Distributing COVID-19 Vaccines
- There are currently four COVID-19 vaccine candidates in phase 3 testing in the United States. Operation Warp Speed is bringing together the Centers for Disease Control and Prevention, the Department of Defense, the states, and other agencies to distribute the vaccine once it is approved by the Food and Drug Administration.
- The CDC’s interim playbook advises state and local health departments to plan for a phased process of distributing and administering vaccines as doses become available.
- Planning for distribution is being done simultaneously with vaccine development and FDA’s safety review. States are accounting for a range of requirements for the vaccine, including storage and handling needs and the number of doses that may be required for immunization.
Operation Warp Speed is expediting the development, manufacturing, and delivery of safe and effective COVID-19 vaccines. The federally backed initiative is allowing typical vaccine development to take place in parallel with manufacturing and distribution planning. Its goal is to have 300 million doses of vaccines, with initial doses available once approved by the Food and Drug Administration. Vaccination will help Americans safely return to work, school, and other public activities. There are four COVID-19 vaccine candidates currently in phase 3 clinical trials in the U.S.
Players in Public-Private Partnership to Deploy Vaccine
The FDA reviews, approves, and conducts certain post-market activities for vaccines. Based on the data from clinical trials, a manufacturer of a vaccine may submit an application to FDA for approval or authorization for use during a specific public health emergency. Vaccines that get an “emergency use authorization” can be used for the duration of a public health emergency, such as the COVID-19 emergency declared by the secretary of Health and Human Services.
HHS is in charge of deploying the COVID-19 vaccine to states, with the help of the Department of Defense. The federal government aims to start shipping vaccines within a day of FDA approval. It will work in partnership with McKesson Corporation, a medical supply distributor that will manage the distribution of the vaccines and related supplies to point-of-care sites like hospitals and doctors’ offices.
The CDC’s Advisory Committee on Immunization Practices and other groups are working to develop plans for vaccine distribution. The National Academies of Sciences, Engineering, and Medicine was asked by the National Institutes of Health and CDC to recommend a framework for equitable allocation of the vaccine. On October 2, the National Academies released its report, which discussed who should receive priority, starting with people at higher risk of spreading or acquiring the virus, like health care workers and those who are most likely to become severely ill if infected.
Possible Phases of COVID-19 Vaccination
CDC has already identified $600 million to begin planning for this major effort. To accompany these resources, CDC also has released an interim playbook for how state and local public health departments should develop plans to distribute and administer the vaccine, with the understanding that supplies will increase over time. CDC is advising states to take a phased approach to vaccine distribution. Health care workers, other essential workers, and people at higher risk for severe COVID-19 illness are likely to be the focus of the first phase. Critical groups also may include people at higher risk of contracting or spreading the virus, such as people who are incarcerated or those working in schools. As the supply of COVID-19 vaccine increases, the second and third phases will expand to reach additional members of the public. In the third phase, the playbook says, “COVID-19 vaccine will be widely available and integrated into routine vaccination programs, run by both public and private partners.” Following FDA’s review, the CDC’s Advisory Committee on Immunization Practices will make the final recommendations to guide distribution and administration of available COVID-19 vaccines. This will help CDC and states prioritize who should receive a vaccine first.
The federal government will take the lead in distributing vaccines to provider sites or other facilities for redistribution, and state and local health departments will coordinate supplying them to people. CDC has asked health departments to submit their distribution plans by October 16. These health departments are making plans without knowing which vaccines the FDA may approve, so they must prepare for different levels of supply and a range of handling and storage needs. To help states and localities prepare, CDC’s playbook includes hypothetical scenarios for vaccines, including assumptions for available supply, storage temperatures, and technical information on how to administer the vaccine. The playbook also encourages public health departments to provide timely information to the public and other outreach to instill confidence in the COVID-19 vaccine.
Three of the four vaccine candidates in late-stage trials currently require two doses to be administered several weeks apart. This requires state plans to consider the need for people to return to their doctor, pharmacy, or other immunization site for the second dose. CDC’s playbook urges vaccine providers to schedule second-dose visits at the time the first dose is administered. In addition to recording immunization information in electronic systems, providers also will receive vaccination record cards in their vaccine supply kits to help ensure people receive the same vaccine for both doses.
Some of the vaccine candidates are expected to require consistent refrigeration, while others might need to be kept frozen or in ultra-cold storage at temperatures as low as -80 degrees Celsius. Maintaining this cold storage along the supply chain is critical; if doses get too warm at any point, they can become ineffective. CDC’s playbook says that vaccine providers will need to give information on the storage capacity and temperature capabilities at each of their vaccination sites. Any vaccine requiring ultra-cold storage will be shipped directly from the manufacturer to vaccination sites, to reduce the risk of temperature fluctuations. In preparation for the surge in demand, major U.S. logistics companies are augmenting their existing cold storage networks. They are expanding their refrigeration capacity and setting up rows of portable freezers in warehouses for storing the vaccines during distribution. Each freezer can hold thousands of vaccine vials at very low temperatures.
Health agencies also are working to make sure that vaccine access is equitable and that doses can reach critical groups of people. These include rural communities, where a doctor’s office or pharmacy may not have an ultra-low temperature freezer for storing vaccines. To help appropriately prepare and address these needs, CDC recently announced $200 million in awards to states, territories, and certain large cities. This funding was provided through the Coronavirus Aid, Relief, and Economic Security Act. A great deal of planning has already started, but additional resources are needed to finish the job. In a recent hearing, CDC Director Robert Redfield told the Appropriations Subcommittee on Labor, Health and Human Services, and Education that an additional $6 billion is needed for distribution. Robert Kadlec, assistant secretary for preparedness and response at HHS, said that it will take an additional $20 billion to manufacture and purchase doses to adequately vaccinate Americans.
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