This webpage provides an overview of the SARS-CoV-2 vaccines (aka “COVID-19 vaccines”) authorized in the U.S., including key documents, resources and tools for each vaccine.
Since mid-December 2020, the U.S. Food and Drug Administration (FDA) has issued three Emergency Use Authorizations (EUA) for COVID-19 vaccines. An EUA is different than a FDA approval (licensure) of a vaccine. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence and assesses any known or potential risks and any known or potential benefits. If the benefit-risk assessment is favorable, the product is made available during the emergency.
Following suit, the Advisory Committee on Immunization Practices (ACIP) voted to recommend the vaccines, a key step that allows healthcare workers to begin administering the vaccine to people in the U.S.
Varying from a reluctance to or a delay in getting vaccinated to adamant refusals and active spread of disinformation, vaccine hesitancy is not a new phenomenon. Nor is it unique to the U.S. and the current authorized COVID-19 vaccines.
A 2014 report opens in a new tab produced for the World Health Organization (WHO) by the Strategic Advisory Group of Experts (SAGE) Working Group on Vaccine Hesitancy is a particularly useful resource for understanding determinants, scope and strategies to address vaccine hesitancy. SAGE provided the following working definition of vaccine hesitancy:
“Vaccine hesitancy refers to delay in acceptance or refusal of vaccines despite availability of vaccine services. Vaccine hesitancy is complex and context specific, varying across time, place, and vaccines. It is influenced by factors such as complacency, convenience and confidence.”
Hesitancy does not apply to situations where vaccine uptake is low because of poor availability (e.g., lack of vaccine/low supply), lack of access to vaccines, unacceptable travel/distances to reach immunization clinics, or poorly designed vaccine programs or communications.
While there is no “one size fits all” solution to vaccine hesitancy, here are a few key considerations:
- Identify the hesitancy and try to understand the factors behind it.
- Build on any strategies/tactics/programs that have worked in the past with other vaccines (e.g., polio, measles or seasonal flu).
- Address and take steps to resolve any supply chain challenges or barriers.
- Design and put into place evidence-based actions, being sure to tailor to the specific population/subgroup, as appropriate. Two important considerations are 1) the message and 2) the messenger. For some audiences, the most trusted source of information will be a respected, trusted leader or elder of the group. Others may trust science and representatives of the healing arts, while for other audiences, it may be a revered religious figure or even a popular entertainer.
COVID-19 Vaccine Hesitancy
Infectious disease expert Dr. Kara Mascitti joins Andy Brailo, Premier’s Chief Customer Officer, to discuss St. Luke’s learnings during the COVID-19 vaccine rollout and how incentives could influence society. It comes down to culture, communications and understanding that motivation is unique to an individual and one size does not fit all.
The CDC tracks estimates of COVID-19 vaccine hesitancy opens in a new tab in the U.S. CDC has compiled resources to support its “Vaccinate with Confidence” opens in a new tab strategy that includes both action steps and support resources to:
- Build trust –
- Empower healthcare personnel –
- Engage communities and individuals –
- Community, Work, and School opens in a new tab
- COVID-19 One-Stop-Shop Toolkits opens in a new tab. Videos, social media, PSAs, print resources, checklists, FAQs and web resources for a variety of audiences.
In addition to CDC’s myths and rumors opens in a new tab resources, here are two common concerns or reservations about the COVID-19 vaccines:
- Perceptions that “corners were cut” or steps were skipped during the development, testing and rollout of the vaccines (i.e., concerns the vaccines are not safe).
- The entire process of vaccine development is extremely rigorous and testing is robust. In the U.S. the degree of transparency throughout the process has been impressive, with many opportunities for public input and comment. The clinical trials’ participants were intentionally diverse, including Black and Hispanic persons, older adults, and persons with other co-morbid conditions, such as diabetes or obesity. While early studies were not designed to include known pregnant women, many did become pregnant during the trials and it appears the vaccines are safe for those breastfeeding opens in a new tab.
- Misunderstandings and/or ineffective communications about normal reactivity opens in a new tab to a vaccine versus serious side effects, such as anaphylaxis opens in a new tab.
