Mariam Fahim

As of November 2020, more than 10.7 million cases of coronavirus disease 2019 (COVID-19) had been confirmed and more than 243,000 deaths had been reported in the United States.

In addition, health care costs have risen upwards of $125 billion, and unemployment rates rose from 6.2 million in February 2020 to 20.5 million in May 2020.

 A COVID-19 vaccine is essential to reduce morbidity and mortality from this infectious disease and to safely reopen communities.

More than 100 COVID-19 vaccine candidates are under development. Four are in phase 3 clinical trials (AstraZeneca; Johnson & Johnson; Novavax, Inc; and Sinovac Biotech), and 2 are in the distribution process (Moderna, Inc and Pfizer Inc). Limited quantities of vaccine may be made available in late 2020, according to the CDC.

 Given the nature and scope of the pandemic, substantial planning and preparation are necessary to ensure an effective vaccine response to COVID-19.

To efficiently and safely distribute vaccinations to the public, the US Department of Health & Human Services (HHS)—including the Biomedical Advanced Research and Development Authority, the CDC, and the National Institutes of Health&mdash;and the Department of Defense have partnered to establish Operation Warp Speed (OWS), with the goal of expediting the distribution of COVID-19 vaccine to the public without compromising efficacy and safety standards.

 OWS will assist in the development, manufacturing, and distribution of vaccine to ensure accessibility to all communities expeditiously.

The initial supply of COVID-19 vaccines will likely be limited.

 The Advisory Committee on Immunization Practices (ACIP) and the CDC recommend a phased approach for distribution and administration, with a focus on vaccinating high-risk populations first.

 High-risk populations indicated by the CDC are individuals in the critical infrastructure workforce, including designated essential workers, health care personnel, and individuals at increased risk for COVID-19 illness, such as those who have cancer, chronic obstructive pulmonary disease, and uncontrolled diabetes.

 Additionally, residents of long-term care (LTC) facilities and individuals who are 65 years and older will receive the vaccine in the first phase.

 Those who may not be at risk for COVID-19 complications but who may be at increased risk for acquiring or transmitting the disease may also be considered for early-phase distribution, should supplies allow.

The second phase of distribution will be expanded to include all designated essential workers and high-risk populations not reached during phase 1, in addition to the general public. The third phase of distribution is expected to cover all eligible and willing individuals.

Agencies approved for vaccine administration will need to plan accordingly to manage widespread administration and follow-up. Through each phase of distribution, estimates of these groups to receive a COVID-19 vaccination must be assessed to ensure that appropriate amounts of vaccine are delivered without waste.

According to the results of a Pew Research Center survey, 51% of adults said that they would definitely or probably receive a COVID-19 vaccination, a significant drop from 72% who said the same in May.

 This degree of vaccine hesitancy may be challenging to overcome. However, effective interventions that may increase this percentage include engaging local religious or other influential community leaders to help communicate the importance of vaccinations, improving the access to and the convenience of vaccination, and increasing patients’ vaccine knowledge.

 Local, national, and state organizations should stay abreast about trends in their populations to appropriately account for vaccination needs.

To meet the demands and effectively expand vaccine administration, the CDC recommends partnerships within essential community organizations, such as federally qualified health centers, first-responder organizations, pharmacies, and rural health communities.

 Pharmacies have a long-standing history in vaccine administration. During the 2018 and 2019 influenza season, community pharmacies administered more than 1.2 million influenza vaccinations.

 This number does not account for pharmacies that are not connected to electronic tracking systems. Therefore, the total number of vaccines administered is likely higher. Furthermore, during the 2009 H1N1 influenza pandemic, the inclusion of pharmacists increased vaccine administration to 25 million doses per week and shortened the time to achieve an 80% vaccination rate in a simulation model.

The HHS under the Public Readiness and Emergency Preparedness Act has issued an amendment to allow licensed pharmacists and interns under their supervision the authority to order and administer vaccines to individuals aged 3 to 18 years. Additional information regarding requirements for eligibility can be found on the HHS website.

During the first phase of distribution, the CDC has contacted CVS Pharmacy and Walgreens about providing on-site vaccination clinics for LTC-facility residents.

