The Trump administration today released a plan to distribute an eventual COVID-19 vaccine free of charge, initially to targeted groups and more broadly as supply increases.
The government is planning a phased distribution using a contract awarded to McKesson in August. The first recipients could include:
- Healthcare personnel likely to be exposed to or treat people with COVID-19.
- People at increased risk for severe illness from COVID-19, including those with underlying medical conditions and people 65 years of age and older.
- Other essential workers.
Final decisions will depend in part on the proven efficacy of the vaccines coming out of Phase 3 trials, according to an interim vaccine distribution “playbook” released today along with a distribution strategy document.
The playbook was written for state, tribal, territorial, and local public health programs and their partners on how to plan and execute a vaccination program within their respective jurisdictions.
Phase 1 would begin upon FDA authorization or approval of a vaccine. Federal officials are planning for distribution and administration to focused populations and have given state and local health departments specific scenarios to plan for during this stage.
In Phase 2, distribution would expand to the larger population as more vaccine doses become available. Phase 3 would make COVID-19 vaccines universally available and integrated into routine public and private vaccination programs if the need persists.
Under this centralized plan, the government said it will adjust the distribution methodology based on experience from COVID-19, real-time data on the virus and its impact on populations, performance of each vaccine, and the ongoing needs of the essential workforce.
“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 in a news release. “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.”
A multi-agency federal team has worked with five pilot jurisdictions — California, Florida, Minnesota, North Dakota and Philadelphia — to use the federal distribution plan to create jurisdiction-specific plans that will serve as models for other parts of the country. Each jurisdiction will be required to develop a “microplan” to identify vaccination sites and logistics.
“Centralized distribution allows the government full visibility, control, and ability to shift assets and use data to optimize vaccine uptake,” the agencies said in the strategy document. “Various plans, supported by the CARES Act and the Families First Coronavirus Response Act, are under development with the objective of ensuring no one will be charged any out-of-pocket expenses for the administration of the vaccine.”
The plans also provide for federal, state, local and tribal government data monitoring to:
- Incorporate claims and payment processes.
- Identify when a person needs a potential second dose.
- Monitor outcomes and adverse events.
- Account for products that the federal government is spending billions of dollars to research, develop and produce.
Long-term safety of these vaccines will be assessed using pharmacovigilance surveillance and post-licensure clinical trials, according to the agencies. But first, they have to convince the public to be vaccinated.
“Identifying the right messages to promote vaccine confidence, countering misinformation and targeting outreach to vulnerable and at-risk populations will be necessary to achieve high coverage,” the agencies said. “CDC will build on its existing relationships with local public health partners and health departments to effectively implement communications, and CDC is also working to develop innovative approaches to improve vaccine uptake among hard-to-reach critical populations.”
The vaccination program should be a boon to parts of the medtech industry. The agencies said they plan to procure and assemble 6.6 million ancillary supply kits, including pediatric, adult and mixed-use kits to enable administration of 660 million doses of vaccine. These kits will include needles, syringes, alcohol pads, vaccination cards and limited personal protective equipment for vaccinators.
The Biomedical Advanced Research and Development Authority (BARDA) has awarded four
large task orders for needles and syringes, including a $42 million contract executed in July with Becton Dickinson (NYSE:BDX).
“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 in the news release. “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.”