CDC ACIP COVID-19 Vaccine Recommendations
- On December 1, the Advisory Committee on Immunization Practices (ACIP) recommended that health care personnel and long-term care facility residents be offered COVID-19 vaccination first (Phase 1a).
- On December 20, ACIP updated interim vaccine allocation recommendations. In Phase 1b, COVID-19 vaccine should be offered to persons aged ≥75 years and non–health care frontline essential workers, and in Phase 1c, to persons aged 65–74 years, persons aged 16–64 years with high-risk medical conditions, and essential workers not included in Phase 1b.
- On May 14, ACIP recommended use of Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12–15 years.
- Children 12-18 years are only able to get the Pfizer-BioNTech COVID-19 Vaccine.
- CDC recommends that people with moderately to severely compromised immune systems receive an additional dose of mRNA COVID-19 vaccine at least 28 days after a second dose of Pfizer-BioNTech COVID-19 vaccine or Moderna COVID-19 vaccine.
The U.S. FDA has approved the Pfizer-BioNTech COVID-19 Vaccine.
ACEP has signed onto a joint statement among medical organizations that calls on all workers in health and long-term care to get vaccinated against the virus. See, Joint Statement in Support of COVID-19 Vaccine Mandates for All Workers in Health and Long-Term Care.
Addressing Vaccine Hesitancy:
Both the Moderna and Pfizer/BioNTech vaccines are messenger RNA (mRNA). The vaccines contain a synthetic (produced in a lab) mRNA that is the template for the spike protein from SARS-CoV-2.
- Lipid nanoparticle-formulated mRNA vaccine.
- Encoding the spike protein – Spike protein: facilitates entry of virus into cells
- Vaccination induces antibodies that can block entry of SARS-CoV-2 into cells, thereby preventing infection
- mRNA vaccines take advantage of the process that cells use to make proteins in order to trigger an immune response
- Like all vaccines, COVID-19 mRNA vaccines have been rigorously tested for safety before being authorized for use in the United States
- mRNA vaccines do not contain a live virus and do not carry a risk of causing disease in the vaccinated person
- mRNA from the vaccine never enters the nucleus of the cell and does not affect or interact with a person’s DNA
The Janssen COVID-19 Vaccine is a viral vector vaccine. This type of vaccine uses a different virus as a vector, which delivers important instructions (in the form of a gene).
- For COVID-19 vaccines, a modified virus delivers a gene that instructs our cells to make a SARS-CoV-2 antigen called the spike protein.
- This antigen triggers production of antibodies and a resulting immune response.
- The virus used in a viral vector vaccine poses no threat of causing illness in humans because it has been modified or, in some cases, because the type of virus used as the vector cannot cause disease in humans.
Allocation and Distribution
Vaccine distribution is being corrinationed by the state/local health departments and/or institutions. Health care providers should contact their local and state health departments, state's Chief Medical Officer (CMO), state Commissioner of Health or hospital's CMO.
The CDC COVID-19 Vaccination Program Interim Operational Guidance for Jurisdictions Playbook: The document’s sections cover specific areas of COVID-19 vaccination program planning and implementation and provide key guidance documents and links to resources to assist those efforts.
Moderna and Pfizer/BioNTech vaccines
- 2-dose series administered intramuscularly 3 weeks apart
- Administration of 2nd dose within 4-day grace period (e.g., day 17-21) considered valid
- If >21 days since 1st dose, 2nd dose should be administered at earliest opportunity (but no doses need to be repeated)
- Both doses are necessary for protection;
- efficacy of a single dose has not been systematically evaluated
- Intramuscular injection administered as a single dose (0.5 mL)
- There are no data available on the use of the Janssen COVID-19 Vaccine to complete a vaccination series initiated with another COVID-19 Vaccine.
Additional (booster) doses
Considerations for use of an additional mRNA COVID-19 vaccine dose after an initial 2-dose primary mRNA COVID-19 vaccine series for immunocompromised people
- On August 12, 2021 FDA modified the EUAs for Pfizer-BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine to allow for administration of an additional dose (i.e., a third dose) of an mRNA COVID-19 vaccine after an initial 2-dose primary mRNA COVID-19 vaccine series for certain immunocompromised people.
- On August 13, 2021, ACIP made an interim recommendation for use of an additional dose of Pfizer-BioNTech COVID-19 vaccine (for persons aged ≥12 years) or Moderna COVID-19 vaccine (for persons aged ≥18 years) after an initial 2-dose primary mRNA COVID-19 vaccine series for moderately to severely immunocompromised people.
- Immunocompromised people who have completed a primary vaccine series (i.e., 2-dose mRNA vaccine series [Pfizer-BioNTech and Moderna] or single dose of the Janssen vaccine) are considered fully vaccinated ≥2 weeks after completion of the series.
- An additional dose of an mRNA COVID-19 vaccine after an initial 2-dose primary mRNA COVID-19 vaccine series should be considered for people with moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments.