 In phase 2 of distribution, the federal government will distribute the vaccine to select pharmacy partners, including retail chain pharmacies and networks of community and independent pharmacies that have a minimum of 200 stores.

 Pharmacies eligible to receive and administer the vaccines will be required to sign a pharmacy provider agreement with the federal government. This agreement will require that pharmacies provide their minimum capacity for vaccine administration, as well as the locations and numbers of all facilities that will administer the vaccine, among other requirements.

 In addition, pharmacies will be required to estimate the number of vaccine doses that can be administered within certain time intervals and demonstrate that their facilities can appropriately store the vaccines at the required temperature.

Although specific guidance from pharmaceutical companies has not been issued, the CDC has provided the assumed storage and handling requirements of the proposed vaccines that will potentially be available in late 2020 or early 2021.

 Pharmacies can prepare by having separate freezers ready to receive the vaccine, because the 2 vaccines that will be distributed initially will either need to be stored between —60 ºC and –80 ºC for vaccine A or between –25 ºC and –15 ºC for vaccine B.

 The ultracold vaccine (—60 ºC to –80 ºC) will come with a container to keep the vaccine cold. The table includes some of the CDC’s storage and handling assumptions for the proposed vaccines.

COVID-19 vaccines are likely to have a 2-dose schedule predicted to be 21 to 28 days apart. Vaccines will not be interchangeable, so vaccine recipients must receive the second dose from the same manufacturer as the initial dose.6 Pharmacists and other health care providers will be tasked with reminder and recall efforts, which may include telephone and/or automatic calls, text messaging, or a combination of these to ensure vaccine series completion.

 Careful record keeping will also be essential, and pharmacies will need to follow local and state jurisdictions regarding specific requirements for documentation and reporting of vaccine administration, including reporting to state immunization information systems, commonly referred to as immunization registries.

 Additionally, the CDC will provide access to a mobile application called the Vaccine Administration Management System, which can be used to record COVID-19 vaccine administration information that complies with CDC requirements.

Judicious postvaccination monitoring also will be required. In accordance with other vaccines, reporting of adverse events, administration errors, multisystem inflammatory syndrome, and COVID-19 infections resulting in death or hospitalization following vaccination must be reported to the Vaccine Adverse Event Reporting System (VAERS).

 In addition to VAERS, expanded monitoring will be established for COVID-19 vaccines. The CDC Vaccine Safety Assessment for Essential Workers will provide a smartphone-based texting service to allow individuals to receive reminders, ask follow-up questions, and report adverse events in an easy and organized manner.

 Agencies administering the vaccines should monitor the CDC website for updates regarding required monitoring and tracking postvaccination.

As vaccines become more widely available following the initial rollout phase, agencies and pharmacies providing vaccination should ensure that they are able to reach individuals who may not have access to care, including those in rural communities, the underinsured, and the uninsured. Rural communities in particular have been shown to have older and sicker residents compared with suburban and urban communities, making COVID-19 vaccine distribution and administration in these areas extremely important.

 Pharmacies will be essential in reaching residents in rural communities because they are easily accessible and allow for walk-in consultation and services. Pharmacies are encouraged to coordinate services with local, national, and state agencies, such as state Medicaid and rural health offices, to increase vaccine administration efforts. Additionally, pharmacies may consider setting up satellite or off-site clinics to assist in serving community needs. Information regarding regulations for such services can be found on the CDC website.

 Pharmacists should also consult their state boards of pharmacy for any legal or regulatory requirements.

Two COVID-19 vaccines are in the manufacturing process, and distribution is likely to begin as early as December 2020. The CDC is recommending a phased approach for distribution and administration. Pharmacies and pharmacists will be essential in the administration of these vaccines to communities. Pharmacies will need to prepare accordingly to store, handle, administer, and follow up per local, national, and state regulations. To ensure public safety and vaccination equity, pharmacists should continuously consult the ACIP and CDC for guidance and updates.

, PharmD, is an assistant professor of pharmacy; and 

Karl Hess, PharmD, APh, CTH, FCPhA, FAPhA, AFTM, RCPS (GLASG)

, is an associate professor of pharmacy practice and the director of Community Pharmacy Practice Innovations, all at Chapman University’s School of Pharmacy in Irvine, California.

