Margaret Foster Riley on the Pandemic Plan: Operation Warp Speed

Margaret Riley has written and presented extensively about health care law, biomedical research, genetics, reproductive technologies, stem cell research, animal biotechnology, health disparities and chronic disease
Margaret Foster Riley has written and presented extensively about health care law, biomedical research, genetics, reproductive technologies, stem cell research, animal biotechnology, health disparities and chronic disease.

With Covid-19 cases rising rapidly amid a stonewalled transition, president-elect Biden’s warning that many more people may die if the Trump administration fails to share information and begin a coordinated response is not hyperbole. The virus is exploding everywhere, and many states still have no coordinated response.

As hospitals fill, reluctant Republican governors are finally issuing mask mandates; but the iron laws of exponential growth may mean those mandates come too late to save thousands of people. Even so, some states steadfastly refuse to undertake any response at all.

The one piece of good news, and it is very good news, is that not just one but two vaccines have demonstrated high efficacy and may soon get emergency-use approval. Others may follow. But approvals do nothing unless there is a comprehensive and viable plan for distribution and access. Delays and missteps could mean that many more people will needlessly die. A badly botched rollout could mean that the United States will be unable to achieve herd immunity, and that could hamper recovery for years.

There is much confusion about the Trump administration’s vaccine development program “Operation Warp Speed.” Much of that confusion is baked in—by using private intermediaries, the Trump administration created an opaque process where costs and plans are either hidden or incomplete.

We do know that Operation Warp Speed provided funding for the development and purchase of Moderna’s mRNA vaccine. That no doubt has allowed Moderna, a relatively small company, to ramp up its manufacturing processes in the United States more quickly and likely helped with clinical trial costs.

Pfizer did not take U.S. funding for the research and development costs for its mRNA vaccine, but it does have a contract with the United States to provide 100 million doses. Neither Pfizer nor Moderna have exclusive contracts with the United States; both companies have significant contracts with other countries and are working to develop manufacturing capacity worldwide.

What the United States seems to have bought with its billions of dollars is earlier access: Both companies project that they could produce enough vaccine for 35 million people in 2020; with luck and money, that will expand to 1 billion people through 2021. That may mean that enough vaccine for about 20 million people is available in the United States by the end of the year.

Operation Warp Speed seems to play an important role in distribution. Both vaccines have complicated storage and transport requirements. Pfizer’s has requirements that are out of reach for many health-care facilities under current conditions. The use of military logistics power and experience will likely solve some of those issues and get the vaccines more readily to the states.

But the responsibility to get the vaccine to individuals and the choices about access and timing of access are in the hands of the states. For this aspect of the process, the Trump administration has signaled a diminished role for the federal government. The incoming Biden administration has stated a desire for a larger footprint, but it is hampered by the fact that the Trump administration has refused to share any information about the planned distribution.

The CDC has provided guidelines with three phases that move on as supplies increase. The CDC’s “playbook” recommends prioritizing health care workers in early distribution, then moving on to particularly vulnerable populations and essential workers, and only going to the general population as vaccine supplies become readily available.

The CDC approach leaves the details of those definitions to the states, whom it has asked to provide plans for distribution as well as capacity and workforce projections. One thing that does seem clear is that the initial distribution will not include children. Pfizer and Moderna got permission to add children above 12 years of age to their clinical trials in October; any emergency-use approval issued in 2020 will likely not include children.

The preliminary plans submitted by the states to CDC demonstrate a wide variation of preparedness. Many lack necessary data about provider capacity, have only begun to plan for immunization registries, and have nonexistent or poorly developed communication plans.

In particular, many states are lacking a strategy for racial/ethnic minorities or vulnerable populations. In addition, although it is clear that there is rampant incorrect data spreading about these vaccines, only about a third of the states have plans to counter misinformation.

Many states are waiting for more facts from the federal government before finalizing any plans. For example, there is evidence that the Trump administration is hoping to provide vaccines directly to some providers in the states, but the states do not have full details. In addition, it is not clear whether all of the states will have equal access to the vaccine available in 2020—and if not, how states will be prioritized.

All states report funding issues. To date, only about $200 million has been provided to states for vaccine preparedness. It is estimated that $6 to $8 billion is needed.

Unfortunately, there is significant evidence that the current distribution preparedness ignores lessons learned from past vaccination efforts. Covid-19 strikes minority, ethnic, and socio-economically vulnerable populations disproportionately. But there are only limited plans to focus outreach to those populations.

We learned the cost of that failure to focus in 2009 with the H1N1 epidemic. Not providing equitable distribution was not only unjust, it hampered economic recovery. In fighting this virus, we are only as strong as the help we provide to the poorest among us.

Garrett Hall at Sunset

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