- These conditions and treatments include but are not limited to:
- Active treatment for solid tumor and hematologic malignancies
- Receipt of solid-organ transplant and taking immunosuppressive therapy
- Receipt of CAR-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
- Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced or untreated HIV infection
- Active treatment with high-dose corticosteroids (i.e., ≥20mg prednisone or equivalent per day), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory.
- The utility of serologic testing or cellular immune testing to assess immune response to vaccination and guide clinical care has not been established. Serologic testing or cellular immune testing outside of the context of research studies is not recommended at this time.
- The additional mRNA COVID-19 vaccine dose should be the same vaccine product as the initial 2-dose mRNA COVID-19 primary vaccine series (Pfizer-BioNTech or Moderna).
- If the mRNA COVID-19 vaccine product given for the first two doses is not available, the other mRNA COVID-19 vaccine product may be administered.
- A person should not receive more than three mRNA COVID-19 vaccine doses.
- Until additional data are available, the additional dose of an mRNA COVID-19 vaccine should be administered at least 28 days after completion of the initial 2-dose mRNA COVID-19 vaccine series, based on expert opinion.
- Currently there are insufficient data to support the use of an additional mRNA COVID-19 vaccine dose after a single-dose Janssen COVID-19 vaccination series in immunocompromised people. FDA and CDC are actively working to provide guidance on this issue.
Please note: As new data become available, these interim considerations may be updated.
Additional information can be found on CDC’s Considerations for use of an additional mRNA COVID-19 vaccine dose after an initial 2-dose COVID-19 mRNA vaccine series for immunocompromised people.
Selected Adverse Events Reported after COVID-19 Vaccination
COVID-19 vaccines are safe and effective. Many people have reported side effects that may affect their ability to do daily activities, but they should go away within a few days. Serious adverse events after COVID-19 vaccination are rare but may occur. The following are rare serious adverse events after COVID-19 Vaccination of interest:
- Has occurred in approximately 2 to 5 people per million vaccinated in the US.
- If this occurs, vaccination providers can effectively and immediately treat the reaction.
- Additional information on COVID-19 vaccines and allergic reactions.
Thrombosis with thrombocytopenia syndrome (TTS) after Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 vaccination
- CDC and FDA identified 38 confirmed reports of people who got the J&J/Janssen COVID-19 Vaccine and later developed TTS.
- As of July 12, 2021, more than 12.8 million doses of the J&J/Janssen COVID-19 Vaccine have been given in the United States.
- Women younger than 50 years old especially should be aware of the rare but increased risk of this adverse event.
- See below for additional information J&J/Janssen COVID-19 Vaccine and TTS.
TTS following mRNA COVID-19 vaccination (Moderna)
- To date, two confirmed cases of TTS following mRNA COVID-19 vaccination (Moderna) have been reported to VAERS after more than 321 million doses of mRNA COVID-19 vaccines administered in the United States.
- Based on available data, there is not an increased risk for TTS after mRNA COVID-19 vaccination.
Guillain-Barré Syndrome (GBS) after J&J/Janssen COVID-19 Vaccine
- CDC and FDA are monitoring reports of Guillain-Barré Syndrome (GBS) in people who have received the J&J/Janssen COVID-19 Vaccine.
- After 12.8 million J&J/Janssen COVID-19 Vaccine doses administered, there have been around 100 preliminary reports of GBS identified in VAERS.
- These cases have largely been reported about 2 weeks after vaccination and mostly in men, many 50 years and older.
- CDC will continue to monitor for and evaluate reports of GBS occurring after COVID-19 vaccination and will share more information as it becomes available.
Myocarditis and pericarditis after COVID-19 vaccination
- As of July 12, 2021, VAERS has received 1,047 reports of myocarditis or pericarditis among people ages 30 and younger who received a COVID-19 vaccine.
- Through follow-up, including medical record reviews, CDC and FDA have confirmed 633 reports of myocarditis or pericarditis. CDC and its partners are investigating these reports to assess whether there is a relationship to COVID-19 vaccination
- Most cases have been reported after mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna), particularly in male adolescents and young adults.
- Additional information on COVID-19 vaccines and myocarditis.
Thrombosis with thrombocytopenia syndrome (TTS) after Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 vaccination
- CDC and FDA identified 38 confirmed reports of people who got the J&J/Janssen COVID-19 Vaccine and later developed TTS.
- As of July 12, 2021, more than 12.8 million doses of the J&J/Janssen COVID-19 Vaccine have been given in the United States.
- In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).
- Most cases have occurred in females ages 18 through 49
- Onset of symptoms approximately one to two weeks after vaccination
- Other thrombotic events have also occurred in these patients, including splanchnic vein thrombosis
- Clinicians should be aware of this rare adverse event in patients who have received the J&J vaccine and present with symptoms: severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination
- It is critical to note that treatment of this specific type of blood clot is different from the treatment that might typically be administered.
- Usually, anticoagulant drug heparin is used to treat blood clots.
- In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.
