With the number of COVID-19 cases in the United States hitting new records each day, the importance of developing a vaccine is clearer than ever. A safe, effective, and widely available vaccine is necessary to protect lives, restore our economy, and enable everyone to get back to a sense of normalcy. There are currently more than 155 possible vaccines being developed globally with 23 currently in human trials.1 Congress has appropriated nearly $10 billion to fund vaccine efforts, and the administration has established Operation Warp Speed (OWS) to coordinate and finance vaccine2 research with the goal of having 300 million doses of a safe, effective vaccine for COVID-19 by January 2021. As part of this effort, OWS has awarded almost $4 billion to six pharmaceutical companies working on a vaccine and recently signed a contract with Pfizer and a German biotechnology company to pay $1.95 billion for 500 million doses of their vaccine if it proves safe and effective.3
Several vaccine candidates have demonstrated promising safety and efficacy results in small studies. This summer and fall they will be tested in phase 3 clinical trials, meaning that thousands of volunteers, reflective of the general population, will receive a vaccine to further assess safety and effectiveness. The Food and Drug Administration has stated that any vaccine candidate would need to be at least 50% more effective than placebo in preventing COVID-19 prior to receiving approval.4
These are the first steps. To successfully combat this virus, policymakers will need to establish a comprehensive national COVID-19 vaccine plan that considers the necessary steps for each of these components: 1) vaccine development (safety and efficacy); 2) production; 3) distribution and prioritization; 4) cost; and 5) public education. There is bipartisan support for such an effort. As the work on this front continues, Congress and the administration should take the following insights into consideration:
Vaccine Development: Safety and Efficacy:
While everyone feels the urgency of having a vaccine as quickly as possible, it is critical that safety and efficacy trials not be rushed. Under normal circumstances, vaccine development takes 10-15 years5 and even the fastest vaccine developed to date, the mumps vaccine, took four years.6. Typically phase 3 trials take years to complete and test thousands of individuals with the goal of catching adverse events even if they are rare or take time to develop. Yet leading scientists and researchers are talking seriously about developing the COVID-19 vaccine within 12-18 months. But even with the critical need, it is important that the science not be rushed to meet a political deadline. Even in a best-case scenario, vaccinating the broader U.S. population will be a 2021, not 2020, endeavor.
Vaccine production is exacting and expensive. Individual vaccines require specific infrastructure to ensure safety throughout the manufacturing process.7 In addition, given the sheer number of people who will need the vaccine, the production challenges are considerable. To help address some of those challenges, OWS has committed to scaling up production for selected vaccine candidates before safety and efficacy is truly proven.8 There is clearly financial risk with this approach, but building this capacity now will enable us to scale up production of the best vaccine candidates after they are approved.
Vaccine Distribution and Prioritization:
As work continues on developing a safe and effective vaccine or vaccines and preparing to manufacture the billions of needed doses, policymakers need to also be thinking now about how to effectively distribute the vaccine and who should get it first. To successfully lay the groundwork and be prepared to efficiently distribute a COVID-19 vaccine, we encourage a strong focus on the following areas:
- Supplies – We need to invest now to ensure that there are sufficient quantities of the supplies like glass vials and syringes that will be needed to administer a vaccine. As we have seen with COVID-19 testing delays and personal protective equipment shortages, a shortage of seemingly small and simple elements can undermine the entire effort. If it appears that there may be shortages of any critical material, the federal government should move expediently to shore up the supply chain or invoke the Defense Production Act to direct domestic manufacturers to meet the needs.
- A Distribution Plan – There are a number of options for getting the vaccine from the manufacturer to the end user. To decide on the best course for the COVID-19 vaccine, policymakers should request the National Vaccine Advisory Committee offer recommendations on how distribution might work. In addition, The Department of Health and Human Services (HHS) should convene a summit of governors and state and local officials to discuss best practices as former HHS Secretary Mike Leavitt did in preparation for H5N1 avian influenza in 2006 and former HHS Secretary Sylvia Burwell did to address the opioid epidemic in 2015. It is important to start these conversations now so that an efficient system can be in place in order to widely distribute a successful vaccine or vaccines as quickly as possible. It is also important that these efforts take into account existing public health expertise and infrastructure and consider the value of meeting people where they are to administer vaccines.
