Christina M. Madison, PharmD, FCCP, AAHIVP

Pharmacy technicians are a critical part of the pharmacy team and have been increasingly leaned on for support during the COVID-19 pandemic. As of September 15, 2022, pharmacists and pharmacy staff have administered more than 266 million doses of COVID-19 vaccines through the Federal Retail Pharmacy Program.

 According to an announcement from the White House in December 2021, more than 2 of 3 COVID-19 vaccine doses were administered at a local pharmacy.

Not only are these vaccines more accessible through pharmacies, but they are also more equitable, with at least 40% of pharmacies located in areas that are underserved and have high social vulnerability index values.

In March 2020, the US Department of Health and Human Services (HHS) secretary issued a Public Readiness and Emergency Preparedness (PREP) Act declaration that provided liability protections to manufacturers, distributors, states, localities, territories, tribes, and licensed health care professionals (including pharmacy professionals) who administered covered countermeasures, including COVID-19 therapeutics authorized under emergency use authorization status by the FDA.

 Results from a poll conducted by business intelligence company Morning Consult and commissioned by the National Association of Chain Drug Stores showed that 70% of all Americans support extending these policies and 68% support making them permanent.

On June 7, 2022, organizations representing patients, public health advocates, pharmacists, pharmacy staff, and pharmacies sent a letter to Xavier Becerra, secretary of the HHS, requesting further clarification from the HHS that pharmacy personnel flexibilities granted through the PREP Act would remain in place through October 1, 2024, as established for other health care providers. Further, the pharmacy-based organizations asked for the declaration to hold true even in the event that the emergency declaration is rescinded because a credible risk of such an emergency remains. This includes the following medical countermeasures

Ordering and administering COVID-19, flu, and pediatric vaccines

Ordering and administering COVID-19 testing and therapeutics

Ensuring qualified pharmacy personnel (eg, pharmacists, technicians, and interns) are part of this provision

The letter also stated that extension of the PREP Act for pharmacy personnel was “essential for effective, proactive community planning and to support continued certainty for public access” to COVID-19 resources. Nearly 100 pharmacy organization and societies signed the letter issued to Becerra.

The COVID-19 PREP Act declaration has been amended several times to expand liability proatections, including prior amendments to cover licensed health care professionals who cross state borders and federal response teams.

It preempts state requirements, such as more limited licensing or scope of practice requirements, that may prohibit a qualified person (eg, pharmacist, pharmacy technician, or registered pharmacy intern) to prescribe, dispense, or administer COVID-19 countermeasures.

 Expanded roles of qualified persons covered under the Ninth Amendment to the COVID-19 PREP Act declaration are described in the 

Expanding Pharamcy Personnel Roles to Meet Demand

We must do our best to provide the “vaccine willing” with access to public health services. Busy pharmacy settings and increased workloads can hinder success in offering these services and limits the time to engage with vaccine-hesitant persons and respond to their inquiries. As a result, we must evaluate how to do more with the available resources; this includes using everyone in the pharmacy team at the top of their licensure and abilities. Pharmacy technicians can support vaccination services and play an import role in addressing patients’ needs, as demands have increased during the COVID-19 pandemic. In a recent systematic review, DeMarco et al assessed the published literature to better define the emerging roles of pharmacy technicians in patient screening and vaccine administration.

 They determined that the expanded role of pharmacy technicians in delivering vaccination services contributes to improved workflow and patient outcomes. Moreover, pharmacy technicians can increase vaccination services efficiently and safely, thereby meeting the needs of more patients.

Pharmacy personnel have successfully provided COVID-19 services—including vaccinations, testing, and therapeutics—in more than 41,000 pharmacies across the United States.

 Because most Americans live within 5 miles of a pharmacy, pharmacy personnel are essential to the effective deployment of COVID-19 vaccines.

 The PREP Act not only expanded access to services being provided by licensed pharmacists, qualified pharmacy technicians, and pharmacy interns, it also cultivated a strong public health and pharmacy collaboration that leveraged the strength of community partners to better serve the public. Because of their essential role in the national response to the ongoing COVID-19 pandemic, it is imperative that the expanded scope of pharmacy personnel becomes permanent.

Have you asked a friend or colleague where they received their most recent vaccination? Most likely, the answer is “at the pharmacy.” The convenience and individualized care associated with a pharmacy has no comparison. Being able to take your family to the trusted pharmacy staff in your community is invaluable, especially as we see more and more consolidation of the health care system and decreased access to quality care. In some communities, the pharmacy is the only source for patients to access their health care needs. In some cases, individuals may live miles from another health care provider and need additional care and services due to lack of transportation.

It would be detrimental to take services away from the public. Extending the PREP Act declaration through October 2024 is a good start; however, families and communities now rely on the neighborhood pharmacy to provide expanded services, and if they are taken away, it could have devasting effects on public health and safety. We must think about not only surviving this pandemic but also thriving and being prepared for the next one.

The impact of expanded coverage for pharmacy personnel under the PREP Act declaration is clear. Because we need to be prepared and respond to future crises, making these changes permanent is a top priority for the profession of pharmacy. Let’s all talk to our state and federal legislators about making this the standard of care. It’s not only good for pharmacy, it’s also good for public health.