- The American Society of Hematology has published considerations relevant to the diagnosis and treatment of thrombosis with thrombocytopenia following the Janssen COVID-19 Vaccine
Additional Clinical Guidance:
- Maintain a high index of suspicion for symptoms that might represent serious thrombotic events or thrombocytopenia in patients who have recently received the J&J COVID-19 vaccine, including:
- Severe headache
- new neurologic symptom
- severe abdominal pain
- shortness of breath
- leg swelling
- petechiae (tiny red spots on the skin) or
- new or easy bruising
- Obtain platelet counts and screen for evidence of immune thrombotic thrombocytopenia.
- In patients with a thrombotic event and thrombocytopenia after the J&J COVID-19 vaccine, evaluate initially with a screening PF4 enzyme-linked immunosorbent (ELISA) assay as would be performed for autoimmune heparin-induced thrombocytopenia .
- Consultation with a hematologist is strongly recommended.
- Do not treat patients with thrombotic events and thrombocytopenia following receipt of J&J COVID-19 vaccine with heparin, unless HIT testing is negative.
- If HIT testing is positive or unable to be performed in patient with thrombotic events and thrombocytopenia following receipt of J&J COVID-19 vaccine, non-heparin anticoagulants and high-dose intravenous immune globulin should be strongly considered.
- Consultation with a hematologist is strongly recommended.
- Report adverse events to VAERS, including serious and life-threatening adverse events and deaths in patients following receipt of COVID-19 vaccines as required under the Emergency Use Authorizations for COVID-19 vaccines.
For additional clinical guidance, the American Society of Hematology has released Immune Thrombotic Thrombocytopenia: Frequently Asked Questions. This FAQ is designed to provide an overview of considerations around the diagnosis and treatment of VITT and will be updated as more information becomes available. Includes questions such as:
- “What clinical presentation should trigger consideration of VITT?"
- "What is an appropriate initial work-up?”
- “How should VITT be treated?”
Johnson & Johnson and AstraZeneca vaccines are both Adenovirus viral vector vaccines and it is important to also note that patients being reviewed appear similar to patients who had thrombotic events after AstraZeneca vaccine, which was determined to be immune-mediated thrombotic thrombocytopenia (ref: Greinacher A, Thiele T, Warkentin TE, et al. Thrombotic thrombocytopenia after ChAdOx1 nCov-19 vaccination. N Engl J Med 2021. doi:10.1056/NEJMoa2104840).
- Pfizer-BioNTech COVID-19 vaccine not interchangeable with other COVID-19 vaccine products
- Safety and efficacy of a mixed series has not been evaluated
- Persons initiating series with Pfizer-BioNTech COVID-19 vaccine should complete series with same product
- If two doses of different mRNA COVID-19 vaccine products inadvertently administered, no additional doses of either vaccine recommended at this time
- Recommendations may be updated as further information becomes available or additional vaccine types authorized
- Interchangeability with other COVID-19 vaccine products
Coadministration with other vaccines
- Pfizer-BioNTech COVID-19 vaccine should be administered alone with a minimum interval of 14 days before or after administration with any other vaccines
- Due to lack of data on safety and efficacy of the vaccine administered simultaneously with other vaccines
- If Pfizer-BioNTech COVID-19 vaccine is inadvertently administered within 14 days of another vaccine, doses do not need to be repeated for either vaccine
Persons with a history of SARS-CoV-2 infection
- Vaccination should be offered to persons regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection
- Data from phase 2/3 clinical trials suggest vaccination safe and likely efficacious in these persons
- Viral or serologic testing for acute or prior infection, respectively, is not recommended for the purpose of vaccine decision-making
Persons with known current SARS-CoV-2 infection
- Vaccination should be deferred until recovery from acute illness (if person had symptoms) and criteria have been met to discontinue isolation
- No minimal interval between infection and vaccination
- However, current evidence suggests reinfection uncommon in the 90 days after initial infection, and thus persons with documented acute infection in the preceding 90 days may defer vaccination until the end of this period, if desired
Vaccines While Pregnant or Breastfeeding
Although the overall risk of severe illness is low, pregnant and recently pregnant people are at an increased risk for severe illness from COVID-19 when compared with non-pregnant people. Additionally, pregnant people with COVID-19 are at increased risk of preterm birth and might be at increased risk of other adverse pregnancy outcomes, compared with pregnant women without COVID-19. COVID-19 vaccination is recommended for all people aged 12 years and older, including people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future.
- COVID-19 vaccination is recommended for all people 12 years and older, including people who are pregnant.
- CDC recommendations align with recommendations:
- If a patient gets pregnant after receiving their first shot of a COVID-19 vaccine that requires two doses (i.e., Pfizer-BioNTech COVID-19 vaccine or Moderna COVID-19 vaccine), the patient should get their second shot to get as much protection as possible.
- COVID-19 vaccination is recommended for all people 12 years and older, including people who are breastfeeding.
- Clinical trials for the COVID-19 vaccines currently used in the United States did not include people who are breastfeeding and therefore there are limited data available on the:
- Safety of COVID-19 vaccines in people who are breastfeeding
- Effects of vaccination on the breastfed baby
- Effects on milk production or excretion
- Recent reports have shown that breastfeeding people who have received mRNA COVID-19 vaccines have antibodies in their breastmilk, which could help protect their babies.
