Kevin Collopy, BA, FP-C, CCEMT-P, NR-P, CMTE, EMS World editorial advisory board member

If it helps anyone with their decision about vax or no vax, 100% of the ED physicians in my group just signed up to get our #CovidVaccine shots this week.  

—Jeffrey Jarvis, MD, medical director, Williamson County (Tex.) EMS

Using the http://vsafe.cdc.gov symptom tracker after your vaccination will inform the CDC about side effects in real time. Today I had a slight headache, mild fatigue, and pain at the injection site. #StillWorkedAFullDay  

—Peter Antevy, MD, EMS World editorial advisory board member

 

Sidebar: Vaccinating on the Front Lines

When the opportunity came to volunteer as a vaccinator at a recent point-of-dispensing (POD) event, I jumped on it. 

There had been a ton of planning and likely many walkthroughs at the local high school where the POD was located. You could hardly go more than six feet without finding a friendly-eyed, masked volunteer pointing you in the right direction.

The vaccinators headed to the cafeteria, where everything was set up neatly on round tables. The supervisor held up the 5-ml Moderna multidose vial and explained the locations of the EpiPens and AED, as well as the required paperwork that tracked how many doses we drew up and delivered. We donned gowns, face shields atop our N95 masks, and gloves, 
performing hand hygiene in between each patient. 

Teamed up with a former colleague, FF/EMT Chris Yashin, I felt empowered, energized, and efficient. The department of health had thought of everything. When I needed more vaccine, I simply held up a sign with the word Vaccine. Soon the purple-vested vaccine supervisor was en route with another vial. When Chris couldn’t find our patient’s name in the CDC’s Vaccine Administration Monitoring System (VAMS) on the tablet, we fished out the Tablet sign. When we were ready to administer another shot, Chris held up the green Next sign.

They waited patiently, masked and six feet apart, for their turn to get the shot. There was a sense of calm excitement; it was orderly and efficient, but once they sat down and bared their deltoids, the mood turned celebratory, and we shared a resolve that felt historic. 

I vaccinated 26 people in two hours—a tiny dent, perhaps, in the infection rate. Most important for me was to ease the stress of our healthcare workers. Many were my colleagues from the fire department. Others were city employees who worked with behavioral health patients; others were radiologists, techs, hygienists working in clinics in the city, and still others were owners and operators in private practice. The commonality? Everyone knew the gravity of the event.

The short event ended with close to 400 people vaccinated. In the after-action meeting over donated boxed lunches in the auditorium, we went over the highs and lows of the day.

After 2½ hours, all the doses were in arms. Those arms were going back to the front lines, protecting the public, and now on the way to being protected themselves. 

—Hilary Gates, MAEd, NRP

 

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