Christina M. Madison, PharmD, FCCP, AAHIVP,

 is the founder and CEO of The Public Health Pharmacist, PLLC, in Las Vegas, Nevada.

1. The Federal Retail Pharmacy Program for COVID-19 vaccination. CDC. Reviewed September 19, 2022. Accessed September 13, 2022. https://www.cdc.gov/vaccines/covid-19/retail-pharmacy-program/index.html

2. President Biden announces new actions to protect Americans against the Delta and Omicron variants as we battle COVID-19 this winter. News release. The White House; December 2, 2021. Accessed September 25, 2022. https://www.whitehouse.gov/briefing-room/ statements-releases/2021/12/02/fact-sheet-president-biden-announces-new-actions-to-protect-americans-against-the-delta-and-omicron-variants-as-we-battle-covid-19-this-winter/

3. COVID-19: federal efforts to provide vaccines to racial and ethnic groups. United States Government Accountability Office. February 2022. Accessed September 25, 2022. https://www.gao.gov/assets/gao-22-105079.pdf

4. Expanding access to COVID 19 therapeutics. Department of Health and Human Services. Reviewed September 21, 2021. Accessed September 25, 2022. https://www.phe.gov/Preparedness/legal/prepact/Pages/PREPact-NinethAmendment.aspx

5. NACDS releases poll: 70% of adults back extension of policies giving access to pharmacies’ pandemic services. National Association of Chain Drug Stores. March 11, 2022. Accessed September 25, 2022. https://www.nacds.org/news/nacds-releases-poll-70-of-adults-back-extension-of-policies-giving-access-to-pharmacies-pandemic-services/

6. Re: request for clarifications to maintain public access to pandemic-related services at the nation’s pharmacies. National Association of Chain Drug Stores. June 7, 2022. Accessed September 25, 2022. https://www.nacds.org/ pdfs/COVID-19-Flexibilites-Clarifications-Sign-On-Letter-June-2022.pdf

7. Ninth amendment to declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19. Federal Register. September 14, 2021. Accessed September 25, 2022. https://www.federalregister.gov/documents/2021/09/14/2021-19790/ ninth-amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical

8. PREP Act immunity from liability for COVID-19 vaccinators. Department of Health and Human Services. Reviewed April 13, 2021. Accessed September 25, 2022. https://www.phe.gov/emergency/events/COVID19/COVIDVaccinators/Pages/PREP-Act-Immunity-from-Liability-for-COVID-19-Vaccinators.aspx

9. DeMarco M, Carter C, Houle SKD, Waite NM. The role of pharmacy technicians in vaccination services: a scoping review. 

. 2022;62(1):15-26.e11. doi:10.1016/j.japh.2021.09.016

Articles

Because we need to be prepared and respond to future crises, making these changes permanent is a top priority for the profession of pharmacy. 

The PREP Act Declaration and How the COVID-19 Pandemic Changed the Perception and Role of Pharmacy Technicians

Pharmacies and pharmacists are increasingly utilized for point-of-care (POC) services, including testing for infections that can be diagnosed via rapid testing, such as influenza, repiratory syncytial virus (RSV), COVID-19, and groups A 

 (group A strep). Our health care system is evolving with greater demand for an expanded access model that includes utilizing the most accessible health care professionals: pharmacists.

Rapid Diagnostic Testing for Respiratory Illness

The use of POC rapid diagnostic testing (RDT) is not new

; however, the global COVID-19 pandemic exacerbated the need for additional testing sites, such as phar- macies, for patients to access these types of tests.3 RDT can quickly identify or rule out a specific pathogen; the results can guide antimicrobial therapy (if appropriate), and aid in decisions regarding infection control measures, such as the need for isolation.

 Because rapid diagnostics can markedly reduce the time to pathogen identification and determination of antimicrobial susceptibility (when indicated), they offer providers the ability to optimize pharma- cotherapy.

 RDT for influenza became available in the 1990s and gained widespread use due to its ease of use, appropriateness for POC testing, and capability to provide quick results to best utilize therapeutics within 48 hours of symptom onset.

 Now, over-the-counter rapid diagnostic tests for COVID-19 have become widely available and are increasingly being used by the public for quick, at-home testing.

Influenza viruses, RSV, group A strep, and SARS-CoV-2 all are common respiratory tract pathogens that cause a variety of signs and symptoms. The illnesses they cause are often spread through respiratory droplets released during talking, sneezing, or coughing by the infected individual.

 COVID-19, which is caused by the SARS-CoV-2 virus, and the flu share common symptoms including fever, chills, cough, runny nose, sore throat, or difficulty breathing. Symptoms may vary, and depending on the causative organism, there may be either a rapid or slow onset of symptoms or differences in duration of illness. SARS-CoV-2 infection can also result in specific symptoms such as loss of taste and smell, which are unique and differentiate COVID-19 from other infections.

Surface transmission can also occur when a person touches an object that has droplets on it and then touches their mouth, nose, or eyes.

The influenza virus infects the nose, throat, and sometimes lungs.

 The most frequent symptoms are fever, chills, cough, sore throat, runny or stuffy nose, muscle or body aches, headache, and fatigue.