- More data are needed to determine what protection these antibodies may provide to the baby.
Johnson & Johnson’s Janssen COVID-19 Vaccine: Women younger than 50 years old should especially be aware of the rare risk of blood clots with low platelets after vaccination. There are other COVID-19 vaccines available for which this risk has not been seen. For additional information please see the CDC/FDA statement.
Additional information can be found on the CDC’s COVID-19 Vaccines While Pregnant or Breastfeeding.
Comirnaty Pfizer (BNT162b2) Vaccine
Moderna (MRNA-1273) Vaccine
Janssen (Ad26.COV2.S) Vaccine
ASHP Patient Information
ACEP Statement on Emergency Physicians' Priority Access to the COVID-19 Vaccine:
The American College of Emergency Physicians supports all emergency physicians and their role on the front lines of the COVID-19 response. We believe all emergency physicians and emergency department staff members should be afforded Group 1A access to the COVID vaccine as recommended by the CDC and FDA so they can safely continue the fight against this pandemic.
ACEP encourages hospitals and state policymakers to make every effort to ensure that all emergency physicians and frontline staff have the opportunity to be vaccinated as soon as possible. This includes physicians working in a part-time or temporary staffing capacity (i.e., part-time, locum tenens, or other temporary staffing capacity), as well as those working in independent free-standing emergency departments. The management of emergency patients takes a team and we must ALL be safely there for our patients.
Link to statement
Additional information can also be found on ACEP.org: What Emergency Physicians Need to Know About the COVID-19 Vaccine
Post Vaccine Considerations
Post Vaccine Considerations for Healthcare Personnel
Systemic signs and symptoms, such as fever, fatigue, headache, chills, myalgia, and arthralgia, can occur following COVID-19 vaccination. Preliminary data from mRNA COVID-19 vaccine trials indicate that:
- most systemic post-vaccination signs and symptoms are mild to moderate in severity,
- occur within the first three days of vaccination
- resolve within 1-2 days of onset
- are more frequent and severe
- following the second dose and
- among younger persons compared to those who are older (>55 yrs)
Cough, shortness of breath, rhinorrhea, sore throat, or loss of taste or smell are not consistent with post-vaccination symptoms, and instead may be symptoms of SARS-CoV-2 or another infection.
According the the CDC Considerations to minimize the impact of post-vaccination systemic signs and symptoms on healthcare staffing include:
- Vaccinating HCP preceding 1-2 days off, during which they are not required to be in the facility.
- Staggering delivery of vaccine to HCP in the facility so that not all HCP in a single department, service, or unit are vaccinated at the same time.
- Staggering considerations may be more important following the second dose when systemic symptoms after vaccination, such as fever, are more likely to occur.
- Informing HCP about the potential for short-term systemic signs and symptoms post-vaccination and potential options for mitigating them if symptoms arise (e.g., nonsteroidal anti-inflammatory medications or acetaminophen).
- Developing a strategy to provide timely assessment of HCP with systemic signs and symptoms post-vaccination, including providing or identifying options for SARS-CoV-2 viral testing, so it is readily available if indicated.
- Testing should have rapid turnaround time from collection time to result reporting (< 24 to 48 hrs).
- Offering non punitive sick leave options (e.g., paid sick leave) for HCP with systemic signs and symptoms post-vaccination to remove barriers to reporting these symptoms.
Suggested approaches to evaluating and managing new-onset systemic post-vaccination signs and symptoms in HCP
The approaches described below apply to HCP who have received COVID-19 vaccination in the prior 3 days (including day of vaccination, which is considered day 1) and are not known to have had unprotected exposure to SARS-CoV-2 in a community or healthcare setting in the previous 14 days.
Positive viral (nucleic acid or antigen) tests for SARS-CoV-2, if performed, should not be attributed to the COVID-19 vaccine, as vaccination does not influence the results of these tests.
COVID-19 Vaccination Considerations for Persons with Underlying Medical Conditions
mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine.
People who have weakened immune systems
They may receive a COVID-19 vaccine. However, they should be aware that:
- Information about the safety of mRNA COVID-19 vaccines for people who have weakened immune systems in this group is not yet available.
- People living with HIV were included in clinical trials, though safety data specific to this group are not yet available at this time.
- People with weakened immune systems should also be aware of the potential for reduced immune responses to the vaccine
People who have autoimmune conditions
People with autoimmune conditions may receive an mRNA COVID-19 vaccine. However, they should be aware that:
- Individuals from this group were eligible for enrollment in clinical trials
- No data are currently available on the safety of mRNA COVID-19 vaccines for them
People who have previously had Bell’s palsy
Persons who have previously had Bell’s Palsy may receive an mRNA COVID-19 vaccine. It is be noted that:
- Cases of Bell’s palsy were reported in participants in the mRNA COVID-19 vaccine clinical trials.
- However, the FDA does not consider these to be above the rate expected in the general population and they have not concluded these cases were caused by vaccination.
People are considered fully vaccinated:
- 2 weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or
- 2 weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine
If it has been less than 2 weeks since your 1-dose shot, or if you still need to get your second dose of a 2-dose vaccine, you are NOT fully protected. Keep taking all prevention steps until you are fully vaccinated.
