The U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) issued a Wednesday morning release consisting of two documents that outline the Trump Administration’s detailed strategy to deliver safe and effective COVID-19 vaccine doses to the American people as quickly and reliably as possible.

The documents, developed by HHS in coordination with DoD and the Centers for Disease Control and Prevention (CDC), provide a strategic distribution overview along with an interim playbook for state, tribal, territorial, and local public health programs and their partners on how to plan and operationalize a vaccination response to COVID-19 within their respective jurisdictions.

“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,” said HHS Secretary Alex Azar. “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.”

“They want to make sure that a vaccine is safe, that it’s effective, and that it’s rolled out correctly. Right, because we have to be able to get the vaccine in order to benefit from the safety and the effectiveness,” Dr. Catherine O’Neal with Our Lady of the Lake Regional Medical Center in Baton Rouge said.

The strategic overview lays out four tasks necessary for the COVID-19 vaccine program:

• Engage with state, tribal, territorial, and local partners, other stakeholders, and the public to communicate public health information around the vaccine and promote vaccine confidence and uptake.

• Distribute vaccines immediately upon granting of Emergency Use Authorization/ Biologics License Application and once CDC has made vaccine recommendations, using a transparently developed, phased allocation methodology.

• Ensure safe administration of the vaccine and availability of administration supplies.

• Monitor necessary data from the vaccination program through an information technology (IT) system capable of supporting and tracking distribution, administration, and other necessary data.

On August 14, CDC executed an existing contract option with McKesson Corporation to support vaccine distribution. The company also distributed the H1N1 vaccine during the H1N1 pandemic in 2009-2010. The current contract with McKesson, awarded as part of a competitive bidding process in 2016, includes an option for the distribution of vaccines in the event of a pandemic.

“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,” said CDC Director Robert Redfield. “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.”

Detailed planning is ongoing to ensure rapid distribution as soon as the FDA authorizes or approves a COVID-19 vaccine and CDC makes recommendations for who should receive initial doses.

“We saw that same sort of action come in to play in h1n1. It was not flu season when H1N1 got to this country and started to really show its face and become a problem. We knew that two vaccines would be needed for anybody who had not been vaccinated before for H1N1,” O’Neal said.

Once these decisions are made, McKesson will work under CDC’s guidance, with logistical support from DoD, to ship COVID-19 vaccines to administration sites.

“The Department of Defense is uniquely positioned to help guide the OWS distribution strategy due to its vast logistical experience,” said General Gustave Perna. “Americans can trust that our country’s best public health and logistics experts are working together to get a vaccine to them as soon as available.”

O’Neal says she is confident that the U.S. will be able to effectively distribute and administer a vaccine very soon, but says more data is needed to determine which vaccines are the most effective at killing the virus and which are safe.

“The implementation of that is something we’ve done before and I feel like we can do again. We’re waiting for the advisory committee on vaccines to give their final recommendations on who should get the vaccine first. And once we have that information we’ll be able to roll it out I think what we’re really waiting on is a safe and efficacious vaccine and until we see that data we’re still sort of waiting for the plan to be released,” O’Neal said.

CDC Director Dr. Robert Redfield told lawmakers in Washington on Wednesday that a vaccine should be available for “November or December” but the supply will be “limited” and “prioritized” based on the advisory committee on vaccines’ recommendations. He said that the general public should have access to it by “late second quarter, (or) third quarter of 2021.”

About Operation Warp Speed:

OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

About HHS & CDC:

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. To learn more about federal support for the nationwide COVID-19 response, visit coronavirus.gov.

CDC works 24/7 protecting America’s health, safety and security. Whether disease start at home or abroad, are curable or preventable, chronic or acute, or from human activity or deliberate attack, CDC responds to America’s most pressing health threats. CDC is headquartered in Atlanta and has experts located throughout the United States and the world.

About DoD:

The Department of Defense’s enduring mission is to provide combat-credible military forces needed to deter war and protect the security of our nation. The Department provides a lethal and effective Joint Force that, combined with our network of allies and partners, sustains American influence and advances shared security and prosperity.