Policy & Regulation News

HHS, DoD Release COVID-19 Vaccine Distribution Strategy

The two documents provide an overview for state, tribal, territorial, and local public health programs on how to plan and operationalize a COVID-19 vaccine distribution strategy.

Vaccine Distribution

Source: Thinkstock

By Samantha McGrail

- HHS and the Department of Defense (DoD) released two documents Wednesday outlining the Trump Administration’s COVID-19 vaccine distribution strategy.

The documents provide four necessary tasks to guide public health programs on how to strategically plan and operationalize a vaccination response to COVID-19, HHS stated.

“As part of Operation Warp Speed, we have been laying the groundwork for months to distribute and administer a safe and effective COVID-19 vaccine as soon as it meets FDA’s gold standard,” HHS Secretary Alex Azar, said in the announcement. 

“This in-depth, round-the-clock planning work with our state and local partners and trusted community organizations, especially through CDC, will ensure that Americans can receive a safe and effective vaccine in record time.”

The first task is to engage with state, tribal, territorial, local, stakeholders, and the general public to communicate information around the vaccine and promote vaccine confidence and uptake.

The second task mentioned in the strategy is to distribute vaccines immediately upon emergency use authorization or biologics application from FDA, using a transparently developed, phased allocation methodology and CDC vaccine recommendations.

The third task is to ensure safe administration of the vaccine and availability of administration supplies.

And finally, the fourth task is to monitor necessary data from the vaccination program through an IT system capable of supporting and tracking distribution, administration, and other data.

“CDC is drawing on its years of planning and cooperation with state and local public health partners to ensure a safe, effective, and life-saving COVID-19 vaccine is ready to be distributed following FDA approval,”  CDC Director Robert Redfield said in the announcemnet. 

“Through the Advisory Committee on Immunization Practices, CDC will play a vital role in deciding, based on input from experts and stakeholders, how initial, limited vaccine doses will be allocated and distributed while reliably producing more than 100 million doses by January 2021.”

Once FDA authorizes a COVID-19 vaccine and CDC makes recommendations on what groups will be prioritized when receiving the vaccine, McKesson will work under CDC’s guidance, with support from DoD, to ship the COVID-19 vaccines to administration sites, HHS said.

On August 14, CDC tapped McKesson Corporation to be a central distributor of future COVID-19 vaccines and related supplies needed to administer the drug.

From 2009 to 2010, McKesson distributed the H1N1 vaccine during the H1N1 pandemic. The current contract with McKesson also included an option for the distribution of vaccines in the event of a pandemic.

“The Department of Defense is using its world-class logistical expertise to plan for distributing a safe and effective vaccine at warp speed,” said General Gustave Perna. “Americans can trust that our country’s best public health and logistics experts are working together to get them vaccines safely as soon as possible.”

HHS has worked continuously through the pandemic to enhance the safety, efficiency, and distribution of COVID-19 vaccines.

Just last week, HHS issued guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand access to safe and effective COVID-19 vaccines when they become available. 

The guidance authorizes state-licensed pharmacists to order and administer COVID-19 vaccinations to individuals three years of age and older, subject to specific requirements. 

The requirements include that the vaccine must be FDA-authorized and ordered and administered according to the Advisory Committee on Immunization Practices COVID-19 vaccine recommendations.