Enlarge /. A sign at the entrance to a pharmacy reads "Covid-19 Vaccine Not Yet Available" November 23, 2020 in Burbank, California.
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Individual states will ultimately decide who will receive the first 6.4 million doses of COVID-19 vaccine, distributed based on the population of each state, rather than the spread of the disease or the number of people at high risk.
The approach, announced in a press conference on Tuesday, deviates from previous plans and reflects frantic efforts to vaccinate a country of nearly 330 million people as soon as possible.
Top officials from Operation Warp Speed - the federal government's program to rapidly develop and deliver COVID-19 vaccines and therapies – said at the briefing that the current approach is to "keep this simple". However, the potential for state differences in early access to vaccines could easily get complicated – and it is time states clarified their distribution plans. It only takes a few weeks for the Food and Drug Administration to issue emergency approval for a vaccine from Pfizer and BioNTech.
Last week Pfizer and BioNTech announced their mRNA vaccine was 95 percent effective against symptomatic COVID-19 in their 43,000-part clinical trial – and on Friday, the companies filed an application with the FDA for emergency approval ( EUA). The FDA is currently reviewing the application and will hold a public meeting with its Advisory Committee on Vaccines and Related Biological Products on December 10th to discuss possible approval.
Federal and state officials, corporations, and private partners all operate under the expectation that the FDA will grant this approval. In this case, the federal government plans to start distributing the vaccine within 24 hours of the EEA appeal. The challenge now is to figure out how this initial supply can be distributed – between and within states.
There are numerous panels of experts who have published recommendations and guidelines for the distribution of COVID-19 vaccines, including panels of experts for the National Academies of Medicine and the World Health Organization. The body traditionally entrusted with this role – and which has been making recommendations on vaccination policy for decades – is the Advisory Committee on Immunization Practices (ACIP), a body made up of the Centers for Disease Control and Prevention.
Broadly, all panels of experts recommend starting vaccine distribution with the groups at greatest risk, including frontline health workers, the elderly and nursing home residents. However, the initial batch of 6.4 million vaccine doses – if the Pfizer / BioNTech vaccine receives an EEA – is insufficient to cover even the selected high-risk groups, so more detailed prioritization plans are required.
ACIP has generally suggested that assignment to states be based on the risk groups in them. In a meeting on Monday, the committee set the framework for the clients who guide their specific prioritization recommendations for risk groups. However, ACIP does not plan to finalize these recommendations until the FDA actually issues the EEA.
Operation Warp Speed officials had previously suggested waiting for ACIP recommendations before calling on government allocations and prioritization recommendations. But that apparently changed late Friday night.
"We pressed the button at 11.35 pm," said General Gustave Perna, Head of Logistics at Operation Warp Speed, at the press conference on Tuesday. "I finally made the decision on Friday night – late Friday night – to crack the chalk line so that states could prioritize based on the amount of vaccine they were assigned, which is based on population size."
state of things
Once these per capita allocations are received, states will have to decide for themselves how the starting doses will be divided among the people in the highest priority groups.
It is up to the federal government to make recommendations for prioritization, said Minister of Health and Human Services Alex Azar at the briefing, but “it will be (up to) our nation's governors in the implementation of the distribution plans to tell us where to ship to (vaccine doses) and they decide who the vaccine will be given to. We hope our recommendations carry weight, but at the end of the day this is the decision you will make. "
Azar went on to say that Operation Warp Speed is not waiting for the final ACIP prioritization recommendations to come up with its own guidance for states. They take on recommendations from all the bodies and the first recommendations from the ACIP, he said.
"We are working rapidly to formulate our recommended prioritization for vaccine distribution based on where we can get the maximum impact at this point in time under the current epidemiological circumstances in the US," said Azar.
Although some states have already signaled that they will distribute vaccines in accordance with the ACIP's final guidelines, Azar noted that vaccine allocations for each state will continue to be on a per capita rather than a risk basis. He stressed that this was meant to keep things simple and consistent.
Aside from who will be vaccinated, Pfizer is concerned with how. The company has conducted "dry runs" of vaccine dispensing and practiced with vaccine vendors how to unpack, store and handle vaccine doses once they arrive. In the first few exercises, dealers showed some "initial hesitation," said Perna, but they became more familiar with the protocols and helped Pfizer refine the training methods.
The distribution of the Pfizer / BioNTech vaccine was a cause for concern as it requires ultra-cold storage conditions of -70 degrees Celsius. Pfizer has worked to address the concerns, however, highlighting the cold chain infrastructure already in place and shipping containers with GPS enabled thermal sensors to track location and temperature. Currently, the dry runs for vaccine distribution do not contain the dry ice necessary to maintain the extreme storage temperature during shipping. According to the Washington Post, Pfizer will begin test shipping with dry ice in the coming weeks.