RSV affects the breathing passages (ie, nose and throat) and lungs. It is associated with cold-like symptoms, notably runny nose, decreased appetite, coughing, sneezing, fever, and wheezing. Infants, young children, and older adults are particularly susceptible to developing severe RSV infections, such as pneumonia and bronchiolitis (inflammation of the small airways in the lungs).

Group A strep bacteria live in the nose and throats of infected individuals. The most common symptoms include sore throat, pain with swallowing, fever, red and swollen tonsils, and swollen lymph nodes.

COVID-19 can be transmitted from respiratory droplets in the nose or throat of infected individuals; these droplets can linger in the air.

 Unlike the common cold, which is associated with symptoms that primarily affect the respiratory system and lungs, COVID-19 can also affect other body systems and produce a wide range of symptoms, with illness ranging from mild to severe.

 Symptoms may include fever, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion and runny nose, nausea, vomiting, and diarrhea.

Understanding if the infection is caused by a virus or a bacterium is extremely important, especially due to the rise in multidrug-resistant organisms from inappropriate antibiotic usage.

 For example, many pathogens are associated with pharyngitis; however, group A strep bacteria are the only ones that should be treated with an antibiotic.

 Contrast this with influenza, RSV, and COVID-19, which are all caused by viruses and have some similar symptoms but are managed very differently.

 The timing of the identification of these organisms also will determine if treatment is indicated. For influenza, antiviral treatment is most effective and ideally administered within 48 hours of onset of illness, although it can still be beneficial if given later.

 With COVID-19 infection, oral antivirals can be administered up to 5 days following symptom onset.

 Currently no specific therapy exists for RSV; however, early identification can ensure that supportive care can be administered quickly.

It can be helpful to explain to patients the differences among common testing modalities so they understand why some tests are available in a pharmacy setting and others are not. Common testing methodologies are described in 

Because RDT often necessitates the evaluation of a clinical specimen such as blood, stool, or bodily fluids, Clinical Laboratory Improvement Amendment (CLIA)-waived testing requirements must be met for testing to be performed in a pharmacy.

 Samples are used qualitatively or quantitatively to produce results within 15 minutes to a few hours, depending on the testing modality.

During the COVID-19 pandemic, the HHS secretary declared a public health emergency and indicated the need to fast-track in vitro diagnostic tests to identify COVID-19 infection.

 Thus, the FDA made some tests available through its Emergency Use Authorization (EUA).

 The FDA may issue EUA status to a product when specific criteria are met. This includes times when there are no adequate, approved, or available alternatives, and the overall scientific evidence suggests that the product may be effective in preventing, diagnosing, or treating a specific condition.

 Diagnostic tests for COVID-19 given EUA have not undergone the same type of review as an FDA-approved or -cleared test.

 The use of these products is in effect only during the emergency declaration and will be terminated after it expires if full FDA clearance or approval is not obtained.

There are several types of testing methods to diagnose and, in some cases, rule out infection with the influenza virus, SARS-CoV-2, and RSV. 

 provide more detailed information about these tests.

An abundance of innovation arose out of necessity to accurately diagnose COVID-19. The use of unique tests, such as the CLIA-waived POC tests from Abbott (ID NOW), has been a game changer for many practices. These products can detect SARS-CoV-2, the influenza virus, and RSV. Details regarding the ID NOW testing platform are provided in 

Quality control (QC) is extremely important when conducting POC testing.

 Proper procedures must be followed to ensure the accuracy of results. Multiple steps must be considered, including how the sample is collected, stored, and handled post collection. Proper handling of samples includes aseptic techniques and the use of personal protective equipment, including clean gloves.

 Further, it is important to control the temperature of the laboratory samples and testing solutions. Most are required to be at room temperature before testing can be performed.

 Positive and negative controls should be tested using the QC test instructions included with the platform.

 QC results are generated as pass or fail. If the QC test fails, no further testing should be performed using that device.

CLIA-waived POC testing is a value-added service that can expand the scope of practice for many community pharmacies. This needed and valuable service to the community can directly impact public health by decreasing the incidence of communicable disease. The early identification, treatment, and management of infectious diseases such as influenza, RSV, group A strep, and COVID-19 can have major societal implications, such as reducing lost work days and productivity. Results from RDT facilitate proper therapeutic management and reduce inappropriate antibiotic utilization. The COVID-19 pandemic has shown us that these types of services can be easily incorporated into the pharmacy setting with some purposeful planning and training. In addition, among the newest platforms are those that have made testing even easier by using a single device to detect multiple organisms via molecular testing. If these types of services were offered in even half of all pharmacy settings, the impact would be tremendous. Increased health and wellness of our communities is possible through these innovative solutions.

, is the founder and CEO of The Public Health Pharmacist, PLLC, in Las Vegas, Nevada.

1. Gasdek Manolakis P, Skelton JB. Pharmacists’ contributions to primary care in the United States collaborating to address unmet patient care needs: the emerging role for pharmacists to address the shortage of primary care providers. 

