COVID-19 Vaccine
Corey Diamond, PharmD
With the advent of the release of a working vaccine for COVID-19 on the horizon, the American Society of Health-System Pharmacists (ASHP), has assumed a strong stance on how the logistics of an inevitable national vaccine administration operation should proceed. In August, the organization released ASHP Principles for COVID-19 Vaccine Distribution, Allocation, and Mass Immunization, which includes ten guiding principles they believe are paramount for an initial vaccination rollout.
The following is the list of the ten guiding principles and what they include.
1. Enforce a transparent and rigorous process for vaccine development, approval, and postmarketing surveillance.
To say that clinical trials for a COVID-19 vaccine are currently advancing at an extremely fast pace is an understatement. According to a May 21 New England Journal of Medicine perspective by Lurie and colleagues, merely 10 weeks after the first genetic sequence of the SARS-CoV-2 virus was released in January, FDA already approved a novel mRNA vaccine Phase I clinical trial, and the vaccine was being given to patients—a process that would usually take years. Within this current climate of urgency, the risk of a vaccine with severe unintended consequences being unknowingly released to the public has never been higher. Principle 1 underscores the need for the health care community to temper this pressure by mitigating risks as much as possible through advocating a rigorous pharmacovigilance process.
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.
Efficient distribution of vaccines, especially at the beginning of a mass vaccination operation, will be critical. Principle 2 highlights the importance of distribution that is not only expeditious but also equitable. For instance, it may be necessary for national guidelines to incorporate recommendations with a degree of flexibility that is contingent on the local epidemiology and demand at both state and local jurisdictions and adjustment for different demographics.
3. Engage, prepare, and protect the immunizer workforce.
Vaccines don’t save lives, vaccinations save lives. A COVID-19 vaccine will not be able to do anything useful if it is simply sitting in its vial due to sick, incapacitated personnel. Principle 3 states the safety of the immunizer workforce (e.g., nurses, physicians, pharmacists, etc.) must be prioritized if a mass immunization effort is to succeed.
4. Expand patient access to COVID-19 vaccines by leveraging a highly qualified and empowered clinical pharmacy workforce in all settings of care.
It is no question that traditional avenues for vaccine administration will be insufficient if this is to be the largest vaccination effort in recent history. Consider that in the United States, most patients live closer to a pharmacy than they do to a clinic. Principle 4 highlights that one of the most well positioned settings for vaccine administration are community pharmacies. Vaccination programs and the mobilization of trained pharmacy personnel will be paramount in a successful mass vaccination program.
5. Adhere to established best practices for proper storage and handling of COVID-19 vaccines throughout the supply chain, from distribution to patient administration.
All experienced pharmacists are, unfortunately, familiar with the fragility of the drug supply chain. A delay of even one component necessary for the operation of vaccine administration, such as vials or alcohol swabs, threatens to grind the entire operation to a halt. Principle 5 emphasizes the need to bolster the resources necessary to maintain the integrity of the vaccine’s journey from manufacturer to patient.
6. Ensure equitable allocation of COVID-19 vaccines across populations and communities, prioritized for greatest public health impact.
There are currently more than 300 million people in the United States. On the day of the first licensure of a COVID-19 vaccine, it is unlikely there will be 300 million doses available. Principle 6 recognizes the need for the health care community to prioritize the initial distribution to reach the most vulnerable populations first. Additionally, the precise allocation of vaccine must be continually reassessed as new vaccine incrementally becomes more available over the subsequent months.
7. Achieve high acceptance and uptake of COVID-19 vaccines by minimizing vaccine hesitancy and misinformation.
Consider that, according to a Morbidity and Mortality Weekly Report in 2010 by CDC, only about 24% of Americans received the H1N1 vaccine when it was first licensed due to public perceptions that it was “rushed” or “untested,” or that the illness was “mild.” When you combine the already high baseline hesitancy with the fact that the COVID-19 vaccine has been developed at an unprecedented speed, you have a recipe for an extremely reluctant population. Principle 7 advises that pharmacists, being the most accessible health care practitioner, should play a central role in the education effort to combat vaccine hesitancy.
8. Seek innovative solutions for adverse drug event monitoring and documentation to improve the thoroughness, accuracy, and usefulness of data collection for improved vaccine safety.
Principle 8 reinforces the need to utilize the national Vaccine Adverse Event Reporting System (VAERS), as well as state registries, in detecting safety concerns. Considering the lack of large data sets, now more than ever, these resources will be critical in detecting serious adverse events associated with the vaccine.
9. Ensure patient access to COVID-19 vaccines by preventing and removing financial barriers.
Principle 9 is simple: Make sure patients can afford the treatment. Not only should efforts be made to reduce the cost of the vaccine as much as possible, they should also be made to disseminate that information as widely as possible. Even a perceived notion of a high-cost vaccine could be a barrier.
10. Remain vigilant with continued research and comprehensive surveillance procedures for COVID-19 vaccine use, safety, and effectiveness.
The health care community could be part of possibly one of the most momentous vaccination efforts ever conducted. Principle 10 recognizes that the data collected now will be invaluable in directing efforts for future outbreaks of similar magnitude.
ASHP principles for COVID-19 vaccine distribution, allocation, and mass immunization
- Enforce a transparent and rigorous process for vaccine development, approval, and postmarketing surveillance.
- 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.
- Engage, prepare, and protect the immunizer workforce.
- Expand patient access to COVID-19 vaccines by leveraging a highly qualified and empowered clinical pharmacy workforce in all settings of care.
- Adhere to established best practices for proper storage and handling of COVID-19 vaccines throughout the supply chain, from distribution to patient administration.
- Ensure equitable allocation of COVID-19 vaccines across populations and communities, prioritized for greatest public health impact.
- Achieve high acceptance and uptake of COVID-19 vaccines by minimizing vaccine hesitancy and misinformation.
- Seek innovative solutions for adverse drug event monitoring and documentation to improve the thoroughness, accuracy, and usefulness of data collection for improved vaccine safety.
- Ensure patient access to COVID-19 vaccines by preventing and removing financial barriers.
- Remain vigilant with continued research and comprehensive surveillance procedures for COVID-19 vaccine use, safety, and effectiveness.