Health officials prepare to distribute COVID-19 vaccine within 24 hours of FDA nod

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Health officials prepare to distribute COVID-19 vaccine within 24 hours of FDA nod

By Sandra Levy - 09/16/2020

The U.S. government plans to transport a coronavirus vaccine to distribution sites across the United States within 24 hours after the Food and Drug Administration grants an emergency authorization or approval, senior administration officials said Wednesday, according to a CNBC report.

The government will use McKesson as its main distributor for the vaccine, said Paul Ostrowski, who is overseeing logistics for the Trump administration’s Covid-19 vaccine program Operation Warp Speed. During a press call with reporters, Ostrowski said, “We will move [the vaccine] as fast as possible within a day or so.”

The Centers for Disease Control and Prevention outlined a sweeping plan Wednesday to make vaccines for COVID-19 available for free to all Americans. In the plan, the CDC said it anticipates a coronavirus vaccine will initially be granted an emergency use authorization before a full formal approval.

Much of the guidance, but not all, described in the plan will overlap with many routine activities for immunizations and pandemic influenza planning, CDC director Robert Redfield said on the same call, according to the CNBC report.

Redfield said the plan will be updated as new information becomes available, including COVID-19 vaccine use in pregnant women and in pediatric populations. He said the vaccine will initially be very limited and will likely go to those most in need, such as health-care workers.

When larger quantities of vaccine become available, the CDC said there will be two simultaneous objectives: to provide widespread access to vaccination and to ensure high uptake in target populations, particularly those who are at high risk of death or complications from Covid-19.

“The CDC’s goal is to have enough Covid-19 vaccine for all in the United States who wish to be vaccinated,” Redfield said.

Earlier this month, the National Academies of Sciences, Engineering, and Medicine released a draft proposal for distributing a vaccine in the United States if and when one is approved for public use. The report was requested by the National Institutes of Health and the CDC.

The vaccine would be distributed in four phases, with health-care workers, the elderly and people with underlying health conditions getting vaccinated first, according to the group. Essential workers, teachers and people in homeless shelters as well as people in prisons would be next on the list, followed by children and young adults.

The comments came a day after President Trump said a vaccine against the coronavirus could be three or four weeks away, a much more optimistic estimate than from his own health officials.

Anthony Fauci, the nation’s leading infectious disease expert, has said it’s “conceivable” but unlikely the U.S. will have a safe and effective vaccine by October.

Pfizer CEO Albert Bourla told CBS’ “Face the Nation” Sunday that a vaccine could be distributed to Americans before the end of the year. He also said that the company should have key data from its late-stage trial for the FDA by the end of October. If the FDA approves the vaccine, the company is prepared to distribute “hundreds of thousands of doses,” he said.

There could be several vaccines from different manufacturers approved and available, the CDC said in its plan today. Many of the vaccines will require two doses at varying intervals that will need to come from the same drugmaker.

If necessary, the government’s McKesson contract can cover rapid distribution of vaccine doses that need to be kept at cold temperatures, the CDC said. Some of the vaccines in development must be stored in very low temperatures, officials have warned.  Pfizer’s vaccine, for example, requires freezers that can store it at approximately 94 degrees below zero.

The U.S. government will determine the amount of vaccine designated to each state or region. The states will then be responsible for managing and approving orders from enrolled providers within their jurisdiction using this allotment, the CDC said. Supplies, such as needles and syringes, will be automatically ordered in amounts to match vaccine orders.

Americans will not be charged for the vaccine or its distribution, the CDC said. Additionally, various plans, supported by the CARES Act and the Families First Coronavirus Response Act, are under development to ensure no American will be charged out-of-pocket expenses for the administration of the vaccine, the agency said.

Commenting on the announcement of a rapid distribution of a vaccine when it is approved, The National Community Pharmacists Association CEO Doug Hoey, said, We’re pleased that this plan acknowledges and looks to utilize the essential nature of community pharmacies when rolling out coronavirus vaccine administration plans. Millions of patients, in particular those in rural and medically underserved areas, rely on community pharmacies. Including these neighborhood pharmacies in addition to chain drugstores will be critical if any pandemic immunization plan is to be successful, a point we have made repeatedly to federal policymakers and to state leaders as well.

“As we approach the day when coronavirus vaccines may be administered, much work remains logistically and in terms of addressing reported vaccine hesitancy issues. Being such trusted health care providers, community pharmacists will play a key role in countering concerns and advocating for patients to utilize the safe, effective vaccines when available. NCPA will continue working to advocate for independent pharmacies’ participation in COVID-19 immunization plans for the communities that they serve,” Hoey added.

The American Society of Health-System Pharmacists vice president of government relations Tom Kraus, said, “ASHP applauds HHS, CDC, and DoD for communicating its vaccine distribution strategy well in advance of the availability of any vaccine. Pharmacists and pharmacies are part of the critical infrastructure necessary for a successful COVID-19 vaccine strategy, and we are pleased to see that reflected in the strategy along with its emphasis on collaboration with state and local public health partners and the focus on utilizing pharmacists to speed vaccine delivery.”

Kraus continued, “We are also encouraged that many of the themes in the documents released today reflect priorities outlined in ASHP’s COVID-19 Vaccine Principles. We look forward to continuing to work with agencies to ensure a successful and equitable mass immunization campaign.”