With Pfizer-BioNTech and Moderna COVID-19 vaccines authorized by the FDA for emergency use, the daunting task of distributing and administering vaccines is officially underway. A rapid and coordinated vaccine rollout is critical to slowing the pandemic’s death toll and relieving pressure on healthcare systems. The U.S. has so far experienced delays at each step of the process, but there are a few solutions in the works to improve the manufacturing and administration of COVID-19 vaccines.
At the manufacturing level, faster production has created a bottleneck in meeting total global demand. Manufacturing challenges are heightened by the fact that vaccine developers face a steep learning curve for rapidly producing these novel technologies at a global scale. In December, Pfizer cut its end-of-year production projection in half, from 100 to 50 million doses globally, due to delays in scaling up its raw material supply chain. Moderna also experienced manufacturing setbacks, discarding 400,000 doses after a filtration issue compromised the product.
Nonetheless, both companies are on target to deliver the doses promised to the U.S. in 2021. To that end, Pfizer recently announced plans to speed up their manufacturing process, cutting the time it takes to produce a batch of vaccine from 110 to 60 days. Pfizer also intends to add manufacturing lines in all plants to increase output along with speed. Moving forward, U.S. supply is expected to meet demand as manufacturers continue to improve production efficiencies.
The cold-chain requirements for COVID-19 vaccines are a significant consideration for distribution logistics. Several states have received shipments of Moderna vaccines that were rendered unusable due to temperature control deviations during transportation. Vaccine boxes are fitted with temperature monitoring and tracking systems, and safe delivery relies on central distributor and subcontracted couriers adhering to cold chain requirements throughout the packaging and shipping process.
Pfizer-BioNTech’s vaccine requires even colder shipping conditions, but the company opted to create its own distribution network. This allows Pfizer to have more control in the process, though states must determine which of their facilities can store the vaccines at ultra-cold temperatures. To mitigate distribution challenges, Pfizer-BioNTech recently submitted data to the FDA demonstrating stability at standard refrigeration temperatures for up to two weeks. While FDA authorization is pending, the two-week period could reduce the pressure to quickly administer shots before expiry and prevent discarding of effective doses.
Fortunately, several yet-to-be-authorized vaccine candidates with less demanding refrigeration requirements may soon address these issues. For example, vaccine candidates that can be stored at standard refrigeration temperatures (35.6°F to 46.4°F) may expand the number of sites that can accommodate COVID-19 vaccines using existing infrastructure, easing shipment difficulties and expanding where patients can be vaccinated.
Pfizer and Moderna have agreed to deliver doses purchased by the U.S. by the end of July 2021, with delivery to administration sites occurring on a rolling basis. However, early in the rollout, local health departments reported a lack of clarity regarding when and where doses would be delivered, with some sites receiving only a few days’ notice before allocated doses arrived and others receiving significantly fewer doses than expected. Unknowns regarding stockpiled doses left many states questioning the actual amount held in reserve by the federal government, if any. In response, state governors have called for improved transparency and more precise communication on delivered and anticipated doses. This could help stakeholders better prepare for large-scale immunization, reduce redundancies in distribution and solve for discrepancies between supply and administration.
As the initial vaccine supply is limited, the Advisory Committee on Immunization Practice recommended a phased allocation to prioritize critical populations, including essential workers and people at increased risk for severe disease. But each state was free to develop its own distribution plan based on the recommendation. In some cases, state plans have created more complex priority groups. This approach may precisely target eligible patients with the limited vaccine supply but has led to greater difficulty in implementing distribution. Vaccination site leaders have argued that the gatekeeping for prioritized occupations or medical conditions overcomplicates the process, particularly when the shelf life of vaccines is limited. Vaccine doses may remain unused prior to the start of the next priority phase or may be discarded while trying to locate eligible recipients. As anecdotal reports emerge across the country on unused or spoiled vaccines, the total number of doses that have been wasted is unclear as some state governments aren’t tracking or reporting unused or wasted vaccines.
At the start of 2021, only a third of vaccine doses that were delivered were also administered. At time of publication, about 79% of vaccine doses delivered are used. Providers are now administering about 1.6 million doses per day on average.
To address some of these challenges, clear communication regarding the timing of supply distribution to the states and detailed state-specific recommendations can help alleviate some of these delays. For more consistency across states, development of a centralized repository of information regarding best practices and key learnings, such as successful priority group targeting or platforms to track vaccine administration, could be shared publicly to help those that may be lagging and help improve allocation to states from the CDC.
Many local and state health departments have cited the increased burden placed on hospitals and a lack of resources to support vaccine administration as the factors contributing to delays. For health systems that are directing resources to treating the high number of new COVID-19 cases, implementing a vaccination distribution plan that includes hiring and training for vaccine-related positions or building a platform for booking appointments is an additional challenge due to lack of personnel and existing infrastructure. Currently, efforts to expand funding for vaccine administration are underway through the Federal Emergency Management Agency, such that state and locally run sites can be reimbursed for the cost of administering vaccines. To ensure resources are allocated appropriately, the agency may need to consider prioritizing based on infection rates and hospital capacity as well as continuing ongoing communication with state and local agencies.
While complexities in the distribution process may persist as more vaccine candidates are approved for emergency use, a few factors are contributing to increased production and vaccination throughput. The federal government has committed to an improved line of sight on vaccine supply to provide states with lead time for planning, as well as enacting the Defense Production Act to ramp up manufacturing and increase resources for distribution. Additionally, plans to open vaccination sites and mobile units across the nation should serve to quickly scale up vaccinations. The rollout also is expected to accelerate as vaccines are dispensed at additional locations such as pharmacies and mass immunization sites. Concrete solutions that improve the distribution, allocation and administration of vaccines will help the U.S. progress toward widespread vaccination.