States Prep for Potential Vaccine Distribution in October - COVID-19 Clinical Trial
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States Prep for Potential Vaccine Distribution in October

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    It’s the accomplishment the entire world has been anxiously anticipating: the approval of a vaccine proven to safely protect against the coronavirus. In early September, the U.S Centers for Disease Control and Prevention (CDC) indicated that a vaccine may finally be within reach when it asked states to develop plans for potential vaccine distribution.  

    Now public health officials in all 50 states and five large cities have been notified by the CDC to prepare to distribute a coronavirus vaccine to health care workers and other high-risk groups within the next few months.  

    Dr. Anthony Fauci, the country’s top infectious disease expert, and Dr. Stephen Hahn, the head of the Food and Drug Administration, have both confirmed in recent interviews that the CDC’s preparations aren’t just empty words.  

    They say that a vaccine may be available to certain groups even before stage 3 and 4 clinical trials are over, as long as the available data is overwhelmingly and unquestionably positive.  

    Vaccine Distribution Predicted to Be a Vast and Complex Effort 

    However, distribution to health care workers and other high-risk groups is just one small piece of the puzzle in what will become a Herculean effort to overcome the logistical challenges of distributing millions of vaccines across the country.  

    The CDC recently developed a hypothetical plan that lays out technical specifications for the distribution of “Vaccine A” and “Vaccine B.” This plan includes requirements for shipping, mixing, storage, and administration. It’s possible that “Vaccine A” and “Vaccine B” are anonymous references to the vaccine products currently being tested by Pfizer and Moderna, the two candidates furthest along in late-stage clinical trials.  

    As it is currently written, the plan indicates about two million doses of Vaccine A and one million doses of Vaccine B would be ready by late October, with tens of millions of additional doses of each vaccine ready before 2021.  

    According to the CDC, “These scenarios are designed to support jurisdictional, federal, and partner planning, but they are still considered hypothetical. The COVID-19 landscape is evolving and uncertain, and these scenarios may evolve as more information is available.” 

    The Association of State and Territorial Health Officials, which represents the public health agencies of all 50 states, said the CDC documents lay out “an aggressive but necessary timetable.” 

    More About the CDC’s Hypothetical Vaccination Planning 

    The CDC used certain “availability assumptions” to prepare its 2020 vaccination plan.  

    For example, Vaccine A is assumed to have approximately 2 million doses by the end of October, 10-20 million doses by the end of November, and 20-30 million doses by the end of December 2020. It must be handled accordingly: 

    • The vaccine is sent directly to site from the manufacturer on dry ice 
    • It is sent in multidose vials with 5 doses per vial 
    • The vaccine diluent and ancillary supply kits are sent directly to site from USG at room temperature 
    • Once on site, Vaccine A must be stored in negative 70 degrees Celsius and used within 10 days. If it is thawed but not reconstituted, the vaccine must be used within 24-48 hours. If it is reconstituted at room temperature, Vaccine A must be used within 6 hours.  

    Vaccine A and B both have 2-dose series with 21 days (Vaccine A) or 28 days (Vaccine B) between doses.  

    It’s easy to see from the CDC’s initial plans that simply creating the vaccine isn’t enough to end the pandemic. Local, state, and federal government agencies must work together to organize efficient distribution and storage. 

    “Given the challenging storage, handling, and administration requirements,” the CDC says, “early vaccination should focus on administration sites that can reach prioritized populations with as much throughput as possible.” 

    Sources

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