This article was updated August 31, 2020.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine rollout must focus on pandemic preparedness, supply chain management, distribution and clinical practice, according to new guidelines released by the American Society of Health-System Pharmacists (ASHP).1

The SARS-CoV-2 vaccine is a highly anticipated countermeasure to the coronavirus disease 2019 (COVID-19) pandemic. According to ASHP, the vaccine push is shaping up to be the largest single vaccination effort in world history. The distribution of hundreds of millions of doses will require massive planning and execution, and collaboration needs to be on a global scale.1

A COVID-19 vaccination is crucial in order to protect communities from worsening and future outbreaks, according to the organization. In preparation, ASHP has released 10 principles for vaccine development, distribution, allocation, mass vaccination, monitoring, and surveillance.1

“If you look at our principles, each one of them is focused on potential challenges that we identified that could occur,” said Anna Legreid Dopp, senior director, Clinical Guidelines & Quality Improvement, ASHP, in an interview with Pharmacy TimesTM“From the approval to postmarketing surveillance, to allocating supplies in an ethical and equitable way, to ensuring that the supply chain is ready to maintain the integrity of these vaccines.”  

These are the 10 principles:
 
  1. Enforce a transparent and rigorous process for vaccine development, approval, and post-marketing surveillance.1,2 The COVID-19 vaccine development and advancement are moving at an unprecedented rate. Having an ethical, rigorous, and transparent procedure in place is of paramount importance. Trials should be transparent, place key importance on informed consent and include key populations. Vaccine effectiveness and safety should be surveilled post-market.1
  2. Collaborate and coordinate with domestic and international public health partners to establish and implement a framework for the ethical and equitable global distribution of COVID-19 vaccines.1,2 Regulatory frameworks and practice models vary on the international, nation, state, and local levels. However, international cooperation is needed in order to help ensure that the vaccine has the largest possible impact.1 
  3. Engage, prepare, and protect the immunizer workforce.1,2 Those providing and administering the vaccine must also be protected. Traditional and nontraditional immunizers will need to be trained to administer the COVID-19 vaccine. Personal protective equipment will also need to be directed to safely protective the immunizing workforce.1
  4. Expand patient access to COVID-19 vaccines by leveraging a highly qualified and empowered clinical pharmacy workforce in all settings of care.1,2 The ASHP principles place a key role on the pharmacy workforce. The fourth principle emphasizes that pharmacists and pharmacists’ workers. They should be used to not only administer the vaccine, but to also educate the public. Barriers such as scope of practice, reimbursement, and legal barriers that may limit of prevent pharmacists from administering the vaccine should be removed.1
  5. Adhere to established best practices for proper storage and handling of COVID-19 vaccine throughout the supply chain, from distribution to patient administration.1,2 In order for vaccine rollout to be as smooth as possible, the supply chain must be airtight. And, this is not just for the vaccine itself, but also vials, syringes and alcohol wipes. Shelf life of the vaccine must also be maximized. Distribution at the state, local, federal, and international levels must also be tracked.1
  6. Ensure equitable allocation of COVID-19 vaccines across populations and communities, prioritized for greatest public health impact.1,2 Vulnerable populations should be vaccinated first, especially since the supply chain is most likely to be strained when the vaccination is first produced. As the supply of the vaccine increases, adjustments must be ongoing.1
  7. Achieve high acceptance and uptake of COVID-19 vaccines by minimizing vaccine hesitancy and misinformation.1,2 Misinformation is a significant barrier to vaccination, according to ASHP. A nationwide campaign to combat the misinformation surrounding the vaccine is needed. Pharmacists, being one of the most accessible health care providers, must be ready to champion the vaccine to the public.1 
  8. Seek innovative solution for adverse drug event monitoring and documentation to improve the thoroughness, accuracy, and usefulness of data collection for improved vaccine safety.1,2 According ASHP, multiple vaccines with different safety profiles are likely. The national Vaccine Adverse Event Reporting System and state immunization systems will be critical tools to detect any concerning safety signals and to track doses from multiple suppliers.
  9. Ensure patient access to COVID-19 vaccines by preventing and removing financial barriers.1,2 Financial barriers also need to be addressed. Higher patient costs will result in lower vaccination rates. Cost reimbursement will help sustain immunization efforts.1
  10. Remain vigilant with continued research and comprehensive surveillance procedures for COVID-19 vaccine use, safety, and effectiveness.1,2 Ongoing research, even after the vaccine is made available, will be crucial. The COVID-19 immunization effort will also help in future mass immunization efforts.1

“It is imperative that the novel COVID-19 vaccine is distributed in an ethical, equitable, and efficient manner. To achieve this, extraordinary efforts will be required to coordinate, prepare, and mobilize an immunization workforce while operationalizing the critical infrastructure for the vaccine supply chain. ASHP acknowledges the multifaceted approaches required for the continuum of mass immunization efforts and is committed to advancing resources and support,” ASHP CEO Paul W. Abramowitz, PharmD, ScD (Hon.), FASHP, said in a prepared statement.2

Ensuring the safe, equitable, and effective rollout of the COVID-19 vaccine is a massive undertaking. The immunization workforce must be prepared, and the supply chain maintained. According to ASHP, a multifaceted approach will be needed.1

“We want to reach, not only the vulnerable population of patients that need the vaccine, but the entire population. And that means meeting people where they are,” Dopp said. “So, providing opportunities to vaccinate within traditional health care settings like a physician’s office and at a pharmacy—but then also being creative in other mass immunizing capacities, and thinking forward about how we can educate, empower, and importantly, protect all of those who are willing to be immunizers.” 

REFERENCES
 
  1. ASHP Issues Principles for COVID-19 Vaccine Rollout and Oversight: New Tenets Outline Path for Vaccine Development, Distribution, Allocation and Supervision [news release].  Bethesda, MD; August 26, 2020: ASHP. [email] Accessed August 27, 2020
  2. ASHP Principles for COVID-19 Vaccine Distribution, Allocation, and Mass Immunization. ASHP. Published August 24, 2020. Accessed August 27, 2020. https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/Coronavirus/docs/ASHP-Principles-for-COVID-19-Vaccine?utm_source=082620-vacprinciples&utm_medium=email