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Last Updated  7/28/2021

COVID-19 Vaccine

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.

The Centers for Disease Control and Prevention (CDC) guidance for the fully vaccinated has evolved in response to new and emerging SARS-CoV-2 variants. Variants are mutations (changes) in a virus. Such changes are normal and to be expected; however, some variants result in a virus being more contagious or make it resistant to treatments or vaccines. Those variants must be monitored more carefully. At present there are four variants circulating in the U.S., the most recent, “Delta,” is a variant of concern.

On July 27, 2021, the CDC revised its recommendations for the fully vaccinated opens in a new tab to “wear a mask indoors in public if you are in an area of substantial or high transmission opens in a new tab.” Other reasons to continue “masking up” include you or a household member having a weakened immune system or underlying medical condition that puts one at an increased risk for severe disease regardless of local transmission rates.

Vaccine Hesitancy

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

Overcoming Vaccine Hesitancy: Premier’s Andy Brailo with St. Luke’s University Health Network opens in a new tab (May 27) 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: 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

COVID-19 Vaccine Hesitancy Resources for Long-Term Care Settings

Effective May 11, 2021, the Centers for Medicare and Medicaid Services (CMS) expanded efforts to grow COVID-19 vaccine confidence and uptake amongst the nation’s most vulnerable – residents in long-term care (LTC) facilities and residential facilities serving clients with intellectual disabilities. CMS issued a new rule requiring LTC facilities to report weekly COVID-19 vaccination status data for both residents and staff opens in a new tab.

COVID-19 Vaccine Hesitancy Resources for Rural Settings

  • 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)
  • On July 22, 2021 opens in a new tab, ACIP met to review safety data from several safety monitoring systems suggesting a possible safety concern, that is, about 100 possible cases of Guillain-Barre’ Syndrome (GBS) within a 42-day window following vaccination with the Janssen product. Annually, approximately 3,000-6,000 cases of GBS are seen in the U.S., usually following a respiratory or gastrointestinal (GI) illness. It has also occurred following certain vaccines. In its review, ACIP demonstrated the benefits of vaccination continue to outweigh the risks. The FDA updated its “Fact Sheets” opens in a new tab for providers and vaccine recipients on July 12.

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