If you’ve been fully vaccinated:
- You can gather indoors with fully vaccinated people without wearing a mask.
- You can gather indoors with unvaccinated people from one other household (for example, visiting with relatives who all live together) without masks, unless any of those people or anyone they live with has an increased risk for severe illness from COVID-19.
- If you’ve been around someone who has COVID-19, you do not need to stay away from others or get tested unless you have symptoms.
- However, if you live in a group setting (like a correctional or detention facility or group home) and are around someone who has COVID-19, you should still stay away from others for 14 days and get tested, even if you don’t have symptoms.
The vaccines are very effective at preventing serious illness from the virus, however, it is possible for those who have been vaccinated to get infected without developing symptoms and unknowingly transmit the virus to others. It takes several weeks to build an adequate protective response, therefore the recommendation is to continue pre-vaccine mitigation efforts post-vaccination. Therefore for now, if you’ve been fully vaccinated:
- You should still take steps to protect yourself and others in many situations, like wearing a mask, staying at least 6 feet apart from others, and avoiding crowds and poorly ventilated spaces. Take these precautions whenever you are:
- In public
- Gathering with unvaccinated people from more than one other household
- Visiting with an unvaccinated person who is at increased risk of severe illness or death from COVID-19 or who lives with a person at increased risk
- You should still avoid medium or large-sized gatherings.
- You should still delay domestic and international travel. If you do travel, you’ll still need to follow CDC requirements and recommendations.
- You should still watch out for symptoms of COVID-19, especially if you’ve been around someone who is sick. If you have symptoms of COVID-19, you should get tested and stay home and away from others.
- You will still need to follow guidance at your workplace.
COVID-19 Emergency Department (ED) Vaccination Programs
Authors: Thomas Benzoni, DO, EM, AOBEM, FACEP – Des Moines University Medicine and Health Sciences; Herbie Duber, MD, MPH, FACEP – University of Washington; Daniel Martin, MD – The Ohio State University Wexner Medical Center; Phillip Moschella, MD, PhD – Prisma Health/University of South Carolina School of Medicine Greenville; and Michael Waxman, MD, MPH, FACEP – Albany Medical Center.
While treatments and preventative measures show promise in curbing the morbidity associated with the SARS-CoV-2 pandemic, the development of safe and effective vaccines represents a clear and positive ray of hope amid the darkness. These vaccines have demonstrated increases in neutralizing antibodies and clinical efficacy of disease prevention with a high patient safety profile. At least 3 vaccines (Pfizer, Moderna, and Astra-Zeneca) have now received FDA Emergency Use Authorization (EUA) and their administration began in mid-December to front line health care workers. As further distribution of vaccines ramps up, emergency department (ED)-based vaccination programs can play a critical public health role.
EDs have been a safety net and have played a key public health role for a number of public health initiatives. Examples include the administration of screening and brief intervention for drug and alcohol use, HIV screening programs, and tetanus immunization. More recently ED-based influenza vaccination programs have been described and recommended by a number of organizations. The rising ED volumes continue to include a disproportionately increasing underserved, uninsured and minority population that is less likely to have had adequate preventive and primary care access and are more likely to be under-immunized. This population has also been disproportionately impacted by SARS-CoV-2 infections resulting in increased morbidity and mortality. For these reasons, EDs represent a potentially important public health opportunity for COVID-19 vaccination programs. At the same time, given current vaccination strategies it is hard to predict when the supply chain and procurement processes will reach distribution to EDs; and, EDs will have to have a certain degree of flexibility and readiness in this process.
ED-based preventive interventions are varied and site specific. Each site will make these individual decisions when considering whether and whom to vaccinate. These decisions will take into consideration local resources, local demand and the ability to refer patients for their second vaccination.
This section presents a toolkit for the development of a COVID-19 ED Vaccination Program including the selection of appropriate vaccine candidates, ED requirements, best practices in ED vaccine administration and documentation. Four important caveats must be kept in mind when accessing this ED COVID-19 vaccination toolkit. First, the toolkit does not intend for any ED to become a primary vaccination site (i.e. patients come to the ED specifically for the vaccine). Second, the toolkit intends for ED patients to obtain a second vaccine (for vaccines requiring a second vaccination) at a site outside the ED. Third, since ED vaccination efforts will often overlap significantly with their larger hospital’s vaccination program, consistency between the ED vaccination program and the larger hospital vaccination program is encouraged. And, fourth, vaccinating for COVID-19 is a dynamic process, with new vaccines becoming available, evolving data, and new recommendations frequently promulgated. This vaccine toolkit gives the best available guidance and links to resources at the time of writing, most stemming from the CDC [COVID-19 Vaccination Toolkits]. Nevertheless, we recommend that each ED checks regularly with local, state, and national recommendations to see if there are important changes. [National Academy for state Health Policy States Plan for Vaccination against COVID-19]
Who should EDs target when developing COVID-19 vaccinations?
