What You Should Know About Vaccine Distribution
Distribution of the successful vaccines will be a huge challenge. And the FDA must grant an Emergency Use Authorization (EUA) for each vaccine, when the application is filed by the company, before distribution can begin. The Pfizer application is first reviewed by an independent advisory group, the Vaccine and Related Biologic Products Advisory Committee (VRBPAC) on Dec. 10th. Members of the committee are drawn from academia, research and clinical practice. The hearings will be televised on Dec. 10th.
The VRBPAC can recommend approval of the vaccine, or request more information from the company. The FDA then makes a final decision, based on the advice from their FDA career scientists and the VRBPAC.
Once approved, the vaccine distribution plans can begin. The CDC is in charge of distribution and they have broad recommendations from the National Academies of Sciences, Engineering, and Medicine, who established 4 phases of vaccination beginning with health care workers. The vaccines will be distributed directly to the states and territories. The states then need to determine who and how they can immunize the first target group. State governors have been complaining that they need funds to support the vast organization that will be needed for storage, personnel training, and scheduling the immunizations, and it is not clear that the current gov't is planning to release these additional funds as quickly as necessary. It is a two dose vaccine and patients will need to be scheduled for the 2nd dose in 3 weeks - which requires careful planning, documentation. and availability of the 2nd dose. The Pfizer vaccine needs to be maintained at -94 degrees Fahrenheit imposing additional limitations in each state until they each develop their own systems. Some states are purchasing ultra-cold freezers for large storage and distribution sites, others will rely on dry ice pellets which the vaccine is packed in for shipment from Pfizer. Read Below
This initial distribution will occur at a time when a new government administration is taking over, including state governors, and there is a surge in cases, and a record number of deaths. Health care workers are already having difficulty with the increase in hospitalizations. The US government may be given 20 million doses of the Pfizer vaccine in 2020, for 10 million health care workers (2 doses each) to be divided among the states and territories based on population. We can only hope this phase of the Pfizer vaccine trial will go smoothly.
I just scanned an Oct 30th 15 page CDC document of information re: vaccine distribution. It was a series of answers to questions raised by the state governors and answered by the Dept. of Health and Human Services. Each state was supposed to develop plans in October.