- The vaccines authorized in the U.S. do not contain live virus, meaning you cannot “get” COVID-19 from the vaccine itself. A sore arm, mild fever and/or body aches for a day or so are a sign your body’s normal immune defenses are working. The FDA opens in a new tab and CDC opens in a new tab have multiple safety systems opens in a new tab in place to support early identification of any “safety signals.” Healthcare providers are required by law to report certain adverse events following vaccinations to the Vaccine Adverse Events Reporting System (VAERS) opens in a new tab. Side effects are expected to surface during a clinical trial, but some serious side effects are so rare, they may not show up until hundreds of thousands get vaccinated.
Additional COVID-19 Vaccine Hesitancy Resources
- American Academy of Family Physicians (AAFP) – COVID-19 Vaccine Patient Education opens in a new tab
- American Medical Association (AMA) – COVID-19 Vaccine Hesitancy: 10 Tips for Talking with Patients opens in a new tab (Feb. 1, 2021)
- American Psychological Association (APA) – Building Vaccine Confidence Through Community Engagement opens in a new tab
- Association for Professionals in Infection Control and Epidemiology (APIC) – Vaccine Hesitancy and Patient Education opens in a new tab
- California Chronic Care Coalition (CCCC) and Healthcare Leadership Council (HLC) – YourVacinationGuide.org opens in a new tab – a specifically designed, consumer-friendly website with resources and information for persons and populations at risk.
- Centers for Disease Control and Prevention (CDC) – COVID-19 Vaccination Toolkits opens in a new tab. Resources for health departments, medical offices, pharmacies, long term care settings, community-based organizations and others.
- Immunization Action Coalition – Key COVID-19 Vaccine Resources opens in a new tab
- Office of the Assistant Secretary for Planning and Evaluation (ASPE) – Vaccine Hesitancy for COVID-19: State, County, and Local Estimates opens in a new tab (April 6, 2021)
COVID-19 Vaccine Hesitancy Resources for Rural Settings
- Health Resources & Services Administration (HRSA) –
- National Rural Health Association (NRHA) – Rural COVID-19 Technical Assistance Center opens in a new tab
- Rural Health Information Hub (RHIhub) – COVID-19 Vaccination in Rural Areas opens in a new tab
- On May 10, the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) opens in a new tab for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age. Here are links to the updated Fact Sheets for Healthcare Providers Administering the Vaccine (Vaccination Providers) opens in a new tab and for Recipients and Caregivers opens in a new tab. This action was followed by a vote on May 12 by the Advisory Committee on Immunization Practices (ACIP) to recommend the expanded use. The Director of the Centers for Disease Control and Prevention (CDC) adopted the recommendation opens in a new tab that same day. On May 14, a CDC informational webinar provided an overview on “What Clinicians Need to Know About Pfizer-BioNTech COVID-19 Vaccination of Adolescents.” opens in a new tab
- On Dec. 11, the FDA issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine. opens in a new tab
- On Dec. 12, the ACIP voted to recommend Americans receive the Pfizer-BioNTech COVID-19 vaccine. The interim recommendation covers people ages 16 years and older under the FDA EUA. Presentations from the Dec 11 and Dec. 12 emergency sessions opens in a new tab.
- On Dec. 13, the ACIP’s Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine — United States, December 2020 opens in a new tab, was published in the CDC’s Morbidity and Mortality Weekly Report (MMWR).
- CDC Clinician Outreach and Communication Activity (COCA) – “What Every Clinician Should Know About COVID-19 Vaccine Safety.” opens in a new tab Webinar held Dec. 14.
- On Dec. 18, the FDA issued its EUA for the Moderna COVID-19 vaccine opens in a new tabfor individuals 18 years of age and older. The dosing regimen is two doses of 0.5 mL each, one month apart. As with the Pfizer vaccine, recipients and caretakers should be provided with a “Fact Sheet” opens in a new tab to help them understand the risks and benefits of the Moderna COVID-19 vaccine. There is a separate “Fact Sheet for Providers.” opens in a new tab
- On Dec. 19, the ACIP met and voted on its interim recommendations for use of the Moderna COVID-19 vaccine. These recommendations were accepted by the Director of the CDC and published in MMWR on Dec. 20 opens in a new tab.