2. Green DA, StGeorge K. Rapid antigen tests for influenza: rationale and significance of the FDA reclassification. 

. 2018;56(10):e00711-e00718. doi:10.1128/JCM.00711-18

3. Coronavirus (COVID-19) update: FDA issued Emergency Use Authorization for point of care antigen test. News release. FDA; July 6, 2020. Accessed June 20, 2022. https://www.fda.gov/news-events/press-an-nouncements/coronavirus-covid-19-update-fda-issued-emergency-use- authorization-point-care-antigen-test

4. Werth BJ, Barber KE, Smith JR, Rybak MJ. Laboratory Tests to Direct Antimicrobial Pharmacotherapy. In: DiPiro JT, Yee GC, Posey L, Haines ST, Nolin TD, Ellingrod V. eds. Pharmacotherapy: A Pathophysiologic Approach, 11e. McGraw Hill; 2020. Accessed June 29, 2022. https://accesspharmacy. mhmedical.com/content.aspx?bookid=2577&sectionid=219306547

5. Guidance for antigen testing for SARS-CoV-2 for healthcare providers testing individuals in the community. Centers for Disease Control and Prevention. Updated April 4, 2022. Accessed June 20, 2022. https://www.cdc. gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html

6. Rader B, Gertz A, Iuliano AD, et al. Use of at-home COVID-19 tests – United States, August 23, 2021-March 12, 2022. 

. 2022;71(13):489-494. doi:10.15585/mmwr.mm7113e1

7. Rubin R. COVID-19 testing moves out of the clinic and into the home. 

. 2021;326(14):1362-1364. doi:10.1001/jama.2021.15679

8. How COVID-19 spreads. Centers for Disease Control and Prevention. Updated July 14, 2021. Accessed June 20, 2022. https://www.cdc.gov/ coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html

9. Key facts about influenza (flu). Centers for Disease Control and Prevention. Reviewed August 26, 2021. Accessed June 20, 2022. https://www.cdc. gov/flu/about/keyfacts.htm

10. Respiratory syncytial virus (RSV). Centers for Disease Control and Prevention. Updated September 14, 2021. Accessed June 20, 2022. https:// www.cdc.gov/dotw/rsv/index.html

11. Strep throat: all you need to know. Centers for Disease Control and Prevention. Updated January 14, 2022. Accessed June 20, 2022. https:// www.cdc.gov/groupastrep/diseases-public/strep-throat.html

12. Similarities and differences between flu and COVID-19. CDC. Updated January 18, 2022. Accessed June 29, 2022. https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm

13. Basics of COVID-19. Centers for Disease Control and Prevention. Updated November 4, 2021. Accessed June 20, 2022. https://www.cdc.gov/coronavirus/2019-ncov/your-health/about-covid-19/basics- covid-19.html

14. Symptoms of COVID-19. Centers for Disease Control and Prevention. Updated March 22, 2022. Accessed June 20, 2022. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html

15. Sore throat. Centers for Disease Control and Prevention. Updated October 6, 2021. Accessed June 20, 2022. https://www.cdc.gov/antibiotic-use/sore-throat.html

16. What you should know about flu antiviral drugs. Centers for Disease Control and Prevention. Updated August 31, 2021. Accessed June 20, 2022. https://www.cdc.gov/flu/treatment/whatyoushould.htm

17. Respiratory syncytial virus infection (RSV): symptoms and care. Centers for Disease Control and Prevention. Updated September 24, 2021. Accessed June 20, 2022. https://www.cdc.gov/rsv/about/symptoms.html

18. Interim clinical considerations for COVID-19 treatment in outpatients. Centers for Disease Control and Prevention. Updated June 15, 2022. Accessed June 20, 2022. https://www.cdc.gov/coronavirus/2019-ncov/hcp/ clinical-care/outpatient-treatment-overview.html

19. Rabold E, Waggoner J. CDC Yellow Book: Chapter 11: Posttravel evalua- tion – rapid diagnostic tests for infectious diseases. Centers for Disease Control and Prevention. Updated June 24, 2019. Accessed June 20, 2022. https://wwwnc.cdc.gov/travel/yellowbook/2020/posttravel-evaluation/ rapid-diagnostic-tests-for-infectious-diseases

20. Pharyngitis (strep throat). Centers for Disease Control and Prevention. Updated November 1, 2018. Accessed June 20, 2022. https://www.cdc.gov/ groupastrep/diseases-hcp/strep-throat.html#diagnosis

21. Rapid testing. Infectious Diseases Society of America. Updated April 11, 2022. Accessed June 20, 2022. https://www.idsociety.org/covid-19-real-time-learning-network/diagnostics/rapid-testing/#

22. Diagnosing flu. Centers for Disease Control and Prevention. Updated September 14, 2021. Accessed June 20, 2022. https://www.cdc.gov/flu/ symptoms/testing.htm

23. Waived tests. Centers for Disease Control and Prevention. Updated September 3, 2021. Accessed June 20, 2022. https://www.cdc.gov/labquality/waived-tests.html

24. Coronavirus disease 2019 (COVID-19) Emergency Use Authorizations for medical devices. FDA. Updated November 15, 2021. Accessed June 20, 2022. https://www.fda.gov/medical-devices/emergency-use-authorizations- medical-devices/coronavirus-disease-2019-covid-19-emergency-use- authorizations-medical-devices