Any candidate ED, must establish what are the goals of this program and how utilizing the ED can augment other local vaccination programs and the populations they serve. Patients most in need of vaccination in the ED setting are likely to have limited access to vaccination in traditional settings: immigrant and limited English-language proficiency communities, low-income populations, communities of color and other underserved populations, etc. The overall priority is to thus offer vaccination to all candidate patients with emphasis on vulnerable populations to whom the ED has unique access. Below are some early steps to plan for such a targeted program.
- Identify what other vaccination programs are available in the area and what populations they serve and their current level of efficiency/efficacy.
- Understand the overall current patient populations that the candidate ED serves.
- Recognize priority populations, with emphasis on vulnerable and underserved persons
- Align the gap on unique patients that the candidate ED serves that are not covered or served by other programs in the local area.
What is required when starting an ED COVID-19 vaccination program?
Instituting a program for COVID-19 vaccination in the ED requires engagement with key stakeholders at the Departmental, Institutional and Regional level.
- ED Nursing. Unless there is an institutional plan for additional external staff to perform COVID-19 vaccination in the ED, vaccination will be performed by nursing and/or pharmacy staff. Nursing leadership needs to be engaged in issues regarding patient flow and vaccination process. Additionally, they will be needed to help facilitate nurse education regarding vaccination processes AND risks/benefits of vaccination for patients.
- ED Medical director and physician staff. Ensuring buy-in from physician leadership and those on shift is critical to facilitating successful ED vaccination programs.
- Pharmacy. Pharmacy consultation and partnership will be necessary for issues of vaccine storage, reconstitution, administration and reporting. Pharmacy staff can also be helpful with key aspects of nursing education. In institutions with ED pharmacists, consider how best to utilize this resource to support vaccination in the ED.
- Hospital leadership. Buy-in from hospital leadership is necessary to ensure the ED has a vaccine supply and receives the necessary external support. A focus on the population health mission of the ED, and special attention to vulnerable populations who may not seek care elsewhere may help facilitate these discussions. Furthermore, hospital leadership can facilitate discussion with primary care groups to support non-ED locations for the second dose in the two-shot series.
- Department of Public Health (DPH). Work with local DPH to ensure clear messaging on the role of the ED in local vaccination efforts (i.e. the ED should not be the primary location for COVID-19 vaccination, but part of a regional effort).
- Regional EDs. Coordination of efforts between EDs, with alignment of mission and opportunities for cross learning of best practices will facilitate regional ED vaccination.
- ACEP state chapters. Leadership at the state level to align messaging and provide support to ED champions.
- Community-based organizations (CBOs). Partnership with CBOs is helpful to create opportunities for the second dose of the two shot vaccination series. CBOs are highly knowledgeable of the local community, including opportunities for primary and urgent care that focus on low-income and underserved communities.
Other important considerations when pursuing an ED-based vaccination programs
- Resources and Volume. Space and human resources need to be considered when pursuing an ED-based vaccination program. This is a dynamic process, which may need to adapt to the day-to-day volume and resources. Tightly linked to resources, ED volume is an important consideration when pursuing an ED-based vaccination program. In particular, low volume EDs may not be able to sustain an effective program. Conversely, the ED may be unable to provide vaccination during times of extremely high volume that strain available resources.
- ED flow. ED-based vaccination needs to fit within the normal ED flow. While modifications may be necessary, they should not lead to extended lengths of stay nor have negative impacts on other important ED metrics.
Continuous monitoring of ED-based vaccination
- Vaccination program monitoring. As with other ED interventions, a QI lens should be applied to a COVID-19 vaccination program. The dual focus of this program should be on ensuring high rates of vaccination and minimal impact on usual ED care and flow. The program should examine the following vaccination program metrics:
- Patients screened for COVID-vaccination status
- Patients eligible for ED-based vaccination program
- Eligible patients vaccinated
- When possible, the writers of this Toolkit recommend assessing for common reasons for vaccine refusal and important sociodemographic variables such as race, age, and comorbidities
- The ED COVID-19 vaccination program
- Implementation of a QI process to integrate lessons learned is useful to ensure program success. Programs may consider utilizing a plan-do-study-act (PDSA) cycle, or another QI tool to implement program modifications.
- Furthermore, it is critical to examine local vaccination rates and epidemiologic trends to assess ongoing need or discontinuation for ED-based COVID-19 vaccination.
COVID-19 Specific Additional Considerations
Single dose vs. two doses
- As of the writing of this Toolkit there is no data on efficacy of a single dose of vaccine. The published studies thus far demonstrate some protection between doses one and two and some countries have supported a strategy that delays the second vaccine dose in favor for more individuals receiving their first dose. However, delayed second dose vaccination has not yet been expressly studied and delaying the second vaccine dose is not currently recommended by CDC or other U.S. recommendation bodies. As of the writing of this toolkit, there are no vaccines approved for single dose schedules, although this will need to be closely monitored as more data on differing vaccines develop. Moreover, the authors of this Toolkit welcome further discourse on the appropriateness of delivering a vaccine single dose to very hard-to-reach-and-vaccinate populations.
