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Last Updated  10/26/2021

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.

On Aug. 23, 2021 opens in a new tab, the FDA approved the Biologics License Application (BLA) opens in a new tab submitted by BioNTech on May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for its mRNA COVID-19 Vaccine. This authorizes BioNTech to manufacture the product, COVID-19 mRNA Vaccine, to persons 16 years of age and older. Younger children (12-15) are still subject to limits of an earlier EUA.

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.

A CDC report opens in a new tab on a recent outbreak of “breakthrough” SARS-CoV-2 infections among the fully vaccinated is enlightening. The viral loads, that is, the amount of virus circulating in the body at a given point in time, were surprisingly similar for both the vaccinated and unvaccinated. This means a vaccinated person could unknowingly be shedding virus, resulting in infections to others. One means of preventing this “spread” is to wear a mask. Known as “source control opens in a new tab,” covering your mouth and nose can reduce the spread of respiratory droplets to those around you.

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

Immunocompromised Individuals

Pregnant or Breastfeeding

Following an acute infection with the SARS-CoV-2 virus or “COVID-19,” some people display an array of symptoms opens in new tab, such as fatigue, shortness of breath, difficulty in thinking or concentrating (a.k.a. “brain fog”), sleep disorders, fevers, gastrointestinal symptoms, anxiety and depression, that persists for months and can range from mild to incapacitating. Age is not a predictor; the syndrome is seen in both young adults and the elderly. Nor does how sick one is during the acute infection seem to matter; even a mild illness can result in a persistent state of ill health. In some children, even without an underlying chronic medical condition, a COVID-19 infection can be followed by the development of a potentially deadly condition called “Multisystem inflammatory syndrome in children (MISC).” Research is underway opens in new tab to understand COVID-19’s effects and long-term outcomes in children. Years ago, post-acute sequelae, including neurological manifestations opens in new tab, were seen following infections with a different Coronavirus (CoV). Severe Acute Respiratory Syndrome (SARS) was caused by the SARS-CoV virus. Chronic post-SARS syndrome insights opens in new tab may provide some assistance to our still-evolving understanding of sequelae following COVID-19. Internationally opens in new tab, there are several names being used for this group of symptoms after a COVID-19 infection, such as “Long COVID,” post-acute COVID-19 syndrome (PACS) or post-acute sequelae of COVID-19 (PASC). One working definition of “Long COVID” opens in new tab suggests it be considered when there are multi-system manifestations following a confirmed or suspected COVID-19 infection that lasts more than 28 days. The good news is persons are not actually infectious during “Long COVID”. As of now, we do not yet fully understand why opens in new tab some individuals develop “Long COVID.” In February 2021, Dr. Francis Collins, the Director of the National Institutes of Health (NIH), announced the launch of a new initiative opens in new tab to better understand “Long COVID.” The goals of these efforts are to improve screening, diagnosis and care coordination/management. Developing strategies to prevent and treat “Long COVID” will enable us to assist individuals to return to a baseline level of health, usual level of function, return to work and the like. Until we learn differently, your best protection against “Long COVID” is to get vaccinated against the SARS-CoV-2 virus, the cause of “COVID-19.”

A booster shot is an additional dose of a vaccine given after the protection provided by the original shot(s) starts to decrease, which can happen over time. Examples of vaccines that require a booster are tetanus and whooping cough (pertussis). Even vaccines with robust effectiveness can become less effective over time, and this is the case with the SARS-CoV-2 vaccines. Early evidence on mRNA vaccines like Pfizer-BioNTech and Moderna suggest they start to lose some of their power against infection and serious illness over time. In adults, the changes that occur in the function of the immune system with age are called immunosenescence. opens in new tab

On Aug. 12, 2021, the FDA extended allowance (via EUA) for an additional dose of either Pfizer-BioNTech or Moderna COVID-19 vaccines for certain immunocompromised persons opens in new tab. Then, on Sept. 22 opens in new tab, the FDA amended the EUA to allow for use of a single booster dose to be administered at least six months after completion of the primary series of only the Pfizer-BioNTech vaccine for select groups. The ACIP met and made its recommendations on Sept. 23 agreeing to support a booster dose in three of the four groups the FDA allowed, citing a current lack of data to support boosters for one group. On Sept. 24, the Director of the CDC, weighing available data and other considerations, ultimately made the (interim) decisions re: boosters opens in new tab. These recommendations only apply to people who previously received a Pfizer-BioNTech primary series (i.e., the first two doses of a COVID-19 vaccine). The primary national goal remains getting the unvaccinated vaccinated.

  • CDC recommends that the following groups should receive a booster shot of Pfizer-BioNTech’s COVID-19 Vaccine at least six months after completing their Pfizer-BioNTech primary series (i.e., the first two doses of a COVID-19 vaccine):
  • People aged 65 years and older.
  • Residents aged 18 years and older in long-term care settings.
  • People aged 50–64 years with underlying medical conditions.
  • CDC recommends that the following groups may receive a booster shot of Pfizer-BioNTech’s COVID-19 Vaccine at least six months after completing their Pfizer-BioNTech primary series, based on their individual benefits and risks:
  • People aged 18–49 years with underlying medical conditions.
  • People aged 18–64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.

Following the FDA’s authorization of a booster dose opens in a new tabfor persons who completed a primary series of Pfizer-BioNTech or Moderna or a single dose of Jonson & Johnson’s COVID-19 vaccine on Oct. 20, 2021, and the ACIP’s opens in a new tab unanimous recommendations for same on Oct. 21, the CDC Director endorsed opens in a new tab those recommendations that same day.

For persons who received a Pfizer-BioNTech or Moderna COVID-19 vaccine, the following are now eligible for a booster shot at six months or more after their initial series:

  • 65 years and older.
  • Age 18+ who live in long-term care settings.
  • Age 18+ who have underlying medical conditions.
  • Age 18+ who live or work in high-risk settings.
For those who got the Johnson & Johnson COVID-19 vaccine, booster shots are also recommended for those who are 18 and older and who were vaccinated two or more months ago.

BLA and Approval

  • On Aug. 23, 2021, the U.S. Food and Drug Administration (FDA) approved Comirnaty, previously known as the Pfizer-BioNTech COVID-19 vaccine, for use in persons ages 16 and older. For prescribing information, fact sheets and frequently asked questions, please click here opens in a new tab.
  • On Aug. 30, 2021 opens in a new tab, the Advisory Committee on Immunization Practices (ACIP) voted unanimously in favor of transition from an interim to a standard ACIP recommendation of the vaccine for persons ages 16 and over, based on the FDA’s approval (BLA) and ongoing safety and efficacy data. The recommendation was endorsed opens in a new tab by the Director. Persons age 12-15 years of age and the severely immunocompromised are still subject to their respective EUAs.

From EUA to BLA

  • 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.