25. FAQs on Emergency Use Authorizations (EUAs) for medical devices during the COVID-19 pandemic. FDA. Updated April 23, 2021. Accessed June 20, 2022. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/ faqs-emergency-use-authorizations-euas-medical-devices-during-covid-19-pandemic

26. Authorization of emergency use of certain medical devices during COVID-19; availability. Fed Register. 2022;87(55):16196-16199. Accessed June 20, 2022. https://www.govinfo.gov/content/pkg/FR-2022-03-22/pdf/2022-06008.pdf

27. CDC’s Influenza SARS-CoV-2 Multiplex Assay and required supplies. Centers for Disease Control and Prevention. Updated October 6, 2021. Accessed June 19, 2022. https://www.cdc.gov/coronavirus/2019-ncov/lab/ multiplex.html

28. Influenza virus testing methods. Centers for Disease Control and Prevention. Updated August 10, 2020. Accessed June 20, 2022. https://www.cdc. gov/flu/professionals/diagnosis/table-testing-methods.htm

29. Fact sheet for healthcare providers: Centers For Disease Control and Prevention (CDC) Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay. FDA. Updated August 5, 2021. Accessed June 20, 2022. https://www.fda.gov/media/139742/download

30. CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay. Instructions for use. FDA. 2021. Accessed June 20, 2022. https://www.fda.gov/media/139743/download

31. Fact sheet for healthcare providers: Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19. FDA. August 27, 2021. Accessed June 19, 2022. https://www.fda.gov/media/136523/download

32. ID NOW RSV. Abbott. 2020. Accessed June 20, 2022. https://www.globalpointofcare.abbott/en/product-details/id-now-rsv.html

33. ID NOW RSV. Product information. Abbott. 2019. Accessed June 20, 2022. https://dam.abbott.com/en-gb/panbio/ID-NOW-RSV-Product-Sheet-EME- English.pdf

34. Venner AA, Beach LA, Shea JL, et al. Quality assurance practices for point of care testing programs: recommendations by the Canadian Society
of Clinical Chemists Point of Care Testing Interest Group. 

. 2021;88:11-17. doi:10.1016/j.clinbiochem.2020.11.008. Published correction appears in Clin Biochem. 2021;92:91.

35. Guidance for SARS-CoV-2 rapid testing performed in point-of-care Settings. Centers for Disease Control and Prevention. Updated April 4, 2022. Accessed June 20, 2022. https://www.cdc.gov/coronavirus/2019-ncov/lab/ point-of-care-testing.html#anchor_1615507063966

36. ID NOW COVID-19. Abbott. 2021. Accessed June 20, 2022. https://www.globalpointofcare.abbott/en/product-details/id-now-covid-19.html

Pharmacies and pharmacists are increasingly utilized for point-of-care (POC) services, including testing for infections that can be diagnosed via rapid testing.

Examining the Public Health Impact of Pharmacies as Additional Sites for Rapid Diagnostic Testing

Pharmacy and public health have a long history of collaboration during an emergency. One example involves efforts taken during the H1N1 influenza pandemic, when pharmacy was mobilized to help administer thousands of influenza vaccines across the country as an extension of public health services.

 More recently, the world faced a new pandemic: coronavirus disease 2019 (COVID-19). Pharmacies and pharmacists continue to play a vital role during this pandemic in providing education and clinical services to support public health mitigation strategies. Since the first COVID-19 vaccines were authorized for emergency use in the United States, strategies have evolved to provide COVID-19 vaccinations, booster doses, testing, and treatment. In addition, steps have been taken to ensure that people wear high-quality masks, maintain social distancing, and access good ventilation in indoor spaces.

 This article highlights the myriad of ways that pharmacists have reinforced and bolstered public health policies over the last 2 years to meet the challenges of the COVID-19 pandemic head-on.

Expanding Capabilities Through The PREP Act

As a result of the COVID-19 pandemic, in March 2020, the secretary of the US Department of Health & Human Services (HHS) issued a declaration under the Public Readiness and Emergency Preparedness (PREP) Act. This statement provides liability protection to persons and federal, state, and local governments (including tribes and territories) involved in the development, manufacture, evaluation, distribution, and administration of covered countermeasures to COVID-19, such as therapeutics authorized by the FDA.

 Among persons protected under the declaration are pharmacy professionals and other health care workers who administer covered products to counter medical conditions related to COVID-19.

 The PREP Act authorizes the secretary of HHS to issue a health declaration when there is a present or credible risk of a future public health emergency. In these cases, health care workers and other parties are protected from liability related to loss that is caused by, related to, or a result of administration or use of antidotes to diseases, threats, and conditions, except when willful conduct can be proven.

 The PREP Act and the declaration preclude state requirements (eg, more limited licensing or scope of practice requirements) that could prevent a qualified person from prescribing, dispensing, or administering vaccines (

Since it was issued, this declaration has been amended several times to expand liability protections, including amendments to cover licensed health care professionals who cross state borders and federal response teams.

 On October 20, 2020, the HHS declared expanded access to childhood vaccines under the PREP Act to decrease the risk of vaccine-preventable disease outbreaks during the COVID-19 pandemic; this action permits licensed pharmacists, qualified pharmacy technicians, and pharmacy interns to administer routine childhood vaccines to children aged 3 to 18 years.