- On Jan. 6, 2021, the CDC updated clinical guidance on the mRNA COVID-19 vaccine opens in a new tab (“Moderna COVID-19 vaccine”) administration, clarifying the four-day grace period for administration of a second dose, management of anaphylaxis and passive antibody therapy and vaccine administration.
- On Jan. 22, 2021, the CDC released “Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine – United States, December 21, 2020- January 10, 2021.” opens in a new tab
- On Feb. 27, the FDA issued its EUA for the Janssen COVID-19 vaccine opens in a new tab for individuals 18 years of age and older. The dosing regimen is a single dose of 0.5 mL intramuscularly. As with the other vaccines, recipients and caretakers should be provided with a “Fact Sheet” to help them understand the risks and benefits of the Moderna COVID-19 vaccine. There is a separate “Fact Sheet for Providers.” opens in a new tab
- On Feb. 28, the ACIP met and voted on its interim recommendations for use of the Janssen COVID-19 vaccine. These recommendations were accepted by the Director of the CDC and published in MMWR on March 2 opens in a new tab.
- On April 13, based on a handful of cases of an extremely rare and serious blood clot condition among recently-vaccinated females, the FDA and the CDC issued a “pause” on vaccine administrations with the Janssen product. The ACIP met on April 14 opens in a new tab to review available data, then again on April 23 opens in a new tab to review additional data and weigh the benefits/risks of resumption of vaccinations with the Janssen product. Their final recommendation was to resume use of the Janssen vaccine with updated EUA Fact Sheets for Providers and Recipients opens in a new tab which now include information that women younger than 50 years old should be aware of the rare risk of blood clots with low platelets after vaccination, and that other COVID-19 vaccines are available where this risk has not been seen. The CDC has scheduled a COCA call “Johnson & Johnson/Janssen COVID-19 Vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS): Update for Clinicians.” (April 27 opens in a new tab)
- American Society of Health-System Pharmacists (ASHP) – COVID-19 Vaccine Security, Storage and Handling Resource Guide. opens in a new tab
- ASHP – COVID-19 Vaccines opens in a new tab.
- CDC COCA webinar “What Every Clinician Should Know about COVID-19 Vaccine Safety and Effectiveness and How to Address Patient Questions and Concerns” (March 9). opens in a new tab This presentation provides clinicians an update on COVID-19 vaccine safety and effectiveness for the two authorized mRNA vaccines, including data on COVID-19 vaccine safety in pregnancy. It also covers the v-safe COVID-19 Pregnancy Registry, which collects additional health information that helps CDC monitor the safety of COVID-19 vaccines in people who are pregnant. Lastly, clinicians will find effective tactics for addressing vaccine hesitancy concerns.
- CDC COCA webinar “What Clinicians Need to Know About the Janssen COVID-19 Vaccine” opens in a new tab. (March 2)
- CDC COCA webinar “COVID-19 Vaccines: Update on Allergic Reactions, Contraindications, and Precautions” (Dec. 30) opens in a new tab. This presentation provides an overview of recommendations for use of COVID-19 vaccines in certain populations. Clinicians will learn more about the recent reports of anaphylaxis following vaccination, as well as the CDC’s updated clinical considerations around contraindications and precautions to vaccination.
- On Dec. 19, the CDC released initial information and resources to address “COVID-19 Vaccines and Severe Allergic Reactions.” opens in a new tab If you have a severe allergic reaction after getting the first shot, you should not get the second shot. “Interim Considerations: Preparing for the Potential Management of Anaphylaxis at COVID-19 Vaccination Sites opens in a new tab” provides detailed information and guidance.
- CDC COCA webinar: “What Clinicians Need to Know About the Pfizer-BioNTech and Moderna COVID-19 Vaccines” (Dec. 18) opens in a new tab. This presentation includes very helpful information about recommended medications and supplies for the management of anaphylaxis at COVID-19 vaccination sites.
- CDC – “V-safe” After Vaccination Health Checker opens in a new tab. V-safe is a 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 will also remind you to get your second COVID-19 vaccine dose if you need one.
