Indications are that vaccines to immunize against COVID-19 will soon be available. Given that the virus first emerged little more than a year ago—and that in the past a new vaccine might have taken a decade to develop, test, and mass produce—that is an amazing achievement. But now that mass vaccination is on the horizon, state and federal policymakers need to quickly complete their preparations for the coming logistical challenges.
While the availability of vaccines will not put an end to COVID-19, it will mark a turning point in making COVID-19 a much more manageable, and far less socially disruptive, infection.REF
Private and Public Action towards the Vaccine
The imminent success of COVID vaccine development was the result of private biomedical companies applying knowledge accumulated from years of leading-edge research to meet the new threat, complemented by the federal government facilitating and supporting their efforts.
For over two decades, scientists have been working to translate advances in genomics into the development of new and better vaccines, not only to counter viral pathogens but also to treat cancer and other diseases. Serendipitously, those efforts were approaching fruition just as COVID-19 emerged. Consequently, a number of biotech companies were well positioned to quickly shift to addressing the new threat.
Indeed, two of the COVID-19 vaccine candidates that have so far advanced the furthest in clinical trials—those developed by Moderna and BioNTech (in collaboration with Pfizer)—are prime examples. Both Moderna and BioNTech were founded to develop innovative therapies derived from insights into how “messenger RNA” (mRNA) could be used to trigger the body’s immune responses.REF Prior to the emergence of COVID-19, both companies were already engaged in far more difficult efforts to develop mRNA vaccines for cancers, and thus were well positioned to pivot to addressing the new threat posed by COVID-19.REF
That base of knowledge and experience enabled researchers in those, and other companies, to develop and begin testing potential COVID-19 vaccines within only a few months—a timeline far shorter than for previous vaccine development that relied on older approaches and technologies.
Furthermore, the new technologies enable companies not only to develop vaccines faster but to also more rapidly mass produce them.REF
The federal government responded to the challenge as well. Crucially, both biomedical companies and federal officials recognized early on that the key to speeding up the effort was to “parallel process” whenever and wherever possible, meaning processes that would normally take place sequentially were pursued simultaneously. For instance:
- A number of different companies simultaneously pursued a variety of different development strategies and technologies.
- The FDA issued detailed guidance for vaccine developers on the data and standards that the agency would need for evaluating candidate vaccines.
- Companies built out large-scale manufacturing capacity in advance.
- Both companies and the government contracted for necessary production supplies while vaccines were still in development.
This approach enabled companies and government officials to significantly shorten the time it normally takes to get a new vaccine to market.
In March, Congress appropriated substantial funding for the development and acquisition of COVID-19 vaccines and other counter-measures.REF The Trump Administration subsequently launched its “Operation Warp Speed” initiative to coordinate the federal government’s support of COVID-19 vaccine and therapeutic development. The Administration used the funding appropriated by Congress to provide grants for research and development and to purchase successful vaccines and related supplies such as vials and syringes.REF
Particularly important was the federal government contracting in advance to purchase large quantities of vaccines if they proved to be safe and effective. Such pre-production purchase orders enabled vaccine makers to build out substantial manufacturing capacity in advance of clinical trials.REF
Meeting the Inoculation Challenge
With it now likely that several promising vaccines will soon be available, the focus is shifting from development and production to distribution. Those efforts are already well underway, but more remains to be done.
In recent months federal officials have leveraged the existing private-sector distribution system. Notably:
- In August federal officials exercised an option in the government’s most recent (2016) contract with McKesson, a major drug wholesaler and distributor, to have that company manage the process of transporting COVID-19 vaccines and related supplies from manufacturers to the sites where vaccines will be administered.REF
- In October federal officials entered into agreements with two major pharmacy chains—CVS and Walgreens—to offer long-term care facilities onsite administration of COVID-19 vaccines to residents and staff.REF
- More broadly, the Centers for Disease Control and Prevention (CDC) has also entered into partnership agreements with major retail pharmacy chains and independent pharmacies to receive and administer COVID-19 vaccines.REF
State and local health officials will also play crucial roles in implementing COVID-19 vaccination efforts. States, not the federal government, regulate health professionals, medical facilities, and congregate living facilities for vulnerable populations such as the elderly, the developmentally disabled, the homeless, and migrant workers. State officials will also need to make decisions about numerous details, such as:
- Which ancillary health providers will be permitted to administer vaccines;
- Whether vaccinations will be offered at community centers, schools, or other designated places; and
- Whether mobile vaccination units will be deployed to reach specific populations.
To inform those efforts, federal officials engaged the National Academies of Sciences, Engineering, and Medicine to develop recommended vaccination priorities and strategies to guide planning by state and local public health officials.REF The CDC also solicited from the states their plans for prioritizing and managing vaccinations.
Once vaccines become available, the focus will shift to how state and local health officials implement their vaccination plans. To prepare for that next phase, policymakers should now do the following:
- Address any remaining gaps in their plans and infrastructure. Some states’ implementation plans are still “works in progress.”REF For example, a number of states are still working on their systems for registering and communicating with vaccinated patients.REF Those systems are important because the vaccines will most likely require two shots, so providers will need to contact patients and schedule them to receive their second doses. Further, returning patients will need to receive the booster shot for the same vaccine that they originally received.
- Better communicate state vaccination plans. The CDC has posted executive summaries of the various state vaccination plans, but they are difficult to locate on the agency’s website.REF Researchers at the Kaiser Family Foundation obtained the full plans directly from almost all the states.REF Federal officials should more prominently post the full state plans and update them as necessary.
- Provide the general public with actionable information and guidance on vaccinations. Much of the information in state plans addresses operational, logistical, and administrative issues that are relevant mainly to health care providers. However, what is most relevant to the general public is the who, where, and when of vaccinations in their areas. State officials should begin posting the population subsets that will be prioritized for vaccination as well as vaccination locations as arrangements with providers are confirmed, and update the information as they get confirmed schedules for the timing of vaccine shipments.
Congress should consider appropriating supplemental funding for state vaccination efforts. Providing widespread and rapid vaccination against COVID-19 will require additional personnel and resources. Congress should inquire as to whether additional, temporary, targeted funds are needed to support state efforts. These funds can be appropriated directly to the CDC, which already administers federal grants to states to support vaccinations and other public health initiatives.REF
Thanks to private biomedical companies applying the latest science, augmented by federal government support and partnerships, the goal of making safe and effective COVID-19 vaccines available is now within sight—and far sooner than almost anyone thought possible just a year ago.
As the focus shifts from developing effective vaccines to large-scale inoculation, policymakers at all levels of government should take helpful steps in this next phase of the response.
Edmund F. Haislmaier is Preston A. Wells, Jr. Senior Research Fellow in Domestic Policy Studies, of the Institute for Family, Community, and Opportunity, at The Heritage Foundation.