 This includes the age-appropriate provision of COVID-19 vaccines and COVID-19 testing.

Federal Retail Pharmacy Program For COVID-19 Vaccinations

With the PREP Act in place, pharmacists were faced with the unique and daunting task of vaccinating hundreds of millions of people. To streamline this process and provide needed vaccine access to communities across the country, the Biden administration created the Federal Retail Pharmacy Program (FRPP) for COVID-19 Vaccinations in February 2021.

 The FRPP is a collaboration between the federal government, states, and territories and 21 national pharmacy partners and independent pharmacy networks across the country.

 With most Americans living within 5 miles of a pharmacy, the FRPP is built upon the existing strength and expertise of pharmacy partners to rapidly deploy vaccinations to the public.

As of May 11, 2022, the FRPP reported that more than 248 million doses of the COVID-19 vaccine have been administered.

 This includes 8 million doses administered onsite at long-term–care facilities in the early days of the vaccine rollout. Health care workers at more than 41,000 locations have been administering doses nationwide, and these vaccinations are available free of charge. This is especially important as we receive new and evolving recommendations concerning the need for booster doses, including a second booster dose for certain populations.

 A list of FRPP partners is available at https://www.cdc.gov/vaccines/ covid-19/retail-pharmacy-program/participating-pharmacies.html.

The COVID-19 pandemic also reinforced the importance of vaccine safety. Ensuring that all staff adhere to safety recommendations may increase the likelihood that they remain healthy, present at work, and able to provide much needed services to the community. A list of recommended protective safety measures is available at https://immunize. org/catg.d/p2009.pdf.

Available COVID-19 Vaccines, Boosters, and Guidance

Currently, the only FDA-approved vaccines for COVID-19 are the PfizerBioNTech vaccine (Comirnaty; an mRNA vaccine formulated for individuals aged ≥ 16 years) and the Moderna vaccine (Spikevax; an mRNA vaccine indicated for individuals aged ≥ 18 years).

 Other formulations of the Pfizer- BioNTech vaccine (for individuals aged 5-11 years and ≥ 12 years) and the Janssen/Johnson & Johnson vaccine (a viral vector vaccine indicated for individuals aged ≥ 18 years) are authorized for emergency use at the time of this publication.

 The recommendations for vaccination include a primary series (2 doses of an mRNA vaccine [preferred] or 1 dose of a viral vector vaccine).

Booster doses using the mRNA vaccine are recommended to increase or restore protection against COVID-19 that may decline after the primary vaccination series is completed. Everyone aged at least 5 years who has completed their primary vaccination series is eligible for a first booster dose.
A second booster dose is currently recommended no less than 4 months after receiving the first booster dose for adults 50 years and older, some individuals with immunosuppressive conditions, and people who received 2 doses—1 primary dose plus 1 booster dose—of the Janssen/Johnson & Johnson viral vector vaccine. The latest guidance is available on the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html.

 summarizes COVID-19 vaccine options that are available to individuals aged 5 years and older who are not moderately or severely immunocompromised; it includes recommended frequency of primary and booster doses, published in May 2022.

 Additional information on COVID-19 vaccine eligibility and availability also can be found by visiting https://www.vaccines.gov/(1-800-232- 0233), by texting a zip code to 438829 (GETVAX), or by contacting a state health department website.

There is no doubt that the measures involving pharmacy have had a positive impact on helping to limit the morbidity and mortality related to the COVID-19 pandemic. In addition, increased responsibilities and tasks have led pharmacists to develop new and creative ways to optimize staffing. The roles of student pharmacists, pharmacy interns, and pharmacy technicians have been bolstered to support patient care and safety as COVID-19–related services are delivered. Community outreach and onsite services—which provide vital opportunities to address COVID-19 vaccine misinformation, hesitancy, and trust—could not have been offered without the help of additional pharmacy staff.

In addition to administering COVID-19 tests and vaccinations, pharmacy staff have had an important role in vaccine education. Patients who may be hesitant to receive a vaccination are more likely to get vaccinated when given incentives, and a trusted relationship with a pharmacist may increase vaccine uptake.

 Ultimately, it is the patient who has the final decision about receiving a vaccination. Through motivational techniques (eg, asking open-ended questions, showing empathy, acknowledging concerns, reframing and reflecting language, providing information, and asking for feedback), pharmacists can provide each patient with the guidance they need to confidently make an informed decision.

 Multiple patient handouts are available on the Immunization Action Coalition website (https://www.immunize.org/handouts/). In addition, the University of California, San Francisco, website offers recommended health coaching techniques regarding COVID-19 at https://cepc.ucsf.edu/health-coaching.

The profession of pharmacy has stepped up to meet the challenges of caring for patients during the COVID-19 pandemic. Pharmacists represent one of the most accessible types of health care providers, and they have played a key role in the administration of COVID-19 vaccines. The positive results of these efforts have proven the effectiveness of a collaboration between pharmacy and public health. It is currently unknown when the COVID-19 emergency declarations will end; however, solidification of the expanded scope of pharmacy professionals remains critical, especially since most Americans now rely on their neighborhood pharmacy for COVID-19 vaccination and related health care needs. Looking forward, when the public health emergency declarations do expire, organizations such as the Centers for Medicare & Medicaid Services should ensure that improved access to quality care and pharmacists is preserved. We must learn from this pandemic so that we are prepared for the next one.