- For COVID-19 vaccines that do require two doses, the ED vaccine program should make specific arrangements to ensure the first-dose-vaccine recipients receive their second dose. Consider working with the hospital to fulfill this need (i.e., infusion centers, vaccine clinics, etc.). There may be unusual circumstances where ED patients with exceptionally high recidivism may receive their second dose in the ED.
How to physically vaccinate?
- For purposes of this discussion, it is assumed all manufacturer's recommendations for storage, transport and reconstitution are followed. Storage is generally a function of State or County entities. We recommend following local pharmacy and best nursing practice. Please find the following links for further information on the vaccination process.
Who can order the COVID-19 vaccine?
- Standing orders are used for many ED functions. E.g., nurses in triage routinely order an EKG. This is a standing order, pre-signed by the department head, MD/DO. These are recognized as proper methods and are fully reimbursable. Having the offer to vaccinate done by nurses or pharmacists may increase uptake. This makes use of nurses as the most trusted profession. It is helpful to have a nurse-champion for outreach to other nurses, using peer-conformity/conformity bias. This could be linked to a process-improvement (PDSA) project. Institute for Healthcare Improvement Plan-Do-Study-Act (PDSA) Worksheet.
- CDC does not specifically require consent for the COVID-19 vaccination. Instead, vaccine consent is guided by individual state laws and regulations, as well as institutional practices. The authors of this toolkit strongly recommend that COVID-19 vaccination is discussed with each potential vaccine recipient and the recipient (or appropriate caregiver) gives permission for the vaccine. Typically, there is at least some discussion with the vaccine recipient and documentation of this discussion in the medical record. This conversation may be the form of a typical signed informed consent or may be verbal or other forms. ED vaccine consent practices will likely be dictated by the institutional processes and forms, which should be consulted when developing an ED COVID-19 vaccine program.
Delivering COVID-19 Vaccine Specific Information to Recipients
- When any health care provider administers a vaccine, the recipient is provided with certain vaccine-specific information, typically in the form of a written piece of paper. For previously developed and authorized vaccines, this is in the form of a vaccine information statement (VIS). Vaccines authorized under an emergency authorization use (EUA) use an alternative document in the form of an FDA issued Fact Sheet, which in turn must be provided to recipients. This will typically be the same sheet given by the ED’s hospital system. CDC maintains a clearinghouse for printable EUA fact sheets for each COVID-19 vaccine.
Vaccine Recipients Receiving Documentation of Their Vaccine
- As of the writing of this toolkit, vaccines shipped to facilities are shipped with an ancillary kit, which includes the ‘CDC COVID-19 Vaccine Record Card.’ This card is filled out and given to the vaccine recipient as a personal record of their COVID-19 vaccination. The recipient then produces this card for redocumentation for their second dose.
Communication with State and Federal Databases and Reporting
- There may be communication that occurs during vaccination between the vaccinating institution and local or state institutions. ED’s will need to check with their own institution’s policies and procedures regarding these communications.
- As of the writing of this toolkit, neither CDC nor any other federal organization has created a national database for all vaccine recipients.
- V-safe is administered through CDC as a way to track vaccine-related adverse events and to help remind recipients of their second dose. V-safe is described by CDC as ‘a free, smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccination. V-safe also reminds you to get your second dose if you need one.’
- Individual states often have statewide databases tracking childhood vaccinations, some of which are currently being used for COVID-19 vaccines as well.
- These statewide vaccine databases may have ‘bidirectional’ digital information flow from an institution's electronic health record (EHR) system to the statewide database. The New York State Immunization Information System (NYSIIS) is a good example. Many hospitals in New York State will have the vaccine status of each patient automatically entered in the hospital’s EHR; and each vaccination event within the hospital automatically entered into NYSIIS .
- Importantly, EDs may use either their own institutional EHR vaccine record keeping or the state vaccine record keeping system to identify ED patients eligible for vaccination.
Where in the ED should this be done?
- COVID-19 vaccination programs are likely to look quite different depending on the ED. While there is a common goal to promote vaccination as a key public health strategy to alleviate the COVID-19 pandemic, we believe that there is no uniform way to correctly pursue ED-based COVID-19 vaccination. Three examples of places where an ED might set up their COVID-19 screening and vaccination are (a) in triage, (b) during treatment, and (c) within discharge flow. Another model includes coordination and referral of appropriate ED patients to an onsite vaccination clinic or with offsite vaccine distribution site. Additionally ACEP has developed resources to address COVID-19 vaccine hesitancy:
- Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.
- Baden LR, El Sahly HM, Essink B, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2020 Dec 30:NEJMoa2035389. doi: 10.1056/NEJMoa2035389. Epub ahead of print.
- Voysey M, Clemens SAC, Madhi SA, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8. Erratum in: Lancet. 2021 Jan 9;397(10269):98.
- Bernstein SL, D'Onofrio G. Public health in the emergency department: Academic Emergency Medicine consensus conference executive summary. Acad Emerg Med. 2009 Nov;16(11):1037-9. doi: 10.1111/j.1553-2712.2009.00548.x.