- Prioritization – Given the limits of our manufacturing capacity, it will take considerable time to make enough vaccine doses to meet national, much less global, demand. That fact requires policy makers to make critical decisions around who will get what vaccine and when. The Centers for Disease Control and Prevention and the National Institutes of Health have tasked the National Academies of Sciences, Engineering, and Medicine and the National Academy of Medicine with the job of developing an overarching framework to assist policymakers in the U.S. and global health communities in planning for equitable allocation of vaccines against COVID-19.9 However, it has traditionally been the role of the Advisory Committee on Immunization Practices to provide recommendations to the CDC on setting vaccination policy.
The administration will need to clarify the roles of each of these entities in helping to make a final decision with respect to vaccine prioritization. In general, we would expect prioritization to build off the approach taken with pandemic flu with the first available doses going to high-risk individuals, health care workers, and other essential personnel, but prioritization will also need to be refined based on the vaccine’s efficacy and epidemiological data. In addition, leaders will need to consider sub-prioritization to determine who will receive a vaccine first if there is not enough within a given tier. This entire process should be transparent and apolitical and the decision-making process should be clear, whether those final decisions are made by HHS or state officials. Policymakers will need to engage in stakeholder outreach and public education so that there is wide-spread understanding about how and why prioritization decisions have been made.
To ensure that a COVID-19 vaccine is widely available, policymakers will need to ensure that it is also affordable. Congress has already taken steps in this direction in the bipartisan CARES Act (H.R. 748). The law included a provision to expedite permanent coverage of a COVID-19 vaccine without cost-sharing as a preventive service for Affordable Care Act-compliant health plans and required Medicare Part B and Medicare Advantage plans to cover the vaccine without cost-sharing beginning on the day that it is approved by the FDA.10 Yet these changes do not guarantee that the vaccine will be affordable for the uninsured, adults in traditional Medicaid if their state doesn’t cover it, or those in private health plans that are not required to cover preventive services.11 Ensuring affordable access to the vaccine for these populations will require a bipartisan solution.
Last year, the World Health Organization named vaccine hesitancy as one of the top threats to global health.12 Even before the COVID-19 pandemic, there was a worrying rise in preventable diseases like measles due to the reluctance to vaccinate. For COVID-19 specifically, a recent Washington Post poll found that less than 50% of adults said that they would definitely get a vaccine, and among black adults the number was only 32% despite the fact that communities of color have been hit much harder by this virus. Overall, 70% of white adults and 78% of Hispanics said they were likely to get the COVID-19 vaccine when available while only 63% of black adults said the same. 13
These numbers are worrying because widespread protection against a virus typically requires that 70-90% of the population needs to be immune – either through vaccination or previously having the illness.14 That is why it will be critical for federal, state, and local public health officials to launch an educational campaign to raise the awareness of the importance of the COVID-19 vaccine, particularly for high risk individuals and underserved communities. This campaign will also need to stress the importance of getting both the flu and COVID-19 vaccines given the danger that co-occurrence of these two viruses could overwhelm our health system.
The campaign should provide transparency about the vaccine development process to assuage concerns about safety due to the rapid development timeline. It should highlight the importance of wide-spread vaccination to returning to normal activities: going to work, visiting grandparents, celebrating life events, and more. Finally, the campaign should be culturally sensitive and, in particular, take seriously the distrust that many in the black community have in the healthcare system.
We are in the midst of one of the greatest trials our country has faced. Rising to this moment and developing a vaccine in record time – years more quickly than previous efforts – is a huge challenge for the scientific community. Successfully manufacturing and distributing a vaccine for 328 million people will be an extraordinary logistical challenge for governments and the private sector. Overcoming fears and distrust to convince vulnerable communities to be vaccinated will also be an immense public health challenge. These are challenges that we must – and can – face, but to be successful, we need to start now.