1. The 2009 H1N1 pandemic: summary highlights, April 2009-April 2010. Centers for Disease Control and Prevention. June 16, 2010. Accessed May 2, 2022. https://www.cdc.gov/h1n1flu/cdcresponse.htm

2. How to protect yourself & others. Centers for Disease Control and Prevention. Updated February 25, 2022. Accessed May 2, 2022. https://www.cdc. gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html

3. Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19. US Department of Health and Human Services. March 17, 2020. Accessed May 2, 2022. https://www. federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures

4. Ninth amendment to declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19. Department of Health & Human Services. September 14, 2021. Accessed May 2, 2022. https://www.federalregister.gov/documents/2021/09/14/2021-19790/ninth-amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical

5. Public Readiness and Emergency Preparedness Act. HHS Office of the Assistant Secretary for Preparedness & Response. US Department of Health and Human Services. Accessed May 2, 2022. https://aspr.hhs.gov/legal/PREPact/Pages/default.aspx

6. PREP Act authorization for pharmacies distributing and administering certain covered countermeasures. US Department of Health & Human Services. October 29, 2020. Accessed May 3, 2022. https://www.hhs.gov/ guidance/sites/default/files/hhs-guidance-documents//prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf

7. Fact sheet: President Biden announces increased vaccine supply,
initial launch of the Federal Retail Pharmacy Program, and expansion
of FEMA reimbursement to states. The White House. February 2, 2021. Accessed May 4, 2022. https://www.whitehouse.gov/briefing-room/ statements-releases/2021/02/02/fact-sheet-president-biden-announces- increased-vaccine-supply-initial-launch-of-the-federal-retail-pharmacy- program-and-expansion-of-fema-reimbursement-to-states/

8. The Federal Retail Pharmacy Program for COVID-19 vaccination. Centers for Disease Control and Prevention. Reviewed May 17, 2022. Accessed May 18, 2022. https://www.cdc.gov/vaccines/covid-19/retail-pharmacy-program/ index.html

9. COVID-19 vaccine boosters. Centers for Disease Control and Prevention. Updated May 24, 2022. Accessed June 1, 2022. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html

10. Learn more about COVID-19 vaccines from the FDA. US Food and Drug Administration. February 8, 2022. Accessed May 18, 2022. https://www.fda. gov/consumers/consumer-updates/learn-more-about-covid-19- vaccines-fda

11. Comirnaty. US Food and Drug Administration. December 16, 2021. Accessed May 9, 2022. https://www.fda.gov/vaccines-blood-biologics/comirnaty

12. Spikevax. Prescribing information. Moderna; 2022. Accessed May 10, 2022. https://assets.ctfassets.net/qjie68e5s6cv/5z3Eh7GEIURixd7wmKA3RW/ 3b781794281d5ab4893a20077c47f5bf/Spikevax-PI-Final_1.31.22.pdf

13. Cominarty and Pfizer-BioNTech COVID-19 vaccine. US Food and Drug Administration. May 17, 2022. Accessed May 18, 2022. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine# additional

14. Janssen COVID-19 vaccine. US Food and Drug Administration. May 5, 2022. Accessed May 18, 2022. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/janssen-covid-19-vaccine

15. Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States. Centers for Disease Control and Prevention. April 21, 2022. Accessed May 18, 2022. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#recommendations

16. Interim COVID-19 Immunization Schedule for Ages 5 Years and Older. May 26, 2022. Accessed June 1, 2022. https://www.cdc.gov/vaccines/covid-19/downloads/COVID-19-immunization-schedule-ages-5yrs-older.pdf

17. Fact sheet: President Biden to announce new actions to get more Americans vaccinated and slow the spread of the delta variant. White House. July 29, 2021. Accessed May 5, 2022. https://www.whitehouse.gov/ briefing-room/statements-releases/2021/07/29/fact-sheet-president-biden-to-announce-new-actions-to-get-more-americans-vaccinated-and-slow-the-spread-of-the-delta-variant/

18. COVID-19 Virtual Training Academy: summary of interview techniques. University of California, San Francisco. Accessed May 5, 2022. https://cepc.ucsf.edu/sites/cepc.ucsf.edu/files/D3_SL_CT_08-31-2020_CT-CI%20 tools%20cheat%20sheet_0.pdf

Pharmacy and public health have a long history of collaboration during an emergency.

Examining the Partnership Between Pharmacy and Public Health During the COVID-19 Pandemic

AIDS was first described in June 1981 when a report published in the CDC’s 

) documented 5 previously healthy individuals with pneumocystis pneumonia, a disease known to mostly affect severely immunocompromised people.

 In 1983, the virus that causes AIDS was identified; it was later named human immunodeficiency virus (HIV).

The medical community has now strived to eradicate HIV for almost 40 years. During that time, those who work closely with HIV have determined that developing and introducing vaccines is the only way to end the AIDS epidemic.

