July ended with three positive developments on the coronavirus vaccine front:
- On the 20, the results from a Phase II trial of a vaccine candidate being developed by AstraZeneca and Oxford University were published. Researchers found that the vaccine has significant positive effects and “no serious adverse events.” Phase II trials (first in humans) are limited to healthy adults (age eighteen to fifty-five). Based on these favorable findings, that vaccine candidate will next go into Phase III trials, which will test it on “older age groups with comorbidities, health-care workers, and those with higher risk for SARS-CoV-2 exposure.”
- On the 22, Pfizer and BioNTech announced that the U.S. government has placed an order to purchase 100 million doses of another promising coronavirus vaccine they are developing. At the beginning of July, those companies reported positive results from the initial trials of that vaccine. The contract is contingent on the vaccine successfully completing Phase III clinical trials and being granted FDA authorization. Under the agreement, the government will pay $1.95 billion ($19.50 per dose), and has the option to purchase up to 500 million additional units.
- On the 24, a new committee organized by the National Academies of Sciences, Engineering, and Medicine and the National Academy of Medicine held its first meeting to begin work on developing “an overarching framework for vaccine allocation.” This joint effort was requested by the National Institutes of Health and the Centers for Disease Control. The committee's task is to develop recommended vaccination priorities based on a number of considerations including: the degree of individual risk associated with factors such as age, underlying health conditions, occupation, and living arrangements; the geographic distribution of active virus spread, and access to health services.
The contract for the Pfizer/BioNTech vaccine is significant because pre-production purchase orders give a company greater clarity into expected product demand. That enables the company to be more confident in building-out its manufacturing capacity and in entering into its own contracts with suppliers to acquire any necessary ingredients, components, or functions. Indeed, pre-production contracting is the quickest and most effective mechanism for ensuring a ramp-up in manufacturing capacity.
The federal government can also contract for quantities of other promising vaccine candidates. And, to the extent that state governments, other countries and the private sector negotiate similar contracts, the companies developing vaccines will have even greater certainty in planning production.
Developing successful vaccines and then mass producing them are the first two challenges. The third challenge will be actually vaccinating the population.
In that regard, the National Academies’ work to develop vaccination priorities is an important first step. Vaccine makers plan to produce hundreds of millions of units within months of one or more vaccines being approved. Yet, even under the most optimistic scenario, it will still take some time for vaccine production to fully meet demand. Consequently, it is important to give both medical providers and the public guidance on “best practices” for prioritizing vaccinations as supplies become available.
Those priorities also will inform the development of plans for vaccination efforts. Those plans will be needed to guide the allocation and distribution of vaccines as quantities become available.
To do that, federal officials will need input from state health officials, who will play a crucial role. It is the states, not the federal government, that regulate medical providers—not only doctors and hospitals but also pharmacies and nursing homes. State public health officials are therefore best positioned to ensure coordination of supplies among medical providers and to design and implement campaigns to promote immunization and efforts to vaccinate priority populations. State officials are also the ones who will need to make the decisions about numerous details—for instance, whether vaccinations will be offered not only at hospitals, clinics and physician offices, or also at retail pharmacies, community centers, schools, or other places, or whether mobile vaccination units will be deployed to reach specific populations.
The federal government should lead that planning effort with two basic initiatives:
Determine the vaccination needs and priorities of programs that provide direct patient care and are either operated or funded by the federal government.
For instance, the federal government operates programs that directly provide patient care to millions of people who are members of the armed services (Department of Defense), veterans (Department of Veterans Affairs), or native Americans (Indian Health Service).
The federal government also provides grant funding, through the Department of Health and Human Services, to nearly 1,400 federally qualified health centers providing primary care services at over 10,000 sites in low-income and underserved areas. HHS should obtain those clinics’ plans and priorities for vaccinating their patients, in order to factor them into plans for allocating and distributing vaccines as quantities become available.
Obtain from state public health authorities their plans for vaccination efforts and outreach campaigns and publicly post those plans.
The federal government collecting and posting state plans (and updating them as states submit additional details or revisions) will enable both medical providers and the public to know what to expect—in their particular locality—when vaccines become available. Doing so will also provide federal officials with information needed for national planning purposes. For instance, in order to coordinate the allocation and distribution of vaccines purchased by the federal government, federal officials will need to know not only each state’s projected total needs, but also the state’s distribution priority sequence and the extent to which the state plans to rely on other, existing supply chains to meet part of its requirements. Having that information will minimize the possibility of distribution issues arising, such as a state not having enough vaccines to immunize its top priority populations, or conversely, a state receiving a larger quantity of vaccines than it can deploy in a timely fashion.
Of course, these two initiatives will also need to be coordinated so that both state and federal officials have clarity about each other’s plans and roles, particularly in places where they are likely to overlap, such as localities with major military bases or areas where a significant portion of the resident population relies on the Indian Health Service for medical care.
The good news is that vaccines for coronavirus might be available sooner than anyone hoped or predicted even a few months ago. If that proves to be the case, it will be a remarkable achievement.
Now, state and federal public health officials need to anticipate that potential success, by accelerating and intensifying vaccination planning, and making their plans public so that Americans know what to expect when vaccines do become available.
This piece originally appeared in The National Interest https://nationalinterest.org/blog/buzz/week-good-news-coronavirus-vaccines-167019