- Cunningham RM, Bernstein SL, Walton M, et al . Alcohol, tobacco, and other drugs: future directions for screening and intervention in the emergency department. Acad Emerg Med. 2009 Nov;16(11):1078-88. doi: 10.1111/j.1553-2712.2009.00552.x.
- Haukoos JS, Lyons MS, Rothman RE. The Evolving Landscape of HIV Screening in the Emergency Department. Ann Emerg Med. 2018 Jul;72(1):54-56. doi: 10.1016/j.annemergmed.2018.01.041. Epub 2018 Feb 17.
- Rothman RE, Hsieh YH, Harvey L, et al. 2009 US emergency department HIV testing practices. Ann Emerg Med. 2011 Jul;58(1 Suppl 1):S3-9.e1-4. doi: 10.1016/j.annemergmed.2011.03.016.
- Hsu SS, Groleau G. Tetanus in the emergency department: a current review. J Emerg Med. 2001 May;20(4):357-65. doi: 10.1016/s0736-4679(01)00312-2.
- Abraham MK, Perkins J, Vilke GM, et al. Influenza in the Emergency Department: Vaccination, Diagnosis, and Treatment: Clinical Practice Paper Approved by American Academy of Emergency Medicine Clinical Guidelines Committee. J Emerg Med. 2016 Mar;50(3):536-42. doi: 10.1016/j.jemermed.2015.10.013. Epub 2016 Jan 4.
- Casalino E, Ghazali A, Bouzid D,et al. Emergency Department influenza vaccination campaign allows increasing influenza vaccination coverage without disrupting time interval quality indicators. Intern Emerg Med. 2018 Aug;13(5):673-678. doi: 10.1007/s11739-018-1852-8. Epub 2018 May 25.
- Grohskopf LA, Alyanak E, Broder KR, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2020-21 Influenza Season. MMWR Recomm Rep. 2020 Aug 21;69(8):1-24. doi: 10.15585/mmwr.rr6908a1.
- UK science advisers: publish evidence behind COVID vaccine changes. Nature. 2021 Jan;589(7841):169-170. doi: 10.1038/d41586-021-00045-8.
- Lardieri, Alexa. Americans Rate Nurses As Most Honest, Poll Finds. usnews.com. 2020 Jan 6.
Prevention and Prophylaxis of COVID-19 Infection
- The COVID-19 Treatment Guidelines recommend that health care providers follow recommendations from the Advisory Committee on Immunization Practices when using SARS-CoV-2 vaccines (AI).
- The guidelines recommend against the use of any drugs for SARS-CoV-2 pre-exposure prophylaxis (PrEP), except in a clinical trial (AIII).
- The guidelines recommend against the use of hydroxychloroquine for SARS-CoV-2 post-exposure prophylaxis (PEP) (AI).
- The guidelines recommend against the use of other drugs for SARS-CoV-2 PEP, except in a clinical trial (AIII).
On August 2nd 2021, the FDA granted EUA to casirivimab and imdevimab (REGEN-COV™) for use of REGEN-COV for post-exposure prophylaxis in certain people exposed to a SARS-CoV-2 infected individual, or who are at high risk of exposure to an infected individual in an institutional setting. REGEN-COV has not been approved, but has been authorized for emergency use by FDA.
- Post-Exposure Prophylaxis:
- REGEN-COV is authorized in adult and pediatric individuals (12 years of age and older weighing at least 40 kg) for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:
- not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications) and
- have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC) or
- who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of COVID-19 infection in other individuals in the same institutional setting (for example, nursing homes, prisons)
- Limitations of Authorized Use (Post-Exposure Prophylaxis):
- Post-exposure prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19
- REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19
Prioritization of Anti-SARS-CoV-2 Monoclonal Antibodies for the Treatment or Prevention of SARS-CoV-2 Infection When There Are Logistical Constraints (NIH COVID-19 Treatment Guideline Statement)
The COVID-19 Treatment Guidelines recommend using anti-SARS-CoV-2 monoclonal antibodies for the treatment of mild to moderate COVID-19 and for post-exposure prophylaxis (PEP) of SARS-CoV-2 infection in individuals who are at high risk for progression to severe COVID-19, as outlined in the FDA EUAs. For additional information, see the individual EUAs for details.
While there are currently no shortages of these monoclonal antibodies, logistical constraints (e.g., limited space, not enough staff who can administer therapy) can make it difficult to administer these agents to all eligible patients. In situations where it is necessary to triage eligible patients, the Guidelines suggests:
- Prioritizing the treatment of COVID-19 over PEP of SARS-CoV-2 infection.
- Prioritizing the following groups over vaccinated individuals who are expected to have mounted an adequate immune response:
- Unvaccinated or incompletely vaccinated individuals who are at high risk of progressing to severe COVID-19
- Vaccinated individuals who are not expected to mount an adequate immune response (e.g., immunocompromised individuals).
Physicians should use their clinical judgment when prioritizing treatment or PEP in a specific situation. When there are no logistical constraints for administering therapy, these considerations should not limit the provision of anti-SARS-CoV-2 monoclonal antibodies.