CDC asks health officials to be ready to distribute coronavirus vaccines by late October or early November
Populations for initial Covid-19 vaccination will likely be critical workforce that provides healthcare and maintains essential functions of society
The US Centers for Disease Control and Prevention (CDC) has asked states and public health officials across the US to be prepared to distribute a potential coronavirus vaccine to healthcare workers and other high-risk groups as soon as late October or early November, reveal documents.
Three documents, put up online by the New York Times, shows the agency outlining planning scenarios that can help states prepare to distribute two vaccines. As far as allocation is concerned, the CDC says that the federal government will issue guidance on groups to prioritize initial coronavirus vaccination. Populations for initial Covid-19 vaccination will likely be critical workforce that provides healthcare and maintains essential functions of society, and staff, and residents in long-term care and assisted living facilities.
“Many Covid-19 vaccine candidates are in development, and clinical trials are being conducted simultaneously with largescale manufacturing. It is not known which vaccines will be approved. Covid-19 vaccination program plans must be flexible and accommodate multiple scenarios. Limited Covid-19 vaccine doses may be available by early November 2020, but the Covid-19 vaccine supply will increase substantially in 2021,” the CDC writes in one document. It adds, “Allocation of Covid-19 vaccine to jurisdictions will be based on multiple factors, including populations recommended by the Advisory Committee on Immunization Practices (with input
from the National Academy of Medicine), current local spread /prevalence of coronavirus, and Covid-19 vaccine production and availability. Jurisdictions should anticipate that allocations may shift during the response based on supply, demand, and risk.”
The agency says that initially available Covid-19 vaccines will either be approved as licensed vaccines or authorized for use under an emergency use authorization (EUA) issued by the US Food and Drug Administration (FDA) and would likely need to be administered twice. “Covid-19 vaccine and ancillary supplies will be procured and distributed by the federal government at no cost to enrolled Covid-19 vaccination providers. CDC will share more information about reimbursement claims for administration fees as it becomes available,” it states.
The directions have been issued amid concerns that the accelerated vaccine development process has become politicized. Recently, FDA commissioner Dr Stephen Hahn said that he is willing to fast-track a Covid-19 vaccine by granting emergency use authorization before large phase three clinical trials are complete if it found it appropriate to do so. This has been criticized by scientists and health experts, who have warned that any decision regarding a coronavirus vaccine should not be made in haste. Three vaccines are currently in phase three clinical trials in the US. They are an AstraZeneca vaccine developed with Oxford University, one from Moderna, and another from Pfizer and German-based BioNTech SE.
In one of the latest documents, the CDC provides guidance for storing, administering, and distributing ‘Vaccine A’ or ‘Vaccine B,” which are unnamed, if they are approved or receive EUA. In a scenario where vaccine A demonstrates sufficient efficacy and safety for emergency use authorization in 2020, the document says that 2 million doses may be available by the end of October, 10 to 20 million doses by November-end, and 20 to 30 million doses by the end of December 2020. It also advises that Vaccine A must be stored at temperatures of minus 70 and degrees Celsius. The availability assumptions for the second candidate vaccine, being referred to as Vaccine B, shows that 1 million doses may be available by October-end, 10 million by November-end, and 15 million doses by the end of this year. The CDC says Vaccine B must be stored at temperatures of minus 20 degrees Celsius.
The scenario documents, however, do not necessarily imply a vaccine will be available by late October or November. The agency emphasizes that the “Covid-19 vaccine landscape is evolving and uncertain, and these scenarios may evolve as more information is available.” It adds, “The planning scenarios described should be used by state and local jurisdictions to develop operation plans for early Covid-19 vaccination when vaccine supply may be constrained. The scenarios describe potential Covid-19 vaccine requirements, early supply estimates after vaccine product approvals, and populations that may be recommended for vaccination during this early period. These scenarios are designed to support jurisdictional, federal, and partner planning, but they are still considered hypothetical.”
Another document is a checklist to assist in early planning for the Covid-19 vaccination program. It recommends that jurisdictions must be prepared to immediately vaccinate identified critical populations when the earliest Covid-19 vaccine doses are available. The document advises jurisdictions and public health officials to identify and estimate sizes of critical populations, particularly those to receive first available doses of vaccine, and other populations that may require special consideration in each jurisdiction for distribution and expanded access. This includes critical infrastructure/essential workers, such as healthcare, homeland, and national security, public safety, education, food, and agriculture workers. People at increased risk for severe illness -- for example, persons who are 65 years of age and older, people with underlying medical conditions that are risk factors for severe Covid-19, long-term care/assisted living facility residents, people from tribal communities, and people from racial and ethnic minority populations -- are mentioned next.
The agency also lists people living in group settings, such as people who are incarcerated or detained, experiencing homelessness or living in shelters, attending colleges or universities, as well as people with limited access to vaccination services, which includes rural communities, individuals with disabilities, and under or uninsured people. “Describe and identify where these critical populations live, including places of employment for critical workforce. Determine the allocation method to Covid-19 vaccination providers for identified critical populations in early and limited supply scenarios,” suggests the CDC. According to the agency, when vaccine supply is available for expanded groups among the general population, a national Covid-19 vaccine finder will be made available. A screening tool on the CDC website will help individuals determine their own eligibility for Covid-19 vaccine and direct them to the vaccine finder, it adds.
Meanwhile, CDC director Dr Robert Redfield has written to governors, asking them to prepare for largescale distribution of Covid-19 vaccines by November 1, two days before the presidential election in the US. It requests governors to waive some licensing and permit requirements, if required, to expedite the process. The letter informs governors that the agency has contracted with McKesson Corporation to distribute Covid-19 vaccines to state and local health departments, medical facilities and doctors’ offices, and other vaccine providers, and that to accomplish this task, the company must quickly open new distribution centers and get new permits and licenses.
“The normal time required to obtain these permits presents a significant barrier to the success of this urgent public health program. CDC urgently requests your assistance in expediting applications for these distribution facilities and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020. The requirements you may be asked to waive in order to expedite vaccine distribution will not compromise the safety or integrity of the products being distributed,” suggests the August 27 letter. “Your assistance in helping expedite the issuance of necessary licenses and permits required for the distribution centers to become operational will be critical to the success of this public health effort to mitigate the threat presented by Covid-19,” writes Redfield.