- CDC – Post-Vaccine Considerations for Healthcare Personnel (Dec. 13) opens in a new tab. Systemic signs and symptoms such as fever, fatigue, headache, chills, myalgia and arthralgia can occur following COVID-19 vaccination. Early data from 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 one to two days of onset and are more frequent and severe following the second dose and among younger persons compared to those who are older (>55 years). 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.
- CDC – Post-Vaccine Considerations for Residents of Long-Term Care Facilities (Dec. 13) opens in a new tab. All symptomatic residents should be assessed; the CDC provides a table of suggested approaches that should be tailored to fit the clinical and epidemiologic characteristics of the specific case.
- Advisory Committee on Immunization Practices opens in a new tab (ACIP) – ACIP is composed of medical and public health experts who develop recommendations on the use of vaccines in the civilian population of the U.S. The recommendations stand as public health guidance for safe use of vaccines and related biological products. On Dec. 1, the ACIP committee made recommendations opens in a new tab for prioritization of initial COVID-19 vaccines. “Phase 1a” will include 1) healthcare personnel and 2) residents of long-term care facilities. State governors will actually decide who gets the initial vaccines.
- CDC – COVID-19: Toolkit for Healthcare Providers (updated Nov.18) opens in a new tab. Guidance and planning documents include:
- Clinical Care Guidance for Healthcare Professionals about Coronavirus Disease 19 (COVID-19) opens in a new tab
- Considerations for Wearing Masks opens in a new tab
- COVID-19 Guidance for Shared or Congregate Housing opens in a new tab
- Interim Guidance for Implementing Home Care of People Not Requiring Hospitalization for Coronavirus Disease 2019 (COVID-19) opens in a new tab
- Interim Additional Guidance for Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed COVID-19 in Outpatient Hemodialysis Facilities opens in a new tab
- CDC – COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations opens in a new tab (Version 2.0; Oct. 29, 2020). Immunization with a safe and effective COVID-19 vaccine is a critical component of the U.S. strategy to reduce COVID-19-related illnesses, hospitalizations and deaths, and to help restore societal functioning. This interim playbook for state, territorial, tribal and local public health programs will be updated as new information (e.g., recommendations for pregnant women or pediatric populations) becomes available.
- FDA – Emergency Use Authorization (EUA) opens in a new tab (content current as of Dec. 1, 2020)
- FDA – Vaccine Facts. “The Path for a COVID19 Vaccine from research to Emergency Use Authorization” opens in a new tab (infographic)
- FDA – COVID-19 Vaccines opens in a new tab (content current as of Nov. 30, 2020). The FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. Currently, there is no FDA-approved or authorized vaccine for the prevention of COVID-19.
- FDA – Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry opens in a new tab (current as of Nov. 18, 2020). This guidance provides sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with non-binding recommendations regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.
- FDA – Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry opens in a new tab (June 30)FDA plays a critical role in protecting the U.S. from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. The purpose of this guidance is to assist sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19.
- National Academy of Medicine (NAM) – “Framework for Equitable Allocation of COVID-19 Vaccine opens in a new tab” (Oct. 2)CDC and the National Institutes of Health (NIH) commissioned the nongovernmental NAM to convene experts and develop recommendations to inform national and local guidelines for equitable COVID-19 vaccine allocation, once vaccines become available. Through a transparent, iterative process, with public input throughout, NAM produced this consensus study. For the initial period when vaccine demand exceeds supply, the report recommends a four-phased approach opens in a new tab to allocation built on widely accepted foundational principles and guided by evidence to maximize societal benefit by reducing morbidity and mortality caused by the transmission of SARS-CoV-2.
- Network for Excellence in Health Innovation (NEHI) – Vaccine Summit Series:
- 1st Vaccine Summit (Aug. 27) – “Looming Challenges of COVID-19 Immunization: Communications and Messaging opens in a new tab”
- 2nd Vaccine Summit (Sept. 22) – “Looming Challenges of COVID-19 Immunization: Preparing the Immunization Infrastructure opens in a new tab”
- Premier – “Flu and COVID-19” – information and resources.