 However, at this moment, the FDA has not approved any prophylactic or therapeutic HIV vaccines, as candidate vaccines have failed or shown limited and questionable efficacy.

Despite this difficulty, promising new vaccines are being studied. The success of the COVID-19 messenger RNA (mRNA) vaccines from Pfizer/BioNTech and Moderna has given many HIV advocates hope that a preventive mRNA vaccine is on the horizon. Adding to this excitement is a phase 1 clinical trial (NCT05001373) that began in September 2021 studying a sequence of mRNA vaccines that may prevent HIV.

This article discusses NCT05001373 and places the trial in the context of research that paved the way for it, institutions supporting the trial, and other HIV research and vaccines in development.

NCT05001373: ASSESSING AN mRNA HIV VACCINE SEQUENCE

The mRNA vaccine trial (NCT05001373) investigates the hypothesis that vaccination by a germline-targeting prime and then by directional boost immunogens can both provoke B-cell specific class response and steer early maturation toward broadly neutralizing antibody (bnAb) growth through an mRNA platform.

This randomized, first-in-human, open label study examines HIV-1 uninfected adults in good general health. Adults 18 to 50 years of age who apply for the trial and meet all inclusion and no exclusion criteria will be enrolled and randomized. Then, depending upon their assigned group, trial participants will receive either or both of the experimental mRNA vaccines (mRNA- 1644 [eOD-GT8 60mer mRNA], mRNA- 1644v2-Core [Core-g28v2 60mer mRNA]) via intramuscular injection. Safety and tolerability, the primary outcome measure, will be assessed by the proportion of participants with mild, moderate, or severe adverse effects at different times throughout the study. Investigators will also study immunogenicity, the secondary outcome measure, by means of presence and magnitude of relevant immune biomarkers at 10 months.

Investigators estimate an enrollment of 56 participants and study completion by May 1, 2023.

RESEARCH BEHIND THE TRIAL: BNABS AND NCT03547245

The bnAbs of interest in NCT05001373 may be the key to protecting uninfected people from HIV. Whereas other prophylactic vaccines contain a series of the same antigen to induce an immune response, the phase 1 trial tests whether a sequence of immunogens may guide the immune system’s antibody response as it develops naive B cells into mature bnAbs. Mature bnAbs can be traced back to a germline-targeting antigen; vaccine sequencing might then begin with germline targeting and shepherd antibody response to produce mature HIV-fighting cells.

NCT05001373, which is a collaboration principally between International AIDS Vaccine Initiative (IAVI) and ModernaTx, Inc, builds upon the success of NCT03547245, the results of which IAVI and Scripps Research announced in February 2021. The trial demonstrated that the eOD-GT8 60mer vaccine could, indeed, stimulate germline B cells, a first step in bnAb production.

FUTURE DIRECTIONS: OTHER HIV RESEARCH AND VACCINES IN DEVELOPMENT

The vaccine sequence that investigators are studying in NCT05001373 may become a tool to ending the AIDS epidemic. However, researchers are investigating other exciting anti-HIV strategies and vaccines, too.

One such strategy is described by Williams et al in a study published in 

in May 2021. The study investigators examined how glycan-reactive B cells in rhesus macaques and humans evolved in the presence of HIV-1 envelope (Env). They discovered and described what they call Fab-dimerized glycan-reactive (FDG) antibodies, which bind to HIV-1 Env glycans. FDG antibodies neutralize HIV-1 and offer hope that another prophylactic vaccine for humans might be developed.

Therapeutic HIV vaccines also show promise. A prophylactic HIV vaccine would prepare the immune system to recognize and effectively fight HIV in uninfected patients.

 By contrast, therapeutic HIV vaccines are designed to improve the immune response in a person who is already infected. Theoretically, this could slow progression from HIV to AIDS and keep a patient’s viral load at undetectable levels without antiretroviral therapy (ART).

 Research has shown that patients with an undetectable viral load are unable to transmit the virus to others through sexual transmission, a concept known as “U = U” for “Undetectable = Untransmittable.”

Institutions like IAVI and the HIV Vaccine Trials Network (HVTN), headquartered at the Fred Hutchinson Cancer Research Center, are at the forefront of HIV vaccine development.

 A global, publicly funded, multidisciplinary collaborative that facilitates HIV vaccine development, HVTN has conducted over 50 HIV-vaccine-related clinical trials over the past decade.

lists the 8 HIV-vaccine-related studies that are part of the HVTN, currently recruiting, and available on ClinicalTrials.gov.

NCT05001373 represents an important step toward having a widely available HIV preventive vaccine available to the general public. Public health and HIV advocates are patiently awaiting the results of this and other groundbreaking trials with the hopes that ending the HIV epidemic is right around the corner.

Christina M. Madison, PharmD, FCCP, AAHIVP, 

is the founder and CEO of The Public Health Pharmacist, PLLC, in Las Vegas, Nevada.

Curran, JW. Editorial note -- 1996. Reproduced in Pneumocystis pneumonia -- Los Angeles. 

The success of the COVID-19 messenger RNA (mRNA) vaccines from Pfizer/BioNTech and Moderna has given many HIV advocates hope that a preventive mRNA vaccine is on the horizon.