WHO Coronavirus disease (COVID-19) dashboard. World Health Organization. Updated November 18, 2020. Accessed November 16, 2020. https://covid19.who.int/table

Cox C, Rudowitz R, Neuman T, Cubanski J, Rae M. How health costs might change with COVID-19. Health System Tracker. April 15, 2020. Accessed November 16, 2020. https://www.healthsystemtracker.org/ brief/how-health-costs-might-change-with-covid-19/

Kochhar R. Unemployment rose higher in three months of COVID-19 than it did in two years of the Great Recession. Pew Research Center. June 11, 2020. Accessed November 16, 2020. https://www.pewresearch. org/fact-tank/2020/06/11/unemployment-rose-higher-in-three-monthsof- covid-19-than-it-did-in-two-years-of-the-great-recession/

How CDC is making COVID-19 vaccine recommendations. CDC. Updated November 9, 2020. Accessed November 16, 2020. https://www. cdc.gov/coronavirus/2019-ncov/vaccines/recommendations-process. html

Fact sheet: explaining Operation Warp Speed. US Department of Health & Human Services. Updated November 13, 2020. Accessed November 16, 2020. https://www.hhs.gov/coronavirus/explaining-operation- warp-speed/index.html

CDC. COVID-19 vaccination program interim playbook for jurisdiction operations. October 29, 2020. Accessed November 16, 2020. https://www. cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination- Program-Interim_Playbook.pdf

Tyson A, Johnson C, Funk C. U.S. public now divided over whether to get a COVID-19 vaccine. Pew Research Center. September 17, 2020. Accessed November 16, 2020. https://www.pewresearch.org/science/ 2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19- vaccine

Jarrett C, Wilson R, O’Leary M, Eckersberger E, Larson HJ; SAGE Working Group on Vaccine Hesitancy. Strategies for addressing vaccine hesitancy — a systematic review. 

. 2015;33(34):4180-4190. doi:10.1016/j.vaccine.2015.04.040

Robinson J. Community pharmacy delivers more than 70,000 more flu vaccines during 2018/2019 season. 

 April 3, 2019. Accessed November 16, 2020. https://www.pharmaceutical-journal. com/news-and-analysis/news/community-pharmacy-delivers-morethan- 70000-more-flu-vaccines-during-2018/2019-season/20206377.article? firstPass=false

Schwerzmann J, Graitcer SB, Jester B, et al. Evaluating the impact of pharmacies on pandemic influenza vaccine administration. 

 2017;11(5):587-593. doi:10.1017/dmp.2017.1

HHS expand access to childhood vaccines during COVID-19 pandemic. News release. US Department of Health & Human Services. August 19, 2020. Accessed November 2020. https://www.hhs.gov/about/ news/2020/08/19/hhs-expands-access-childhood-vaccines-duringcovid-19-pandemic.html

Vann JCJ, Jacobson RM, Coyne-Beasley T, Asafu-Adjei J, Szilagyi PG. Patient reminder and recall interventions to improve immunization rates. 

. 2018;1(1):CD003941. doi:10.1002/14651858. CD003941.pub3

Immunization information systems (IIS). CDC. Updated June 7, 2019. Accessed November 16, 2020. https://www.cdc.gov/vaccines/programs/ iis/index.html

George K. Using pharmacists to provide care in rural areas. The NCSL blog. Accessed November 16, 2020. https://www.ncsl.org/ blog/2020/08/03/using-pharmacists-to-provide-care-in-rural-areas.aspx

Ensuring the safety of COVID-19 vaccines in the United States. CDC. Updated October 14, 2020. Accessed November 16, 2020. https://www. cdc.gov/coronavirus/2019-ncov/vaccines/safety.html\

Guidance for planning vaccination clinics held at satellite, temporary, satellite, or off-site locations. CDC. Updated July 23, 2020. Accessed November 18, 2020. https://www.cdc.gov/vaccines/hcp/admin/ mass-clinic-activities/index.html

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Pharmacies must be ready to store, handle, administer, and follow up per local, national, and state regulations.