Five Issues Limiting the Vaccine Rollout — and How to Fix Them

As a national convener of hospital and non-acute vaccination sites across the nation, the Premier healthcare alliance recognized early on that a mass vaccination effort would be the biggest logistical challenge of the pandemic.

Now a month in, it’s clear that despite tireless efforts on the part of our frontline caregivers, swift intervention from the federal government is needed to speed the administration of vaccines in order to reduce the national infection rate, save lives and alleviate the systemic strain new cases and viral mutations place on the healthcare system.

Working with our provider members to understand the evolving on-the-ground realities, Premier has identified five systemic issues limiting the vaccine rollout that need immediate remediation.

Premier is urging the incoming Biden Administration to immediately take the following actions to overcome these obstacles and streamline and expedite the vaccination process throughout the country.

1. Vaccine Hesitancy

On the ground reports suggest that a consistent 30 to 50 percent — and as high as 80 percent — of healthcare workers eligible to receive the vaccine have not been vaccinated. The unanticipatedly high hesitancy rate has disrupted the Center for Disease Control and Prevention's (CDC) prioritization pathway as providers grapple with finding willing persons to accept the vaccine in the short timeframe that it remains viable.

What we need is broad and consistent education involving:

• The Food and Drug Administration (FDA) and vaccine manufacturers making all evidence supporting the safety and efficacy of COVID-19 vaccines publicly available as would normally occur for a new drug;
• A concerted, evidenced-based national public awareness campaign on COVID-19 vaccines that aggressively debunks myths while addressing vaccine safety, efficacy, their role in society and their importance in our return to normal;
• Data transparency around vaccine safety and efficacy during phase IV clinical trials, ongoing surveillance for adverse events and real-world evidence; and
• Permitting unbranded direct-to-consumer advertising on vaccine availability, safety and efficacy.

Education should be coupled with appropriate incentives to encourage Americans to receive the vaccine, including:

• Temporarily waiving the Stark and anti-kickback requirements to allow providers to offer patients incentives to receive the COVID-19 vaccine;
• Urging Medicare Advantage (MA) plans to leverage the Rewards and Incentive Programs to encourage MA enrollees to receive the COVID-19 vaccine; and
• Providing bonus payments to providers and payers and temporary tax incentives for employers for vaccinating a specified percentage of their patient and employee population by the end of the federal fiscal year 2021 (Sept. 30, 2021).

2. Clinical Staffing Limitations

According to a December survey of Premier members, 53 percent said lack of clinical staff was the top challenge to their COVID-19 response efforts – and that was before the current caseload surge and the added staff needed to administer vaccines that has only exacerbated staffing shortages.

States and the Biden Administration should take the following steps to identify new cohorts of vaccinators to prevent bottlenecks at vaccination sites:

• Recruiting retired pharmacists and pharmacy technicians, as well as student pharmacists who have successfully completed coursework related to the administration of vaccines;
• Leveraging the National Guard to assist with logistical vaccination support, including to support hospitals, retail settings, and community physicians to achieve mass vaccination;
• Temporarily waiving state reciprocity requirements for vaccinators if they are licensed vaccinators in good standing in another state; and
• Appealing to employers to support licensed healthcare workers who are in non-healthcare roles to return to the frontlines.

3. Distribution Challenges

The current Operation Warp Speed decentralized, opaque distribution process is creating uncertainty for providers around shipments, leading to throughput limits and/or wastage. At the same time, there are proliferating concerns about an emerging counterfeit market for vaccines and the integrity of the distribution channel.

The key to overcoming distribution challenges is building a true end-to-end supply chain that is transparent and resilient. To do this, we need:

• A centralized, national, real-time tracking and tracing system to provide visibility into the complete vaccine supply chain;
• A data-driven dynamic allocation process to match vaccine allocation with the number of eligible patients in the state based upon the prioritization pathway; and
• Concrete steps to prevent proliferation of the gray market and ensure supply chain integrity including establishing a national, centralized clearinghouse to vet all gray market offers regarding vaccine availability and cracking down on bad actors.

4. Supply Shortages

Shortages of needles and exam gloves are obstacles limiting the speed of vaccination. Premier members report an inability to order the additional needles needed to administer the maximum number of doses per vial, as well as a 40 percent increase in exam glove demand, which has caused spot shortages.

The key to overcoming supply shortages is to leverage a data-driven approach to drive transparency in the supply chain and forecast demand needs, which can be accomplished by:

• Adding to the ancillary kits accompanying vaccines the additional needles and syringes needed, as well as nitrile exam gloves;
• The Strategic National Stockpile (SNS) releasing any existing supply of needles to Operation Warp Speed to support vaccination efforts and leveraging the Defense Production Act to expeditiously refill the SNS inventory;
• Leveraging public-private partnerships to monitor the rollout, collaboratively discuss challenges and work proactively to resolve any supply chain challenges that may arise; and
• Ensuring the FDA device shortage list is more specific around the exact product and manufacturer that is impacted.

5. Communication Gaps

Operation Warp Speed is a large-scale effort but with insufficient coordination. As a result, vaccination sites report widespread confusion, with providers unsure of which state or federal agency is making decisions or where to turn to solve problems.

The key to overcoming communication gaps is establishing a single source of truth with:

• A clear and consistent command and control structure that explains the roles and responsibilities of the various entities involved in the rollout, what decision making authority they have, and how to engage with them;
• A reconfigured CDC vaccine reporting website to provide data on the first and second dose administered;
• An appointment-based vaccination system with an active waitlist that can be leveraged if there are no shows;
• A Biden Administration-led fact-finding process to understand why there are jurisdictional differences in vaccination administration rates and standardized reporting of key administration metrics to allow for data mining to identify best practices to improve vaccination rates in the future; and
• Standardized definitions (e.g., “essential worker”) that are applicable across jurisdictions.

Read Premier’s full recommendations to improve the nation’s COVID-19 vaccine response.